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Diabetes MellitusPhase 2NCT01069965

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

A Phase 2 study testing BGP-15 100 mg QD, BGP-15 100 mg BID and BGP-15 200 mg QD in people with Diabetes Mellitus, run by N-Gene Research Laboratories, Inc. at 30 sites in 3 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 30 to 70 years
Conditions the study is for
Diabetes Mellitus
What is being tested?
BGP-15 100 mg QD, BGP-15 100 mg BID and BGP-15 200 mg QD
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
196 participants
Where
30 sitesin 3 countries
Study dates
Oct 2010to Oct 2011
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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:
  • 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.

Who cannot join

  • 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;
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  • 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;
  • Fasting triglycerides >700 mg/dL at screening; or,
  • Diagnosis or treatment of cancer within the past 5 years except for excision of basal cell or squamous cell skin lesions.

Trial locations and contacts

30 sites in 3 countries.

30 sites in 3 countries

United States20 sites

  • Athens Medical Group

    Athens, Tennessee, 37303

  • ICCT Research International, Inc.

    Chicago, Illinois, 60611

  • Clinical Research of South Florida

    Coral Gables, Florida, 33134

  • Atlanta Pharmaceutical Research

    Decatur, Georgia, 30033

  • Creekside Endocrine Associates PC

    Denver, Colorado, 80209

  • Upstate Pharmaceutical Research

    Greenville, South Carolina, 29615

  • Mountain View Clinical Research

    Greer, South Carolina, 29651

  • Juno Research, LLC.

    Houston, Texas, 77074

  • Medstar Health Research Institute

    Hyattsville, Maryland, 20782

  • The Center for Pharmaceutical Research, P.C.

    Kansas City, Missouri, 64114

  • Juno Research, LLC.

    Katy, Texas, 77451

  • Nevada Alliance Against Diabetes

    Las Vegas, Nevada, 89101

  • Andrew J. Lewin Medical Corporation DBA National Research Institute

    Los Angeles, California, 90057

  • Center for Clinical Trials, LLC.

    Paramount, California, 90723

  • Cetero Research-San Antonio

    San Antonio, Texas, 78229

  • Southeastern Research Associates, Inc.

    Taylors, South Carolina, 29687

  • Orange County Research Center

    Tustin, California, 92780

  • Metabolic Research Institute, Inc.

    West Palm Beach, Florida, 33401

  • New Hanover Medical Research

    Wilmington, North Carolina, 28401

  • Piedmont Medical Research, LLC.

    Winston-Salem, North Carolina, 27103

Other trials in United States

Germany5 sites

  • Diabetespraxis Bad Mergentheim

    Bad Mergentheim, 97980

  • Universitätsklinikum Köln

    Cologne, 50937

  • Praxis Dr. Schätzl

    Großheirath-Rossach, 96269

  • Schwerpunktpraxis Diabetes

    Neuwied, 56564

  • Diabetologische Schwerpunktpraxis

    Siegen, 57072

Other trials in Germany

Hungary5 sites

  • DRUG Research Center Hungary Kft.

    Balatonfüred, 8230

  • Semmelweis University 2nd Clinic for Internal Medicine

    Budapest, 1088

  • Petz Aladar Country Teaching Hospital, Dept of Diabetology and Metabolism

    Győr, 9024

  • Dr. Bugyi Istvan Hospital, Diabetology Outpatient Clinic

    Szentes, 6600

  • Zala County Hospital Department of Diabetology

    Zalaegerszeg, 8900

Other trials in Hungary

About this study

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

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.

Read the 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.
Being tested
BGP-15 100 mg QD, BGP-15 100 mg BID, Placebo BID, BGP-15 200 mg QD, BGP-15 200 mg BID
Keywords
Type 2
Medical subject headings
Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BGP-15 100 mg QDDrug

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

  • BGP-15 100 mg BIDDrug

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

  • Placebo BIDDrug

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

  • BGP-15 200 mg QDDrug

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

  • BGP-15 200 mg BIDDrug

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

  • BGP-15 400 mg QDDrug

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

Study groups in NCT01069965
Study groupRoleWhat they receive
6. BGP-15Experimental400 mg BGP-15 + Placebo
Receives: Drug: BGP-15 400 mg QD
5. BGP-15Experimental200 mg BGP-15 BID
Receives: Drug: BGP-15 200 mg BID
4. BGP-15Experimental200 mg BGP-15 + Placebo
Receives: Drug: BGP-15 200 mg QD
3. BGP-15ExperimentalTwo 50 mg BGP-15 capsules by mouth in the morning; and two 50 mg BGP-15 capsules by mouth in the evening
Receives: Drug: BGP-15 100 mg BID
2. BGP-15Experimental100 mg BGP-15 + placebo
Receives: Drug: BGP-15 100 mg QD
1. PlaceboExperimentalPlacebo BID
Receives: Drug: Placebo BID

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Baseline in Glycosylated Hemoglobin at Week 13

    Measured: Baseline and Week 13

Secondary outcomes (3)

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

    Measured: Baseline and Weeks 4, 8, and 13

  2. Change from Baseline in Plasma Glucose at Week 13

    Measured: Baseline and Week 13

  3. Cardiovascular and metabolic biomarkers at Baseline and 13 weeks

    Measured: Baseline and Week 13

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Feb 2010 (estimated)
  2. Study startOct 2010
  3. Primary completionAug 2011
  4. Study completionOct 2011

Why it stopped: Funding support withdrawn.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
196 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01069965
Sponsor's protocol ID
BGP-15-CLIN-IR04
Other IDs
2009-013328-21, 2009
Status last verified
Sep 2014
First submitted
16 Feb 2010
Last updated
29 Sep 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BGP-15 100 mg QD, BGP-15 100 mg BID and BGP-15 200 mg QD in people with Diabetes Mellitus, run by N-Gene Research Laboratories, Inc. at 30 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 29 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in United States, Germany, Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Funding support withdrawn.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline in Glycosylated Hemoglobin at Week 13 (time frame: Baseline and Week 13). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01069965.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2014.

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