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

NCT00873821 | Completed Phase 1 Results

• 2 other identifiers: 0941-0122008_533
• Study Type: interventional
• Target: 44
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (3)

• Number of Participants With Any Clinical Adverse Experience

  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.

  2 months

• Number of Participants With Any Laboratory Adverse Experience

  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.

  2 months

• Change From Baseline to Day 13 in Weighted Mean Plasma Glucose Concentration

  Weighted mean plasma glucose concentration was calculated as the 24-hour area under the plasma concentration-time curve divided by 24

  Baseline (predose Day 1) to Day 13

Study Arms (2)

1

EXPERIMENTAL

MK-0941

Drug: MK-0941

2

PLACEBO COMPARATOR

Placebo Comparator

Drug: Comparator: Placebo

Interventions

MK-0941 DRUG

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.

1

Comparator: Placebo DRUG

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.

2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

3-((6-(ethylsulfonyl)-3-pyridinyl)oxy)-5-(2-hydroxy-1-methylethoxy)-N-(1-methyl-1H-pyrazol-3-yl)benzamide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2009
• First Posted: April 2, 2009
• Study Start: December 1, 2008
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: March 9, 2015
• Results First Posted: July 11, 2012

Record last verified: 2015-02