NCT00479466

Brief Summary

A study to compare MK0893 to metformin or placebo for patients with Type 2 diabetes (Diabetes Mellitus).

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
342

participants targeted

Target at P75+ for phase_2 diabetes-mellitus-type-2

Timeline
Completed

Started Jul 2007

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 25, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 28, 2007

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2007

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
3.5 years until next milestone

Results Posted

Study results publicly available

November 11, 2011

Completed
Last Updated

September 9, 2015

Status Verified

September 1, 2015

Enrollment Period

10 months

First QC Date

May 25, 2007

Results QC Date

October 7, 2011

Last Update Submit

September 8, 2015

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline to Week 12 in Fasting Plasma Glucose (FPG)

    Week 12

Secondary Outcomes (2)

  • Change From Baseline to Week 12 in Hemoglobin A1c (HbA1c)

    Week 12

  • Change From Baseline to Week 12 in 2-Hour Post Prandial Glucose (PPG)

    Week 12

Study Arms (6)

MK0893 80 mg

EXPERIMENTAL

MK0893 tablets totaling 80 mg once daily.

Drug: MK0893Drug: Placebo to MK0893Drug: Placebo to Metformin

MK0893 60 mg

EXPERIMENTAL

MK0893 tablets totaling 60 mg once daily.

Drug: MK0893Drug: Placebo to MK0893Drug: Placebo to Metformin

MK0893 40 mg

EXPERIMENTAL

MK0893 40 mg tablet once daily.

Drug: MK0893Drug: Placebo to MK0893Drug: Placebo to Metformin

MK0893 20 mg

EXPERIMENTAL

MK0893 20 mg tablet once daily.

Drug: MK0893Drug: Placebo to MK0893Drug: Placebo to Metformin

Metformin

ACTIVE COMPARATOR

Metformin HCL 500 mg tablet twice daily BID titrating up to 1000 mg twice daily over 3 weeks.

Drug: MetforminDrug: Placebo to MK0893

Placebo

PLACEBO COMPARATOR

PLA tablets. 12 week treatment period.

Drug: Placebo to MK0893Drug: Placebo to Metformin

Interventions

MK0893DRUG

MK0893 taken orally once daily; 20 mg and 40 mg tablets used in combination according to dose.

MK0893 20 mgMK0893 40 mgMK0893 60 mgMK0893 80 mg
MetforminDRUG

Metformin HCL 500 mg tablet twice daily titrating up to 1000 mg twice daily over 3 weeks.

Metformin
Placebo to MK0893DRUG

Dose-matched placebo tablets to MK0893; taken orally once daily.

MK0893 20 mgMK0893 40 mgMK0893 60 mgMK0893 80 mgMetforminPlacebo
Placebo to MetforminDRUG

Dose-matched placebo tablets to metformin (500 mg); taken orally twice daily.

MK0893 20 mgMK0893 40 mgMK0893 60 mgMK0893 80 mgPlacebo

Eligibility Criteria

Age21 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who have Type 2 Diabetes Mellitus, with suboptimal glucose control, while either not on AHA (antihyperglycemic agent) therapy or on monotherapy or on low-dose combination therapy

You may not qualify if:

  • Patients have a history of Type 1 Diabetes Mellitus
  • Patients taking insulin or thiazolidinedione (TZD, a peroxisome proliferator-activated receptor \[PPAR\]-gamma agonist)
  • Patients who have a contraindication to metformin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

N-((4-(1-(3-(3,5-dichlorophenyl)-5-(6-methoxynaphthalen-2-yl)-1H-pyrazol-1-yl)ethyl)phenyl)carbonyl)-beta-alanineMetformin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Limitations and Caveats

Sufficient data regarding the dose-response to MK-0893 had been obtained from the first cohort of the study to assess the safety and efficacy, thus the study was discontinued.

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
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2007

First Posted

May 28, 2007

Study Start

July 1, 2007

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

September 9, 2015

Results First Posted

November 11, 2011

Record last verified: 2015-09