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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

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ClinicalTrials.gov Identifier: NCT01257412
Recruitment Status : Suspended (FSI delayed until 15 January 2013)
First Posted : December 9, 2010
Last Update Posted : March 1, 2012
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
AstraZeneca

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Drug: Dapagliflozin Drug: placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 375 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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.
Study Start Date : January 2012
Estimated Primary Completion Date : June 2013
Estimated Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. change in glycosylated haemoglobin A1c (HbA1c). [ Time Frame: From baseline to week 24 ]

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


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01257412     History of Changes
Other Study ID Numbers: D1693C00002
First Posted: December 9, 2010    Key Record Dates
Last Update Posted: March 1, 2012
Last Verified: February 2012

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