Clinical trial NCT01111955: Safety Study of BMS-823778 in Subjects With Type 2 Diabetes
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2010-04-28
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Lowering of fasting plasma glucose (FPG) throughout the study to see if there is a decrease from baseline
timeFrame: Within 28 days following dosing
Secondary outcomes:
measure: Pharmacokinetics (measuring trough concentrations)
timeFrame: On days 7, 14 and 28
measure: Pharmacodynamics (measuring daily glucose, glucose AUC, HbA1c, lipid profiles, HPA markers, free testosterone, and SHBG)
timeFrame: Within 28 days following dosing
Other outcomes:
Locations:
city: Hialeah
country: United States
facility: Farid Marquez, Md
state: Florida
city: Olympia
country: United States
facility: Capital Clinical Reserch Center
state: Washington
city: Milwaukee
country: United States
facility: Aurora Advanced Healthcare
state: Wisconsin
city: Blacktown
country: Australia
facility: Local Institution
state: New South Wales
city: Box Hill
country: Australia
facility: Local Institution
state: Victoria
city: Freemantle
country: Australia
facility: Local Institution
state: Western Australia
city: Surrey
country: Canada
facility: Local Institution
state: British Columbia
city: Winnipeg
country: Canada
facility: Local Institution
state: Manitoba
city: Bathurst
country: Canada
facility: Local Institution
state: New Brunswick
city: St. John'S
country: Canada
facility: Local Institution
state: Newfoundland and Labrador
city: Thornhill
country: Canada
facility: Local Institution
state: Ontario
city: Mirabel
country: Canada
facility: Local Institution
state: Quebec
city: Saskatoon
country: Canada
facility: Local Institution
state: Saskatchewan
city: Quebec
country: Canada
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: