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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01046422




Registration number
NCT01046422
Ethics application status
Date submitted
11/01/2010
Date registered
12/01/2010
Date last updated
12/10/2015

Titles & IDs
Public title
Safety Study of BMS-770767 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-770767 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
2009-014308-79
Secondary ID [2] 0 0
MB117-003
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 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-770767
Treatment: Drugs - BMS-770767
Treatment: Drugs - BMS-770767
Treatment: Drugs - BMS-770767
Treatment: Drugs - Placebo
Treatment: Drugs - Metformin

Experimental: BMS-770767 ± metformin (Treatment A) -

Experimental: BMS-770767 ± metformin (Treatment B) -

Experimental: BMS-770767 ± metformin (Treatment C) -

Experimental: BMS-770767 ± metformin (Treatment D) -

Placebo comparator: Placebo ± metformin (Treatment E) -


Treatment: Drugs: BMS-770767
Capsule, Oral, 15mg, Active, Daily, 28 days

Treatment: Drugs: BMS-770767
Capsule, Oral, 50mg, Active, Daily, 28 days

Treatment: Drugs: BMS-770767
Capsule, Oral, 150mg, Active, Daily, 28 days

Treatment: Drugs: BMS-770767
Capsule, Oral, 50mg BID, Active, Daily, 28 days

Treatment: Drugs: Placebo
Capsule, Oral, 0mg, Daily, 28 days

Treatment: Drugs: Metformin
Tablet, Oral, = 1500mg, Active, Daily, 28 days
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Fasting Plasma Glucose Improvement
Timepoint [1] 0 0
Within seven days following dosing
Secondary outcome [1] 0 0
Mean daily glucose (3-day 7 pt-fingerstick)
Timepoint [1] 0 0
Within 28 days following dosing
Secondary outcome [2] 0 0
Four (4)-hour post-prandial glucose AUC
Timepoint [2] 0 0
Within 28 days following dosing
Secondary outcome [3] 0 0
HbA1C
Timepoint [3] 0 0
Within 28 days following dosing
Secondary outcome [4] 0 0
Lipid profiles
Timepoint [4] 0 0
Within 28 days following dosing

Eligibility
Key inclusion criteria
* Diagnosed with type 2 diabetes with inadequate glycemic control and treated with either diet and exercise alone, or with stable doses (= 1500mg/d) of metformin for at least 8 weeks prior to screening
* HbA1c = 7.0% and = 10.0% with FPG = 240mg/dL (13.3 mmol/dL)
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Women of childbearing potential
* History of diabetic ketoacidosis or hyperosmolar nonketotic coma
* Significant cardiovascular history
* History of unstable or rapidly progressing renal disease
* Impaired renal function defined by a serum creatinine > 1.4mg/dL (124 µmol/L) for women and >1.5mg/dL (133 µmol/L) for men
* Active liver disease and /or significant abnormal liver function defined as AST > 3X ULN and/or ALT > 3XULN and /or serum total bilirubin > 2.0mg/dl

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 assessing the outcomes
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
1/05/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2011
Sample size
Target
Accrual to date
Final
76
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Local Institution - Caboolture
Recruitment hospital [2] 0 0
Local Institution - Meadowbrook
Recruitment hospital [3] 0 0
Local Institution - Daw Park
Recruitment hospital [4] 0 0
Local Institution - Geelong
Recruitment hospital [5] 0 0
Local Institution - Nedlands
Recruitment postcode(s) [1] 0 0
4510 - Caboolture
Recruitment postcode(s) [2] 0 0
4131 - Meadowbrook
Recruitment postcode(s) [3] 0 0
5041 - Daw Park
Recruitment postcode(s) [4] 0 0
3220 - Geelong
Recruitment postcode(s) [5] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Nevada
Country [3] 0 0
Canada
State/province [3] 0 0
Manitoba
Country [4] 0 0
Canada
State/province [4] 0 0
Newfoundland and Labrador
Country [5] 0 0
Canada
State/province [5] 0 0
Ontario
Country [6] 0 0
Canada
State/province [6] 0 0
Prince Edward Island
Country [7] 0 0
Canada
State/province [7] 0 0
Quebec
Country [8] 0 0
Korea, Republic of
State/province [8] 0 0
Incheon
Country [9] 0 0
Korea, Republic of
State/province [9] 0 0
Suwon

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 determine if BMS-770767 is safe, well tolerated, measure its levels in the blood (pharmacokinetics), and measure the levels of chemicals (biomarkers) that may be affected by this drug (pharmacodynamics) in a type 2 diabetes patient population
Trial website
https://clinicaltrials.gov/study/NCT01046422
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/NCT01046422