Trial Outcomes & Findings for Evaluate Efficacy and Safety of Saxagliptin in Adult Patients With Type 2 Diabetes Inadequate Glycemic Control (NCT NCT00698932)
NCT ID: NCT00698932
Last Updated: 2011-09-21
Results Overview
Adjusted\* mean change from baseline in HbA1c achieved with saxagliptin 5 mg versus placebo at week 24 (LOCF, Full Analysis set). HbA1c is a continuous measure, the change from baseline for each subject is calculated as the week 24 values minus the baseline value. HbA1c data were excluded on and after rescue medication.
COMPLETED
PHASE3
568 participants
Baseline , Week 24
2011-09-21
Participant Flow
Participant milestones
| Measure |
Saxagliptin 5 mg
Saxagliptin 5 mg tablet, once daily (OD) for 24 weeks
|
Placebo
Placebo tablet, once daily( OD) for 24 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
284
|
284
|
|
Overall Study
COMPLETED
|
262
|
248
|
|
Overall Study
NOT COMPLETED
|
22
|
36
|
Reasons for withdrawal
| Measure |
Saxagliptin 5 mg
Saxagliptin 5 mg tablet, once daily (OD) for 24 weeks
|
Placebo
Placebo tablet, once daily( OD) for 24 weeks
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
2
|
|
Overall Study
Incorrect enrollment
|
0
|
2
|
|
Overall Study
Study specific discontinuation criteria
|
3
|
4
|
|
Overall Study
Withdrawal by Subject
|
11
|
23
|
|
Overall Study
Lost to Follow-up
|
6
|
1
|
|
Overall Study
Severe non-compliance to protocol
|
1
|
2
|
|
Overall Study
Safety reasons
|
0
|
2
|
|
Overall Study
Death
|
1
|
0
|
Baseline Characteristics
Evaluate Efficacy and Safety of Saxagliptin in Adult Patients With Type 2 Diabetes Inadequate Glycemic Control
Baseline characteristics by cohort
| Measure |
Saxagliptin 5 mg
n=284 Participants
Saxagliptin 5 mg tablet, once daily (OD) for 24 weeks
|
Placebo
n=284 Participants
Placebo tablet, once daily( OD) for 24 weeks
|
Total
n=568 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
51.23 Years
STANDARD_DEVIATION 10.04 • n=99 Participants
|
51.57 Years
STANDARD_DEVIATION 10.34 • n=107 Participants
|
51.4 Years
STANDARD_DEVIATION 10.18 • n=206 Participants
|
|
Sex: Female, Male
Female
|
124 Participants
n=99 Participants
|
129 Participants
n=107 Participants
|
253 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
160 Participants
n=99 Participants
|
155 Participants
n=107 Participants
|
315 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline , Week 24Population: Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Wk 24 LOCF for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement. If participant received rescue medication, that measurement must have been taken before rescue.
Adjusted\* mean change from baseline in HbA1c achieved with saxagliptin 5 mg versus placebo at week 24 (LOCF, Full Analysis set). HbA1c is a continuous measure, the change from baseline for each subject is calculated as the week 24 values minus the baseline value. HbA1c data were excluded on and after rescue medication.
Outcome measures
| Measure |
Saxagliptin 5 mg
n=277 Participants
Saxagliptin 5 mg tablet, once daily (OD) for 24 weeks
|
Placebo
n=274 Participants
Placebo tablet, once daily( OD) for 24 weeks
|
|---|---|---|
|
Absolute Change From Baseline to Week 24 in Glycosylated Haemoglobin A1c (HbA1c)
Baseline
|
8.15 percent
Standard Error 0.050
|
8.14 percent
Standard Error 0.050
|
|
Absolute Change From Baseline to Week 24 in Glycosylated Haemoglobin A1c (HbA1c)
Week 24
|
7.25 percent
Standard Error 0.063
|
7.75 percent
Standard Error 0.076
|
|
Absolute Change From Baseline to Week 24 in Glycosylated Haemoglobin A1c (HbA1c)
Adjusted Mean Change from Baseline
|
-0.84 percent
Standard Error 0.067
|
-0.34 percent
Standard Error 0.065
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Wk 24 LOCF for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement. If participant received rescue medication, that measurement must have been taken before rescue.
Adjusted\* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 5 mg versus placebo at week 24 (Last Observation Carried Forward (LOCF), Full Analysis set). FPG is a continuous measure, the change from baseline for each subject is calculated as the week 24 values minus the baseline value. FPG data were excluded on and after rescue medication.
Outcome measures
| Measure |
Saxagliptin 5 mg
n=280 Participants
Saxagliptin 5 mg tablet, once daily (OD) for 24 weeks
|
Placebo
n=279 Participants
Placebo tablet, once daily( OD) for 24 weeks
|
|---|---|---|
|
Absolute Change (mmol/L) From Baseline to Week 24 in Fasting Plasma Glucose (FPG)
Baseline
|
9.15 mmol/L
Standard Error 0.125
|
9.05 mmol/L
Standard Error 0.141
|
|
Absolute Change (mmol/L) From Baseline to Week 24 in Fasting Plasma Glucose (FPG)
week 24
|
8.10 mmol/L
Standard Error 0.129
|
8.77 mmol/L
Standard Error 0.163
|
|
Absolute Change (mmol/L) From Baseline to Week 24 in Fasting Plasma Glucose (FPG)
Adjusted mean change from Baseline
|
-0.90 mmol/L
Standard Error 0.144
|
-0.17 mmol/L
Standard Error 0.141
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Wk 24 LOCF for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement. If participant received rescue medication, that measurement must have been taken before rescue.
Adjusted\* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 5 mg versus placebo at week 24 (LOCF, Full Analysis set). FPG is a continuous measure, the change from baseline for each subject is calculated as the week 24 values minus the baseline value. FPG data were excluded on and after rescue medication.
Outcome measures
| Measure |
Saxagliptin 5 mg
n=280 Participants
Saxagliptin 5 mg tablet, once daily (OD) for 24 weeks
|
Placebo
n=279 Participants
Placebo tablet, once daily( OD) for 24 weeks
|
|---|---|---|
|
Absolute Change (mg/dL) From Baseline to Week 24 in Fasting Plasma Glucose (FPG)
Baseline
|
164.85 mg/dL
Standard Error 2.253
|
163.03 mg/dL
Standard Error 2.543
|
|
Absolute Change (mg/dL) From Baseline to Week 24 in Fasting Plasma Glucose (FPG)
Week 24
|
145.97 mg/dL
Standard Error 2.317
|
158.04 mg/dL
Standard Error 2.942
|
|
Absolute Change (mg/dL) From Baseline to Week 24 in Fasting Plasma Glucose (FPG)
Adjusted mean change from Baseline
|
-16.13 mg/dL
Standard Error 2.586
|
-3.01 mg/dL
Standard Error 2.544
|
SECONDARY outcome
Timeframe: Baseline , Week 24Population: MMTT was measured on a subset of patients in China cohort only at baseline and Wk 24. Randomized subjects, who took at least 1 dose of double-blind treatment to be included in analysis: change from baseline to Wk 24 (LOCF), must have had baseline and post-baseline data. Measurements observed on and after rescue medication were excluded.
Adjusted\* mean change from baseline in PPG AUC achieved with saxagliptin 5 mg versus placebo at week 24 (LOCF, Full Analysis set). Trapezoidal method was used to compute AUC under the 3 hour PPG curve. Change from baseline for each subject is computed as the week 24 value minus the baseline value.PPG data were excluded on and after rescue medication
Outcome measures
| Measure |
Saxagliptin 5 mg
n=94 Participants
Saxagliptin 5 mg tablet, once daily (OD) for 24 weeks
|
Placebo
n=77 Participants
Placebo tablet, once daily( OD) for 24 weeks
|
|---|---|---|
|
Absolute Change (mmol*Min/L) From Baseline to Week 24 in Area Under the Curve (AUC) From 0 to 180 Minutes for Postprandial Glucose (PPG) During Mixed Meal (Instant Noodles) Tolerance Tests (MMTT) in All MMTT Participants
Baseline
|
2474 mmol*min/L
Standard Error 46.9
|
2506 mmol*min/L
Standard Error 64.9
|
|
Absolute Change (mmol*Min/L) From Baseline to Week 24 in Area Under the Curve (AUC) From 0 to 180 Minutes for Postprandial Glucose (PPG) During Mixed Meal (Instant Noodles) Tolerance Tests (MMTT) in All MMTT Participants
Week 24
|
2063 mmol*min/L
Standard Error 41.1
|
2262 mmol*min/L
Standard Error 57.6
|
|
Absolute Change (mmol*Min/L) From Baseline to Week 24 in Area Under the Curve (AUC) From 0 to 180 Minutes for Postprandial Glucose (PPG) During Mixed Meal (Instant Noodles) Tolerance Tests (MMTT) in All MMTT Participants
Adjusted mean change from Baseline
|
-417 mmol*min/L
Standard Error 36.5
|
-235 mmol*min/L
Standard Error 40.4
|
SECONDARY outcome
Timeframe: Baseline , Week 24Population: MMTT was measured on a subset of patients in China cohort only at baseline and Wk 24. Randomized subjects, who took at least 1 dose of double-blind treatment to be included in analysis: change from baseline to Wk 24 (LOCF), must have had baseline and post-baseline data. Measurements observed on and after rescue medication were excluded.
Adjusted\* mean change from baseline in PPG AUC achieved with saxagliptin 5 mg versus placebo at week 24 (LOCF, Full Analysis set). Trapezoidal method was used to compute AUC under the 3 hour PPG curve. Change from baseline for each subject is computed as the week 24 value minus the baseline value.PPG data were excluded on and after rescue medication
Outcome measures
| Measure |
Saxagliptin 5 mg
n=94 Participants
Saxagliptin 5 mg tablet, once daily (OD) for 24 weeks
|
Placebo
n=77 Participants
Placebo tablet, once daily( OD) for 24 weeks
|
|---|---|---|
|
Absolute Change (mg*Min/dL) From Baseline to Week 24 in Area Under the Curve (AUC) From 0 to 180 Minutes for Postprandial Glucose (PPG) During Mixed Meal (Instant Noodles) Tolerance Tests (MMTT) in All MMTT Participants
Baseline
|
44586 mg*min/dL
Standard Error 844.8
|
45146 mg*min/dL
Standard Error 1170.5
|
|
Absolute Change (mg*Min/dL) From Baseline to Week 24 in Area Under the Curve (AUC) From 0 to 180 Minutes for Postprandial Glucose (PPG) During Mixed Meal (Instant Noodles) Tolerance Tests (MMTT) in All MMTT Participants
week 24
|
37166 mg*min/dL
Standard Error 739.6
|
40751 mg*min/dL
Standard Error 1036.6
|
|
Absolute Change (mg*Min/dL) From Baseline to Week 24 in Area Under the Curve (AUC) From 0 to 180 Minutes for Postprandial Glucose (PPG) During Mixed Meal (Instant Noodles) Tolerance Tests (MMTT) in All MMTT Participants
Adjusted mean change from Baseline
|
-7534 mg*min/dL
Standard Error 657.4
|
-4255 mg*min/dL
Standard Error 726.4
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Wk 24 LOCF for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement. If participant received rescue medication, that measurement must have been taken before rescue.
Proportion of participants (expressed in percentage of total participants) achieving HbA1c \< 7.0% for saxagliptin versus placebo at week 24. HbA1c Data were excluded on and after rescue medication
Outcome measures
| Measure |
Saxagliptin 5 mg
n=277 Participants
Saxagliptin 5 mg tablet, once daily (OD) for 24 weeks
|
Placebo
n=274 Participants
Placebo tablet, once daily( OD) for 24 weeks
|
|---|---|---|
|
Proportion of Patients Achieving a Therapeutic Glycemic Response Defined as HbA1c <7.0% at Week 24
|
45.8 Percentage of Participants
|
28.8 Percentage of Participants
|
Adverse Events
Saxagliptin 5 mg
Placebo
Serious adverse events
| Measure |
Saxagliptin 5 mg
n=284 participants at risk
Saxagliptin 5 mg tablet, once daily (OD) for 24 weeks
|
Placebo
n=284 participants at risk
Placebo tablet, once daily( OD) for 24 weeks
|
|---|---|---|
|
Cardiac disorders
Angina Unstable
|
0.70%
2/284
|
0.00%
0/284
|
|
Cardiac disorders
Myocardial Infarction
|
0.35%
1/284
|
0.00%
0/284
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
0.35%
1/284
|
0.00%
0/284
|
|
Injury, poisoning and procedural complications
Anal Injury
|
0.35%
1/284
|
0.00%
0/284
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.35%
1/284
|
0.00%
0/284
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.35%
1/284
|
0.00%
0/284
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.35%
1/284
|
0.00%
0/284
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/284
|
0.35%
1/284
|
|
Infections and infestations
Cellulitis
|
0.00%
0/284
|
0.35%
1/284
|
|
Infections and infestations
Pneumonia
|
0.00%
0/284
|
0.70%
2/284
|
|
Infections and infestations
Renal Abscess
|
0.00%
0/284
|
0.35%
1/284
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/284
|
0.35%
1/284
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/284
|
0.35%
1/284
|
Other adverse events
| Measure |
Saxagliptin 5 mg
n=284 participants at risk
Saxagliptin 5 mg tablet, once daily (OD) for 24 weeks
|
Placebo
n=284 participants at risk
Placebo tablet, once daily( OD) for 24 weeks
|
|---|---|---|
|
Infections and infestations
Upper Respiratory Tract Infection
|
6.3%
18/284
|
7.7%
22/284
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Principal Investigator undertakes to provide AstraZeneca as soon as possible with preliminary data and drafts of proposed publications and disclosures, whether oral or in writing, and as soon as available, with the proposed final manuscript. AstraZeneca shall have a period of 30 days from receipt of the proposed final manuscript for any publication or other disclosure to review it and may within such time require that submission for publication or disclosure of the manuscript be delayed
- Publication restrictions are in place
Restriction type: OTHER