Trial Outcomes & Findings for Assessing the Efficacy, Safety, and Tolerability of Met DR in Subjects With T2DM Over 12 Weeks (NCT NCT01819272)
NCT ID: NCT01819272
Last Updated: 2017-03-15
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
240 participants
Primary outcome timeframe
Baseline and 4 weeks after the first dose of study medication
Results posted on
2017-03-15
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo once daily in the morning
|
600 mg DR
600 mg delayed-release metformin once daily in the morning
Met DR: metformin delayed-release tablets
|
800 mg DR
800 mg delayed-release metformin once daily in the morning
Met DR: metformin delayed-release tablets
|
1000 mg DR
1000 mg delayed-release metformin once daily in the morning
Met DR: metformin delayed-release tablets
|
1000 mg XR
1000 mg extended-release metformin once daily in the evening
Met XR: metformin extended-release tablets
|
2000 mg XR
2000 mg extended-release metformin once daily in the evening
Met XR: metformin extended-release tablets
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
41
|
39
|
40
|
40
|
40
|
40
|
|
Overall Study
COMPLETED
|
35
|
36
|
37
|
35
|
36
|
33
|
|
Overall Study
NOT COMPLETED
|
6
|
3
|
3
|
5
|
4
|
7
|
Reasons for withdrawal
| Measure |
Placebo
Placebo once daily in the morning
|
600 mg DR
600 mg delayed-release metformin once daily in the morning
Met DR: metformin delayed-release tablets
|
800 mg DR
800 mg delayed-release metformin once daily in the morning
Met DR: metformin delayed-release tablets
|
1000 mg DR
1000 mg delayed-release metformin once daily in the morning
Met DR: metformin delayed-release tablets
|
1000 mg XR
1000 mg extended-release metformin once daily in the evening
Met XR: metformin extended-release tablets
|
2000 mg XR
2000 mg extended-release metformin once daily in the evening
Met XR: metformin extended-release tablets
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
2
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
3
|
0
|
1
|
0
|
0
|
3
|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
1
|
2
|
3
|
|
Overall Study
Physician Decision
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal of Consent
|
0
|
1
|
2
|
1
|
0
|
1
|
|
Overall Study
Loss of Glucose Control
|
2
|
1
|
0
|
1
|
2
|
0
|
Baseline Characteristics
Assessing the Efficacy, Safety, and Tolerability of Met DR in Subjects With T2DM Over 12 Weeks
Baseline characteristics by cohort
| Measure |
Placebo
n=41 Participants
Placebo once daily in the morning
|
600 mg DR
n=39 Participants
600 mg delayed-release metformin once daily in the morning
Met DR: metformin delayed-release tablets
|
800 mg DR
n=40 Participants
800 mg delayed-release metformin once daily in the morning
Met DR: metformin delayed-release tablets
|
1000 mg DR
n=40 Participants
1000 mg delayed-release metformin once daily in the morning
Met DR: metformin delayed-release tablets
|
1000 mg XR
n=40 Participants
1000 mg extended-release metformin once daily in the evening
Met XR: metformin extended-release tablets
|
2000 mg XR
n=40 Participants
2000 mg extended-release metformin once daily in the evening
Met XR: metformin extended-release tablets
|
Total
n=240 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
51.4 years
STANDARD_DEVIATION 10.22 • n=99 Participants
|
53.5 years
STANDARD_DEVIATION 8.34 • n=107 Participants
|
52.6 years
STANDARD_DEVIATION 9.69 • n=206 Participants
|
51.8 years
STANDARD_DEVIATION 9.05 • n=7 Participants
|
51.0 years
STANDARD_DEVIATION 9.62 • n=31 Participants
|
52.0 years
STANDARD_DEVIATION 9.53 • n=30 Participants
|
52.0 years
STANDARD_DEVIATION 9.37 • n=3 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
14 Participants
n=7 Participants
|
22 Participants
n=31 Participants
|
21 Participants
n=30 Participants
|
127 Participants
n=3 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
26 Participants
n=7 Participants
|
18 Participants
n=31 Participants
|
19 Participants
n=30 Participants
|
113 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
17 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
14 Participants
n=7 Participants
|
10 Participants
n=31 Participants
|
10 Participants
n=30 Participants
|
75 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
26 Participants
n=7 Participants
|
30 Participants
n=31 Participants
|
30 Participants
n=30 Participants
|
165 Participants
n=3 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
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 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
|
1 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
6 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
14 Participants
n=31 Participants
|
12 Participants
n=30 Participants
|
68 Participants
n=3 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
30 Participants
n=7 Participants
|
24 Participants
n=31 Participants
|
27 Participants
n=30 Participants
|
162 Participants
n=3 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
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
2 Participants
n=3 Participants
|
|
BMI
|
33.6 kg/m²
STANDARD_DEVIATION 5.28 • n=99 Participants
|
33.1 kg/m²
STANDARD_DEVIATION 5.74 • n=107 Participants
|
33.5 kg/m²
STANDARD_DEVIATION 5.86 • n=206 Participants
|
33.3 kg/m²
STANDARD_DEVIATION 5.55 • n=7 Participants
|
32.8 kg/m²
STANDARD_DEVIATION 5.27 • n=31 Participants
|
33.7 kg/m²
STANDARD_DEVIATION 5.22 • n=30 Participants
|
33.3 kg/m²
STANDARD_DEVIATION 5.44 • n=3 Participants
|
|
Previous T2DM Regimen
Diet and exercise alone
|
3 participants
n=99 Participants
|
7 participants
n=107 Participants
|
2 participants
n=206 Participants
|
4 participants
n=7 Participants
|
6 participants
n=31 Participants
|
5 participants
n=30 Participants
|
27 participants
n=3 Participants
|
|
Previous T2DM Regimen
DPP-4 inhibitor alone
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
0 participants
n=206 Participants
|
0 participants
n=7 Participants
|
0 participants
n=31 Participants
|
0 participants
n=30 Participants
|
1 participants
n=3 Participants
|
|
Previous T2DM Regimen
Metformin alone
|
35 participants
n=99 Participants
|
29 participants
n=107 Participants
|
35 participants
n=206 Participants
|
36 participants
n=7 Participants
|
30 participants
n=31 Participants
|
33 participants
n=30 Participants
|
198 participants
n=3 Participants
|
|
Previous T2DM Regimen
Metformin/DPP-4 inhibitor combination
|
3 participants
n=99 Participants
|
2 participants
n=107 Participants
|
3 participants
n=206 Participants
|
0 participants
n=7 Participants
|
4 participants
n=31 Participants
|
2 participants
n=30 Participants
|
14 participants
n=3 Participants
|
|
Screening Fasting Plasma Glucose
|
146.5 mg/dL
STANDARD_DEVIATION 36.70 • n=99 Participants
|
147.5 mg/dL
STANDARD_DEVIATION 42.56 • n=107 Participants
|
142.4 mg/dL
STANDARD_DEVIATION 34.60 • n=206 Participants
|
141.4 mg/dL
STANDARD_DEVIATION 29.79 • n=7 Participants
|
139.0 mg/dL
STANDARD_DEVIATION 34.22 • n=31 Participants
|
148.9 mg/dL
STANDARD_DEVIATION 41.36 • n=30 Participants
|
144.3 mg/dL
STANDARD_DEVIATION 36.57 • n=3 Participants
|
|
Screening HbA1c
|
7.19 %
STANDARD_DEVIATION 0.838 • n=99 Participants
|
7.27 %
STANDARD_DEVIATION 0.864 • n=107 Participants
|
7.17 %
STANDARD_DEVIATION 0.829 • n=206 Participants
|
7.13 %
STANDARD_DEVIATION 0.899 • n=7 Participants
|
7.10 %
STANDARD_DEVIATION 0.819 • n=31 Participants
|
7.17 %
STANDARD_DEVIATION 0.869 • n=30 Participants
|
7.17 %
STANDARD_DEVIATION 0.846 • n=3 Participants
|
|
Baseline Fasting Plasma Glucose
|
176.5 mg/dL
STANDARD_DEVIATION 54.70 • n=99 Participants
|
180.1 mg/dL
STANDARD_DEVIATION 49.72 • n=107 Participants
|
162.9 mg/dL
STANDARD_DEVIATION 40.10 • n=206 Participants
|
172.3 mg/dL
STANDARD_DEVIATION 44.45 • n=7 Participants
|
165.7 mg/dL
STANDARD_DEVIATION 50.01 • n=31 Participants
|
180.3 mg/dL
STANDARD_DEVIATION 57.52 • n=30 Participants
|
173.0 mg/dL
STANDARD_DEVIATION 49.72 • n=3 Participants
|
|
Baseline HbA1c
|
7.40 %
STANDARD_DEVIATION 0.951 • n=99 Participants
|
7.45 %
STANDARD_DEVIATION 0.887 • n=107 Participants
|
7.33 %
STANDARD_DEVIATION 0.908 • n=206 Participants
|
7.37 %
STANDARD_DEVIATION 0.890 • n=7 Participants
|
7.36 %
STANDARD_DEVIATION 0.997 • n=31 Participants
|
7.38 %
STANDARD_DEVIATION 0.980 • n=30 Participants
|
7.38 %
STANDARD_DEVIATION 0.928 • n=3 Participants
|
PRIMARY outcome
Timeframe: Baseline and 4 weeks after the first dose of study medicationPopulation: Week 4 Evaluable
Outcome measures
| Measure |
Placebo
n=37 Participants
Placebo once daily in the morning
|
600 mg DR
n=35 Participants
600 mg delayed-release metformin once daily in the morning
Met DR: metformin delayed-release tablets
|
800 mg DR
n=37 Participants
800 mg delayed-release metformin once daily in the morning
Met DR: metformin delayed-release tablets
|
1000 mg DR
n=36 Participants
1000 mg delayed-release metformin once daily in the morning
Met DR: metformin delayed-release tablets
|
1000 mg XR
n=35 Participants
1000 mg extended-release metformin once daily in the evening
Met XR: metformin extended-release tablets
|
2000 mg XR
n=35 Participants
2000 mg extended-release metformin once daily in the evening
Met XR: metformin extended-release tablets
|
|---|---|---|---|---|---|---|
|
Change in Fasting Plasma Glucose (mg/dL) at 4 Weeks
|
-4 mg/dL
Interval -69.0 to 48.0
|
-11 mg/dL
Interval -124.0 to 150.0
|
-13 mg/dL
Interval -62.0 to 145.0
|
-18 mg/dL
Interval -90.0 to 113.0
|
-12 mg/dL
Interval -111.0 to 58.0
|
-25 mg/dL
Interval -110.0 to 20.0
|
SECONDARY outcome
Timeframe: Baseline and 4 to 12 weeks after the first dose of study medicationPopulation: Week 12 Evaluable
Outcome measures
| Measure |
Placebo
n=30 Participants
Placebo once daily in the morning
|
600 mg DR
n=34 Participants
600 mg delayed-release metformin once daily in the morning
Met DR: metformin delayed-release tablets
|
800 mg DR
n=37 Participants
800 mg delayed-release metformin once daily in the morning
Met DR: metformin delayed-release tablets
|
1000 mg DR
n=34 Participants
1000 mg delayed-release metformin once daily in the morning
Met DR: metformin delayed-release tablets
|
1000 mg XR
n=31 Participants
1000 mg extended-release metformin once daily in the evening
Met XR: metformin extended-release tablets
|
2000 mg XR
n=30 Participants
2000 mg extended-release metformin once daily in the evening
Met XR: metformin extended-release tablets
|
|---|---|---|---|---|---|---|
|
AUC4-12wk of Change in Fasting Plasma Glucose (mg/dL*Week) Concentrations From Baseline to 12 Weeks
|
4.00 mg/dL*week
Interval -784.0 to 698.0
|
-96.00 mg/dL*week
Interval -894.0 to 414.0
|
-108.00 mg/dL*week
Interval -556.0 to 612.0
|
-156.00 mg/dL*week
Interval -782.0 to 522.0
|
-98.00 mg/dL*week
Interval -880.0 to 314.0
|
-215.00 mg/dL*week
Interval -856.0 to 186.0
|
SECONDARY outcome
Timeframe: Baseline and 12 weeks after the first dose of study medicationPopulation: Week 12 Evaluable
Outcome measures
| Measure |
Placebo
n=30 Participants
Placebo once daily in the morning
|
600 mg DR
n=34 Participants
600 mg delayed-release metformin once daily in the morning
Met DR: metformin delayed-release tablets
|
800 mg DR
n=37 Participants
800 mg delayed-release metformin once daily in the morning
Met DR: metformin delayed-release tablets
|
1000 mg DR
n=34 Participants
1000 mg delayed-release metformin once daily in the morning
Met DR: metformin delayed-release tablets
|
1000 mg XR
n=31 Participants
1000 mg extended-release metformin once daily in the evening
Met XR: metformin extended-release tablets
|
2000 mg XR
n=30 Participants
2000 mg extended-release metformin once daily in the evening
Met XR: metformin extended-release tablets
|
|---|---|---|---|---|---|---|
|
Change in HbA1c (%) at 12 Weeks
|
0.45 HbA1c (%)
Standard Error 0.137
|
-0.03 HbA1c (%)
Standard Error 0.125
|
0.00 HbA1c (%)
Standard Error 0.121
|
0.10 HbA1c (%)
Standard Error 0.124
|
0.00 HbA1c (%)
Standard Error 0.132
|
-0.21 HbA1c (%)
Standard Error 0.133
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
600 mg DR
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
800 mg DR
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
1000 mg DR
Serious events: 2 serious events
Other events: 9 other events
Deaths: 0 deaths
1000 mg XR
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
2000 mg XR
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=41 participants at risk
Placebo once daily in the morning
|
600 mg DR
n=39 participants at risk
600 mg delayed-release metformin once daily in the morning
Met DR: metformin delayed-release tablets
|
800 mg DR
n=40 participants at risk
800 mg delayed-release metformin once daily in the morning
Met DR: metformin delayed-release tablets
|
1000 mg DR
n=40 participants at risk
1000 mg delayed-release metformin once daily in the morning
Met DR: metformin delayed-release tablets
|
1000 mg XR
n=40 participants at risk
1000 mg extended-release metformin once daily in the evening
Met XR: metformin extended-release tablets
|
2000 mg XR
n=40 participants at risk
2000 mg extended-release metformin once daily in the evening
Met XR: metformin extended-release tablets
|
|---|---|---|---|---|---|---|
|
Metabolism and nutrition disorders
Hyperglycaemic hyperosmolar nonketotic syndrome
|
0.00%
0/41 • Approximately 83 to 107 days depending on the number of intervening days between study visits
|
2.6%
1/39 • Approximately 83 to 107 days depending on the number of intervening days between study visits
|
0.00%
0/40 • Approximately 83 to 107 days depending on the number of intervening days between study visits
|
0.00%
0/40 • Approximately 83 to 107 days depending on the number of intervening days between study visits
|
0.00%
0/40 • Approximately 83 to 107 days depending on the number of intervening days between study visits
|
0.00%
0/40 • Approximately 83 to 107 days depending on the number of intervening days between study visits
|
|
Infections and infestations
Kidney infection
|
0.00%
0/41 • Approximately 83 to 107 days depending on the number of intervening days between study visits
|
0.00%
0/39 • Approximately 83 to 107 days depending on the number of intervening days between study visits
|
0.00%
0/40 • Approximately 83 to 107 days depending on the number of intervening days between study visits
|
2.5%
1/40 • Approximately 83 to 107 days depending on the number of intervening days between study visits
|
0.00%
0/40 • Approximately 83 to 107 days depending on the number of intervening days between study visits
|
0.00%
0/40 • Approximately 83 to 107 days depending on the number of intervening days between study visits
|
|
Blood and lymphatic system disorders
Intravascular haemolysis
|
0.00%
0/41 • Approximately 83 to 107 days depending on the number of intervening days between study visits
|
0.00%
0/39 • Approximately 83 to 107 days depending on the number of intervening days between study visits
|
0.00%
0/40 • Approximately 83 to 107 days depending on the number of intervening days between study visits
|
2.5%
1/40 • Approximately 83 to 107 days depending on the number of intervening days between study visits
|
0.00%
0/40 • Approximately 83 to 107 days depending on the number of intervening days between study visits
|
0.00%
0/40 • Approximately 83 to 107 days depending on the number of intervening days between study visits
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/41 • Approximately 83 to 107 days depending on the number of intervening days between study visits
|
0.00%
0/39 • Approximately 83 to 107 days depending on the number of intervening days between study visits
|
0.00%
0/40 • Approximately 83 to 107 days depending on the number of intervening days between study visits
|
2.5%
1/40 • Approximately 83 to 107 days depending on the number of intervening days between study visits
|
0.00%
0/40 • Approximately 83 to 107 days depending on the number of intervening days between study visits
|
0.00%
0/40 • Approximately 83 to 107 days depending on the number of intervening days between study visits
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/41 • Approximately 83 to 107 days depending on the number of intervening days between study visits
|
0.00%
0/39 • Approximately 83 to 107 days depending on the number of intervening days between study visits
|
0.00%
0/40 • Approximately 83 to 107 days depending on the number of intervening days between study visits
|
0.00%
0/40 • Approximately 83 to 107 days depending on the number of intervening days between study visits
|
2.5%
1/40 • Approximately 83 to 107 days depending on the number of intervening days between study visits
|
0.00%
0/40 • Approximately 83 to 107 days depending on the number of intervening days between study visits
|
Other adverse events
| Measure |
Placebo
n=41 participants at risk
Placebo once daily in the morning
|
600 mg DR
n=39 participants at risk
600 mg delayed-release metformin once daily in the morning
Met DR: metformin delayed-release tablets
|
800 mg DR
n=40 participants at risk
800 mg delayed-release metformin once daily in the morning
Met DR: metformin delayed-release tablets
|
1000 mg DR
n=40 participants at risk
1000 mg delayed-release metformin once daily in the morning
Met DR: metformin delayed-release tablets
|
1000 mg XR
n=40 participants at risk
1000 mg extended-release metformin once daily in the evening
Met XR: metformin extended-release tablets
|
2000 mg XR
n=40 participants at risk
2000 mg extended-release metformin once daily in the evening
Met XR: metformin extended-release tablets
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
2.4%
1/41 • Approximately 83 to 107 days depending on the number of intervening days between study visits
|
7.7%
3/39 • Approximately 83 to 107 days depending on the number of intervening days between study visits
|
2.5%
1/40 • Approximately 83 to 107 days depending on the number of intervening days between study visits
|
12.5%
5/40 • Approximately 83 to 107 days depending on the number of intervening days between study visits
|
5.0%
2/40 • Approximately 83 to 107 days depending on the number of intervening days between study visits
|
5.0%
2/40 • Approximately 83 to 107 days depending on the number of intervening days between study visits
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/41 • Approximately 83 to 107 days depending on the number of intervening days between study visits
|
5.1%
2/39 • Approximately 83 to 107 days depending on the number of intervening days between study visits
|
5.0%
2/40 • Approximately 83 to 107 days depending on the number of intervening days between study visits
|
0.00%
0/40 • Approximately 83 to 107 days depending on the number of intervening days between study visits
|
2.5%
1/40 • Approximately 83 to 107 days depending on the number of intervening days between study visits
|
2.5%
1/40 • Approximately 83 to 107 days depending on the number of intervening days between study visits
|
|
Nervous system disorders
Dizziness
|
4.9%
2/41 • Approximately 83 to 107 days depending on the number of intervening days between study visits
|
0.00%
0/39 • Approximately 83 to 107 days depending on the number of intervening days between study visits
|
5.0%
2/40 • Approximately 83 to 107 days depending on the number of intervening days between study visits
|
2.5%
1/40 • Approximately 83 to 107 days depending on the number of intervening days between study visits
|
5.0%
2/40 • Approximately 83 to 107 days depending on the number of intervening days between study visits
|
7.5%
3/40 • Approximately 83 to 107 days depending on the number of intervening days between study visits
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
4.9%
2/41 • Approximately 83 to 107 days depending on the number of intervening days between study visits
|
5.1%
2/39 • Approximately 83 to 107 days depending on the number of intervening days between study visits
|
2.5%
1/40 • Approximately 83 to 107 days depending on the number of intervening days between study visits
|
2.5%
1/40 • Approximately 83 to 107 days depending on the number of intervening days between study visits
|
2.5%
1/40 • Approximately 83 to 107 days depending on the number of intervening days between study visits
|
0.00%
0/40 • Approximately 83 to 107 days depending on the number of intervening days between study visits
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/41 • Approximately 83 to 107 days depending on the number of intervening days between study visits
|
0.00%
0/39 • Approximately 83 to 107 days depending on the number of intervening days between study visits
|
2.5%
1/40 • Approximately 83 to 107 days depending on the number of intervening days between study visits
|
0.00%
0/40 • Approximately 83 to 107 days depending on the number of intervening days between study visits
|
5.0%
2/40 • Approximately 83 to 107 days depending on the number of intervening days between study visits
|
2.5%
1/40 • Approximately 83 to 107 days depending on the number of intervening days between study visits
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/41 • Approximately 83 to 107 days depending on the number of intervening days between study visits
|
2.6%
1/39 • Approximately 83 to 107 days depending on the number of intervening days between study visits
|
5.0%
2/40 • Approximately 83 to 107 days depending on the number of intervening days between study visits
|
0.00%
0/40 • Approximately 83 to 107 days depending on the number of intervening days between study visits
|
0.00%
0/40 • Approximately 83 to 107 days depending on the number of intervening days between study visits
|
0.00%
0/40 • Approximately 83 to 107 days depending on the number of intervening days between study visits
|
|
Gastrointestinal disorders
Abdominal Distension
|
0.00%
0/41 • Approximately 83 to 107 days depending on the number of intervening days between study visits
|
0.00%
0/39 • Approximately 83 to 107 days depending on the number of intervening days between study visits
|
0.00%
0/40 • Approximately 83 to 107 days depending on the number of intervening days between study visits
|
0.00%
0/40 • Approximately 83 to 107 days depending on the number of intervening days between study visits
|
5.0%
2/40 • Approximately 83 to 107 days depending on the number of intervening days between study visits
|
0.00%
0/40 • Approximately 83 to 107 days depending on the number of intervening days between study visits
|
|
Infections and infestations
Sinusitis
|
0.00%
0/41 • Approximately 83 to 107 days depending on the number of intervening days between study visits
|
2.6%
1/39 • Approximately 83 to 107 days depending on the number of intervening days between study visits
|
0.00%
0/40 • Approximately 83 to 107 days depending on the number of intervening days between study visits
|
5.0%
2/40 • Approximately 83 to 107 days depending on the number of intervening days between study visits
|
2.5%
1/40 • Approximately 83 to 107 days depending on the number of intervening days between study visits
|
2.5%
1/40 • Approximately 83 to 107 days depending on the number of intervening days between study visits
|
|
Infections and infestations
Bronchitis
|
0.00%
0/41 • Approximately 83 to 107 days depending on the number of intervening days between study visits
|
0.00%
0/39 • Approximately 83 to 107 days depending on the number of intervening days between study visits
|
0.00%
0/40 • Approximately 83 to 107 days depending on the number of intervening days between study visits
|
5.0%
2/40 • Approximately 83 to 107 days depending on the number of intervening days between study visits
|
5.0%
2/40 • Approximately 83 to 107 days depending on the number of intervening days between study visits
|
0.00%
0/40 • Approximately 83 to 107 days depending on the number of intervening days between study visits
|
|
Infections and infestations
Nasopharyngitis
|
4.9%
2/41 • Approximately 83 to 107 days depending on the number of intervening days between study visits
|
0.00%
0/39 • Approximately 83 to 107 days depending on the number of intervening days between study visits
|
5.0%
2/40 • Approximately 83 to 107 days depending on the number of intervening days between study visits
|
0.00%
0/40 • Approximately 83 to 107 days depending on the number of intervening days between study visits
|
0.00%
0/40 • Approximately 83 to 107 days depending on the number of intervening days between study visits
|
0.00%
0/40 • Approximately 83 to 107 days depending on the number of intervening days between study visits
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/41 • Approximately 83 to 107 days depending on the number of intervening days between study visits
|
0.00%
0/39 • Approximately 83 to 107 days depending on the number of intervening days between study visits
|
2.5%
1/40 • Approximately 83 to 107 days depending on the number of intervening days between study visits
|
2.5%
1/40 • Approximately 83 to 107 days depending on the number of intervening days between study visits
|
0.00%
0/40 • Approximately 83 to 107 days depending on the number of intervening days between study visits
|
5.0%
2/40 • Approximately 83 to 107 days depending on the number of intervening days between study visits
|
|
Skin and subcutaneous tissue disorders
rash
|
4.9%
2/41 • Approximately 83 to 107 days depending on the number of intervening days between study visits
|
0.00%
0/39 • Approximately 83 to 107 days depending on the number of intervening days between study visits
|
0.00%
0/40 • Approximately 83 to 107 days depending on the number of intervening days between study visits
|
0.00%
0/40 • Approximately 83 to 107 days depending on the number of intervening days between study visits
|
0.00%
0/40 • Approximately 83 to 107 days depending on the number of intervening days between study visits
|
2.5%
1/40 • Approximately 83 to 107 days depending on the number of intervening days between study visits
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The results of the Study may be published by INSTITUTE, however the publication shall not disclose any SPONSOR Confidential Information, the INSTITUTE shall send the SPONSOR a copy of any such proposed publication 90 days prior to submission for publication, the INSTITUTE, on request of the SPONSOR, shall delete any SPONSOR Confidential Information in the proposed publication, and the INSTITUTE shall, on the SPONSOR's request, delay submission while the SPONSOR files applications for patents.
- Publication restrictions are in place
Restriction type: OTHER