A Pharmacokinetic Study of MK-0941 After Multiple Daily Doses in Subjects With Type 2 Diabetes (MK-0941-012)(COMPLETED)
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Drug: MK-0941
- Registration Number
- NCT00873821
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
A study to test the pharmacokinetics after twice daily administration of MK-0941 or placebo in subjects with type 2 diabetes who have inadequate control on metformin.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 44
- Subject has a BMI < 42 kg/m2
- Subject is taking >1500 mg metformin per day for at least 8 weeks
- Subject has HbA1c value of 7.0% and < 11% at screening
- Subject is willing to follow AHA weight maintaining diet and exercise program
- Subject is a nonsmoker for at least 6 months
- Subject has type 1 diabetes
- Subject has a history of stroke or chronic seizure
- Subject has a history of neoplastic disease
- Subject has a history of gastrointestinal, cardiovascular, blood, liver kidney, respiratory, immunological or genitourinary disorders or diseases
- Subject is currently taking 2 or more diabetes medications
- Subject has glaucoma or is blind
- If female, subject is pregnant or breastfeeding
- Subject consumes > 3 alcoholic beverages per day
- Subject has had major surgery or has donated blood in the last 4 weeks
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 MK-0941 MK-0941
- Primary Outcome Measures
Name Time Method Number of Participants With Any Clinical Adverse Experience 2 months An adverse experience was defined as any unfavorable and unintended change in the structure or function of the body temporally associated with the use of study drug. Adverse experiences were collected using Medical Dictionary for Regulatory Activities (MedDRA) version 13.0.
Number of Participants With Any Laboratory Adverse Experience 2 months Laboratory adverse experiences were those related to changes in hematology, fasted blood chemistry, or urinalysis laboratory results. Adverse experiences were collected using MedDRA version 13.0.
Change From Baseline to Day 13 in Weighted Mean Plasma Glucose Concentration Baseline (predose Day 1) to Day 13 Weighted mean plasma glucose concentration was calculated as the 24-hour area under the plasma concentration-time curve divided by 24
- Secondary Outcome Measures
Name Time Method