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A Pharmacokinetic Study of MK-0941 After Multiple Daily Doses in Subjects With Type 2 Diabetes (MK-0941-012)(COMPLETED)

Phase 1
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
Inclusion Criteria
  • 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
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Exclusion Criteria
  • 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
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
1MK-0941MK-0941
Primary Outcome Measures
NameTimeMethod
Number of Participants With Any Clinical Adverse Experience2 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 Experience2 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 ConcentrationBaseline (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
NameTimeMethod
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