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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

This study has suspended participant recruitment.
(FSI delayed until 15 January 2013)
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01257412
First received: December 8, 2010
Last updated: February 29, 2012
Last verified: February 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes
 Drug: Dapagliflozin
Drug: placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • change in glycosylated haemoglobin A1c (HbA1c). [ Time Frame: From baseline to week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • mean change in fasting plasma glucose (FPG) [ Time Frame: From baseline to week 24 ] [ Designated as safety issue: No ]
  • mean change in 2- hour postprandial glucose by Mixed Meal Test [ Time Frame: From baseline to week 24 ] [ Designated as safety issue: No ]
  • mean change from baseline in fasting plasma glucose (FPG) [ Time Frame: From baseline to week 1 ] [ Designated as safety issue: No ]

Estimated Enrollment: 375
Study Start Date: January 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Dapagliflozin
5mg Oral dose od
Experimental: 2 Drug: Dapagliflozin
10 mg Oral dose od
Placebo Comparator: 3 Drug: placebo
5/10 mg Oral dose od

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01257412

Locations
India
Research Site
Hyderabad, Andhra Pradesh, India
Research Site
Vijaywada, Andhra Pradesh, India
Research Site
Ahmedabad, Gujarat, India
Research Site
Bangalore, Karnataka, India
Research Site
Mysore, Karnataka, India
Research Site
Trivandrum, Kerala, India
Research Site
Indore, Madhya Pradesh, India
Research Site
Mumbai, Maharashtra, India
Research Site
Nagpur, Maharashtra, India
Research Site
Pune, Maharashtra, India
Research Site
Jaipur, Rajasthan, India
Research Site
Chennai, Tamil Nadu, India
Research Site
Coimbatore, Tamil Nadu, India
Research Site
Madurai, Tamil Nadu, India
Research Site
Ghaziabad, Uttar Pradesh, India
Sponsors and Collaborators
AstraZeneca
Bristol-Myers Squibb
Investigators
Principal Investigator: Prof. A. Ramachandran, MD, PhD Dr. A. Ramachandran's Diabetes Hospital
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01257412     History of Changes
Other Study ID Numbers: D1693C00002
Study First Received: December 8, 2010
Last Updated: February 29, 2012
Health Authority: India: Drugs Controller General of India

Keywords provided by AstraZeneca:
Phase III
Type 2 Diabetes Mellitus
inadequate glycaemic control

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on June 17, 2013