Evaluate Saxagliptin in Adult Indian Patients With Type 2 Diabetes Inadequate Glycemic Control

Phase 3

Completed

• Conditions: Type 2 Diabetes
• Interventions: Drug: Saxagliptin; Drug: Placebo

• Registration Number: NCT00918879
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-06-05
• Study First Submitted QC: 2009-06-10
• Study First Posted: 2009-06-11
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Results First Submitted: 2011-06-28
• Status Verified: 2011-08
• Results First Submitted QC: 2011-08-18
• Last Update Submitted: 2011-08-18
• Results First Posted: 2011-09-26
• Last Update Posted: 2011-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 213

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Saxagliptin	Saxagliptin
2	Placebo	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Research Site; 🇮🇳 Maharashtra, Pune, India