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

Sponsor
N-Gene Research Laboratories, Inc. (Industry)
Overall Status
Terminated
CT.gov ID
NCT01069965
Collaborator
Integrium (Industry), Msource Medical Development GmbH (Other), Kinexum LLC (Other), Thermo Fisher Scientific, Inc (Industry), Haupt Pharma Wülfing GmbH (Other), Barc NV (Industry)
196
Enrollment
30
Locations
6
Arms
12
Duration (Months)
6.5
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • 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

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
196 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, 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
Study Start Date :
Oct 1, 2010
Actual Primary Completion Date :
Aug 1, 2011
Actual Study Completion Date :
Oct 1, 2011

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. Change from Baseline in Glycosylated Hemoglobin at Week 13 [Baseline and Week 13]

Secondary Outcome Measures

  1. Change from Baseline in Fasting Plasma Glucose at Weeks 4, 8, 13 [Baseline and Weeks 4, 8, and 13]

  2. Change from Baseline in Plasma Glucose at Week 13 [Baseline and Week 13]

  3. Cardiovascular and metabolic biomarkers at Baseline and 13 weeks [Baseline and Week 13]

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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:

  8. They have a negative serum pregnancy test at Screening;

  9. They are not breast feeding; and,

  10. They do not plan to become pregnant during the study AND if one of the following three criteria is met:

  1. 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,
  1. 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;

  1. Willingness to sign an informed consent document; and,

  2. 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

Locations

Site City State Country Postal Code
1 Andrew J. Lewin Medical Corporation DBA National Research Institute Los Angeles California United States 90057
2 Center for Clinical Trials, LLC. Paramount California United States 90723
3 Orange County Research Center Tustin California United States 92780
4 Creekside Endocrine Associates PC Denver Colorado United States 80209
5 Clinical Research of South Florida Coral Gables Florida United States 33134
6 Metabolic Research Institute, Inc. West Palm Beach Florida United States 33401
7 Atlanta Pharmaceutical Research Decatur Georgia United States 30033
8 ICCT Research International, Inc. Chicago Illinois United States 60611
9 Medstar Health Research Institute Hyattsville Maryland United States 20782
10 The Center for Pharmaceutical Research, P.C. Kansas City Missouri United States 64114
11 Nevada Alliance Against Diabetes Las Vegas Nevada United States 89101
12 New Hanover Medical Research Wilmington North Carolina United States 28401
13 Piedmont Medical Research, LLC. Winston-Salem North Carolina United States 27103
14 Upstate Pharmaceutical Research Greenville South Carolina United States 29615
15 Mountain View Clinical Research Greer South Carolina United States 29651
16 Southeastern Research Associates, Inc. Taylors South Carolina United States 29687
17 Athens Medical Group Athens Tennessee United States 37303
18 Juno Research, LLC. Houston Texas United States 77074
19 Juno Research, LLC. Katy Texas United States 77451
20 Cetero Research-San Antonio San Antonio Texas United States 78229
21 Diabetespraxis Bad Mergentheim Bad Mergentheim Germany 97980
22 Praxis Dr. Schätzl Großheirath-Rossach Germany 96269
23 Universitätsklinikum Köln Köln Germany 50937
24 Schwerpunktpraxis Diabetes Neuwied Germany 56564
25 Diabetologische Schwerpunktpraxis Siegen Germany 57072
26 DRUG Research Center Hungary Kft. Balatonfüred Hungary 8230
27 Semmelweis University 2nd Clinic for Internal Medicine Budapest Hungary 1088
28 Petz Aladar Country Teaching Hospital, Dept of Diabetology and Metabolism Győr Hungary 9024
29 Dr. Bugyi Istvan Hospital, Diabetology Outpatient Clinic Szentes Hungary 6600
30 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, Inc
  • 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
  • Principal Investigator: Laszlo Koranyi, MD, Drug Research Center, Balatonfured, Hungary

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
N-Gene Research Laboratories, Inc.
ClinicalTrials.gov Identifier:
NCT01069965
Other Study ID Numbers:
  • BGP-15-CLIN-IR04
  • 2009-013328-21
First Posted:
Feb 17, 2010
Last Update Posted:
Sep 29, 2014
Last Verified:
Sep 1, 2014
Keywords provided by N-Gene Research Laboratories, Inc.
Type 2
Additional relevant MeSH terms:
Diabetes Mellitus
BGP 15

Study Results

No Results Posted as of Sep 29, 2014