Safety and Efficacy of BGP-15 in Patients With Type 2 Diabetes Mellitus
Diabetes Mellitus
About this trial
This is an interventional treatment trial for Diabetes Mellitus focused on measuring Type 2
Eligibility Criteria
Inclusion criteria
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.
Exclusion criteria
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.
Sites / Locations
- Andrew J. Lewin Medical Corporation DBA National Research Institute
- Center for Clinical Trials, LLC.
- Orange County Research Center
- Creekside Endocrine Associates PC
- Clinical Research of South Florida
- Metabolic Research Institute, Inc.
- Atlanta Pharmaceutical Research
- ICCT Research International, Inc.
- Medstar Health Research Institute
- The Center for Pharmaceutical Research, P.C.
- Nevada Alliance Against Diabetes
- New Hanover Medical Research
- Piedmont Medical Research, LLC.
- Upstate Pharmaceutical Research
- Mountain View Clinical Research
- Southeastern Research Associates, Inc.
- Athens Medical Group
- Juno Research, LLC.
- Juno Research, LLC.
- Cetero Research-San Antonio
- Diabetespraxis Bad Mergentheim
- Praxis Dr. Schätzl
- Universitätsklinikum Köln
- Schwerpunktpraxis Diabetes
- Diabetologische Schwerpunktpraxis
- DRUG Research Center Hungary Kft.
- Semmelweis University 2nd Clinic for Internal Medicine
- Petz Aladar Country Teaching Hospital, Dept of Diabetology and Metabolism
- Dr. Bugyi Istvan Hospital, Diabetology Outpatient Clinic
- Zala County Hospital Department of Diabetology
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
6. BGP-15
5. BGP-15
4. BGP-15
3. BGP-15
2. BGP-15
1. Placebo
400 mg BGP-15 + Placebo
200 mg BGP-15 BID
200 mg BGP-15 + Placebo
Two 50 mg BGP-15 capsules by mouth in the morning; and two 50 mg BGP-15 capsules by mouth in the evening
100 mg BGP-15 + placebo
Placebo BID