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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.

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
GroupInterventionDescription
2. BGP-15BGP-15 100 mg QD100 mg BGP-15 + placebo
3. BGP-15BGP-15 100 mg BIDTwo 50 mg BGP-15 capsules by mouth in the morning; and two 50 mg BGP-15 capsules by mouth in the evening
6. BGP-15BGP-15 400 mg QD400 mg BGP-15 + Placebo
4. BGP-15BGP-15 200 mg QD200 mg BGP-15 + Placebo
5. BGP-15BGP-15 200 mg BID200 mg BGP-15 BID
1. PlaceboPlacebo BIDPlacebo BID
Primary Outcome Measures
NameTimeMethod
Change from Baseline in Glycosylated Hemoglobin at Week 13Baseline and Week 13
Secondary Outcome Measures
NameTimeMethod
Change from Baseline in Fasting Plasma Glucose at Weeks 4, 8, 13Baseline and Weeks 4, 8, and 13
Change from Baseline in Plasma Glucose at Week 13Baseline and Week 13
Cardiovascular and metabolic biomarkers at Baseline and 13 weeksBaseline 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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Andrew J. Lewin Medical Corporation DBA National Research Institute
🇺🇸Los Angeles, California, United States

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