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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

Primary Purpose

Type 2 Diabetes

Status
Suspended
Phase
Phase 3
Locations
India
Study Type
Interventional
Intervention
Dapagliflozin
Dapagliflozin
placebo
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring Phase III, Type 2 Diabetes Mellitus, inadequate glycaemic control

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

1

2

3

Arm Description

Outcomes

Primary Outcome Measures

change in glycosylated haemoglobin A1c (HbA1c).

Secondary Outcome Measures

mean change in fasting plasma glucose (FPG)
mean change in 2- hour postprandial glucose by Mixed Meal Test
mean change from baseline in fasting plasma glucose (FPG)

Full Information

First Posted
December 8, 2010
Last Updated
February 29, 2012
Sponsor
AstraZeneca
Collaborators
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT01257412
Brief Title
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
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Suspended
Why Stopped
FSI delayed until 15 January 2013
Study Start Date
January 2012 (undefined)
Primary Completion Date
June 2013 (Anticipated)
Study Completion Date
June 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
Collaborators
Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
Phase III, Type 2 Diabetes Mellitus, inadequate glycaemic control

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
375 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Arm Title
3
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Dapagliflozin
Intervention Description
5mg Oral dose od
Intervention Type
Drug
Intervention Name(s)
Dapagliflozin
Intervention Description
10 mg Oral dose od
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
5/10 mg Oral dose od
Primary Outcome Measure Information:
Title
change in glycosylated haemoglobin A1c (HbA1c).
Time Frame
From baseline to week 24
Secondary Outcome Measure Information:
Title
mean change in fasting plasma glucose (FPG)
Time Frame
From baseline to week 24
Title
mean change in 2- hour postprandial glucose by Mixed Meal Test
Time Frame
From baseline to week 24
Title
mean change from baseline in fasting plasma glucose (FPG)
Time Frame
From baseline to week 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prof. A. Ramachandran, MD, PhD
Organizational Affiliation
Dr. A. Ramachandran's Diabetes Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Hyderabad
State/Province
Andhra Pradesh
Country
India
Facility Name
Research Site
City
Vijaywada
State/Province
Andhra Pradesh
Country
India
Facility Name
Research Site
City
Ahmedabad
State/Province
Gujarat
Country
India
Facility Name
Research Site
City
Bangalore
State/Province
Karnataka
Country
India
Facility Name
Research Site
City
Mysore
State/Province
Karnataka
Country
India
Facility Name
Research Site
City
Trivandrum
State/Province
Kerala
Country
India
Facility Name
Research Site
City
Indore
State/Province
Madhya Pradesh
Country
India
Facility Name
Research Site
City
Mumbai
State/Province
Maharashtra
Country
India
Facility Name
Research Site
City
Nagpur
State/Province
Maharashtra
Country
India
Facility Name
Research Site
City
Pune
State/Province
Maharashtra
Country
India
Facility Name
Research Site
City
Jaipur
State/Province
Rajasthan
Country
India
Facility Name
Research Site
City
Chennai
State/Province
Tamil Nadu
Country
India
Facility Name
Research Site
City
Coimbatore
State/Province
Tamil Nadu
Country
India
Facility Name
Research Site
City
Madurai
State/Province
Tamil Nadu
Country
India
Facility Name
Research Site
City
Ghaziabad
State/Province
Uttar Pradesh
Country
India

12. IPD Sharing Statement

Learn more about this trial

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

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