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

This study has been terminated.
Sponsor:
Collaborators:
Integrium
Msource Medical Development GmbH
Kinexum LLC
Thermo Fisher Scientific
Haupt Pharma Wülfing GmbH
BARC nv
Information provided by (Responsible Party):
N-Gene Research Laboratories, Inc.
ClinicalTrials.gov Identifier:
NCT01069965
First received: February 16, 2010
Last updated: July 31, 2013
Last verified: July 2013

February 16, 2010
July 31, 2013
October 2010
August 2013   (final data collection date for primary outcome measure)
Change from Baseline in Glycosylated Hemoglobin at Week 13 [ Time Frame: Baseline and Week 13 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01069965 on ClinicalTrials.gov Archive Site
  • Change from Baseline in Fasting Plasma Glucose at Weeks 4, 8, 13 [ Time Frame: Baseline and Weeks 4, 8, and 13 ] [ Designated as safety issue: No ]
  • Change from Baseline in Plasma Glucose at Week 13 [ Time Frame: Baseline and Week 13 ] [ Designated as safety issue: No ]
  • Cardiovascular and metabolic biomarkers at Baseline and 13 weeks [ Time Frame: Baseline and Week 13 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Safety and Efficacy of BGP-15 in Patients With Type 2 Diabetes Mellitus
Randomized, Double-blind, Placebo-controlled, Parallel Group, Multiple Dose, Multicenter Study to Assess Safety & Efficacy of BGP-15 Administered Orally 1 or 2 Times Daily With Metformin & Sulfonylurea or Metformin in T2 Diabetic Patients

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.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Diabetes Mellitus
  • Drug: BGP-15 100 mg QD
    Two 50 mg BGP-15 capsules by mouth in the morning; and two Placebo capsules by mouth in the evening
  • Drug: BGP-15 100 mg BID
    One 100 mg BGP-15 capsule by mouth in the morning; and one 100 mg BGP-15 capsule by mouth in the evening
  • Drug: Placebo BID
    Two Placebo capsules by mouth in the morning; and two Placebo capsules by mouth in the evening
  • Drug: BGP-15 200 mg QD
    Two 100 mg BGP-15 capsule by mouth in the morning; and two Placebo capsule by mouth in the evening
  • Drug: BGP-15 200 mg BID
    Two 100 mg BGP-15 capsules by mouth in the morning; and two 100 mg BGP-15 capsules by mouth in the evening
  • Drug: BGP-15 400 mg QD
    Two 200 mg BGP-15 capsules by mouth in the morning; and two Placebo capsules by mouth in the evening
  • Experimental: 6. BGP-15
    400 mg BGP-15 + Placebo
    Intervention: Drug: BGP-15 400 mg QD
  • Experimental: 5. BGP-15
    200 mg BGP-15 BID
    Intervention: Drug: BGP-15 200 mg BID
  • Experimental: 4. BGP-15
    200 mg BGP-15 + Placebo
    Intervention: Drug: BGP-15 200 mg QD
  • Experimental: 3. BGP-15
    Two 50 mg BGP-15 capsules by mouth in the morning; and two 50 mg BGP-15 capsules by mouth in the evening
    Intervention: Drug: BGP-15 100 mg BID
  • Experimental: 2. BGP-15
    100 mg BGP-15 + placebo
    Intervention: Drug: BGP-15 100 mg QD
  • Experimental: 1. Placebo
    Placebo BID
    Intervention: Drug: Placebo BID
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
300
August 2013
August 2013   (final data collection date for primary outcome measure)

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.
Both
30 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Germany,   Hungary
 
NCT01069965
BGP-15-CLIN-IR04, 2009-013328-21
No
N-Gene Research Laboratories, Inc.
N-Gene Research Laboratories, Inc.
  • Integrium
  • Msource Medical Development GmbH
  • Kinexum LLC
  • Thermo Fisher Scientific
  • Haupt Pharma Wülfing GmbH
  • BARC nv
Study Director: Peter Damsbo, MD Kinexum LLC, Harper's Ferry, WV, USA
Principal Investigator: Robert Ratner, MD Medstar Research Institute, Hyattsville, Maryland, USA
Principal Investigator: Ioanna Gouni-Berthold, MD University of Cologne, Germany
Principal Investigator: Laszlo Koranyi, MD Drug Research Center, Balatonfured, Hungary
N-Gene Research Laboratories, Inc.
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP