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

NCT ID: NCT01069965

Last Updated: 2014-09-29

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 196 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2011-10-31

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.

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.

Conditions

Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

6. BGP-15

400 mg BGP-15 + Placebo

Group Type: EXPERIMENTAL

BGP-15 400 mg QD

Intervention Type: DRUG

Two 200 mg BGP-15 capsules by mouth in the morning; and two Placebo capsules by mouth in the evening

5. BGP-15

200 mg BGP-15 BID

Group Type: EXPERIMENTAL

BGP-15 200 mg BID

Intervention Type: DRUG

Two 100 mg BGP-15 capsules by mouth in the morning; and two 100 mg BGP-15 capsules by mouth in the evening

4. BGP-15

200 mg BGP-15 + Placebo

Group Type: EXPERIMENTAL

BGP-15 200 mg QD

Intervention Type: DRUG

Two 100 mg BGP-15 capsule by mouth in the morning; and two Placebo capsule by mouth in the evening

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

Group Type: EXPERIMENTAL

BGP-15 100 mg BID

Intervention Type: DRUG

One 100 mg BGP-15 capsule by mouth in the morning; and one 100 mg BGP-15 capsule by mouth in the evening

2. BGP-15

100 mg BGP-15 + placebo

Group Type: EXPERIMENTAL

BGP-15 100 mg QD

Intervention Type: DRUG

Two 50 mg BGP-15 capsules by mouth in the morning; and two Placebo capsules by mouth in the evening

1. Placebo

Placebo BID

Group Type: EXPERIMENTAL

Placebo BID

Intervention Type: DRUG

Two Placebo capsules by mouth in the morning; and two Placebo capsules by mouth in the evening

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

Placebo BID

Two Placebo capsules by mouth in the morning; and two Placebo capsules by mouth in the evening

Intervention Type: 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

Intervention Type: 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

Intervention Type: 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

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Integrium

INDUSTRY

Sponsor Role: collaborator

Msource Medical Development GmbH

UNKNOWN

Sponsor Role: collaborator

Kinexum LLC

UNKNOWN

Sponsor Role: collaborator

Thermo Fisher Scientific, Inc

INDUSTRY

Sponsor Role: collaborator

Haupt Pharma Wülfing GmbH

UNKNOWN

Sponsor Role: collaborator

Barc NV

INDUSTRY

Sponsor Role: collaborator

N-Gene Research Laboratories, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter Damsbo, MD

Role: STUDY_DIRECTOR

Kinexum LLC, Harper's Ferry, WV, USA

Robert Ratner, MD

Role: PRINCIPAL_INVESTIGATOR

Medstar Research Institute, Hyattsville, Maryland, USA

Ioanna Gouni-Berthold, MD

Role: PRINCIPAL_INVESTIGATOR

University of Cologne

Laszlo Koranyi, MD

Role: PRINCIPAL_INVESTIGATOR

Drug Research Center, Balatonfured, Hungary

Locations

Andrew J. Lewin Medical Corporation DBA National Research Institute

Los Angeles, California, United States

Center for Clinical Trials, LLC.

Paramount, California, United States

Orange County Research Center

Tustin, California, United States

Creekside Endocrine Associates PC

Denver, Colorado, United States

Clinical Research of South Florida

Coral Gables, Florida, United States

Metabolic Research Institute, Inc.

West Palm Beach, Florida, United States

Atlanta Pharmaceutical Research

Decatur, Georgia, United States

ICCT Research International, Inc.

Chicago, Illinois, United States

Medstar Health Research Institute

Hyattsville, Maryland, United States

The Center for Pharmaceutical Research, P.C.

Kansas City, Missouri, United States

Nevada Alliance Against Diabetes

Las Vegas, Nevada, United States

New Hanover Medical Research

Wilmington, North Carolina, United States

Piedmont Medical Research, LLC.

Winston-Salem, North Carolina, United States

Upstate Pharmaceutical Research

Greenville, South Carolina, United States

Mountain View Clinical Research

Greer, South Carolina, United States

Southeastern Research Associates, Inc.

Taylors, South Carolina, United States

Athens Medical Group

Athens, Tennessee, United States

Juno Research, LLC.

Houston, Texas, United States

Juno Research, LLC.

Katy, Texas, United States

Cetero Research-San Antonio

San Antonio, Texas, United States

Diabetespraxis Bad Mergentheim

Bad Mergentheim, , Germany

Universitätsklinikum Köln

Cologne, , Germany

Praxis Dr. Schätzl

Großheirath-Rossach, , Germany

Schwerpunktpraxis Diabetes

Neuwied, , Germany

Diabetologische Schwerpunktpraxis

Siegen, , Germany

DRUG Research Center Hungary Kft.

Balatonfüred, , Hungary

Semmelweis University 2nd Clinic for Internal Medicine

Budapest, , Hungary

Petz Aladar Country Teaching Hospital, Dept of Diabetology and Metabolism

Győr, , Hungary

Dr. Bugyi Istvan Hospital, Diabetology Outpatient Clinic

Szentes, , Hungary

Zala County Hospital Department of Diabetology

Zalaegerszeg, , Hungary

Countries

United States; Germany; Hungary

Other Identifiers

2009-013328-21

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

BGP-15-CLIN-IR04

Identifier Type: -

Identifier Source: org_study_id