Type 2 Diabetes Mellitus
Conditions
Brief summary
To assess the safety and tolerability and the PK/PD relationship of BMS-767778 administered as single and multiple oral doses in healthy subjects, and in subjects with T2DM
Interventions
DRUGBMS-767778 or Placebo
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Parts A and Part B of the study (maximum age 45 years): Inclusion Criteria: * Healthy male and female subjects as determined by medical history, physical examination, 12-lead electrocardiogram (ECG), and clinical laboratory evaluations will be eligible to participate in the study. * Men and women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile)
Exclusion criteria
* Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations Part C of the study (maximum age 65 years): Inclusion criteria: * Drug naive patients with T2DM or patients who are on metformin-monotherapy (at current dose for ≥ 8 weeks) with inadequately controlled blood glucose levels (HbA1c \>7 %and \<10 %) Men and women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AEs, vital signs, ECG and clinical laboratory test results | throughout the study |
Secondary
| Measure | Time frame |
|---|---|
| Single and multiple dose (14 days) PK | throughout the study |
| DPP-4 inhibition and incretin response | throughout the study |
Countries
Canada
Outcome results
None listed