Single Doses of MK-0941 in Type 2 Diabetics (MK-0941-027)

NCT01106287 | Completed Phase 1 Results

• 3 other identifiers: 0941-0272010_526MK-0941-027
• Study Type: interventional
• Target: 13
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will evaluate the safety and tolerability of single doses of MK-0941 based on assessment of clinical and laboratory adverse experiences

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (2)

• Number of Participants Who Experienced One or More Adverse Events During the Study

  Up to 30 days after the last dose of study drug

• Number of Participants Who Discontinued Study Drug Due to an Adverse Event

  Only treatment-emergent adverse events were examined for this outcome measure.

  Up to 6 weeks after the first dose of study drug

Study Arms (4)

Treatment Sequence 1

EXPERIMENTAL

Period 1: Placebo - Period 2: 80 mg - Period 3: 100 mg - Period 4: Placebo - Period 5: 140 mg

Drug: MK-0941; Drug: Comparator: Placebo

Treatment Sequence 2

EXPERIMENTAL

Period 1: 60 mg - Period 2: 80 mg - Period 3: 100 mg - Period 4: 120 mg - Period 5: Placebo

Drug: MK-0941; Drug: Comparator: Placebo

Treatment Sequence 3

EXPERIMENTAL

Period 1: 60 mg - Period 2: Placebo - Period 3: 100 mg - Period 4: 120 mg - Period 5: 140 mg

Drug: MK-0941; Drug: Comparator: Placebo

Treatment Sequence 4

EXPERIMENTAL

Period 1: 60 mg - Period 2: 80 mg - Period 3: Placebo - Period 4: 120 mg - Period 5: 140 mg

Drug: MK-0941; Drug: Comparator: Placebo

Interventions

MK-0941 DRUG

A single 60, 80, 100, 120 or 140 mg oral dose of MK-0941 will be administered in each period

Treatment Sequence 1; Treatment Sequence 2; Treatment Sequence 3; Treatment Sequence 4

Comparator: Placebo DRUG

a single oral placebo will be administered in the designated period (Periods 1-5)

Treatment Sequence 1; Treatment Sequence 2; Treatment Sequence 3; Treatment Sequence 4

Eligibility Criteria

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

You may qualify if:

• Female participants of reproductive potential must test negative for pregnancy and agree to use two acceptable methods of birth control
• Diagnosis of Type 2 Diabetes and is either being treated with diet and exercise alone or with a single or combination oral anti-hyperglycemic agent
• No treatment with three of more anti-hyperglycemic agents or any treatment regimen that includes insulin
• In good health (except for Type 2 Diabetes)
• Willingness to follow a specific diet throughout the study (consisting of 50% carbohydrates, 20%protein and 30% fat)
• Nonsmoker

You may not qualify if:

• History of stroke, chronic seizure or major neurological disorder
• History of cancer
• History of Type 1 Diabetes
• Recent history of eye infection
• Glaucoma or blindness
• Eye surgery (by incision or laser) within the past three months

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: Vice President, Late Stage Development Group Leader
• 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: April 16, 2010
• First Posted: April 19, 2010
• Study Start: October 1, 2009
• Primary Completion: January 1, 2010
• Study Completion: March 1, 2010
• Last Updated: February 4, 2016
• Results First Posted: December 13, 2012

Record last verified: 2016-02