Trial Outcomes & Findings for A Multi-center 12-week Study of HMS5552 in T2DM (NCT NCT02561338)
NCT ID: NCT02561338
Last Updated: 2020-03-10
Results Overview
Assess the percentage of Hemoglobin A1c (HbA1c) changes at week 12. In the group HMS5552 dose3, a subject without follow-up data for HbA1c available was excluded. And in the group HMS5552 dose4, two subjects without follow-up data for HbA1c available were excluded. So the overall number of baseline participants is not consistent with numbers provided in any of the rows in the participant flow module.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
258 participants
Primary outcome timeframe
Baseline and 12 weeks
Results posted on
2020-03-10
Participant Flow
Participant milestones
| Measure |
HMS5552 Dose 1
HMS5552: 75mgQD
|
HMS5552 Dose 2
HMS5552: 100mgQD
|
HMS5552 Dose 3
HMS5552: 50mgBID
|
HMS5552 Dose 4
HMS5552: 75mgBID
|
Placebo
Placebo, BID/QD
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
53
|
50
|
51
|
51
|
53
|
|
Overall Study
COMPLETED
|
45
|
44
|
42
|
46
|
51
|
|
Overall Study
NOT COMPLETED
|
8
|
6
|
9
|
5
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Multi-center 12-week Study of HMS5552 in T2DM
Baseline characteristics by cohort
| Measure |
HMS5552 Dose 1
n=53 Participants
HMS5552: 75mgQD
|
HMS5552 Dose 2
n=50 Participants
HMS5552: 100mgQD
|
HMS5552 Dose 3
n=50 Participants
HMS5552: 50mgBID
|
HMS5552 Dose 4
n=49 Participants
HMS5552: 75mgBID
|
Placebo
n=53 Participants
Placebo: BID/QD
|
Total
n=255 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
57.58 years
STANDARD_DEVIATION 9.159 • n=99 Participants
|
56.7 years
STANDARD_DEVIATION 7.670 • n=107 Participants
|
54.92 years
STANDARD_DEVIATION 8.137 • n=206 Participants
|
55.42 years
STANDARD_DEVIATION 7.659 • n=7 Participants
|
54.73 years
STANDARD_DEVIATION 8.499 • n=31 Participants
|
55.88 years
STANDARD_DEVIATION 8.271 • n=30 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
18 Participants
n=7 Participants
|
22 Participants
n=31 Participants
|
104 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
31 Participants
n=7 Participants
|
31 Participants
n=31 Participants
|
151 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
53 Participants
n=99 Participants
|
50 Participants
n=107 Participants
|
50 Participants
n=206 Participants
|
49 Participants
n=7 Participants
|
53 Participants
n=31 Participants
|
255 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Asian
|
53 Participants
n=99 Participants
|
50 Participants
n=107 Participants
|
50 Participants
n=206 Participants
|
49 Participants
n=7 Participants
|
53 Participants
n=31 Participants
|
255 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Region of Enrollment
China
|
53 participants
n=99 Participants
|
50 participants
n=107 Participants
|
50 participants
n=206 Participants
|
49 participants
n=7 Participants
|
53 participants
n=31 Participants
|
255 participants
n=30 Participants
|
|
HbA1c
|
8.44 percentage of glycated hemoglobin
STANDARD_DEVIATION 0.803 • n=99 Participants
|
8.27 percentage of glycated hemoglobin
STANDARD_DEVIATION 0.639 • n=107 Participants
|
8.33 percentage of glycated hemoglobin
STANDARD_DEVIATION 0.653 • n=206 Participants
|
8.46 percentage of glycated hemoglobin
STANDARD_DEVIATION 0.670 • n=7 Participants
|
8.39 percentage of glycated hemoglobin
STANDARD_DEVIATION 0.780 • n=31 Participants
|
8.38 percentage of glycated hemoglobin
STANDARD_DEVIATION 0.712 • n=30 Participants
|
|
FPG
|
9.933 mmol/L
STANDARD_DEVIATION 2.3356 • n=99 Participants
|
9.127 mmol/L
STANDARD_DEVIATION 1.4868 • n=107 Participants
|
9.390 mmol/L
STANDARD_DEVIATION 1.5317 • n=206 Participants
|
9.859 mmol/L
STANDARD_DEVIATION 1.9902 • n=7 Participants
|
9.277 mmol/L
STANDARD_DEVIATION 1.7608 • n=31 Participants
|
9.518 mmol/L
STANDARD_DEVIATION 1.8663 • n=30 Participants
|
|
2h PPG
|
18.042 mmol/L
STANDARD_DEVIATION 3.3004 • n=99 Participants
|
17.429 mmol/L
STANDARD_DEVIATION 3.2023 • n=107 Participants
|
17.243 mmol/L
STANDARD_DEVIATION 3.0943 • n=206 Participants
|
17.884 mmol/L
STANDARD_DEVIATION 3.1303 • n=7 Participants
|
16.950 mmol/L
STANDARD_DEVIATION 3.7282 • n=31 Participants
|
17.509 mmol/L
STANDARD_DEVIATION 3.3052 • n=30 Participants
|
|
Body Mass Index (BMI) units: kg/m^2
|
24.718 kg/m^2
STANDARD_DEVIATION 2.8672 • n=99 Participants
|
25.010 kg/m^2
STANDARD_DEVIATION 2.9374 • n=107 Participants
|
24.686 kg/m^2
STANDARD_DEVIATION 2.3112 • n=206 Participants
|
25.321 kg/m^2
STANDARD_DEVIATION 2.5419 • n=7 Participants
|
25.188 kg/m^2
STANDARD_DEVIATION 2.6113 • n=31 Participants
|
25.321 kg/m^2
STANDARD_DEVIATION 2.5419 • n=30 Participants
|
|
Diagnosis time
|
3.37 years
STANDARD_DEVIATION 4.053 • n=99 Participants
|
3.24 years
STANDARD_DEVIATION 4.304 • n=107 Participants
|
3.27 years
STANDARD_DEVIATION 4.220 • n=206 Participants
|
2.82 years
STANDARD_DEVIATION 3.230 • n=7 Participants
|
3.41 years
STANDARD_DEVIATION 4.195 • n=31 Participants
|
3.23 years
STANDARD_DEVIATION 3.984 • n=30 Participants
|
PRIMARY outcome
Timeframe: Baseline and 12 weeksAssess the percentage of Hemoglobin A1c (HbA1c) changes at week 12. In the group HMS5552 dose3, a subject without follow-up data for HbA1c available was excluded. And in the group HMS5552 dose4, two subjects without follow-up data for HbA1c available were excluded. So the overall number of baseline participants is not consistent with numbers provided in any of the rows in the participant flow module.
Outcome measures
| Measure |
HMS5552 Dose 1
n=53 Participants
HMS5552: 75mgQD
|
HMS5552 Dose 2
n=50 Participants
HMS5552:100mgQD
|
HMS5552 Dose 3
n=50 Participants
HMS5552: 50mgBID
|
HMS5552 Dose 4
n=49 Participants
HMS5552: 75mgBID
|
Placebo
n=53 Participants
Placebo:BID/QD
|
|---|---|---|---|---|---|
|
After 12-week Treatment, the Change From Baseline in HbA1c
|
-0.39 Percentage of glycated hemoglobin
Interval -0.64 to -0.16
|
-0.65 Percentage of glycated hemoglobin
Interval -0.92 to -0.38
|
-0.79 Percentage of glycated hemoglobin
Interval -1.06 to -0.52
|
-1.12 Percentage of glycated hemoglobin
Interval -1.39 to -0.86
|
-0.35 Percentage of glycated hemoglobin
Interval -0.6 to -0.1
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksUsing a standard meal tolerance test, to assess 2-h postprandial glucose (2hPPG). In this test, subjects were received meals standardised by China National Cereals, which supplied by Oils and Foodstuffs Corporation and contained 353 kcal, 75 g carbohydrate, 1.48 g fat, and 8.0 g protein. Collect the blood samples to detect blood glucose 2 hours after starting the meal.
Outcome measures
| Measure |
HMS5552 Dose 1
n=53 Participants
HMS5552: 75mgQD
|
HMS5552 Dose 2
n=50 Participants
HMS5552:100mgQD
|
HMS5552 Dose 3
n=50 Participants
HMS5552: 50mgBID
|
HMS5552 Dose 4
n=49 Participants
HMS5552: 75mgBID
|
Placebo
n=53 Participants
Placebo:BID/QD
|
|---|---|---|---|---|---|
|
Change From Baseline in 2hPPG
|
-4.669 mmol/L
Standard Deviation 2.325
|
-4.945 mmol/L
Standard Deviation 3.387
|
-3.898 mmol/L
Standard Deviation 3.535
|
-4.899 mmol/L
Standard Deviation 3.921
|
-1.987 mmol/L
Standard Deviation 3.312
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksOutcome measures
| Measure |
HMS5552 Dose 1
n=53 Participants
HMS5552: 75mgQD
|
HMS5552 Dose 2
n=50 Participants
HMS5552:100mgQD
|
HMS5552 Dose 3
n=50 Participants
HMS5552: 50mgBID
|
HMS5552 Dose 4
n=49 Participants
HMS5552: 75mgBID
|
Placebo
n=53 Participants
Placebo:BID/QD
|
|---|---|---|---|---|---|
|
Change From Baseline in FPG
|
-0.307 mmol/L
Standard Deviation 2.000
|
-0.382 mmol/L
Standard Deviation 1.602
|
-0.758 mmol/L
Standard Deviation 2.150
|
-1.319 mmol/L
Standard Deviation 2.258
|
-0.801 mmol/L
Standard Deviation 1.752
|
POST_HOC outcome
Timeframe: Baseline and week 12Population: Both of disposition index and HOMA-IR could reflect the function of β cell.
Disposition index, i.e DI, by the insulin secretion sensitivity index-2 (ISSI-2). This is an calculated value which represents the ability of a person's pancreatic beta cells to lower blood glucose. A higher number means the pancreas is better able to secrete insulin and improve glucose levels. HOMA IR is an index used to evaluate the individual's insulin resistance level. The HOMA-IR index of normal individuals is 1. With the increase of insulin resistance, HOMA-IR index will be higher than 1.
Outcome measures
| Measure |
HMS5552 Dose 1
n=53 Participants
HMS5552: 75mgQD
|
HMS5552 Dose 2
n=50 Participants
HMS5552:100mgQD
|
HMS5552 Dose 3
n=50 Participants
HMS5552: 50mgBID
|
HMS5552 Dose 4
n=49 Participants
HMS5552: 75mgBID
|
Placebo
n=53 Participants
Placebo:BID/QD
|
|---|---|---|---|---|---|
|
Change From Baseline in MMTT (Mixed Meal Tolerance Test) β-cell Function Index
Disposition Index
|
0.292 units on a scale
Interval 0.065 to 0.838
|
0.198 units on a scale
Interval -0.075 to 0.532
|
0.216 units on a scale
Interval 0.008 to 0.532
|
0.140 units on a scale
Interval -0.01 to 0.58
|
0.080 units on a scale
Interval -0.061 to 0.265
|
|
Change From Baseline in MMTT (Mixed Meal Tolerance Test) β-cell Function Index
HOMA-IR
|
-0.530 units on a scale
Interval -1.77 to 0.26
|
-0.520 units on a scale
Interval -2.05 to 0.15
|
-0.550 units on a scale
Interval -1.93 to 0.26
|
-1.185 units on a scale
Interval -2.485 to -0.385
|
-0.680 units on a scale
Interval -1.65 to 0.28
|
Adverse Events
HMS5552 Dose 1
Serious events: 1 serious events
Other events: 16 other events
Deaths: 0 deaths
HMS5552 Dose 2
Serious events: 1 serious events
Other events: 21 other events
Deaths: 0 deaths
HMS5552 Dose 3
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
HMS5552 Dose 4
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
HMS5552 Dose 1
n=53 participants at risk
HMS5552: 75mgQD
|
HMS5552 Dose 2
n=50 participants at risk
HMS5552: 100mgQD
|
HMS5552 Dose 3
n=51 participants at risk
HMS5552: 50mgBID
|
HMS5552 Dose 4
n=51 participants at risk
HMS5552: 75mgBID
|
Placebo
n=53 participants at risk
Placebo: BID/QD
|
|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Right Achilles Tendon Rupture
|
0.00%
0/53 • From randomization to 7 days after 12-week treatment
Note: Hypoglycemia in this study was collected and analyzed as Special attention event separated from the analysis of Any other Advance Event. The Number Affected by Hypoglycemia was not included in the Total Number Affected by Any Other (Not including Serious) Adverse Event Above the Frequency Threshold in the third table.
|
0.00%
0/50 • From randomization to 7 days after 12-week treatment
Note: Hypoglycemia in this study was collected and analyzed as Special attention event separated from the analysis of Any other Advance Event. The Number Affected by Hypoglycemia was not included in the Total Number Affected by Any Other (Not including Serious) Adverse Event Above the Frequency Threshold in the third table.
|
2.0%
1/51 • Number of events 1 • From randomization to 7 days after 12-week treatment
Note: Hypoglycemia in this study was collected and analyzed as Special attention event separated from the analysis of Any other Advance Event. The Number Affected by Hypoglycemia was not included in the Total Number Affected by Any Other (Not including Serious) Adverse Event Above the Frequency Threshold in the third table.
|
0.00%
0/51 • From randomization to 7 days after 12-week treatment
Note: Hypoglycemia in this study was collected and analyzed as Special attention event separated from the analysis of Any other Advance Event. The Number Affected by Hypoglycemia was not included in the Total Number Affected by Any Other (Not including Serious) Adverse Event Above the Frequency Threshold in the third table.
|
0.00%
0/53 • From randomization to 7 days after 12-week treatment
Note: Hypoglycemia in this study was collected and analyzed as Special attention event separated from the analysis of Any other Advance Event. The Number Affected by Hypoglycemia was not included in the Total Number Affected by Any Other (Not including Serious) Adverse Event Above the Frequency Threshold in the third table.
|
|
Nervous system disorders
Lacunar Infarction
|
1.9%
1/53 • Number of events 1 • From randomization to 7 days after 12-week treatment
Note: Hypoglycemia in this study was collected and analyzed as Special attention event separated from the analysis of Any other Advance Event. The Number Affected by Hypoglycemia was not included in the Total Number Affected by Any Other (Not including Serious) Adverse Event Above the Frequency Threshold in the third table.
|
0.00%
0/50 • From randomization to 7 days after 12-week treatment
Note: Hypoglycemia in this study was collected and analyzed as Special attention event separated from the analysis of Any other Advance Event. The Number Affected by Hypoglycemia was not included in the Total Number Affected by Any Other (Not including Serious) Adverse Event Above the Frequency Threshold in the third table.
|
0.00%
0/51 • From randomization to 7 days after 12-week treatment
Note: Hypoglycemia in this study was collected and analyzed as Special attention event separated from the analysis of Any other Advance Event. The Number Affected by Hypoglycemia was not included in the Total Number Affected by Any Other (Not including Serious) Adverse Event Above the Frequency Threshold in the third table.
|
0.00%
0/51 • From randomization to 7 days after 12-week treatment
Note: Hypoglycemia in this study was collected and analyzed as Special attention event separated from the analysis of Any other Advance Event. The Number Affected by Hypoglycemia was not included in the Total Number Affected by Any Other (Not including Serious) Adverse Event Above the Frequency Threshold in the third table.
|
0.00%
0/53 • From randomization to 7 days after 12-week treatment
Note: Hypoglycemia in this study was collected and analyzed as Special attention event separated from the analysis of Any other Advance Event. The Number Affected by Hypoglycemia was not included in the Total Number Affected by Any Other (Not including Serious) Adverse Event Above the Frequency Threshold in the third table.
|
|
Nervous system disorders
Right Cerebral Infarction Of Basal Ganglia
|
0.00%
0/53 • From randomization to 7 days after 12-week treatment
Note: Hypoglycemia in this study was collected and analyzed as Special attention event separated from the analysis of Any other Advance Event. The Number Affected by Hypoglycemia was not included in the Total Number Affected by Any Other (Not including Serious) Adverse Event Above the Frequency Threshold in the third table.
|
2.0%
1/50 • Number of events 1 • From randomization to 7 days after 12-week treatment
Note: Hypoglycemia in this study was collected and analyzed as Special attention event separated from the analysis of Any other Advance Event. The Number Affected by Hypoglycemia was not included in the Total Number Affected by Any Other (Not including Serious) Adverse Event Above the Frequency Threshold in the third table.
|
0.00%
0/51 • From randomization to 7 days after 12-week treatment
Note: Hypoglycemia in this study was collected and analyzed as Special attention event separated from the analysis of Any other Advance Event. The Number Affected by Hypoglycemia was not included in the Total Number Affected by Any Other (Not including Serious) Adverse Event Above the Frequency Threshold in the third table.
|
0.00%
0/51 • From randomization to 7 days after 12-week treatment
Note: Hypoglycemia in this study was collected and analyzed as Special attention event separated from the analysis of Any other Advance Event. The Number Affected by Hypoglycemia was not included in the Total Number Affected by Any Other (Not including Serious) Adverse Event Above the Frequency Threshold in the third table.
|
0.00%
0/53 • From randomization to 7 days after 12-week treatment
Note: Hypoglycemia in this study was collected and analyzed as Special attention event separated from the analysis of Any other Advance Event. The Number Affected by Hypoglycemia was not included in the Total Number Affected by Any Other (Not including Serious) Adverse Event Above the Frequency Threshold in the third table.
|
Other adverse events
| Measure |
HMS5552 Dose 1
n=53 participants at risk
HMS5552: 75mgQD
|
HMS5552 Dose 2
n=50 participants at risk
HMS5552: 100mgQD
|
HMS5552 Dose 3
n=51 participants at risk
HMS5552: 50mgBID
|
HMS5552 Dose 4
n=51 participants at risk
HMS5552: 75mgBID
|
Placebo
n=53 participants at risk
Placebo: BID/QD
|
|---|---|---|---|---|---|
|
Infections and infestations
Upper Respiratory Tract Infection
|
11.3%
6/53 • Number of events 6 • From randomization to 7 days after 12-week treatment
Note: Hypoglycemia in this study was collected and analyzed as Special attention event separated from the analysis of Any other Advance Event. The Number Affected by Hypoglycemia was not included in the Total Number Affected by Any Other (Not including Serious) Adverse Event Above the Frequency Threshold in the third table.
|
12.0%
6/50 • Number of events 6 • From randomization to 7 days after 12-week treatment
Note: Hypoglycemia in this study was collected and analyzed as Special attention event separated from the analysis of Any other Advance Event. The Number Affected by Hypoglycemia was not included in the Total Number Affected by Any Other (Not including Serious) Adverse Event Above the Frequency Threshold in the third table.
|
2.0%
1/51 • Number of events 1 • From randomization to 7 days after 12-week treatment
Note: Hypoglycemia in this study was collected and analyzed as Special attention event separated from the analysis of Any other Advance Event. The Number Affected by Hypoglycemia was not included in the Total Number Affected by Any Other (Not including Serious) Adverse Event Above the Frequency Threshold in the third table.
|
7.8%
4/51 • Number of events 5 • From randomization to 7 days after 12-week treatment
Note: Hypoglycemia in this study was collected and analyzed as Special attention event separated from the analysis of Any other Advance Event. The Number Affected by Hypoglycemia was not included in the Total Number Affected by Any Other (Not including Serious) Adverse Event Above the Frequency Threshold in the third table.
|
5.7%
3/53 • Number of events 3 • From randomization to 7 days after 12-week treatment
Note: Hypoglycemia in this study was collected and analyzed as Special attention event separated from the analysis of Any other Advance Event. The Number Affected by Hypoglycemia was not included in the Total Number Affected by Any Other (Not including Serious) Adverse Event Above the Frequency Threshold in the third table.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
5.7%
3/53 • Number of events 3 • From randomization to 7 days after 12-week treatment
Note: Hypoglycemia in this study was collected and analyzed as Special attention event separated from the analysis of Any other Advance Event. The Number Affected by Hypoglycemia was not included in the Total Number Affected by Any Other (Not including Serious) Adverse Event Above the Frequency Threshold in the third table.
|
12.0%
6/50 • Number of events 6 • From randomization to 7 days after 12-week treatment
Note: Hypoglycemia in this study was collected and analyzed as Special attention event separated from the analysis of Any other Advance Event. The Number Affected by Hypoglycemia was not included in the Total Number Affected by Any Other (Not including Serious) Adverse Event Above the Frequency Threshold in the third table.
|
5.9%
3/51 • Number of events 3 • From randomization to 7 days after 12-week treatment
Note: Hypoglycemia in this study was collected and analyzed as Special attention event separated from the analysis of Any other Advance Event. The Number Affected by Hypoglycemia was not included in the Total Number Affected by Any Other (Not including Serious) Adverse Event Above the Frequency Threshold in the third table.
|
7.8%
4/51 • Number of events 4 • From randomization to 7 days after 12-week treatment
Note: Hypoglycemia in this study was collected and analyzed as Special attention event separated from the analysis of Any other Advance Event. The Number Affected by Hypoglycemia was not included in the Total Number Affected by Any Other (Not including Serious) Adverse Event Above the Frequency Threshold in the third table.
|
3.8%
2/53 • Number of events 2 • From randomization to 7 days after 12-week treatment
Note: Hypoglycemia in this study was collected and analyzed as Special attention event separated from the analysis of Any other Advance Event. The Number Affected by Hypoglycemia was not included in the Total Number Affected by Any Other (Not including Serious) Adverse Event Above the Frequency Threshold in the third table.
|
|
Nervous system disorders
Dizziness
|
3.8%
2/53 • Number of events 4 • From randomization to 7 days after 12-week treatment
Note: Hypoglycemia in this study was collected and analyzed as Special attention event separated from the analysis of Any other Advance Event. The Number Affected by Hypoglycemia was not included in the Total Number Affected by Any Other (Not including Serious) Adverse Event Above the Frequency Threshold in the third table.
|
8.0%
4/50 • Number of events 9 • From randomization to 7 days after 12-week treatment
Note: Hypoglycemia in this study was collected and analyzed as Special attention event separated from the analysis of Any other Advance Event. The Number Affected by Hypoglycemia was not included in the Total Number Affected by Any Other (Not including Serious) Adverse Event Above the Frequency Threshold in the third table.
|
7.8%
4/51 • Number of events 6 • From randomization to 7 days after 12-week treatment
Note: Hypoglycemia in this study was collected and analyzed as Special attention event separated from the analysis of Any other Advance Event. The Number Affected by Hypoglycemia was not included in the Total Number Affected by Any Other (Not including Serious) Adverse Event Above the Frequency Threshold in the third table.
|
0.00%
0/51 • From randomization to 7 days after 12-week treatment
Note: Hypoglycemia in this study was collected and analyzed as Special attention event separated from the analysis of Any other Advance Event. The Number Affected by Hypoglycemia was not included in the Total Number Affected by Any Other (Not including Serious) Adverse Event Above the Frequency Threshold in the third table.
|
0.00%
0/53 • From randomization to 7 days after 12-week treatment
Note: Hypoglycemia in this study was collected and analyzed as Special attention event separated from the analysis of Any other Advance Event. The Number Affected by Hypoglycemia was not included in the Total Number Affected by Any Other (Not including Serious) Adverse Event Above the Frequency Threshold in the third table.
|
|
Investigations
Protein Urine Present
|
5.7%
3/53 • Number of events 3 • From randomization to 7 days after 12-week treatment
Note: Hypoglycemia in this study was collected and analyzed as Special attention event separated from the analysis of Any other Advance Event. The Number Affected by Hypoglycemia was not included in the Total Number Affected by Any Other (Not including Serious) Adverse Event Above the Frequency Threshold in the third table.
|
4.0%
2/50 • Number of events 2 • From randomization to 7 days after 12-week treatment
Note: Hypoglycemia in this study was collected and analyzed as Special attention event separated from the analysis of Any other Advance Event. The Number Affected by Hypoglycemia was not included in the Total Number Affected by Any Other (Not including Serious) Adverse Event Above the Frequency Threshold in the third table.
|
0.00%
0/51 • From randomization to 7 days after 12-week treatment
Note: Hypoglycemia in this study was collected and analyzed as Special attention event separated from the analysis of Any other Advance Event. The Number Affected by Hypoglycemia was not included in the Total Number Affected by Any Other (Not including Serious) Adverse Event Above the Frequency Threshold in the third table.
|
3.9%
2/51 • Number of events 2 • From randomization to 7 days after 12-week treatment
Note: Hypoglycemia in this study was collected and analyzed as Special attention event separated from the analysis of Any other Advance Event. The Number Affected by Hypoglycemia was not included in the Total Number Affected by Any Other (Not including Serious) Adverse Event Above the Frequency Threshold in the third table.
|
1.9%
1/53 • Number of events 1 • From randomization to 7 days after 12-week treatment
Note: Hypoglycemia in this study was collected and analyzed as Special attention event separated from the analysis of Any other Advance Event. The Number Affected by Hypoglycemia was not included in the Total Number Affected by Any Other (Not including Serious) Adverse Event Above the Frequency Threshold in the third table.
|
|
Infections and infestations
Urinary Tract Infection
|
1.9%
1/53 • Number of events 1 • From randomization to 7 days after 12-week treatment
Note: Hypoglycemia in this study was collected and analyzed as Special attention event separated from the analysis of Any other Advance Event. The Number Affected by Hypoglycemia was not included in the Total Number Affected by Any Other (Not including Serious) Adverse Event Above the Frequency Threshold in the third table.
|
6.0%
3/50 • Number of events 3 • From randomization to 7 days after 12-week treatment
Note: Hypoglycemia in this study was collected and analyzed as Special attention event separated from the analysis of Any other Advance Event. The Number Affected by Hypoglycemia was not included in the Total Number Affected by Any Other (Not including Serious) Adverse Event Above the Frequency Threshold in the third table.
|
0.00%
0/51 • From randomization to 7 days after 12-week treatment
Note: Hypoglycemia in this study was collected and analyzed as Special attention event separated from the analysis of Any other Advance Event. The Number Affected by Hypoglycemia was not included in the Total Number Affected by Any Other (Not including Serious) Adverse Event Above the Frequency Threshold in the third table.
|
2.0%
1/51 • Number of events 1 • From randomization to 7 days after 12-week treatment
Note: Hypoglycemia in this study was collected and analyzed as Special attention event separated from the analysis of Any other Advance Event. The Number Affected by Hypoglycemia was not included in the Total Number Affected by Any Other (Not including Serious) Adverse Event Above the Frequency Threshold in the third table.
|
5.7%
3/53 • Number of events 3 • From randomization to 7 days after 12-week treatment
Note: Hypoglycemia in this study was collected and analyzed as Special attention event separated from the analysis of Any other Advance Event. The Number Affected by Hypoglycemia was not included in the Total Number Affected by Any Other (Not including Serious) Adverse Event Above the Frequency Threshold in the third table.
|
|
Investigations
Blood Creatine Phosphokinase Increased
|
0.00%
0/53 • From randomization to 7 days after 12-week treatment
Note: Hypoglycemia in this study was collected and analyzed as Special attention event separated from the analysis of Any other Advance Event. The Number Affected by Hypoglycemia was not included in the Total Number Affected by Any Other (Not including Serious) Adverse Event Above the Frequency Threshold in the third table.
|
2.0%
1/50 • Number of events 1 • From randomization to 7 days after 12-week treatment
Note: Hypoglycemia in this study was collected and analyzed as Special attention event separated from the analysis of Any other Advance Event. The Number Affected by Hypoglycemia was not included in the Total Number Affected by Any Other (Not including Serious) Adverse Event Above the Frequency Threshold in the third table.
|
2.0%
1/51 • Number of events 1 • From randomization to 7 days after 12-week treatment
Note: Hypoglycemia in this study was collected and analyzed as Special attention event separated from the analysis of Any other Advance Event. The Number Affected by Hypoglycemia was not included in the Total Number Affected by Any Other (Not including Serious) Adverse Event Above the Frequency Threshold in the third table.
|
2.0%
1/51 • Number of events 1 • From randomization to 7 days after 12-week treatment
Note: Hypoglycemia in this study was collected and analyzed as Special attention event separated from the analysis of Any other Advance Event. The Number Affected by Hypoglycemia was not included in the Total Number Affected by Any Other (Not including Serious) Adverse Event Above the Frequency Threshold in the third table.
|
9.4%
5/53 • Number of events 5 • From randomization to 7 days after 12-week treatment
Note: Hypoglycemia in this study was collected and analyzed as Special attention event separated from the analysis of Any other Advance Event. The Number Affected by Hypoglycemia was not included in the Total Number Affected by Any Other (Not including Serious) Adverse Event Above the Frequency Threshold in the third table.
|
|
Investigations
White Blood Cells Urine Positive
|
1.9%
1/53 • Number of events 1 • From randomization to 7 days after 12-week treatment
Note: Hypoglycemia in this study was collected and analyzed as Special attention event separated from the analysis of Any other Advance Event. The Number Affected by Hypoglycemia was not included in the Total Number Affected by Any Other (Not including Serious) Adverse Event Above the Frequency Threshold in the third table.
|
0.00%
0/50 • From randomization to 7 days after 12-week treatment
Note: Hypoglycemia in this study was collected and analyzed as Special attention event separated from the analysis of Any other Advance Event. The Number Affected by Hypoglycemia was not included in the Total Number Affected by Any Other (Not including Serious) Adverse Event Above the Frequency Threshold in the third table.
|
3.9%
2/51 • Number of events 2 • From randomization to 7 days after 12-week treatment
Note: Hypoglycemia in this study was collected and analyzed as Special attention event separated from the analysis of Any other Advance Event. The Number Affected by Hypoglycemia was not included in the Total Number Affected by Any Other (Not including Serious) Adverse Event Above the Frequency Threshold in the third table.
|
5.9%
3/51 • Number of events 3 • From randomization to 7 days after 12-week treatment
Note: Hypoglycemia in this study was collected and analyzed as Special attention event separated from the analysis of Any other Advance Event. The Number Affected by Hypoglycemia was not included in the Total Number Affected by Any Other (Not including Serious) Adverse Event Above the Frequency Threshold in the third table.
|
1.9%
1/53 • Number of events 1 • From randomization to 7 days after 12-week treatment
Note: Hypoglycemia in this study was collected and analyzed as Special attention event separated from the analysis of Any other Advance Event. The Number Affected by Hypoglycemia was not included in the Total Number Affected by Any Other (Not including Serious) Adverse Event Above the Frequency Threshold in the third table.
|
|
Hepatobiliary disorders
Hepatic Function Abnormal
|
3.8%
2/53 • Number of events 2 • From randomization to 7 days after 12-week treatment
Note: Hypoglycemia in this study was collected and analyzed as Special attention event separated from the analysis of Any other Advance Event. The Number Affected by Hypoglycemia was not included in the Total Number Affected by Any Other (Not including Serious) Adverse Event Above the Frequency Threshold in the third table.
|
2.0%
1/50 • Number of events 1 • From randomization to 7 days after 12-week treatment
Note: Hypoglycemia in this study was collected and analyzed as Special attention event separated from the analysis of Any other Advance Event. The Number Affected by Hypoglycemia was not included in the Total Number Affected by Any Other (Not including Serious) Adverse Event Above the Frequency Threshold in the third table.
|
5.9%
3/51 • Number of events 3 • From randomization to 7 days after 12-week treatment
Note: Hypoglycemia in this study was collected and analyzed as Special attention event separated from the analysis of Any other Advance Event. The Number Affected by Hypoglycemia was not included in the Total Number Affected by Any Other (Not including Serious) Adverse Event Above the Frequency Threshold in the third table.
|
0.00%
0/51 • From randomization to 7 days after 12-week treatment
Note: Hypoglycemia in this study was collected and analyzed as Special attention event separated from the analysis of Any other Advance Event. The Number Affected by Hypoglycemia was not included in the Total Number Affected by Any Other (Not including Serious) Adverse Event Above the Frequency Threshold in the third table.
|
1.9%
1/53 • Number of events 1 • From randomization to 7 days after 12-week treatment
Note: Hypoglycemia in this study was collected and analyzed as Special attention event separated from the analysis of Any other Advance Event. The Number Affected by Hypoglycemia was not included in the Total Number Affected by Any Other (Not including Serious) Adverse Event Above the Frequency Threshold in the third table.
|
|
Investigations
High Density Lipoprotein Decreased
|
1.9%
1/53 • Number of events 1 • From randomization to 7 days after 12-week treatment
Note: Hypoglycemia in this study was collected and analyzed as Special attention event separated from the analysis of Any other Advance Event. The Number Affected by Hypoglycemia was not included in the Total Number Affected by Any Other (Not including Serious) Adverse Event Above the Frequency Threshold in the third table.
|
0.00%
0/50 • From randomization to 7 days after 12-week treatment
Note: Hypoglycemia in this study was collected and analyzed as Special attention event separated from the analysis of Any other Advance Event. The Number Affected by Hypoglycemia was not included in the Total Number Affected by Any Other (Not including Serious) Adverse Event Above the Frequency Threshold in the third table.
|
2.0%
1/51 • Number of events 1 • From randomization to 7 days after 12-week treatment
Note: Hypoglycemia in this study was collected and analyzed as Special attention event separated from the analysis of Any other Advance Event. The Number Affected by Hypoglycemia was not included in the Total Number Affected by Any Other (Not including Serious) Adverse Event Above the Frequency Threshold in the third table.
|
7.8%
4/51 • Number of events 4 • From randomization to 7 days after 12-week treatment
Note: Hypoglycemia in this study was collected and analyzed as Special attention event separated from the analysis of Any other Advance Event. The Number Affected by Hypoglycemia was not included in the Total Number Affected by Any Other (Not including Serious) Adverse Event Above the Frequency Threshold in the third table.
|
1.9%
1/53 • Number of events 1 • From randomization to 7 days after 12-week treatment
Note: Hypoglycemia in this study was collected and analyzed as Special attention event separated from the analysis of Any other Advance Event. The Number Affected by Hypoglycemia was not included in the Total Number Affected by Any Other (Not including Serious) Adverse Event Above the Frequency Threshold in the third table.
|
|
Cardiac disorders
Ventricular Extrasystoles
|
0.00%
0/53 • From randomization to 7 days after 12-week treatment
Note: Hypoglycemia in this study was collected and analyzed as Special attention event separated from the analysis of Any other Advance Event. The Number Affected by Hypoglycemia was not included in the Total Number Affected by Any Other (Not including Serious) Adverse Event Above the Frequency Threshold in the third table.
|
2.0%
1/50 • Number of events 1 • From randomization to 7 days after 12-week treatment
Note: Hypoglycemia in this study was collected and analyzed as Special attention event separated from the analysis of Any other Advance Event. The Number Affected by Hypoglycemia was not included in the Total Number Affected by Any Other (Not including Serious) Adverse Event Above the Frequency Threshold in the third table.
|
0.00%
0/51 • From randomization to 7 days after 12-week treatment
Note: Hypoglycemia in this study was collected and analyzed as Special attention event separated from the analysis of Any other Advance Event. The Number Affected by Hypoglycemia was not included in the Total Number Affected by Any Other (Not including Serious) Adverse Event Above the Frequency Threshold in the third table.
|
5.9%
3/51 • Number of events 3 • From randomization to 7 days after 12-week treatment
Note: Hypoglycemia in this study was collected and analyzed as Special attention event separated from the analysis of Any other Advance Event. The Number Affected by Hypoglycemia was not included in the Total Number Affected by Any Other (Not including Serious) Adverse Event Above the Frequency Threshold in the third table.
|
0.00%
0/53 • From randomization to 7 days after 12-week treatment
Note: Hypoglycemia in this study was collected and analyzed as Special attention event separated from the analysis of Any other Advance Event. The Number Affected by Hypoglycemia was not included in the Total Number Affected by Any Other (Not including Serious) Adverse Event Above the Frequency Threshold in the third table.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/53 • From randomization to 7 days after 12-week treatment
Note: Hypoglycemia in this study was collected and analyzed as Special attention event separated from the analysis of Any other Advance Event. The Number Affected by Hypoglycemia was not included in the Total Number Affected by Any Other (Not including Serious) Adverse Event Above the Frequency Threshold in the third table.
|
2.0%
1/50 • Number of events 2 • From randomization to 7 days after 12-week treatment
Note: Hypoglycemia in this study was collected and analyzed as Special attention event separated from the analysis of Any other Advance Event. The Number Affected by Hypoglycemia was not included in the Total Number Affected by Any Other (Not including Serious) Adverse Event Above the Frequency Threshold in the third table.
|
5.9%
3/51 • Number of events 3 • From randomization to 7 days after 12-week treatment
Note: Hypoglycemia in this study was collected and analyzed as Special attention event separated from the analysis of Any other Advance Event. The Number Affected by Hypoglycemia was not included in the Total Number Affected by Any Other (Not including Serious) Adverse Event Above the Frequency Threshold in the third table.
|
0.00%
0/51 • From randomization to 7 days after 12-week treatment
Note: Hypoglycemia in this study was collected and analyzed as Special attention event separated from the analysis of Any other Advance Event. The Number Affected by Hypoglycemia was not included in the Total Number Affected by Any Other (Not including Serious) Adverse Event Above the Frequency Threshold in the third table.
|
0.00%
0/53 • From randomization to 7 days after 12-week treatment
Note: Hypoglycemia in this study was collected and analyzed as Special attention event separated from the analysis of Any other Advance Event. The Number Affected by Hypoglycemia was not included in the Total Number Affected by Any Other (Not including Serious) Adverse Event Above the Frequency Threshold in the third table.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
5.7%
3/53 • Number of events 8 • From randomization to 7 days after 12-week treatment
Note: Hypoglycemia in this study was collected and analyzed as Special attention event separated from the analysis of Any other Advance Event. The Number Affected by Hypoglycemia was not included in the Total Number Affected by Any Other (Not including Serious) Adverse Event Above the Frequency Threshold in the third table.
|
4.0%
2/50 • Number of events 2 • From randomization to 7 days after 12-week treatment
Note: Hypoglycemia in this study was collected and analyzed as Special attention event separated from the analysis of Any other Advance Event. The Number Affected by Hypoglycemia was not included in the Total Number Affected by Any Other (Not including Serious) Adverse Event Above the Frequency Threshold in the third table.
|
5.9%
3/51 • Number of events 3 • From randomization to 7 days after 12-week treatment
Note: Hypoglycemia in this study was collected and analyzed as Special attention event separated from the analysis of Any other Advance Event. The Number Affected by Hypoglycemia was not included in the Total Number Affected by Any Other (Not including Serious) Adverse Event Above the Frequency Threshold in the third table.
|
5.9%
3/51 • Number of events 10 • From randomization to 7 days after 12-week treatment
Note: Hypoglycemia in this study was collected and analyzed as Special attention event separated from the analysis of Any other Advance Event. The Number Affected by Hypoglycemia was not included in the Total Number Affected by Any Other (Not including Serious) Adverse Event Above the Frequency Threshold in the third table.
|
0.00%
0/53 • From randomization to 7 days after 12-week treatment
Note: Hypoglycemia in this study was collected and analyzed as Special attention event separated from the analysis of Any other Advance Event. The Number Affected by Hypoglycemia was not included in the Total Number Affected by Any Other (Not including Serious) Adverse Event Above the Frequency Threshold in the third table.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place