MedTrace Logo

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 · Status: SUSPENDED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 375

Last updated 2012-03-01

No results posted yet for this study

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

Interventions

DRUG

Dapagliflozin

5mg Oral dose od

DRUG

Dapagliflozin

10 mg Oral dose od

DRUG

placebo

5/10 mg Oral dose od

Sponsors & Collaborators

Principal Investigators

  • Prof. A. Ramachandran, MD, PhD · Dr. A. Ramachandran's Diabetes Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2013-06-30
Completion
2013-06-30

Countries

  • India

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01257412 on ClinicalTrials.gov