Skip to main content
OpenTrials
Completed

NCT Number: NCT00918879

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Gujarat, Ahmedabad, India

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Saxagliptin

Drug

Oral tablet, once daily for 24 weeks

Other names: Onglyza

Placebo

Drug

Oral tablet, once daily for 24 weeks

Primary outcomes

  1. Absolute Change From Baseline to Week 24 in Glycosylated Haemoglobin A1c (HbA1c)

    Time frame: 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 outcomes

  1. Absolute Change From Baseline to Week 24 in Fasting Plasma Glucose (FPG)

    Time frame: 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.

  2. Proportion of Patients (Expressed in Percentage of Total Participants) Achieving a Therapeutic Glycemic Response Defined as HbA1c < 7.0% at Week 24

    Time frame: 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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • Bristol-Myers Squibb

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jun 11, 2009
Registry last updated
Sep 26, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.