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)

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

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

Southeastern Research Associates, Inc.; 🇺🇸 Taylors, South Carolina, United States

Schwerpunktpraxis Diabetes; 🇩🇪 Neuwied, Germany

Athens Medical Group; 🇺🇸 Athens, Tennessee, United States

Dr. Bugyi Istvan Hospital, Diabetology Outpatient Clinic; 🇭🇺 Szentes, Hungary

Mountain View Clinical Research; 🇺🇸 Greer, South Carolina, United States

DRUG Research Center Hungary Kft.; 🇭🇺 Balatonfüred, Hungary

Zala County Hospital Department of Diabetology; 🇭🇺 Zalaegerszeg, Hungary

Piedmont Medical Research, LLC.; 🇺🇸 Winston-Salem, North Carolina, United States

Praxis Dr. Schätzl; 🇩🇪 Großheirath-Rossach, Germany

Diabetespraxis Bad Mergentheim; 🇩🇪 Bad Mergentheim, Germany

Petz Aladar Country Teaching Hospital, Dept of Diabetology and Metabolism; 🇭🇺 Győr, Hungary

Diabetologische Schwerpunktpraxis; 🇩🇪 Siegen, Germany

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

Upstate Pharmaceutical Research; 🇺🇸 Greenville, South Carolina, United States

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

New Hanover Medical Research; 🇺🇸 Wilmington, North Carolina, United States

Juno Research, LLC.; 🇺🇸 Katy, Texas, United States

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

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

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

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

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

Nevada Alliance Against Diabetes; 🇺🇸 Las Vegas, Nevada, United States

Cetero Research-San Antonio; 🇺🇸 San Antonio, Texas, United States

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

Universitätsklinikum Köln; 🇩🇪 Köln, Germany

Semmelweis University 2nd Clinic for Internal Medicine; 🇭🇺 Budapest, Hungary