NCT00511472

Brief Summary

A study to assess safety, pharmacokinetics (PK), and pharmacodynamics (PD) of MK-0941 in Type 2 diabetics being treated with basal insulin.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P75+ for phase_1 type-2-diabetes-mellitus

Timeline
Completed

Started Jul 2007

Typical duration for phase_1 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

July 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 2, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 6, 2007

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
4.3 years until next milestone

Results Posted

Study results publicly available

July 11, 2012

Completed
Last Updated

July 15, 2015

Status Verified

June 1, 2015

Enrollment Period

9 months

First QC Date

August 2, 2007

Results QC Date

April 10, 2012

Last Update Submit

June 19, 2015

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • Number of Participants Who Experienced an Adverse Event During the Study

    39 days

Secondary Outcomes (4)

  • Number of Participants Who Experienced an Adverse Event - Titration Scheme 1

    25 days

  • Number of Participants Who Experienced an Adverse Event - Titration Scheme 2

    25 days

  • 24-Hour Weighted Mean Blood Glucose Levels (mg/dL) by Treatment Group on Day 7

    24 hours

  • Number of Participants Who Experienced an Adverse Event During the Outpatient Treatment Period

    Outpatient Days 1 to 14

Study Arms (2)

MK-0941

EXPERIMENTAL
Drug: MK-0941Drug: LANTUS insulin

Placebo

PLACEBO COMPARATOR
Drug: PlaceboDrug: LANTUS insulin

Interventions

MK-0941DRUG

In Titration Scheme #1, MK-0941/matching placebo was initiated at 10-mg q.a.c. dose and increased on a daily basis (Titration Dose \[TD\] Days 1 to 4 of the Titration Phase 1) in 10-mg q.a.c. increments. Titration Scheme #2 was a flexible-dose titration scheme in which MK-0941/matching placebo was given at a dose determined by a pre-prandial plasma glucose concentration for the subsequent meal on the previous day of administration on Days 1 to 4 of the Titration Phase 2.

MK-0941
PlaceboDRUG

10 mg Placebo (Pbo), 20 mg Pbo, 30 mg Pbo or 40 mg Pbo q.a.c.

Placebo
LANTUS insulinDRUG

LANTUS insulin dose will be similar to participant's previous dose of immediate or long-acting insulin

Also known as: LANTUS
MK-0941Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female (of non-childbearing potential) between 18 to 70 years of age
  • Diagnosed with Type 2 Diabetes and currently being treated with basal insulin
  • Smokers may participate, but they are limited to 10 cigarettes per day while at the clinic and must follow clinic smoking rules

You may not qualify if:

  • History of Type 1 diabetes
  • Treated with peroxisome proliferator-activated receptor (PPAR) agonists within 12 weeks prior to study start
  • History of severe hypoglycemia
  • Allergic to insulin

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)benzamideInsulin Glargine

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

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

August 2, 2007

First Posted

August 6, 2007

Study Start

July 1, 2007

Primary Completion

April 1, 2008

Study Completion

April 1, 2008

Last Updated

July 15, 2015

Results First Posted

July 11, 2012

Record last verified: 2015-06