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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

Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Type 2 Diabetes

Intervention: Dapagliflozin (Drug); Dapagliflozin (Drug); placebo (Drug)

Phase: Phase 3

Status: Suspended

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Prof. A. Ramachandran, MD, PhD, Principal Investigator, Affiliation: Dr. A. Ramachandran's Diabetes Hospital

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.

Clinical Details

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

Primary outcome: change in glycosylated haemoglobin A1c (HbA1c).

Secondary outcome:

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)

Eligibility

Minimum age: 19 Years. Maximum age: N/A. Gender(s): Both.

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)

Locations and Contacts

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

Additional Information

Starting date: January 2012
Last updated: February 29, 2012

Page last updated: August 23, 2015

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