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

NCT01069965 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 196

Last updated 2014-09-29

No results posted yet for this study

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

Interventions

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

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

DRUG

Placebo BID

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

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

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

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

Sponsors & Collaborators

  • Integrium

    collaborator INDUSTRY

  • Msource Medical Development GmbH

    collaborator UNKNOWN

  • Kinexum LLC

    collaborator UNKNOWN

  • Thermo Fisher Scientific, Inc

    collaborator INDUSTRY

  • Haupt Pharma Wülfing GmbH

    collaborator UNKNOWN

  • Barc NV

    collaborator INDUSTRY

  • N-Gene Research Laboratories, Inc.

    lead INDUSTRY

Principal Investigators

  • Peter Damsbo, MD · Kinexum LLC, Harper's Ferry, WV, USA

  • Robert Ratner, MD · Medstar Research Institute, Hyattsville, Maryland, USA

  • Ioanna Gouni-Berthold, MD · University of Cologne

  • Laszlo Koranyi, MD · Drug Research Center, Balatonfured, Hungary

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2011-08-31
Completion
2011-10-31

Countries

  • United States
  • Germany
  • Hungary

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01069965 on ClinicalTrials.gov