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

• Status: Terminated
• Trial end date: 2011-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: N-Gene Research Laboratories, Inc.
• Collaborators: Barc NV; Haupt Pharma Wülfing GmbH; Integrium; Kinexum LLC; Msource Medical Development GmbH; Thermo Fisher Scientific
• Treatments: BGP 15

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.