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

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00918879
First received: June 5, 2009
Last updated: August 18, 2011
Last verified: August 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes
 Drug: Saxagliptin
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

Drug Information available for: Saxagliptin
U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Absolute Change From Baseline to Week 24 in Glycosylated Haemoglobin A1c (HbA1c) [ Time Frame: Baseline , Week 24 ] [ Designated as safety issue: No ]
    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:
  • Absolute Change From Baseline to Week 24 in Fasting Plasma Glucose (FPG) [ Time Frame: Baseline , Week 24 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline , Week 24 ] [ Designated as safety issue: No ]
    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


Enrollment: 213
Study Start Date: May 2009
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Saxagliptin
 Drug: Saxagliptin
Oral tablet, once daily for 24 weeks
Other Name: Onglyza
Placebo Comparator: 2 Drug: Placebo
Oral tablet, once daily for 24 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00918879

Locations
India
Research Site
Gujarat, Ahmedabad, India
Research Site
Karnataka, Bangalore, India
Research Site
Tamil Nadu, Chennai, India
Research Site
Tamil Nadu, Coimbatore, India
Research Site
Andhra Pradesh, Hyderabad, India
Research Site
Madhya Pradesh, Indore, India
Research Site
Haryana, Karnal, India
Research Site
Kerala, Kochi, India
Research Site
Maharashtra, Pune, India
Sponsors and Collaborators
AstraZeneca
Bristol-Myers Squibb
Investigators
Study Director: Peter Ohman, MD, PhD AstraZeneca, Wilmington, USA
Study Chair: Deborah Price, MSc AstraZeneca, Wilmington, USA
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00918879     History of Changes
Other Study ID Numbers: D1680C00008
Study First Received: June 5, 2009
Results First Received: June 28, 2011
Last Updated: August 18, 2011
Health Authority: India: Drugs Controller General of India

Keywords provided by AstraZeneca:
DPP-4 inhibitors
HbA1c
Incretins

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Saxagliptin
Dipeptidyl-Peptidase IV Inhibitors
 Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 22, 2013