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

September 26, 2014 updated by: N-Gene Research Laboratories, Inc.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
196

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

30 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change from Baseline in Glycosylated Hemoglobin at Week 13
Time Frame: Baseline and Week 13
Baseline and Week 13

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change from Baseline in Fasting Plasma Glucose at Weeks 4, 8, 13
Time Frame: Baseline and Weeks 4, 8, and 13
Baseline and Weeks 4, 8, and 13
Change from Baseline in Plasma Glucose at Week 13
Time Frame: Baseline and Week 13
Baseline and Week 13
Cardiovascular and metabolic biomarkers at Baseline and 13 weeks
Time Frame: Baseline and Week 13
Baseline and Week 13

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
N-Gene Research Laboratories, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Thermo Fisher Scientific, Inc
Integrium
Msource Medical Development GmbH
Kinexum LLC
Haupt Pharma Wülfing GmbH
Barc NV

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 16, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 16, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 17, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 29, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 26, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BGP-15-CLIN-IR04
  • 2009-013328-21 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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