Type 2 Diabetes
Conditions
Keywords
DPP-4 inhibitors, HbA1c, Incretins
Brief summary
Saxagliptin is a new investigational medication being developed for treatment of type 2 diabetes. This study is designed to evaluate the efficacy and safety in adult Indian patients with inadequate glycaemic control with diet and exercise.
Interventions
DRUGSaxagliptin
Oral tablet, once daily for 24 weeks
DRUGPlacebo
Oral tablet, once daily for 24 weeks
Sponsors
Bristol-Myers Squibb
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosed with Type 2 diabetes * Patients should be drug naïve ie, not received medical treatment for diabetes * HbA1c ≥ 7.2% and ≤10.0% (at enrolment), HbA1c ≥ 7.0% and ≤10.0% (at randomization)
Exclusion criteria
* Insulin therapy within one year of enrolment (with the exception of insulin therapy during a hospitalization or use in gestational diabetes) * Type 1 diabetes,history of ketoacidosis or hyperosmolar non-ketonic koma
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Absolute Change From Baseline to Week 24 in Glycosylated Haemoglobin A1c (HbA1c) | Baseline , Week 24 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Absolute Change From Baseline to Week 24 in Fasting Plasma Glucose (FPG) | Baseline , Week 24 | 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. |
| Proportion of Patients (Expressed in Percentage of Total Participants) Achieving a Therapeutic Glycemic Response Defined as HbA1c < 7.0% at Week 24 | Baseline , Week 24 | 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 |
Countries
India
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Saxagliptin 5 mg Saxagliptin 5 mg tablet, once daily( OD) for 24 weeks | 107 |
| Placebo Placebo tablet, once daily( OD) for 24 weeks | 106 |
| Total | 213 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 1 |
| Overall Study | Severe non-compliance to protocol | 1 | 1 |
| Overall Study | Withdrawal by Subject | 4 | 4 |
Baseline characteristics
| Characteristic | Saxagliptin 5 mg | Placebo | Total |
|---|---|---|---|
| Age Continuous | 49.07 Years STANDARD_DEVIATION 8.77 | 48.29 Years STANDARD_DEVIATION 9.59 | 48.68 Years STANDARD_DEVIATION 9.17 |
| Sex: Female, Male Female | 50 Participants | 43 Participants | 93 Participants |
| Sex: Female, Male Male | 57 Participants | 63 Participants | 120 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 9 / 107 | 10 / 106 |
| serious Total, serious adverse events | 0 / 107 | 0 / 106 |
Outcome results
Primary
Absolute Change From Baseline to Week 24 in Glycosylated Haemoglobin A1c (HbA1c)
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.
Time frame: Baseline , Week 24
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Saxagliptin 5 mg | Absolute Change From Baseline to Week 24 in Glycosylated Haemoglobin A1c (HbA1c) | Baseline | 8.33 percent | Standard Error 0.08 |
| Saxagliptin 5 mg | Absolute Change From Baseline to Week 24 in Glycosylated Haemoglobin A1c (HbA1c) | Week 24 | 7.82 percent | Standard Error 0.116 |
| Saxagliptin 5 mg | 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 |
| Placebo | Absolute Change From Baseline to Week 24 in Glycosylated Haemoglobin A1c (HbA1c) | Baseline | 8.33 percent | Standard Error 0.072 |
| Placebo | Absolute Change From Baseline to Week 24 in Glycosylated Haemoglobin A1c (HbA1c) | Week 24 | 8.28 percent | Standard Error 0.114 |
| Placebo | Absolute Change From Baseline to Week 24 in Glycosylated Haemoglobin A1c (HbA1c) | Adjusted Change from Baseline to Week 24 | -0.05 percent | Standard Error 0.098 |
p-value: 0.001195% CI: [-0.73, -0.18]ANCOVA
Secondary
Absolute Change From Baseline to Week 24 in Fasting Plasma Glucose (FPG)
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.
Time frame: Baseline , Week 24
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Saxagliptin 5 mg | Absolute Change From Baseline to Week 24 in Fasting Plasma Glucose (FPG) | Baseline | 150.77 mg/dL | Standard Error 3.569 |
| Saxagliptin 5 mg | Absolute Change From Baseline to Week 24 in Fasting Plasma Glucose (FPG) | Week 24 | 140.58 mg/dL | Standard Error 3.326 |
| Saxagliptin 5 mg | 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 |
| Placebo | Absolute Change From Baseline to Week 24 in Fasting Plasma Glucose (FPG) | Adjusted Change from Baseline to Week 24 | -0.16 mg/dL | Standard Error 3.863 |
| Placebo | Absolute Change From Baseline to Week 24 in Fasting Plasma Glucose (FPG) | Baseline | 151.35 mg/dL | Standard Error 3.693 |
| Placebo | Absolute Change From Baseline to Week 24 in Fasting Plasma Glucose (FPG) | Week 24 | 151.02 mg/dL | Standard Error 4.833 |
p-value: 0.062395% CI: [-20.91, 0.53]ANCOVA
Secondary
Absolute Change From Baseline to Week 24 in Fasting Plasma Glucose (FPG)
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.
Time frame: Baseline , Week 24
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Saxagliptin 5 mg | Absolute Change From Baseline to Week 24 in Fasting Plasma Glucose (FPG) | Baseline | 8.37 mmol/L | Standard Error 0.198 |
| Saxagliptin 5 mg | Absolute Change From Baseline to Week 24 in Fasting Plasma Glucose (FPG) | Week 24 | 7.80 mmol/L | Standard Error 0.185 |
| Saxagliptin 5 mg | 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 |
| Placebo | Absolute Change From Baseline to Week 24 in Fasting Plasma Glucose (FPG) | Baseline | 8.40 mmol/L | Standard Error 0.205 |
| Placebo | Absolute Change From Baseline to Week 24 in Fasting Plasma Glucose (FPG) | Week 24 | 8.38 mmol/L | Standard Error 0.268 |
| Placebo | Absolute Change From Baseline to Week 24 in Fasting Plasma Glucose (FPG) | Adjusted Change from Baseline to Week 24 | -0.00 mmol/L | Standard Error 0.214 |
p-value: 0.062395% CI: [-1.17, 0.02]ANCOVA
Secondary
Proportion of Patients (Expressed in Percentage of Total Participants) Achieving a Therapeutic Glycemic Response Defined as HbA1c < 7.0% at Week 24
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
Time frame: Baseline , Week 24
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Saxagliptin 5 mg | 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 |
| Placebo | Proportion of Patients (Expressed in Percentage of Total Participants) Achieving a Therapeutic Glycemic Response Defined as HbA1c < 7.0% at Week 24 | 13.3 Percentage of Participants |
95% CI: [-1.7, 19.3]Fisher Exact