Evaluate Efficacy and Safety of Saxagliptin in Adult Indian Patients with Type 2 Diabetes inadequate glycemic control.

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2009/091/000217
• Date of registration: 29-05-2009
• Prospective Registration: No
• Primary sponsor: AstraZeneca AB
• Public title: Evaluate Efficacy and Safety of Saxagliptin in Adult Indian Patients with Type 2 Diabetes inadequate glycemic control.
• Scientific 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.
• Date of first enrolment: 27-05-2009
• Target sample size: 213
• Recruitment status: Completed
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=470
• Study type: Interventional
• Study design: Randomized, Parallel Group, Placebo Controlled Trial; Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Participant, Investigator and Outcome Assessor Blinded
• Phase: Phase 3

Countries of recruitment

India

Contacts

• Name: Ms Ranju Sharma

• Name: Dr Bhavesh Kotak

Key inclusion & exclusion criteria

Inclusion criteria: Key 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: Key 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

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- Type 2 Diabetes Health Condition 2: E119- Type 2 diabetes mellitus without complications

Intervention(s)

Intervention1: saxagliptin: Plain, yellow, biconvex, round,film coated. Treatment is planned for 24 weeks
Control Intervention1: Placebo: Plain,yellow,biconvex,round,film coated tablet to match saxagliptin

Primary Outcome(s)

The Primary Outcome measure is absolute change from baseline in glycocylated haemoglobin A1c (HbA1c) after 24 weeks oral administrationTimepoint: 24 Weeks

Secondary Outcome(s)

The Secondary Outcome measures are to compare the effects of Saxagliptin versus placebo after 24 weeks double-blind treatment for the following: - The change from baseline in fasting plasma glucose (FPG)- The proportion of patients achieving a therapeutic glycaemic response defined as HbA1c 7.0%- Change from baseline in beta cell function and insulin sensitivity (as measured by Homeostasis Model Assessment- HOMA-2).Timepoint: 24 Weeks

Secondary ID(s)

D1680C00008

Source(s) of Monetary Support

AstraZeneca Pharma India Ltd.Bangalore-560 024, Karnataka, India

Secondary Sponsor(s)

Collaborator BristolMyers Squibb

Ethics review

Status: Approved
Approval date:
Contact:

Ethics Committee - Dr. V. Seshiah Diabetes Care & Research Institute, Chennai

Status: Approved
Approval date:
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Ethics Committee- Bangalore Diabetic Hospital

Status: Approved
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Contact:

Ethics Committee of Diabetes Thyroid Hormone Research Institute Pvt. Ltd, Indore

Status: Approved
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Contact:

Institutional Ethics Committee - Amrita Institute of Medical Sciences

Status: Approved
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Contact:

Institutional Ethics Committee - B.R.I.D.E. , Karnal

Status: Approved
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Institutional Ethics Committee -Nizam's Institute

Status: Approved
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Contact:

KEM Hospital Research Centre Ethics Committee

Status: Approved
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Medisys Clinisearch Ethical Review Board, Bangalore

Status: Approved
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Poona Medical Research Foundation

Status: Approved
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Regional Ethics Committee, Coimbatore

Status: Approved
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Contact:

Science For Health

Status: Approved
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Contact:

Sterling Hospital Ethics Committee

Status: Not Applicable
Approval date:
Contact:

Clinicom (Address:Bhooma No.7, 17A Cross, Malleshwaram west, Bangalore - 560055)

Results

• Date Completed: 27/07/2010