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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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/show/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
Other publications