Evaluation of Efficacy and Safety of Dapagliflozin as Monotherapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycaemic Control With Diet and Exercise Alone

February 29, 2012 updated by: AstraZeneca

A 24-week National Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase III Trial in India to Evaluate the Efficacy and Safety of Dapagliflozin as Monotherapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycaemic Control With Diet and Exercise Alone.

This study intends to compare the efficacy and safety of dapagliflozin versus placebo in treatment-naïve subjects with type 2 diabetes who have inadequate glycaemic control with diet and exercise alone.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

375

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Andhra Pradesh
      • Hyderabad, Andhra Pradesh, India
        • Research Site
      • Vijaywada, Andhra Pradesh, India
        • Research Site
    • Gujarat
      • Ahmedabad, Gujarat, India
        • Research Site
    • Karnataka
      • Bangalore, Karnataka, India
        • Research Site
      • Mysore, Karnataka, India
        • Research Site
    • Kerala
      • Trivandrum, Kerala, India
        • Research Site
    • Madhya Pradesh
      • Indore, Madhya Pradesh, India
        • Research Site
    • Maharashtra
      • Mumbai, Maharashtra, India
        • Research Site
      • Nagpur, Maharashtra, India
        • Research Site
      • Pune, Maharashtra, India
        • Research Site
    • Rajasthan
      • Jaipur, Rajasthan, India
        • Research Site
    • Tamil Nadu
      • Chennai, Tamil Nadu, India
        • Research Site
      • Coimbatore, Tamil Nadu, India
        • Research Site
      • Madurai, Tamil Nadu, India
        • Research Site
    • Uttar Pradesh
      • Ghaziabad, Uttar Pradesh, India
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Provision of informed consent before participating in the study
  • Diagnosed with type 2 diabetes (high blood sugar); HbA1c ≥ 7.2% and ≤10.0%
  • Subjects should be drug naïve
  • Women of childbearing potential who comply to use an adequate method of contraception to avoid pregnancy throughout the study & who have a negative serum or urine pregnancy test

Exclusion Criteria:

  • Subjects received Insulin therapy within one year of enrollment
  • Subjects who have severe uncontrolled hypertension
  • Subjects who have history of unstable or rapidly progressing renal disease
  • Subjects who have severe liver disease
  • Subjects who receiving treatment for Human immunodeficiency virus (HIV)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: Dapagliflozin
5mg Oral dose od
Drug: Dapagliflozin
10 mg Oral dose od
Experimental: 2
Drug: Dapagliflozin
5mg Oral dose od
Drug: Dapagliflozin
10 mg Oral dose od
Placebo Comparator: 3
Drug: placebo
5/10 mg Oral dose od

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
change in glycosylated haemoglobin A1c (HbA1c).
Time Frame: From baseline to week 24
From baseline to week 24

Secondary Outcome Measures

Outcome Measure
Time Frame
mean change in fasting plasma glucose (FPG)
Time Frame: From baseline to week 24
From baseline to week 24
mean change in 2- hour postprandial glucose by Mixed Meal Test
Time Frame: From baseline to week 24
From baseline to week 24
mean change from baseline in fasting plasma glucose (FPG)
Time Frame: From baseline to week 1
From baseline to week 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Collaborators

Bristol-Myers Squibb

Investigators

  • Principal Investigator: Prof. A. Ramachandran, MD, PhD, Dr. A. Ramachandran's Diabetes Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Anticipated)

June 1, 2013

Study Completion (Anticipated)

June 1, 2013

Study Registration Dates

First Submitted

December 8, 2010

First Submitted That Met QC Criteria

December 8, 2010

First Posted (Estimate)

December 9, 2010

Study Record Updates

Last Update Posted (Estimate)

March 1, 2012

Last Update Submitted That Met QC Criteria

February 29, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D1693C00002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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