Evaluate Efficacy and Safety of 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.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2009/091/000217

Enrollment

213

Registered

2009-05-29

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

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 saxagl

Eligibility

Inclusion criteria

Inclusion criteria: Key inclusion criteria- - Diagnosed with Type 2 diabetes- Patients should be drug naÃ¯ve 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

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

India

Contacts

Public ContactMs Ranju Sharma

bhavesh.kotak@astrazeneca.com91-80-67748514

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026