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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT00873821
First received: March 31, 2009
Last updated: June 6, 2012
Last verified: June 2012
History of Changes

March 31, 2009
June 6, 2012
December 2008
May 2009   (final data collection date for primary outcome measure)
  • Number of Participants With Any Clinical Adverse Experience [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Baseline (predose Day 1) to Day 13 ] [ Designated as safety issue: No ]
    Weighted mean plasma glucose concentration was calculated as the 24-hour area under the plasma concentration-time curve divided by 24
clinical assessment of adverse experiences and by repeated physical examinations 12-lead ECGs, vital sign measurements, standard laboratory safety tests (hematology, chemistry and urinalysis) and frequent sampling for plasma glucose concentrations [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00873821 on ClinicalTrials.gov Archive Site
Not Provided
to assess the post-prandial reduction in plasma glucose concentrations [ Time Frame: On Day -1 and Day 13 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Pharmacokinetic Study of MK-0941 After Multiple Daily Doses in Subjects With Type 2 Diabetes (MK-0941-012)(COMPLETED)
A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK0941 After Multiple Daily Administration in Subjects With Type 2 Diabetes

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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • Drug: MK-0941
    Part 1 (in house): MK-0941 twice daily on Days 1 through 13 before breakfast and dinner with 240 mL water. The starting dose on Day 1 was 10 mg tablets twice daily and titrated to a maximum dose of 60 mg twice daily through Day 9. The Day 9 dose was maintained throughout Day 13. Part 2 (at home): participants continued treatment for an additional 14 days with MK-0941 60 mg tablets (or maximum dose achieved in Part 1) twice daily, before meals with 240 mL of water.
  • Drug: Comparator: Placebo
    Part 1 (in house): placebo twice daily on Days 1 through 13 before breakfast and dinner with 240 mL water. Part 2 (at home): participants continued treatment for an additional 14 days with placebo twice daily, before meals with 240 mL of water.
  • Experimental: 1
    MK-0941
    Intervention: Drug: MK-0941
  • Placebo Comparator: 2
    Placebo Comparator
    Intervention: Drug: Comparator: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
44
May 2009
May 2009   (final data collection date for primary outcome measure)

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

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00873821
MK-0941-012, 2008_533
No
Merck
Merck
Not Provided
Study Director: Medical Monitor Merck
Merck
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP