Type 2 Diabetes
Conditions
Brief summary
This study will assess the pharmacokinetics of MK-0941 in participants with varying degrees of renal insufficiency.
Interventions
DRUGMK-0941 20 mg
Two 10-mg tablets of MK-0941 administered as a single oral dose.
DRUGMK-0941 5 mg
MK-0941 administered as one single 5-mg tablet.
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Male or nonpregnant female age 18 to 75 years * Female of childbearing potential on appropriate method of contraception * Body mass index (BMI) less than or equal to 40 kg/m2 * Participant is in good health * Participant diagnosed with Type 2 Diabetes * Participant agrees to follow smoking restrictions * Willing to follow the study diet restrictions
Exclusion criteria
* Mental or legal incapacitation * Participant has had kidney removed * History of Type 1 diabetes * History of stroke, chronic seizures or major neurological disorder * History of neoplastic disease * Nursing mother * Consumes greater than 4 glasses of alcoholic beverages per day * Consumes greater than 6 servings of caffeinated beverages per day * Participant has had surgery or donated 1 unit of blood within 1 month of screening * Participant has history of recent eye infection within 2 weeks of study drug administration * Clinically diagnosed with glaucoma or blindness * Has trauma to one or both eyes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 72 Hours Post-Dose | 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. |
| 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 | 72-Hours Post-Dose | 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. |
| 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 | 72-Hours Post-Dose | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 72-Hours Post-Dose | 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. |
| Tmax After Administration of a Single Oral Dose of 20 mg of MK-0941 Among Participants With Moderate Renal Insufficiency vs Matched Controls | 72-Hours Post-Dose | 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. |
| Tmax After Administration of a Single Oral Dose of 5 mg of MK-0941 Among Participants With Severe Renal Insufficiency vs Matched Controls | 72-Hours Post-Dose | 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. |
| 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 | 72-Hours Post-Dose | 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. |
| 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 | 72-Hours Post-Dose | 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. |
| 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 | 72-Hours Post-Dose | 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. |
| 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 | 36-Hours Post-Dose | 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. |
| 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 | 72-Hours Post-Dose | 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. |
| Fe After Administration of a Single Oral Dose of 5 mg of MK-0941 Among Participants With Severe Renal Insufficiency Versus Matched Controls | 36-Hours Post-Dose | 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. |
| CLCR After Administration of a Single Oral Dose of 20 mg of MK-0941 to Participants With Mild Renal Insufficiency Versus Matched Controls | 36-Hours Post-Dose | 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. |
| CLCR After Administration of a Single Oral Dose of 20 mg of MK-0941 to Participants With Moderate Renal Insufficiency Versus Matched Controls | 36-Hours Post-Dose | 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. |
| CLCR After Administration of a Single Oral Dose of 5 mg of MK-0941 to Participants With Severe Renal Insufficiency Versus Matched Controls | 36-Hours Post-Dose | 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. |
| 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 | Up to 12 Hours Post-Dose | 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. |
| 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 | Up to 12 Hours Post-Dose | 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. |
| 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 | Up to 12 Hours Post-Dose | 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. |
| Fe After Administration of a Single Oral Dose of 20 mg of MK-0941 Among Participants With Moderate Renal Insufficiency Versus Matched Controls | 36-Hours Post-Dose | 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. |
| Cmax After Administration of a Single Oral Dose of 20 mg of MK-0941 Among Participants With Moderate Renal Insufficiency vs Matched Controls | 72-Hours Post-Dose | 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. |
| Cmax After Administration of a Single Oral Dose of 5 mg of MK-0941 Among Participants With Severe Renal Insufficiency vs Matched Controls | 72-Hours Post-Dose | 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| MK-0941 20 mg Mild Renal Insufficiency MK-0941 administered as a single oral dose of 20 mg (10 mg x 2) to participants with mild renal insufficiency. | 8 |
| Control + MK-0941 20 mg Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus but without mild renal insufficiency (T2DM) who received MK-941 at a dose of 20 mg administered as a single oral dose of 10 mg x 2. | 8 |
| MK-0941 20 mg Moderate Renal Insufficiency MK-0941 administered as a single oral dose of 20 mg (10 mg x 2) to participants with moderate renal insufficiency. | 8 |
| Control + 20 mg MK-0941 Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) but without moderate renal insufficiency who received MK-941 at a dose of 20 mg administered as a single oral dose of 10 mg x 2. | 8 |
| MK-0941 5 mg Severe Renal Insufficiency MK-0941 administered as a single oral dose of 5 mg to participants with severe renal insufficiency. | 0 |
| Control + MK-0941 5 mg Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) but without severe renal insufficiency who received MK-941 at a dose of 5 mg administered as a single oral dose. | 0 |
| Total | 32 |
Baseline characteristics
| Characteristic | MK-0941 20 mg Mild Renal Insufficiency | Control + MK-0941 20 mg | MK-0941 20 mg Moderate Renal Insufficiency | Control + 20 mg MK-0941 | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants |
| Age, Categorical >=65 years | 2 participants | 2 participants | 1 participants | 1 participants | 6 participants |
| Age, Categorical Between 18 and 65 years | 6 participants | 6 participants | 7 participants | 7 participants | 26 participants |
| Gender Female | 6 participants | 6 participants | 5 participants | 5 participants | 22 participants |
| Gender Male | 2 participants | 2 participants | 3 participants | 3 participants | 10 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 3 / 16 | 3 / 8 | 4 / 8 |
| serious Total, serious adverse events | 0 / 16 | 0 / 8 | 0 / 8 |
Outcome results
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.
Time frame: 72 Hours Post-Dose
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| MK-0941 20 mg | 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 | 1481.42 nM per Hour |
| Control + MK-0941 20 mg | 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 | 1553.50 nM per Hour |
p-value: 0.71890% CI: [0.76, 1.2]ANCOVA
Primary
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.
Time frame: 72-Hours Post-Dose
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| MK-0941 20 mg | 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 | 2084.00 nM per Hour |
| Control + MK-0941 20 mg | 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 | 1278.83 nM per Hour |
p-value: 0.01490% CI: [1.21, 2.2]ANCOVA
Primary
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.
Time frame: 72-Hours Post-Dose
Population: This study was discontinued early and participants were not treated with the 5 mg dose.
Secondary
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.
Time frame: 36-Hours Post-Dose
Population: This study was discontinued early and this evaluation was not conducted.
Secondary
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.
Time frame: 36-Hours Post-Dose
Population: This study was discontinued early and this evaluation was not conducted.
Secondary
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.
Time frame: 36-Hours Post-Dose
Population: This study was discontinued early and this evaluation was not conducted.
Secondary
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.
Time frame: 36-Hours Post-Dose
Population: This study was discontinued early and this evaluation was not conducted.
Secondary
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.
Time frame: 72-Hours Post-Dose
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| MK-0941 20 mg | Cmax After Administration of a Single Oral Dose of 20 mg of MK-0941 Among Participants With Moderate Renal Insufficiency vs Matched Controls | 499.12 nM |
| Control + MK-0941 20 mg | Cmax After Administration of a Single Oral Dose of 20 mg of MK-0941 Among Participants With Moderate Renal Insufficiency vs Matched Controls | 438.57 nM |
p-value: 0.50590% CI: [0.81, 1.6]ANCOVA
Secondary
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.
Time frame: 72-Hours Post-Dose
Population: This study was discontinued early and participants were not treated with the 5 mg dose.
Secondary
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.
Time frame: 36-Hours Post-Dose
Population: This study was discontinued early and this evaluation was not conducted.
Secondary
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.
Time frame: 36-Hours Post-Dose
Population: This study was discontinued early and this evaluation was not conducted.
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.
Time frame: 72-Hours Post-Dose
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| MK-0941 20 mg | 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 | 401.39 nM |
| Control + MK-0941 20 mg | 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 | 543.45 nM |
p-value: 0.32590% CI: [0.43, 1.26]ANCOVA
Secondary
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.
Time frame: Up to 12 Hours Post-Dose
Population: This study was discontinued early and this evaluation was not conducted.
Secondary
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.
Time frame: Up to 12 Hours Post-Dose
Population: This study was discontinued early and this evaluation was not conducted.
Secondary
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.
Time frame: Up to 12 Hours Post-Dose
Population: This study was discontinued early and this evaluation was not conducted.
Secondary
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.
Time frame: 72-Hours Post-Dose
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| MK-0941 20 mg | 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 | 13.59 Hours | Standard Deviation 4.9 |
| Control + MK-0941 20 mg | 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 | 11.92 Hours | Standard Deviation 5.7 |
Secondary
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.
Time frame: 72-Hours Post-Dose
Population: This study was discontinued early and participants were not treated with the 5 mg dose.
Secondary
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.
Time frame: 72-Hours Post-Dose
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| MK-0941 20 mg | 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 | 19.02 Hours | Standard Deviation 5.45 |
| Control + MK-0941 20 mg | 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 | 15.75 Hours | Standard Deviation 7.12 |
Secondary
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.
Time frame: 72-Hours Post-Dose
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| MK-0941 20 mg | 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 | 1.00 Hours |
| Control + MK-0941 20 mg | 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 | 0.50 Hours |
90% CI: [0, 0.5]ANCOVA
Secondary
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.
Time frame: 72-Hours Post-Dose
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| MK-0941 20 mg | Tmax After Administration of a Single Oral Dose of 20 mg of MK-0941 Among Participants With Moderate Renal Insufficiency vs Matched Controls | 0.75 Hours |
| Control + MK-0941 20 mg | Tmax After Administration of a Single Oral Dose of 20 mg of MK-0941 Among Participants With Moderate Renal Insufficiency vs Matched Controls | 0.50 Hours |
90% CI: [0, 0.5]ANCOVA
Secondary
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.
Time frame: 72-Hours Post-Dose
Population: This study was discontinued early and participants were not treated with the 5 mg dose.