An Investigational Drug Study in Adults With Type 2 Diabetes on Basal Insulin (MK-0941-006)
NCT ID: NCT00511472
Last Updated: 2015-07-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
70 participants
INTERVENTIONAL
2007-07-31
2008-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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MK-0941
MK-0941
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.
LANTUS insulin
LANTUS insulin dose will be similar to participant's previous dose of immediate or long-acting insulin
Placebo
Placebo
10 mg Placebo (Pbo), 20 mg Pbo, 30 mg Pbo or 40 mg Pbo q.a.c.
LANTUS insulin
LANTUS insulin dose will be similar to participant's previous dose of immediate or long-acting insulin
Interventions
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MK-0941
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.
Placebo
10 mg Placebo (Pbo), 20 mg Pbo, 30 mg Pbo or 40 mg Pbo q.a.c.
LANTUS insulin
LANTUS insulin dose will be similar to participant's previous dose of immediate or long-acting insulin
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Treated with peroxisome proliferator-activated receptor (PPAR) agonists within 12 weeks prior to study start
* History of severe hypoglycemia
* Allergic to insulin
18 Years
70 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Other Identifiers
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2007_596
Identifier Type: -
Identifier Source: secondary_id
MK-0941-006
Identifier Type: -
Identifier Source: secondary_id
0941-006
Identifier Type: -
Identifier Source: org_study_id
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