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

Type 2 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00918879
• Other study ID #: D1680C00008
• Status: Completed
• Phase: Phase 3
• First received: June 5, 2009
• Last updated: August 18, 2011
• Start date: May 2009
• Est. completion date: July 2010

Study information

• Verified date: August 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Drugs Controller General of India
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 213
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• Saxagliptin
Oral tablet, once daily for 24 weeks
• Placebo
Oral tablet, once daily for 24 weeks

Locations

Country	Name	City	State
India	Research Site	Andhra Pradesh	Hyderabad
India	Research Site	Gujarat	Ahmedabad
India	Research Site	Haryana	Karnal
India	Research Site	Karnataka	Bangalore
India	Research Site	Kerala	Kochi
India	Research Site	Madhya Pradesh	Indore
India	Research Site	Maharashtra	Pune
India	Research Site	Tamil Nadu	Chennai
India	Research Site	Tamil Nadu	Coimbatore

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Bristol-Myers Squibb

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Baseline , Week 24	No
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.	Baseline , Week 24	No
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	Baseline , Week 24	No