Safety Study to Evaluate BMS-767778 in Healthy Subjects and Subjects With Type 2 Diabetes Mellitus (T2DM)

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00707590
• Date of registration: 27/06/2008
• Primary sponsor: Bristol-Myers Squibb
• Public title: Safety Study to Evaluate BMS-767778 in Healthy Subjects and Subjects With Type 2 Diabetes Mellitus (T2DM)
• Scientific title: Randomized, Double-Blind, Placebo-Controlled Ascending Single and Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-767778 in Healthy Subjects and Subjects With Type 2 Diabetes Mellitus
• Date of first enrolment: August 2008
• Target sample size: 120
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT00707590
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Countries of recruitment

Canada

Contacts

• Name: Bristol-Myers Squibb
• Affiliation: Bristol-Myers Squibb

Key inclusion & exclusion 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)

Exclusion criteria:

- Poorly controlled diabetes with either new onset or worsening of symptoms of polyuria
and polydipsia, weight loss, fatigue, abdominal pain, or other significant signs and
symptoms

- Any of the following medical conditions: uncontrolled hypertension, unstable angina
pectora, Cushing's syndrome, Addison's disease, uncontrolled hyperthyroidism or
hypothyroidism, significant liver disease or renal failure, malignant diseases, or
immunodeficiency (e.g., HIV/AIDS or organ-transplant), or history of myocardial
infarction, congestive heart failure defined as New York Heart Association (NYHA)
stage II and above, significant valvular disease, cardiac arrhythmia, or transient
ischemic attack or cerebrovascular accidents (occurred within 6 months prior to entry
into the study), or family history of Long QT Syndrome



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Type 2 Diabetes Mellitus

Intervention(s)

Drug: BMS-767778 or Placebo

Primary Outcome(s)

AEs, vital signs, ECG and clinical laboratory test results [Time Frame: throughout the study]

Secondary Outcome(s)

DPP-4 inhibition and incretin response [Time Frame: throughout the study]

Single and multiple dose (14 days) PK [Time Frame: throughout the study]

Secondary ID(s)

MB116-001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors