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

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes

Treatments: Drug: Saxagliptin; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00918879

D1680C00008

Details and patient eligibility

About

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.

Enrollment: 213 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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213 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

Saxagliptin

Treatment:

Drug: Saxagliptin

2

Placebo Comparator group

Treatment:

Drug: Placebo