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

NCT01257412 | Suspended Phase 3

• 1 other identifier: D1693C00002
• Study Type: interventional
• Target: 375
• Locations: 1 country
• Sites: 15

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.

Conditions

Type 2 Diabetes

Keywords

Phase III; Type 2 Diabetes Mellitus; inadequate glycaemic control

Outcome Measures

Primary Outcomes (1)

• change in glycosylated haemoglobin A1c (HbA1c).

  From baseline to week 24

Secondary Outcomes (3)

• mean change in fasting plasma glucose (FPG)

  From baseline to week 24

• mean change in 2- hour postprandial glucose by Mixed Meal Test

  From baseline to week 24

• mean change from baseline in fasting plasma glucose (FPG)

  From baseline to week 1

Study Arms (3)

1

EXPERIMENTAL

Drug: Dapagliflozin

2

EXPERIMENTAL

Drug: Dapagliflozin

3

PLACEBO COMPARATOR

Drug: placebo

Interventions

Dapagliflozin DRUG

5mg Oral dose od

1

placebo DRUG

5/10 mg Oral dose od

3

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• AstraZeneca: lead
• Bristol-Myers Squibb: collaborator

Study Sites (15)

Research Site

Hyderabad, Andhra Pradesh, India

Location

Research Site

Vijaywada, Andhra Pradesh, India

Location

Research Site

Ahmedabad, Gujarat, India

Location

Research Site

Bangalore, Karnataka, India

Location

Research Site

Mysore, Karnataka, India

Location

Research Site

Trivandrum, Kerala, India

Location

Research Site

Indore, Madhya Pradesh, India

Location

Research Site

Mumbai, Maharashtra, India

Location

Research Site

Nagpur, Maharashtra, India

Location

Research Site

Pune, Maharashtra, India

Location

Research Site

Jaipur, Rajasthan, India

Location

Research Site

Chennai, Tamil Nadu, India

Location

Research Site

Coimbatore, Tamil Nadu, India

Location

Research Site

Madurai, Tamil Nadu, India

Location

Research Site

Ghaziabad, Uttar Pradesh, India

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

dapagliflozin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Prof. A. Ramachandran, MD, PhD

  Dr. A. Ramachandran's Diabetes Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2010
• First Posted: December 9, 2010
• Study Start: January 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: March 1, 2012

Record last verified: 2012-02

Locations

IN (15)