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

A 24-Week National, Multi-centre, Randomized, Parallel-group, Double-blind, Placebo-controlled, Phase IIIb Study in India to Evaluate the Efficacy and Safety of Saxagliptin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycaemic Control With Diet and Exercise

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Drug: Saxagliptin; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 213
• Phase: Phase 3

Contacts and Locations

Study Locations

• India
  • Ahmedabad
    • Gujarat, Ahmedabad, India
      • Research Site
  • Bangalore
    • Karnataka, Bangalore, India
      • Research Site
  • Chennai
    • Tamil Nadu, Chennai, India
      • Research Site
  • Coimbatore
    • Tamil Nadu, Coimbatore, India
      • Research Site
  • Hyderabad
    • Andhra Pradesh, Hyderabad, India
      • Research Site
  • Indore
    • Madhya Pradesh, Indore, India
      • Research Site
  • Karnal
    • Haryana, Karnal, India
      • Research Site
  • Kochi
    • Kerala, Kochi, India
      • Research Site
  • Pune
    • Maharashtra, Pune, India
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 2	Drug: Placebo; Oral tablet, once daily for 24 weeks
Experimental: 1; Saxagliptin	Drug: Saxagliptin; Oral tablet, once daily for 24 weeks; Other Names: Onglyza

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline , Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline , Week 24
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	Baseline , Week 24

Collaborators and Investigators

• Sponsor: AstraZeneca
• Collaborators: Bristol-Myers Squibb
• Investigators: Study Director: Peter Öhman, MD, PhD, AstraZeneca, Wilmington, USA; Study Chair: Deborah Price, MSc, AstraZeneca, Wilmington, USA

Publications and helpful links

General Publications

• Perl S, Cook W, Wei C, Iqbal N, Hirshberg B. Saxagliptin Efficacy and Safety in Patients With Type 2 Diabetes and Moderate Renal Impairment. Diabetes Ther. 2016 Sep;7(3):527-35. doi: 10.1007/s13300-016-0184-9. Epub 2016 Jul 11.

Study record dates

Study Major Dates

• Study Start: May 1, 2009
• Primary Completion (Actual): July 1, 2010
• Study Completion (Actual): July 1, 2010

Study Registration Dates

• First Submitted: June 5, 2009
• First Submitted That Met QC Criteria: June 10, 2009
• First Posted (Estimate): June 11, 2009

Study Record Updates

• Last Update Posted (Estimate): September 26, 2011
• Last Update Submitted That Met QC Criteria: August 18, 2011
• Last Verified: August 1, 2011

More Information

Terms related to this study

• Keywords: HbA1c; DPP-4 inhibitors; Incretins
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Protease Inhibitors; Incretins; Dipeptidyl-Peptidase IV Inhibitors; Saxagliptin
• Other Study ID Numbers: D1680C00008

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No