NCT00824616

Brief Summary

The purpose of this study is to test the effect MK-0941 as add-on therapy for adults taking insulin for Type 2 Diabetes.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
68

participants targeted

Target at P25-P50 for phase_2 type-2-diabetes-mellitus

Timeline
Completed

Started Jan 2009

Typical duration for phase_2 type-2-diabetes-mellitus

Status
completed

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

Study Start

First participant enrolled

January 1, 2009

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

January 16, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 19, 2009

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

August 21, 2012

Completed
Last Updated

July 28, 2015

Status Verified

July 1, 2015

Enrollment Period

1.3 years

First QC Date

January 16, 2009

Results QC Date

July 17, 2012

Last Update Submit

July 21, 2015

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

  • Change From Baseline in Hemoglobin A1c (HbA1c) Level

    HbA1c level is a blood test measurement of the amount (percent) of hemoglobin that is glycated (or has glucose on it). HbA1c level is related to the average blood glucose concentration over the previous 2-3 months, with a higher HbA1c level indicating a higher amount of average plasma glucose. A negative number for change from baseline in HbA1c level means a reduction in HbA1c level and indicates better control of average plasma glucose levels.

    Baseline (Day 1) and End of Treatment (Week 20)

  • Number of Participants Who Experienced One or More Episodes of Hypoglycemia (Symptomatic or Asymptomatic)

    Hypoglycemic episodes - with or without symptoms - are defined as a fingerstick glucose measurement of ≤70 mg/dL (3.9 mmol/L). Excludes data after initiation of glycemic rescue therapy.

    From first dose of study drug (Week 0) to last dose of study drug (Week 20)

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Participants receiving placebo tablets three times daily plus insulin injection once daily

Drug: PlaceboDrug: Insulin

MK-0941

EXPERIMENTAL

Participants receiving MK-0941 tablets three times daily plus insulin injection once daily

Drug: MK-0941Drug: Insulin

Interventions

MK-0941DRUG

MK-0941 tablets 5 mg or 10 mg, taken 3 times daily, with increasing doses to maximally effective dose.

MK-0941
PlaceboDRUG

Placebo tablets, taken 3 times daily.

Placebo
InsulinDRUG

Insulin glargine (rDNA origin) injection solution for subcutaneous (SC) injection, taken once daily.

Also known as: LANTUS®
MK-0941Placebo

Eligibility Criteria

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

You may qualify if:

  • Participant has Type 2 Diabetes Mellitus

You may not qualify if:

  • Participant has a history of Type 1 Diabetes Mellitus or ketoacidosis
  • Participant is on a weight loss program and is not in the maintenance phase or is taking a weight loss medication
  • Participant has had surgery within 30 days of starting the study or has planned major surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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)benzamideInsulinInsulin Glargine

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

ProinsulinInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsInsulin, Long-Acting

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 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

January 16, 2009

First Posted

January 19, 2009

Study Start

January 1, 2009

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

July 28, 2015

Results First Posted

August 21, 2012

Record last verified: 2015-07