Safety Study of BMS-823778 in Subjects With Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

A Double-blind, Placebo-Controlled, Parallel-group, Randomized, Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects of BMS-823778 in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Either Diet and Exercise Alone or on a Background of Metformin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01111955
• Other study ID #: MB121-002
• Status: Completed
• Phase: Phase 2
• First received: April 26, 2010
• Last updated: September 23, 2015
• Start date: July 2010
• Est. completion date: January 2011

Study information

• Verified date: September 2015
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods AdministrationCanada: Health CanadaUnited States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the safety, tolerability and pharmacodynamic effects on fasting plasma glucose (FPG).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Type 2 diabetes mellitus

• Drug naive or on stable metformin therapy

• HbA1c 7-10%

• FPG = 240mg/dL

Exclusion Criteria:

• History of myocardial infarction, coronary angioplasty or bypass grafts, valvular disease or repair, unstable angina pectoris, transient ischemic attack, or cerebrovascular accidents within six months prior to entry into the study

• Congestive heart failure

• Active liver disease

• Impaired renal function

• Hepatitis C, B and HIV

This list is not inclusive; additional information is provided in the protocol

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Drug:
• BMS-823778
Capsules, Oral, 2 mg, once daily, 28 days
• BMS-823778
Capsules, Oral, 10 mg, once daily, 28 days
• BMS-823778
Capsules, Oral, 20 mg, once daily, 28 days
• Placebo
Capsules, Oral, 0 mg, once daily, 28 days
• Metformin
Capsules, Oral, = 1500 mg, once daily, 28 days

Locations

Country	Name	City	State
Australia	Local Institution	Blacktown	New South Wales
Australia	Local Institution	Box Hill	Victoria
Australia	Local Institution	Freemantle	Western Australia
Canada	Local Institution	Bathurst	New Brunswick
Canada	Local Institution	Mirabel	Quebec
Canada	Local Institution	Quebec
Canada	Local Institution	Saskatoon	Saskatchewan
Canada	Local Institution	St. John'S	Newfoundland and Labrador
Canada	Local Institution	Surrey	British Columbia
Canada	Local Institution	Thornhill	Ontario
Canada	Local Institution	Winnipeg	Manitoba
United States	Farid Marquez, Md	Hialeah	Florida
United States	Aurora Advanced Healthcare	Milwaukee	Wisconsin
United States	Capital Clinical Reserch Center	Olympia	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Australia,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lowering of fasting plasma glucose (FPG) throughout the study to see if there is a decrease from baseline		Within 28 days following dosing	No
Secondary	Pharmacokinetics (measuring trough concentrations)		On days 7, 14 and 28	Yes
Secondary	Pharmacodynamics (measuring daily glucose, glucose AUC, HbA1c, lipid profiles, HPA markers, free testosterone, and SHBG)		Within 28 days following dosing	Yes

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
•   Investigator Inquiry form