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Clinical trialNCT01069965TerminatedPhase 2Interventional

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

SponsorN-Gene Research Laboratories, Inc.Enrollment196Diabetes Mellitus
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

30 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Germany
  • Diabetespraxis Bad Mergentheim

    Bad Mergentheim, Germany

  • Universitätsklinikum Köln

    Cologne, Germany

  • Praxis Dr. Schätzl

    Großheirath-Rossach, Germany

  • Schwerpunktpraxis Diabetes

    Neuwied, Germany

  • Diabetologische Schwerpunktpraxis

    Siegen, Germany

Hungary
  • 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

United States
  • 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

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

BGP-15 100 mg BIDBGP-15 100 mg QDBGP-15 200 mg BIDBGP-15 200 mg QDBGP-15 400 mg QDPlacebo BID
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
31 Oct 2010
Primary completion
31 Aug 2011
Completion
31 Oct 2011
Last update posted
29 Sept 2014
Registered enrollment
196
Registry id
NCT01069965

Cross-registrations

EU-CTR / CTIS (EudraCT)2009-013328-21

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.