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

Type 2 Diabetes Clinical Trial

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.

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT01257412
• Other study ID #: D1693C00002
• Status: Suspended
• Phase: Phase 3
• First received: December 8, 2010
• Last updated: February 29, 2012
• Start date: January 2012
• Est. completion date: June 2013

Study information

• Verified date: February 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Drugs Controller General of India
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 375
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• Dapagliflozin
5mg Oral dose od
• Dapagliflozin
10 mg Oral dose od
• placebo
5/10 mg Oral dose od

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Bristol-Myers Squibb

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in glycosylated haemoglobin A1c (HbA1c).		From baseline to week 24	No
Secondary	mean change in fasting plasma glucose (FPG)		From baseline to week 24	No
Secondary	mean change in 2- hour postprandial glucose by Mixed Meal Test		From baseline to week 24	No
Secondary	mean change from baseline in fasting plasma glucose (FPG)		From baseline to week 1	No