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| ID | Type | Description | Link |
|---|---|---|---|
| 2008_023 | Other Identifier | Merck Registration ID | |
| MK-0941-011 | Other Identifier | Merck Protocol ID |
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The multiple dose study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of MK-0941 in Japanese patients with Type 2 Diabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo/MK-0941 20mg | Experimental | Participants received Placebo during Period 1 and MK-0941 20 mg during Period 2. There was a washout period of at least 8 days between the two treatment periods. |
|
| MK-0941 5mg/Placebo | Experimental | Participants received MK-0941 5 mg during Period 1 and Placebo during Period 2. There was a washout period of at least 8 days between the two treatment periods. |
|
| MK-0941 5mg/MK-0941 20mg | Experimental | Participants received MK-0941 5 mg during Period 1 and MK-0941 20 mg during Period 2. There was a washout period of at least 8 days between the two treatment periods. |
|
| Placebo/MK-0941 40mg | Experimental | Participants received Placebo during Period 1 and MK-0941 40 mg during Period 2. There was a washout period of at least 8 days between the two treatment periods. |
|
| MK-0941 10mg/Placebo | Experimental | Participants received MK-0941 10 mg during Period 1 and Placebo during Period 2. There was a washout period of at least 8 days between the two treatment periods. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Placebo tablets before every meal (q.a.c) Treatment period is 5 days. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experienced at Least One Adverse Event (AE) | An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Participants were monitored for occurrence AEs for up to 8 days after last dose of study drug during Period 1 and for up to 14 days after last dose of study drug during Period 2. | Up to 14 days after last dose of study drug |
| Number of Participants Who Discontinued Study Drug Due to an AE | An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Participants were monitored for occurrence AEs for up to 8 days after last dose of study drug during Period 1 and for up to 14 days after last dose of study drug during Period 2. | Up to 14 days after last dose of study drug |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Pharmacokinetic Parameter: Area Under the Concentration-time Curve (AUC)(0-24hr) of MK-0941 | Blood samples for measurement of plasma pharmacokinetic parameters were collected from predose to up to 24 hours postdose on Day 1 and from predose to up to 72 hours postdose on Day 5 in each treatment period. | Up to 72 hours after study drug administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo/MK-0941 20mg | Participants received Placebo during Period 1 and MK-0941 20 mg during Period 2 |
| FG001 | MK-0941 5mg/Placebo | Participants received MK-0941 5 mg during Period 1 and Placebo during Period 2 |
| FG002 | MK-0941 5mg/MK-0941 20mg | Participants received MK-0941 5 mg during Period 1 and MK-0941 20 mg during Period 2 |
| FG003 | Placebo/MK-0941 40mg | Participants received Placebo during Period 1 and MK-0941 40 mg during Period 2 |
| FG004 | MK-0941 10mg/Placebo | Participants received MK-0941 10 mg during Period 1 and Placebo during Period 2 |
| FG005 | MK-0941 10mg/MK-0941 40mg | Participants received MK-0941 10 mg during Period 1 and MK-0941 40 mg during Period 2 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 (5 Days) |
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| Washout Period (>=8 Days) |
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| Period 2 (5 Days) |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo/MK-0941 20mg | Participants received Placebo during Period 1 and MK-0941 20 mg during Period 2 |
| BG001 | MK-0941 5mg/Placebo | Participants received MK-0941 5 mg during Period 1 and Placebo during Period 2 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Who Experienced at Least One Adverse Event (AE) | An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Participants were monitored for occurrence AEs for up to 8 days after last dose of study drug during Period 1 and for up to 14 days after last dose of study drug during Period 2. | Safety Population, consisting of all randomized participants who received at least one dose of study drug. | Posted | Number | participants | Up to 14 days after last dose of study drug |
|
Participants were monitored for occurrence AEs for up to 8 days after last dose of study drug during Period 1 and for up to 14 days after last dose of study drug during Period 2.
This is a crossover-design study; a single participant may be represented in up to two different reporting groups.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Participants receiving Placebo doses three times daily |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diabetic retinopathy | Eye disorders | MedDRA (11.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C569222 | 3-((6-(ethylsulfonyl)-3-pyridinyl)oxy)-5-(2-hydroxy-1-methylethoxy)-N-(1-methyl-1H-pyrazol-3-yl)benzamide |
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|
| MK-0941 10mg/MK-0941 40mg | Experimental | Participants received MK-0941 10 mg during Period 1 and MK-0941 40 mg during Period 2. There was a washout period of at least 8 days between the two treatment periods. |
|
| MK-0941 | Drug | MK-0941 5 mg tablets q.a.c.; 10 mg tablets q.a.c.; 20 mg tablets q.a.c.; or 40 mg tablets q.a.c. Treatment period is 5 days. |
|
| Plasma Pharmacokinetic Parameter: Maximum Concentration (Cmax) of MK-0941 | Blood samples for measurement of plasma pharmacokinetic parameters were collected from predose to up to 24 hours postdose on Day 1 and from predose to up to 72 hours postdose on Day 5 in each treatment period. | Up to 72 hours after study drug administration |
| Plasma Pharmacokinetic Parameter: Time to Reach Cmax (Tmax) of MK-0941 | Blood samples for measurement of plasma pharmacokinetic parameters were collected from predose to up to 24 hours postdose on Day 1 and from predose to up to 72 hours postdose on Day 5 in each treatment period. | Up to 72 hours after study drug administration |
| Plasma Pharmacokinetic Parameter: Concentration of MK-0941 at 24 Hours (C24hr) | Blood samples for measurement of plasma pharmacokinetic parameters were collected from predose to up to 24 hours postdose on Day 1 and from predose to up to 72 hours postdose on Day 5 in each treatment period. | Up to 72 hours after study drug administration |
| Plasma Pharmacokinetic Parameter: Apparent Terminal Elimination Half-life (t1/2) of MK-0941 | Blood samples for measurement of plasma pharmacokinetic parameters were collected from predose to up to 24 hours postdose on Day 1 and from predose to up to 72 hours postdose on Day 5 in each treatment period. | Up to 72 hours after study drug administration |
| Plasma Pharmacokinetic Parameter: Day 5 to Day 1 Accumulation Ratio for AUC (0-24hr), Cmax, and C24hr | Geometric Mean of the Day 5 to Day 1 Accumulation Ratio | Day 5 and Day 1 |
| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
|
| BG002 | MK-0941 5mg/MK-0941 20mg | Participants received MK-0941 5 mg during Period 1 and MK-0941 20 mg during Period 2 |
| BG003 | Placebo/MK-0941 40mg | Participants received Placebo during Period 1 and MK-0941 40 mg during Period 2 |
| BG004 | MK-0941 10mg/Placebo | Participants received MK-0941 10 mg during Period 1 and Placebo during Period 2 |
| BG005 | MK-0941 10mg/MK-0941 40mg | Participants received MK-0941 10 mg during Period 1 and MK-0941 40 mg during Period 2 |
| BG006 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| MK-0941 5mg |
Participants receiving MK-0941 5 mg doses three times daily |
| OG002 | MK-0941 10mg | Participants receiving MK-0941 10 mg doses three times daily |
| OG003 | MK-0941 20mg | Participants receiving MK-0941 20 mg doses three times daily |
| OG004 | MK-0941 40mg | Participants receiving MK-0941 40 mg doses three times daily. One participant randomized to receive MK-0941 10 mg during Period 1 and MK-0941 40 mg during Period 2 received MK-0941 10 mg during both Periods 1 and 2. |
|
|
| Secondary | Plasma Pharmacokinetic Parameter: Area Under the Concentration-time Curve (AUC)(0-24hr) of MK-0941 | Blood samples for measurement of plasma pharmacokinetic parameters were collected from predose to up to 24 hours postdose on Day 1 and from predose to up to 72 hours postdose on Day 5 in each treatment period. | Participants with an AUC(0-24hr) measurement | Posted | Mean | Standard Deviation | nmol*hr/L | Up to 72 hours after study drug administration |
|
|
|
| Secondary | Plasma Pharmacokinetic Parameter: Maximum Concentration (Cmax) of MK-0941 | Blood samples for measurement of plasma pharmacokinetic parameters were collected from predose to up to 24 hours postdose on Day 1 and from predose to up to 72 hours postdose on Day 5 in each treatment period. | Participants with a Cmax measurement | Posted | Mean | Standard Deviation | nmol/L | Up to 72 hours after study drug administration |
|
|
|
| Secondary | Plasma Pharmacokinetic Parameter: Time to Reach Cmax (Tmax) of MK-0941 | Blood samples for measurement of plasma pharmacokinetic parameters were collected from predose to up to 24 hours postdose on Day 1 and from predose to up to 72 hours postdose on Day 5 in each treatment period. | Participants with a Tmax measurement | Posted | Median | Full Range | hr | Up to 72 hours after study drug administration |
|
|
|
| Secondary | Plasma Pharmacokinetic Parameter: Concentration of MK-0941 at 24 Hours (C24hr) | Blood samples for measurement of plasma pharmacokinetic parameters were collected from predose to up to 24 hours postdose on Day 1 and from predose to up to 72 hours postdose on Day 5 in each treatment period. | Participants with a C24hr measurement | Posted | Mean | Standard Deviation | nmol/L | Up to 72 hours after study drug administration |
|
|
|
| Secondary | Plasma Pharmacokinetic Parameter: Apparent Terminal Elimination Half-life (t1/2) of MK-0941 | Blood samples for measurement of plasma pharmacokinetic parameters were collected from predose to up to 24 hours postdose on Day 1 and from predose to up to 72 hours postdose on Day 5 in each treatment period. | Participants with a t1/2 measurement | Posted | Mean | Standard Deviation | hr | Up to 72 hours after study drug administration |
|
|
|
| Primary | Number of Participants Who Discontinued Study Drug Due to an AE | An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Participants were monitored for occurrence AEs for up to 8 days after last dose of study drug during Period 1 and for up to 14 days after last dose of study drug during Period 2. | Safety Population, consisting of all randomized participants who received at least one dose of study drug. | Posted | Number | participants | Up to 14 days after last dose of study drug |
|
|
|
| Secondary | Plasma Pharmacokinetic Parameter: Day 5 to Day 1 Accumulation Ratio for AUC (0-24hr), Cmax, and C24hr | Geometric Mean of the Day 5 to Day 1 Accumulation Ratio | All participants with pharmacokinetic measurements on Days 1 and 5 | Posted | Geometric Mean | Full Range | Ratio | Day 5 and Day 1 |
|
|
|
| 0 |
| 8 |
| 2 |
| 8 |
| EG001 | MK-0941 5mg | Participants receiving MK-0941 5 mg doses three times daily | 0 | 6 | 2 | 6 |
| EG002 | MK-0941 10mg | Participants receiving MK-0941 10 mg doses three times daily | 0 | 6 | 2 | 6 |
| EG003 | MK-0941 20mg | Participants receiving MK-0941 20 mg doses three times daily | 0 | 6 | 2 | 6 |
| EG004 | MK-0941 40mg | Participants receiving MK-0941 40 mg doses three times daily. One participant randomized to receive MK-0941 10 mg during Period 1 and MK-0941 40 mg during Period 2 received MK-0941 10 mg during both Periods 1 and 2. | 0 | 5 | 2 | 5 |
| Retinopathy | Eye disorders | MedDRA (11.0) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Wound | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| Blood glucose decreased | Investigations | MedDRA (11.0) | Systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (11.0) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA (11.0) | Systematic Assessment |
|
| Haemorrhage | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
|
The Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the SPONSOR as confidential must be deleted prior to submission.
| D004700 | Endocrine System Diseases |
| Day 5 |
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| Day 5 |
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| Day 5 |
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| Day 5 |
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| Day 5 |
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| Cmax Day 5/Day 1 Accumulation Ratio |
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| C24hr Day 5/Day 1 Accumulation Ratio |
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