Type 2 Diabetes
Conditions
Brief summary
The purpose of this study is to evaluate the safety, pharmacokinetics and pharmacodynamics of single doses of BMS-686117
Interventions
DRUGPlacebo
Injection solution, Subcutaneous, 1 mg, Once daily, Single dose.
DRUGBMS-686117
Injection solution, Subcutaneous, 1 mg, Once daily, Single dose.
DRUGByetta
Injection solution, Subcutaneous, 5 mcg, Once daily, Single dose.
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of Type 2 diabetes for ≥ 3 months treated with metformin, thiazolidinedione, or sulfonylurea (either monotherapy or combination) or diet alone (drug naïve) * Fasting plasma glucose: 126 - 240 mg/dL * Hemoglobin A1c: 6 - 10% * Estimated CrCl ≥ 60 mL/min * ALT ≤ 1.5 x ULN and total bilirubin ≤ 2 x ULN * Stable and well controlled hypertension and/or dyslipidemia * Concomitant medications used for hypertension and/or dyslipidemia, thyroid hormone replacement therapy and low dose aspirin will be allowed if stable for at least 6 weeks
Exclusion criteria
* Women of childbearing potential * Symptomatic diabetes with polyuria and/or polydipsia * History of diabetic ketoacidosis or hyperosmolar nonketotic syndrome * History of renal disease including diabetic nephropathy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety: incidence of adverse events | from subject enrollment to study discharge |
Secondary
| Measure | Time frame |
|---|---|
| PK parameters: Cmax, Tmax, AUC(0-24h), AUC(INF) and T-HALF | from pre-dose to 24 hrs post-dose |
| PD Measures: Fasting and postprandial serum glucose (AUC), serum insulin, and plasma glucagon concentrations. Acetaminophen plasma concentrations will be measured after a single dose of acetaminophen | from pre-dose to 9 hrs post-dose |
Countries
United States
Outcome results
None listed