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

Phase 2

Terminated

• Conditions: Diabetes Mellitus
• Interventions: Drug: BGP-15 100 mg QD; Drug: BGP-15 100 mg BID; Drug: BGP-15 400 mg QD; Drug: BGP-15 200 mg QD; Drug: BGP-15 200 mg BID; Drug: Placebo BID

• Registration Number: NCT01069965
• Lead Sponsor: N-Gene Research Laboratories, Inc.

Brief 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.

Detailed 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 Timeline

• Study First Submitted: 2010-02-16
• Study First Submitted QC: 2010-02-16
• Study First Posted: 2010-02-17
• Study Start: 2010-10
• Primary Completion: 2011-08
• Study Completion: 2011-10
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-26
• Last Update Posted: 2014-09-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 196

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2. BGP-15	BGP-15 100 mg QD	100 mg BGP-15 + placebo
3. BGP-15	BGP-15 100 mg BID	Two 50 mg BGP-15 capsules by mouth in the morning; and two 50 mg BGP-15 capsules by mouth in the evening
6. BGP-15	BGP-15 400 mg QD	400 mg BGP-15 + Placebo
4. BGP-15	BGP-15 200 mg QD	200 mg BGP-15 + Placebo
5. BGP-15	BGP-15 200 mg BID	200 mg BGP-15 BID
1. Placebo	Placebo BID	Placebo BID

Primary Outcome Measures

Name	Time	Method
Change from Baseline in Glycosylated Hemoglobin at Week 13	Baseline and Week 13

Secondary Outcome Measures

Name	Time	Method
Change from Baseline in Fasting Plasma Glucose at Weeks 4, 8, 13	Baseline and Weeks 4, 8, and 13
Change from Baseline in Plasma Glucose at Week 13	Baseline and Week 13
Cardiovascular and metabolic biomarkers at Baseline and 13 weeks	Baseline and Week 13

Trial Locations

Locations (29)

Andrew J. Lewin Medical Corporation DBA National Research Institute; 🇺🇸 Los Angeles, California, United States

Center for Clinical Trials, LLC.; 🇺🇸 Paramount, California, United States

Orange County Research Center; 🇺🇸 Tustin, California, United States

Creekside Endocrine Associates PC; 🇺🇸 Denver, Colorado, United States

Clinical Research of South Florida; 🇺🇸 Coral Gables, Florida, United States

Metabolic Research Institute, Inc.; 🇺🇸 West Palm Beach, Florida, United States

Atlanta Pharmaceutical Research; 🇺🇸 Decatur, Georgia, United States

ICCT Research International, Inc.; 🇺🇸 Chicago, Illinois, United States

Medstar Health Research Institute; 🇺🇸 Hyattsville, Maryland, United States

The Center for Pharmaceutical Research, P.C.; 🇺🇸 Kansas City, Missouri, United States

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