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

PHASE2TerminatedINTERVENTIONAL
Enrollment

196

Participants

Timeline

Start Date

October 31, 2010

Primary Completion Date

August 31, 2011

Study Completion Date

October 31, 2011

Conditions
Diabetes Mellitus
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

Trial Locations (30)

1088

Semmelweis University 2nd Clinic for Internal Medicine, Budapest

6600

Dr. Bugyi Istvan Hospital, Diabetology Outpatient Clinic, Szentes

8230

DRUG Research Center Hungary Kft., Balatonfüred

8900

Zala County Hospital Department of Diabetology, Zalaegerszeg

9024

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

20782

Medstar Health Research Institute, Hyattsville

27103

Piedmont Medical Research, LLC., Winston-Salem

28401

New Hanover Medical Research, Wilmington

29615

Upstate Pharmaceutical Research, Greenville

29651

Mountain View Clinical Research, Greer

29687

Southeastern Research Associates, Inc., Taylors

30033

Atlanta Pharmaceutical Research, Decatur

33134

Clinical Research of South Florida, Coral Gables

33401

Metabolic Research Institute, Inc., West Palm Beach

37303

Athens Medical Group, Athens

50937

Universitätsklinikum Köln, Cologne

56564

Schwerpunktpraxis Diabetes, Neuwied

57072

Diabetologische Schwerpunktpraxis, Siegen

60611

ICCT Research International, Inc., Chicago

64114

The Center for Pharmaceutical Research, P.C., Kansas City

77074

Juno Research, LLC., Houston

77451

Juno Research, LLC., Katy

78229

Cetero Research-San Antonio, San Antonio

80209

Creekside Endocrine Associates PC, Denver

89101

Nevada Alliance Against Diabetes, Las Vegas

90057

Andrew J. Lewin Medical Corporation DBA National Research Institute, Los Angeles

90723

Center for Clinical Trials, LLC., Paramount

92780

Orange County Research Center, Tustin

96269

Praxis Dr. Schätzl, Großheirath-Rossach

97980

Diabetespraxis Bad Mergentheim, Bad Mergentheim

Sponsors
All Listed Sponsors
collaborator

Integrium

INDUSTRY

collaborator

Msource Medical Development GmbH

UNKNOWN

collaborator

Kinexum LLC

UNKNOWN

collaborator

Thermo Fisher Scientific, Inc

INDUSTRY

collaborator

Haupt Pharma Wülfing GmbH

UNKNOWN

collaborator

Barc NV

INDUSTRY

lead

N-Gene Research Laboratories, Inc.

INDUSTRY

NCT01069965 - Safety and Efficacy of BGP-15 in Patients With Type 2 Diabetes Mellitus | Biotech Hunter | Biotech Hunter