Trial Outcomes & Findings for Evaluate Saxagliptin in Adult Indian Patients With Type 2 Diabetes Inadequate Glycemic Control (NCT NCT00918879)
NCT ID: NCT00918879
Last Updated: 2011-09-26
Results Overview
Adjusted\* mean change from baseline in glycosylated haemoglobin A1c (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
213 participants
Baseline , Week 24
2011-09-26
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
|
107
|
106
|
|
Overall Study
COMPLETED
|
101
|
100
|
|
Overall Study
NOT COMPLETED
|
6
|
6
|
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
Withdrawal by Subject
|
4
|
4
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Severe non-compliance to protocol
|
1
|
1
|
Baseline Characteristics
Evaluate Saxagliptin in Adult Indian Patients With Type 2 Diabetes Inadequate Glycemic Control
Baseline characteristics by cohort
| Measure |
Saxagliptin 5 mg
n=107 Participants
Saxagliptin 5 mg tablet, once daily( OD) for 24 weeks
|
Placebo
n=106 Participants
Placebo tablet, once daily( OD) for 24 weeks
|
Total
n=213 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
49.07 Years
STANDARD_DEVIATION 8.77 • n=5 Participants
|
48.29 Years
STANDARD_DEVIATION 9.59 • n=7 Participants
|
48.68 Years
STANDARD_DEVIATION 9.17 • n=5 Participants
|
|
Sex: Female, Male
Female
|
50 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
57 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
120 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline , Week 24Population: Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of 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 glycosylated haemoglobin A1c (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=104 Participants
Saxagliptin 5 mg tablet, once daily( OD) for 24 weeks
|
Placebo
n=105 Participants
Placebo tablet, once daily( OD) for 24 weeks
|
|---|---|---|
|
Absolute Change From Baseline to Week 24 in Glycosylated Haemoglobin A1c (HbA1c)
Baseline
|
8.33 percent
Standard Error 0.080
|
8.33 percent
Standard Error 0.072
|
|
Absolute Change From Baseline to Week 24 in Glycosylated Haemoglobin A1c (HbA1c)
Week 24
|
7.82 percent
Standard Error 0.116
|
8.28 percent
Standard Error 0.114
|
|
Absolute Change From Baseline to Week 24 in Glycosylated Haemoglobin A1c (HbA1c)
Adjusted Change from Baseline to Week 24
|
-0.51 percent
Standard Error 0.098
|
-0.05 percent
Standard Error 0.098
|
SECONDARY outcome
Timeframe: Baseline , Week 24Population: Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of 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=106 Participants
Saxagliptin 5 mg tablet, once daily( OD) for 24 weeks
|
Placebo
n=104 Participants
Placebo tablet, once daily( OD) for 24 weeks
|
|---|---|---|
|
Absolute Change From Baseline to Week 24 in Fasting Plasma Glucose (FPG)
Baseline
|
150.77 mg/dL
Standard Error 3.569
|
151.35 mg/dL
Standard Error 3.693
|
|
Absolute Change From Baseline to Week 24 in Fasting Plasma Glucose (FPG)
Week 24
|
140.58 mg/dL
Standard Error 3.326
|
151.02 mg/dL
Standard Error 4.833
|
|
Absolute Change From Baseline to Week 24 in Fasting Plasma Glucose (FPG)
Adjusted Change from Baseline to Week 24
|
-10.35 mg/dL
Standard Error 3.827
|
-0.16 mg/dL
Standard Error 3.863
|
SECONDARY outcome
Timeframe: Baseline , Week 24Population: Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of 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=106 Participants
Saxagliptin 5 mg tablet, once daily( OD) for 24 weeks
|
Placebo
n=104 Participants
Placebo tablet, once daily( OD) for 24 weeks
|
|---|---|---|
|
Absolute Change From Baseline to Week 24 in Fasting Plasma Glucose (FPG)
Baseline
|
8.37 mmol/L
Standard Error 0.198
|
8.40 mmol/L
Standard Error 0.205
|
|
Absolute Change From Baseline to Week 24 in Fasting Plasma Glucose (FPG)
Week 24
|
7.80 mmol/L
Standard Error 0.185
|
8.38 mmol/L
Standard Error 0.268
|
|
Absolute Change From Baseline to Week 24 in Fasting Plasma Glucose (FPG)
Adjusted Change from Baseline to Week 24
|
-0.58 mmol/L
Standard Error 0.212
|
-0.00 mmol/L
Standard Error 0.214
|
SECONDARY outcome
Timeframe: Baseline , Week 24Population: Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of 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 (LOCF, Full Analysis set). HbA1c data were excluded on and after rescue medication
Outcome measures
| Measure |
Saxagliptin 5 mg
n=104 Participants
Saxagliptin 5 mg tablet, once daily( OD) for 24 weeks
|
Placebo
n=105 Participants
Placebo tablet, once daily( OD) for 24 weeks
|
|---|---|---|
|
Proportion of Patients (Expressed in Percentage of Total Participants) Achieving a Therapeutic Glycemic Response Defined as HbA1c < 7.0% at Week 24
|
22.1 Percentage of Participants
|
13.3 Percentage of Participants
|
Adverse Events
Saxagliptin 5 mg
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Saxagliptin 5 mg
n=107 participants at risk
Saxagliptin 5 mg tablet, once daily( OD) for 24 weeks
|
Placebo
n=106 participants at risk
Placebo tablet, once daily( OD) for 24 weeks
|
|---|---|---|
|
Infections and infestations
Urinary Tract Infection
|
8.4%
9/107
|
9.4%
10/106
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place