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Safety and Efficacy of BGP-15 in Patients With Type 2 Diabetes Mellitus

2014-08-27 03:15:50 | BioPortfolio

Summary

This is a safety and dose finding efficacy study to evaluate the effects of BGP-15 over the dose range of 100 mg/day to 400 mg/day. Doses are applied once or twice a day for 13 weeks as add-on therapy to the combination of metformin and sulfonylurea treatment or metformin alone in patients with Type 2 Diabetes Mellitus.

Description

This is a randomized, double-blind, placebo-controlled, parallel group, multiple dose, multicenter study with 5 treatment arms and 1 placebo arm. Patients should be treated with both metformin and SU or metformin alone. Patients will be randomized to 100,100 + 100, 200, 200 + 200, and 400 mg/day or placebo, as an add-on to their current treatment. The study consists of 2 periods:

- A 14-day screening period for ascertaining the inclusion/exclusion criteria; and,

- A 13-week treatment period with different doses of BGP-15 or placebo as an add-on therapy to metformin and SU treatment or metformin treatment alone.

Study Design

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

Conditions

Diabetes Mellitus

Intervention

BGP-15 100 mg QD, BGP-15 100 mg BID, Placebo BID, BGP-15 200 mg QD, BGP-15 200 mg BID, BGP-15 400 mg QD

Status

Not yet recruiting

Source

N-Gene Research Laboratories, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:15:50-0400

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