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
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus
Drug: BGP-15 100 mg QD
Drug: BGP-15 100 mg BID
Drug: Placebo BID
Drug: BGP-15 200 mg QD
Drug: BGP-15 200 mg BID
Drug: BGP-15 400 mg QD
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by N-Gene Research Laboratories, Inc.:

Primary Outcome Measures:
  • Change from Baseline in Glycosylated Hemoglobin at Week 13 [ Time Frame: Baseline and Week 13 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 300
Study Start Date: October 2010
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 6. BGP-15
400 mg BGP-15 + Placebo
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: 5. BGP-15
200 mg BGP-15 BID
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
Experimental: 4. BGP-15
200 mg BGP-15 + Placebo
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
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
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
Experimental: 2. BGP-15
100 mg BGP-15 + placebo
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
Experimental: 1. Placebo
Placebo BID
Drug: Placebo BID
Two Placebo capsules by mouth in the morning; and two Placebo capsules by mouth in the evening

Detailed Description:

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

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01069965

  Show 30 Study Locations
Sponsors and Collaborators
N-Gene Research Laboratories, Inc.
Integrium
Msource Medical Development GmbH
Kinexum LLC
Thermo Fisher Scientific
Haupt Pharma Wülfing GmbH
BARC nv
Investigators
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
  More Information

No publications provided

Responsible Party: N-Gene Research Laboratories, Inc.
ClinicalTrials.gov Identifier: NCT01069965     History of Changes
Other Study ID Numbers: BGP-15-CLIN-IR04, 2009-013328-21
Study First Received: February 16, 2010
Last Updated: July 31, 2013
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy

Keywords provided by N-Gene Research Laboratories, Inc.:
Type 2

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 23, 2014