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Clinical Trial Details

Trial ID: L2160
Source ID: NCT00830791
Associated Drug: Mk-0941 20 Mg
Title: A Single Dose Study to Investigate the Pharmacokinetics of MK-0941 in Participants With Renal Insufficiency (MK-0941-015-02)
Acronym:
Status: TERMINATED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00830791/results
Conditions: Type 2 Diabetes
Interventions: DRUG: MK-0941 20 mg|DRUG: MK-0941 5 mg
Outcome Measures: Primary: Plasma Area Under the Curve (AUC [0-infinity]) After Administration of a Single Oral Dose of 20 mg of MK-0941 Among Participants With Mild Renal Insufficiency vs Matched Controls, Plasma AUC (0-infinity) was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and mild renal insufficiency taking a single oral dose of 20 mg of MK-0941 versus controls with normal renal function taking a single oral dose of 20 mg of MK-0941. Mild renal insufficiency was defined as a 24-hour creatinine clearance (CLCR) of \> 50 to 80 mL/min/1.73m\^2., 72 Hours Post-Dose|Plasma AUC (0-infinity) After Administration of a Single Oral Dose of 20 mg of MK-0941 Among With Moderate Renal Insufficiency vs Matched Controls, Plasma AUC (0-infinity) was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and moderate renal insufficiency taking a single oral dose of 20 mg of MK-0941 versus controls with normal renal function taking a single oral dose of 20 mg of MK-0941. Moderate renal insufficiency was defined as a 24-hour CLCR of 30 to 50 mL/min/1.73m\^2., 72-Hours Post-Dose|Plasma AUC (0-infinity) After Administration of a Single Oral Dose of 5 mg of MK-0941 Among Participants With Severe Renal Insufficiency vs Matched Controls, Plasma AUC (0-infinity) was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and severe renal insufficiency taking a single oral dose of 5 mg of MK-0941 versus controls with normal renal function taking a single oral dose of 5 mg of MK-0941. Severe renal insufficiency was defined as a 24-hour CLCR of \> 30 mL/min/1.73m\^2., 72-Hours Post-Dose | Secondary: Maximum Plasma Concentration (Cmax) After Administration of a Single Oral Dose of 20 mg of MK-0941 Among Participants With Mild Renal Insufficiency vs Matched Controls, Cmax was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and mild renal insufficiency who received 20 mg of MK-0941 versus controls with normal renal function who received 20 mg of MK-0941. Mild renal insufficiency was defined as a 24-hour CLCR of \> 50 to 80 mL/min/1.73m\^2., 72-Hours Post-Dose|Cmax After Administration of a Single Oral Dose of 20 mg of MK-0941 Among Participants With Moderate Renal Insufficiency vs Matched Controls, Cmax was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and moderate renal insufficiency who received 20 mg of MK-0941 versus controls with normal renal function who received 20 mg of MK-0941. Moderate renal insufficiency was defined as a 24-hour CLCR of 30 to 50 mL/min/1.73m\^2., 72-Hours Post-Dose|Cmax After Administration of a Single Oral Dose of 5 mg of MK-0941 Among Participants With Severe Renal Insufficiency vs Matched Controls, Cmax was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and severe renal insufficiency who received 5 mg of MK-0941 versus controls with normal renal function who received 5 mg of MK-0941. Severe renal insufficiency was defined as a 24-hour CLCR of \> 30 mL/min/1.73m\^2., 72-Hours Post-Dose|Time to Maximum Plasma Concentration (Tmax) After Administration of a Single Oral Dose of 20 mg of MK-0941 Among Participants With Mild Renal Insufficiency vs Matched Controls, Tmax was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and mild renal insufficiency who received 20 mg of MK-0941 versus controls with normal renal function who received 20 mg of MK-0941. Mild renal insufficiency was defined as a 24-hour CLCR of \> 50 to 80 mL/min/1.73m\^2., 72-Hours Post-Dose|Tmax After Administration of a Single Oral Dose of 20 mg of MK-0941 Among Participants With Moderate Renal Insufficiency vs Matched Controls, Tmax was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and moderate renal insufficiency who received 20 mg of MK-0941 versus controls with normal renal function who received 20 mg of MK-0941. Moderate renal insufficiency was defined as a 24-hour CLCR of 30 to 50 mL/min/1.73m\^2., 72-Hours Post-Dose|Tmax After Administration of a Single Oral Dose of 5 mg of MK-0941 Among Participants With Severe Renal Insufficiency vs Matched Controls, Tmax was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and severe renal insufficiency who received 5 mg of MK-0941 versus controls with normal renal function who received 5 mg of MK-0941. Severe renal insufficiency was defined as a 24-hour CLCR of \> 30 mL/min/1.73m\^2., 72-Hours Post-Dose|Time to Apparent Half Life (T 1/2) After Administration of a Single Oral Dose of 20 mg of MK-0941 Among Participants With Mild Renal Insufficiency vs Matched Controls, T 1/2 was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and mild renal insufficiency who received 20 mg of MK-0941 versus controls with normal renal function who received 20 mg of MK-0941. Mild renal insufficiency was defined as a 24-hour CLCR of \> 50 to 80 mL/min/1.73m\^2., 72-Hours Post-Dose|T 1/2 After Administration of a Single Oral Dose of 20 mg of MK-0941 Among Participants With Moderate Renal Insufficiency vs Matched Controls, T 1/2 was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and moderate renal insufficiency that received 20 mg of MK-0941 versus controls with normal renal function that received 20 mg of MK-0941. Moderate renal insufficiency was defined as a 24-hour CLCR of 30 to 50 mL/min/1.73m\^2., 72-Hours Post-Dose|T 1/2 After Administration of a Single Oral Dose of 5 mg of MK-0941 Among Participants With Severe Renal Insufficiency vs Matched Controls, T 1/2 was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and severe renal insufficiency who received 5 mg of MK-0941 versus controls with normal renal function who received 5 mg of MK-0941. Severe renal insufficiency was defined as a 24-hour CLCR of \> 30 mL/min/1.73m\^2., 72-Hours Post-Dose|Amount of MK-0941 Excreted Unchanged in the Urine (Fe) After Administration of a Single Oral Dose of 20 mg of MK-0941 Among Participants With Mild Renal Insufficiency Versus Matched Controls, Fe was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and mild renal insufficiency who received 20 mg of MK-0941 versus controls with normal renal function who received 20 mg of MK-0941. Mild renal insufficiency was defined as a 24-hour CLCR of \> 50 to 80 mL/min/1.73m\^2., 36-Hours Post-Dose|Fe After Administration of a Single Oral Dose of 20 mg of MK-0941 Among Participants With Moderate Renal Insufficiency Versus Matched Controls, Fe was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and moderate renal insufficiency that received 20 mg of MK-0941 versus controls with normal renal function that received 20 mg of MK-0941. Moderate renal insufficiency was defined as a 24-hour CLCR of 30 to 50 mL/min/1.73m\^2., 36-Hours Post-Dose|Fe After Administration of a Single Oral Dose of 5 mg of MK-0941 Among Participants With Severe Renal Insufficiency Versus Matched Controls, Fe was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and moderate renal insufficiency that received 5 mg of MK-0941 versus controls with normal renal function that received 5 mg of MK-0941. Severe renal insufficiency was defined as a 24-hour CLCR of \< 30 mL/min/1.73m\^2., 36-Hours Post-Dose|CLCR After Administration of a Single Oral Dose of 20 mg of MK-0941 to Participants With Mild Renal Insufficiency Versus Matched Controls, CICR was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and mild renal insufficiency who received 20 mg of MK-0941 versus controls with normal renal function who received 20 mg of MK-0941. Mild renal insufficiency was defined as a 24-hour CLCR of \> 50 to 80 mL/min/1.73m\^2., 36-Hours Post-Dose|CLCR After Administration of a Single Oral Dose of 20 mg of MK-0941 to Participants With Moderate Renal Insufficiency Versus Matched Controls, CICR was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and moderate renal insufficiency that received 20 mg of MK-0941 versus controls with normal renal function that received 20 mg of MK-0941. Moderate renal insufficiency was defined as a 24-hour CLCR of 30 to 50 mL/min/1.73m\^2., 36-Hours Post-Dose|CLCR After Administration of a Single Oral Dose of 5 mg of MK-0941 to Participants With Severe Renal Insufficiency Versus Matched Controls, CICR was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and severe renal insufficiency that received 5 mg of MK-0941 versus controls with normal renal function that received 5 mg of MK-0941. Severe renal insufficiency was defined as a 24-hour CLCR of \< 30 mL/min/1.73m\^2., 36-Hours Post-Dose|Plasma Glucose Concentration After Administration of a Single Oral Dose of 20 mg of MK-0941 to Participants With Mild Renal Insufficiency Versus Matched Controls, The glucose concentration-time profile was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and mild renal insufficiency who received 20 mg of MK-0941 versus controls with normal renal function who received 20 mg of MK-0941. Mild renal insufficiency was defined as a 24-hour CLCR of \> 50 to 80 mL/min/1.73m\^2., Up to 12 Hours Post-Dose|Plasma Glucose Concentration After Administration of a Single Oral Dose of 20 mg of MK-0941 to Participants With Moderate Renal Insufficiency Versus Matched Controls, The glucose concentration-time profile was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and moderate renal insufficiency who received 20 mg of MK-0941 versus controls with normal renal function who received 20 mg of MK-0941. Moderate renal insufficiency was defined as a 24-hour CLCR of 30 to \< 50 mL/min/1.73m\^2., Up to 12 Hours Post-Dose|Plasma Glucose Concentration After Administration of a Single Oral Dose of 5 mg of MK-0941 to Participants With Severe Renal Insufficiency Versus Matched Controls, The glucose concentration-time profile was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and severe renal insufficiency who received 5 mg of MK-0941 versus controls with normal renal function who received 5 mg of MK-0941. Severe renal insufficiency was defined as a 24-hour CLCR of \< 30 mL/min/1.73m\^2., Up to 12 Hours Post-Dose
Sponsor/Collaborators: Sponsor: Merck Sharp & Dohme LLC
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 32
Study Type: INTERVENTIONAL
Study Designs: Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2009-01
Completion Date: 2009-09
Results First Posted: 2012-07-23
Last Update Posted: 2015-02-26
Locations:
URL: https://clinicaltrials.gov/show/NCT00830791