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| Sponsored by: |
Merck |
|---|---|
| Information provided by: | Merck |
| ClinicalTrials.gov Identifier: | NCT00511472 |
Purpose
A study to assess safety, Pharmacokinetic (PK) and Pharmacodynamic (PD) of an MK0941 in Type 2 Diabetics being treated with basal insulin.
| Condition | Intervention | Phase |
|---|---|---|
|
Type 2 Diabetes Mellitus |
Drug: MK0941 Drug: LANTUS® insulin Drug: Comparator: Placebo (unspecified) |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Single Group Assignment, Safety Study |
| Official Title: | Multicenter, 2-Part, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Assess the Safety, Tolerability, PK and PD of MK0941 on Postprandial Plasma Glucose Concentrations After Daily Administration MK0941 Before Each Meal in Subjects With T2D Being Treated With Basal Insulin |
| Estimated Enrollment: | 66 |
| Study Start Date: | August 2007 |
| Estimated Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Part I-Phase 1
Phase 1: All patients will receive LANTUS® insulin (dose will be similar to patient's previous dose of immediate or long-acting insulin).
|
Drug: MK0941
MK0941 10 mg, 20 mg, 30 mg or 40 mg q.a.c.
Drug: LANTUS® insulin
LANTUS® insulin (dose will be similar to patient's previous dose of immediate or long-acting insulin)
|
|
Part I-Phase 2
Phase 2: Patients will continue to receive individualized dose of LANTUS® insulin for 1 week.
|
Drug: MK0941
MK0941 10 mg, 20 mg, 30 mg or 40 mg q.a.c.
Drug: LANTUS® insulin
LANTUS® insulin (dose will be similar to patient's previous dose of immediate or long-acting insulin)
|
|
Part I-Phase 3
Phase 3: Patients will continue with previously established dose of LANTUS® insulin and will be randomized into 1 of 2 titration schemes of MK0941 or Pbo. Titration Scheme 1: 4 day, fixed dose titration with q.a.c. administration of MK0941/Pbo. Day 1: 10 mg q.a.c. dose of MK0941/Pbo. Dose will be increased daily in 10 mg q.a.c. increments on days 2, 3, and 4. Titration Scheme 2: 4-day flexible dose titration with MK0941/Pbo given q.a.c. Day 1, study drug will be administered with each dose selected based on the pre-prandial plasma glucose concentrations according to sliding scale of 10 mg, 20 mg, 30 mg or 40 mg. Days 2-4, dose of MK0941/Pbo determined from the post-prandial plasma glucose concentration from previous day meal.
|
Drug: MK0941
MK0941 10 mg, 20 mg, 30 mg or 40 mg q.a.c.
Drug: LANTUS® insulin
LANTUS® insulin (dose will be similar to patient's previous dose of immediate or long-acting insulin)
Drug: Comparator: Placebo (unspecified)
MK0941 10 mg Pbo, 20 mg Pbo, 30 mg Pbo or 40 mg Pbo q.a.c.
|
|
Part I-Phase 4
Phase 4: All patients will continue to receive previously established individualized dose of LANTUS® insulin and MK0941/Pbo for an additional week while in-house during Multiple-Dose Administration.
|
Drug: MK0941
MK0941 10 mg, 20 mg, 30 mg or 40 mg q.a.c.
Drug: LANTUS® insulin
LANTUS® insulin (dose will be similar to patient's previous dose of immediate or long-acting insulin)
Drug: Comparator: Placebo (unspecified)
MK0941 10 mg Pbo, 20 mg Pbo, 30 mg Pbo or 40 mg Pbo q.a.c.
|
|
Part II
Part II: Patients will continue their individualized doses of LANTUS® insulin and MK0941/Pbo established in Part I for an additional 2 weeks while at home.
|
Drug: MK0941
MK0941 10 mg, 20 mg, 30 mg or 40 mg q.a.c.
Drug: LANTUS® insulin
LANTUS® insulin (dose will be similar to patient's previous dose of immediate or long-acting insulin)
Drug: Comparator: Placebo (unspecified)
MK0941 10 mg Pbo, 20 mg Pbo, 30 mg Pbo or 40 mg Pbo q.a.c.
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Toll Free Number | 1-888-577-8839 |
| United States, Alabama | |
| Call for Information | Recruiting |
| Anniston, Alabama, United States, 36207 | |
| United States, Arkansas | |
| Call for Information | Recruiting |
| Little Rock, Arkansas, United States, 72202 | |
| United States, California | |
| Call for Information | Recruiting |
| Chula Vista, California, United States, 91911 | |
| United States, Florida | |
| Call for Information | Recruiting |
| Miramar, Florida, United States, 33025 | |
| Call for Information | Recruiting |
| Fort Myers, Florida, United States, 33901 | |
| United States, Louisiana | |
| Call for Information | Recruiting |
| Baton Rouge, Louisiana, United States, 70809 | |
| United States, Texas | |
| Call for Information | Recruiting |
| San Antonio, Texas, United States, 78229-0000 | |
| Study Director: | Medical Monitor | Merck |
More Information
| Responsible Party: | Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences ) |
| Study ID Numbers: | 2007_596, MK0941-006 |
| Study First Received: | August 2, 2007 |
| Last Updated: | January 8, 2009 |
| ClinicalTrials.gov Identifier: | NCT00511472 |
| Health Authority: | United States: Food and Drug Administration |
|
Insulin, Long-Acting Metabolic Diseases Diabetes Mellitus, Type 2 Glargine Diabetes Mellitus |
Endocrine System Diseases Endocrinopathy Metabolic disorder Glucose Metabolism Disorders Insulin |
|
Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
