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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01069965

  Hide Study Locations
Locations
United States, California
Andrew J. Lewin Medical Corporation DBA National Research Institute
Los Angeles, California, United States, 90057
Center for Clinical Trials, LLC.
Paramount, California, United States, 90723
Orange County Research Center
Tustin, California, United States, 92780
United States, Colorado
Creekside Endocrine Associates PC
Denver, Colorado, United States, 80209
United States, Florida
Clinical Research of South Florida
Coral Gables, Florida, United States, 33134
Metabolic Research Institute, Inc.
West Palm Beach, Florida, United States, 33401
United States, Georgia
Atlanta Pharmaceutical Research
Decatur, Georgia, United States, 30033
United States, Illinois
ICCT Research International, Inc.
Chicago, Illinois, United States, 60611
United States, Maryland
Medstar Health Research Institute
Hyattsville, Maryland, United States, 20782
United States, Missouri
The Center for Pharmaceutical Research, P.C.
Kansas City, Missouri, United States, 64114
United States, Nevada
Nevada Alliance Against Diabetes
Las Vegas, Nevada, United States, 89101
United States, North Carolina
New Hanover Medical Research
Wilmington, North Carolina, United States, 28401
Piedmont Medical Research, LLC.
Winston-Salem, North Carolina, United States, 27103
United States, South Carolina
Upstate Pharmaceutical Research
Greenville, South Carolina, United States, 29615
Mountain View Clinical Research
Greer, South Carolina, United States, 29651
Southeastern Research Associates, Inc.
Taylors, South Carolina, United States, 29687
United States, Tennessee
Athens Medical Group
Athens, Tennessee, United States, 37303
United States, Texas
Juno Research, LLC.
Houston, Texas, United States, 77074
Juno Research, LLC.
Katy, Texas, United States, 77451
Cetero Research-San Antonio
San Antonio, Texas, United States, 78229
Germany
Diabetespraxis Bad Mergentheim
Bad Mergentheim, Germany, 97980
Praxis Dr. Schätzl
Großheirath-Rossach, Germany, 96269
Universitätsklinikum Köln
Köln, Germany, 50937
Schwerpunktpraxis Diabetes
Neuwied, Germany, 56564
Diabetologische Schwerpunktpraxis
Siegen, Germany, 57072
Hungary
DRUG Research Center Hungary Kft.
Balatonfüred, Hungary, 8230
Semmelweis University 2nd Clinic for Internal Medicine
Budapest, Hungary, 1088
Petz Aladar Country Teaching Hospital, Dept of Diabetology and Metabolism
Győr, Hungary, 9024
Dr. Bugyi Istvan Hospital, Diabetology Outpatient Clinic
Szentes, Hungary, 6600
Zala County Hospital Department of Diabetology
Zalaegerszeg, Hungary, 8900
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 August 19, 2014