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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Diabetes Mellitus

In brief

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.

Key facts

Study ID: NCT01069965
Run by: N-Gene Research Laboratories, Inc.
People needed: 196
Starts: 2010-10-01
Expected to finish: 2011-10-01
Last updated by the study team: 2014-09-29

Who can join

Age: 30 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patients meeting all of the following criteria will be eligible for enrollment:
Male and female patients with T2DM at time of diagnosis as defined by the American Diabetes Association (ADA) criteria;
Age between 30 and 70 years (inclusive);
HbA1c ≥7.5% - ≤12.0% at Screening, Visit 1;
FPG ≤270 mg/dL (15.0 mmol/L);
Body mass index (BMI) >27 and ≤40 kg/m2;
Current treatment with either metformin alone or in combination with SU. The dose of the current treatment must be stable for at least 8 weeks prior to randomization. Patients being treated with metformin must be at their optimal or near-optimal dose (≥1500 mg/day ± 500 mg/day for a range of 1000 to 2000 mg/day), and patients being treated with SU must be receiving at least one half of the maximum approved SU dose;
Women may be enrolled if all three of the following criteria are met:
They have a negative serum pregnancy test at Screening;
They are not breast feeding; and,
They do not plan to become pregnant during the study AND if one of the following three criteria is met:
i. They have had a hysterectomy or tubal ligation at least 6 months prior to signing the informed consent form; ii. They have been postmenopausal for at least 1 year; or, iii. They are of childbearing potential and will practice one of the following methods of birth control throughout the study: injectable or implantable hormonal contraception or intrauterine device; or two of the following methods of birth control throughout the study: oral or patch contraception plus a barrier contraceptive (eg, diaphragm plus spermicide, male or female condom plus spermicide, or vasectomized male partner). Abstinence, partner's use of condoms, and vasectomy are NOT acceptable methods of contraception;
Willingness to sign an informed consent document; and,
No conditions that hinder participation in the trial, as determined by the Investigator and Sponsor.

You may not qualify if…

Patients meeting any of the following criteria will be ineligible for enrollment:
Treatment with peroxisome proliferator-activated receptor (PPAR) agonists (including fibrates) within the last 3 months;
Treatment with dipeptidyl peptidase 4 (DPP-4) inhibitors, acarbose, or incretins within the last 3 months;
Chronic use of insulin injections within the last 1 month;
Hypoglycemia requiring third party assistance within the last 3 months;
Impaired hepatic function measured as alanine aminotransferase (ALAT) >2X the upper reference limit;
Impaired renal function measured as serum creatinine >150 umol/L (1.7 mg/dL);
Decompensated heart failure (New York Heart Association [NYHA] class III and IV);
Unstable angina pectoris or myocardial infarction within the last 12 months;
Clinically significant ECG abnormalities at screening including QTc interval (Bazett's) ≥450 msec or AV block >1st degree;
Uncontrolled, treated or untreated hypertension (systolic blood pressure [BP] ≥160 mmHg and/or diastolic BP ≥100 mmHg);
Any condition that the Investigator and/or Sponsor feel would interfere with trial participation or evaluation of the results eg, drug abuse or serious disease such as acquired immunodeficiency syndrome/human immunodeficiency syndrome (AIDS/HIV) antibodies, Hepatitis B, or Hepatitis C;
Pregnancy or breastfeeding, the intention to become pregnant, or judged to be using inadequate contraceptive measures;
History of alcohol and/or drug dependence within the last 2 years;
Receipt of any investigational drug or medical device within 3 months prior to this trial;
Fasting triglycerides >700 mg/dL at screening; or,
Diagnosis or treatment of cancer within the past 5 years except for excision of basal cell or squamous cell skin lesions.

Where it is running

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
Nevada Alliance Against Diabetes — Las Vegas, Nevada, United States
New Hanover Medical Research — Wilmington, North Carolina, United States
Piedmont Medical Research, LLC. — Winston-Salem, North Carolina, United States
Upstate Pharmaceutical Research — Greenville, South Carolina, United States
Mountain View Clinical Research — Greer, South Carolina, United States
Southeastern Research Associates, Inc. — Taylors, South Carolina, United States
Athens Medical Group — Athens, Tennessee, United States
Juno Research, LLC. — Houston, Texas, United States
Juno Research, LLC. — Katy, Texas, United States
Cetero Research-San Antonio — San Antonio, Texas, United States
Diabetespraxis Bad Mergentheim — Bad Mergentheim, Germany
Universitätsklinikum Köln — Cologne, Germany
Praxis Dr. Schätzl — Großheirath-Rossach, Germany
Schwerpunktpraxis Diabetes — Neuwied, Germany
Diabetologische Schwerpunktpraxis — Siegen, Germany

Full record on ClinicalTrials.gov

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