Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01111955




Registration number
NCT01111955
Ethics application status
Date submitted
26/04/2010
Date registered
28/04/2010
Date last updated
12/10/2015

Titles & IDs
Public title
Safety Study of BMS-823778 in Subjects With Type 2 Diabetes
Scientific 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
Secondary ID [1] 0 0
MB121-002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus, Type 2 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BMS-823778
Treatment: Drugs - BMS-823778
Treatment: Drugs - BMS-823778
Treatment: Drugs - Placebo
Treatment: Drugs - Metformin

Active comparator: BMS-823778 (2 mg) - + metformin

Active comparator: BMS-823778 (10 mg) - + metformin

Active comparator: BMS-823778 (20 mg) - + metformin

Placebo comparator: Placebo - + metformin


Treatment: Drugs: BMS-823778
Capsules, Oral, 2 mg, once daily, 28 days

Treatment: Drugs: BMS-823778
Capsules, Oral, 10 mg, once daily, 28 days

Treatment: Drugs: BMS-823778
Capsules, Oral, 20 mg, once daily, 28 days

Treatment: Drugs: Placebo
Capsules, Oral, 0 mg, once daily, 28 days

Treatment: Drugs: Metformin
Capsules, Oral, = 1500 mg, once daily, 28 days
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Lowering of fasting plasma glucose (FPG) throughout the study to see if there is a decrease from baseline
Timepoint [1] 0 0
Within 28 days following dosing
Secondary outcome [1] 0 0
Pharmacokinetics (measuring trough concentrations)
Timepoint [1] 0 0
On days 7, 14 and 28
Secondary outcome [2] 0 0
Pharmacodynamics (measuring daily glucose, glucose AUC, HbA1c, lipid profiles, HPA markers, free testosterone, and SHBG)
Timepoint [2] 0 0
Within 28 days following dosing

Eligibility
Key inclusion criteria
* Type 2 diabetes mellitus
* Drug naive or on stable metformin therapy
* HbA1c 7-10%
* FPG = 240mg/dL
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2011
Sample size
Target
Accrual to date
Final
62
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
Local Institution - Blacktown
Recruitment hospital [2] 0 0
Local Institution - Box Hill
Recruitment hospital [3] 0 0
Local Institution - Freemantle
Recruitment postcode(s) [1] 0 0
2148 - Blacktown
Recruitment postcode(s) [2] 0 0
3128 - Box Hill
Recruitment postcode(s) [3] 0 0
6959 - Freemantle
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Washington
Country [3] 0 0
United States of America
State/province [3] 0 0
Wisconsin
Country [4] 0 0
Canada
State/province [4] 0 0
British Columbia
Country [5] 0 0
Canada
State/province [5] 0 0
Manitoba
Country [6] 0 0
Canada
State/province [6] 0 0
New Brunswick
Country [7] 0 0
Canada
State/province [7] 0 0
Newfoundland and Labrador
Country [8] 0 0
Canada
State/province [8] 0 0
Ontario
Country [9] 0 0
Canada
State/province [9] 0 0
Quebec
Country [10] 0 0
Canada
State/province [10] 0 0
Saskatchewan

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to assess the safety, tolerability and pharmacodynamic effects on fasting plasma glucose (FPG).
Trial website
https://clinicaltrials.gov/study/NCT01111955
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01111955