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

NCT01069965 | Terminated Phase 2

• 2 other identifiers: BGP-15-CLIN-IR042009-013328-21
• Study Type: interventional
• Target: 196
• Locations: 3 countries
• Sites: 30

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.

Conditions

Diabetes Mellitus

Keywords

Type 2

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Glycosylated Hemoglobin at Week 13

  Baseline and Week 13

Secondary Outcomes (3)

• Change from Baseline in Fasting Plasma Glucose at Weeks 4, 8, 13

  Baseline and Weeks 4, 8, and 13

• Change from Baseline in Plasma Glucose at Week 13

  Baseline and Week 13

• Cardiovascular and metabolic biomarkers at Baseline and 13 weeks

  Baseline and Week 13

Study Arms (6)

6. BGP-15

EXPERIMENTAL

400 mg BGP-15 + Placebo

Drug: BGP-15 400 mg QD

5. BGP-15

EXPERIMENTAL

200 mg BGP-15 BID

Drug: BGP-15 200 mg BID

4. BGP-15

EXPERIMENTAL

200 mg BGP-15 + Placebo

Drug: BGP-15 200 mg QD

3. BGP-15

EXPERIMENTAL

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

2. BGP-15

EXPERIMENTAL

100 mg BGP-15 + placebo

Drug: BGP-15 100 mg QD

1. Placebo

EXPERIMENTAL

Placebo BID

Drug: Placebo BID

Interventions

BGP-15 100 mg QD DRUG

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

2. BGP-15

BGP-15 100 mg BID DRUG

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

3. BGP-15

Placebo BID DRUG

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

1. Placebo

BGP-15 200 mg QD DRUG

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

4. BGP-15

BGP-15 200 mg BID DRUG

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

5. BGP-15

BGP-15 400 mg QD DRUG

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

6. BGP-15

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients meeting all of the following criteria will be eligible for enrollment:
• Male and female patients with T2DM at time of diagnosis as defined by the American Diabetes Association (ADA) criteria;
• Age between 30 and 70 years (inclusive);
• HbA1c ≥7.5% - ≤12.0% at Screening, Visit 1;
• FPG ≤270 mg/dL (15.0 mmol/L);
• Body mass index (BMI) \>27 and ≤40 kg/m2;
• 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;
• Women may be enrolled if all three of the following criteria are met:
• They have a negative serum pregnancy test at Screening;
• They are not breast feeding; and,
• 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;
• Willingness to sign an informed consent document; and,
• No conditions that hinder participation in the trial, as determined by the Investigator and Sponsor.

You may not qualify if:

• Patients meeting any of the following criteria will be ineligible for enrollment:
• Treatment with peroxisome proliferator-activated receptor (PPAR) agonists (including fibrates) within the last 3 months;
• Treatment with dipeptidyl peptidase 4 (DPP-4) inhibitors, acarbose, or incretins within the last 3 months;
• Chronic use of insulin injections within the last 1 month;
• Hypoglycemia requiring third party assistance within the last 3 months;
• Impaired hepatic function measured as alanine aminotransferase (ALAT) \>2X the upper reference limit;
• Impaired renal function measured as serum creatinine \>150 umol/L (1.7 mg/dL);
• Decompensated heart failure (New York Heart Association \[NYHA\] class III and IV);
• Unstable angina pectoris or myocardial infarction within the last 12 months;
• Clinically significant ECG abnormalities at screening including QTc interval (Bazett's) ≥450 msec or AV block \>1st degree;
• Uncontrolled, treated or untreated hypertension (systolic blood pressure \[BP\] ≥160 mmHg and/or diastolic BP ≥100 mmHg);
• 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;
• Pregnancy or breastfeeding, the intention to become pregnant, or judged to be using inadequate contraceptive measures;
• History of alcohol and/or drug dependence within the last 2 years;
• Receipt of any investigational drug or medical device within 3 months prior to this trial;

Sponsors & Collaborators

• N-Gene Research Laboratories, Inc.: lead
• Integrium: collaborator
• Msource Medical Development GmbH: collaborator
• Kinexum LLC: collaborator
• Thermo Fisher Scientific, Inc: collaborator
• Haupt Pharma Wülfing GmbH: collaborator
• Barc NV: collaborator

Study Sites (30)

Andrew J. Lewin Medical Corporation DBA National Research Institute

Los Angeles, California, 90057, United States

Location

Center for Clinical Trials, LLC.

Paramount, California, 90723, United States

Location

Orange County Research Center

Tustin, California, 92780, United States

Location

Creekside Endocrine Associates PC

Denver, Colorado, 80209, United States

Location

Clinical Research of South Florida

Coral Gables, Florida, 33134, United States

Location

Metabolic Research Institute, Inc.

West Palm Beach, Florida, 33401, United States

Location

Atlanta Pharmaceutical Research

Decatur, Georgia, 30033, United States

Location

ICCT Research International, Inc.

Chicago, Illinois, 60611, United States

Location

Medstar Health Research Institute

Hyattsville, Maryland, 20782, United States

Location

The Center for Pharmaceutical Research, P.C.

Kansas City, Missouri, 64114, United States

Location

Nevada Alliance Against Diabetes

Las Vegas, Nevada, 89101, United States

Location

New Hanover Medical Research

Wilmington, North Carolina, 28401, United States

Location

Piedmont Medical Research, LLC.

Winston-Salem, North Carolina, 27103, United States

Location

Upstate Pharmaceutical Research

Greenville, South Carolina, 29615, United States

Location

Mountain View Clinical Research

Greer, South Carolina, 29651, United States

Location

Southeastern Research Associates, Inc.

Taylors, South Carolina, 29687, United States

Location

Athens Medical Group

Athens, Tennessee, 37303, United States

Location

Juno Research, LLC.

Houston, Texas, 77074, United States

Location

Juno Research, LLC.

Katy, Texas, 77451, United States

Location

Cetero Research-San Antonio

San Antonio, Texas, 78229, United States

Location

Diabetespraxis Bad Mergentheim

Bad Mergentheim, 97980, Germany

Location

Universitätsklinikum Köln

Cologne, 50937, Germany

Location

Praxis Dr. Schätzl

Großheirath-Rossach, 96269, Germany

Location

Schwerpunktpraxis Diabetes

Neuwied, 56564, Germany

Location

Diabetologische Schwerpunktpraxis

Siegen, 57072, Germany

Location

DRUG Research Center Hungary Kft.

Balatonfüred, 8230, Hungary

Location

Semmelweis University 2nd Clinic for Internal Medicine

Budapest, 1088, Hungary

Location

Petz Aladar Country Teaching Hospital, Dept of Diabetology and Metabolism

Győr, 9024, Hungary

Location

Dr. Bugyi Istvan Hospital, Diabetology Outpatient Clinic

Szentes, 6600, Hungary

Location

Zala County Hospital Department of Diabetology

Zalaegerszeg, 8900, Hungary

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

BGP 15; BID protein, human

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Peter Damsbo, MD

  Kinexum LLC, Harper's Ferry, WV, USA

  STUDY DIRECTOR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2010
• First Posted: February 17, 2010
• Study Start: October 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: October 1, 2011
• Last Updated: September 29, 2014

Record last verified: 2014-09

Locations

DE (5); HU (5); US (20)