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

Merck Sharp & Dohme (MSD) logo

Merck Sharp & Dohme (MSD)

Status and phase

Completed
Phase 1

Conditions

Diabetes Mellitus, Type 2

Treatments

Drug: MK-0941
Drug: Comparator: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00873821
0941-012
2008_533

Details and patient eligibility

About

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.

Enrollment

44 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

44 participants in 2 patient groups, including a placebo group

1
Experimental group
Description:
MK-0941
Treatment:
Drug: MK-0941
2
Placebo Comparator group
Description:
Placebo Comparator
Treatment:
Drug: Comparator: Placebo

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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