safety and efficacy of bgp-15 in patients with type 2 diabetes mellitus

Conditions: Diabetes Mellitus

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.

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.

Eligibility criteria:
inclusion criteria patients meeting all of the following criteria will be eligible for enrollment: 1. male and female patients with t2dm at time of diagnosis as defined by the american diabetes association (ada) criteria; 2. age between 30 and 70 years (inclusive); 3. hba1c ≥7.5% - ≤12.0% at screening, visit 1; 4. fpg ≤270 mg/dl (15.0 mmol/l); 5. body mass index (bmi) \>27 and ≤40 kg/m2; 6. 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; 7. women may be enrolled if all three of the following criteria are met: 1. they have a negative serum pregnancy test at screening; 2. they are not breast feeding; and, 3. 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; 8. willingness to sign an informed consent document; and, 9. 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: 1. treatment with peroxisome proliferator-activated receptor (ppar) agonists (including fibrates) within the last 3 months; 2. treatment with dipeptidyl peptidase 4 (dpp-4) inhibitors, acarbose, or incretins within the last 3 months; 3. chronic use of insulin injections within the last 1 month; 4. hypoglycemia requiring third party assistance within the last 3 months; 5. impaired hepatic function measured as alanine aminotransferase (alat) \>2x the upper reference limit; 6. impaired renal function measured as serum creatinine \>150 umol/l (1.7 mg/dl); 7. decompensated heart failure (new york heart association \[nyha\] class iii and iv); 8. unstable angina pectoris or myocardial infarction within the last 12 months; 9. clinically significant ecg abnormalities at screening including qtc interval (bazett's) ≥450 msec or av block \>1st degree; 10. uncontrolled, treated or untreated hypertension (systolic blood pressure \[bp\] ≥160 mmhg and/or diastolic bp ≥100 mmhg); 11. 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; 12. pregnancy or breastfeeding, the intention to become pregnant, or judged to be using inadequate contraceptive measures; 13. history of alcohol and/or drug dependence within the last 2 years; 14. receipt of any investigational drug or medical device within 3 months prior to this trial; 15. fasting triglycerides \>700 mg/dl at screening; or, 16. diagnosis or treatment of cancer within the past 5 years except for excision of basal cell or squamous cell skin lesions.

Keywords: type 2