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| ID | Type | Description | Link |
|---|---|---|---|
| 2007_595 |
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A multiple dose study to assess the safety and pharmacokinetics of an investigational drug in patients with type 2 diabetes. The primary hypotheses of the study are that multiple daily MK-0941 in subjects with T2DM with or without adequate control on metformin will be sufficiently safe and well tolerated to permit continued clinical investigation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MK0941 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK0941 | Drug | MK0941 10 mg, 20 mg, 30 mg, or 40 mg before each meal or before 2 meals each day, or 60 mg before 2 meals each day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Participants With Any Clinical Adverse Experience | Approximately 30 days after last dose of study drug (14 days for participants receiving MK0941 40 mg before each meal) | |
| Participants Discontinued Because of Any Clinical Adverse Experience | Approximately 30 days after last dose of study drug (14 days for participants receiving MK0941 40 mg before each meal) |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-time Curve (AUC0-24) of MK-0941 After Multiple Doses of MK0941 | Up to 72 hours after dosing (up to 24 hours for participants receiving MK0941 60 mg before 2 meals each day) | |
| Maximum Concentration (Cmax) of MK-0941 After Multiple Doses of MK-0941 |
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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 | MK-0941 | All participants receiving any dose of MK-0941 |
| FG001 | Placebo | All participants receiving any dose of placebo |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | MK-0941 | All participants receiving any dose of MK-0941 |
| BG001 | Placebo | All participants receiving any dose of placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 | Participants With Any Clinical Adverse Experience | Posted | Number | percentage of of participants | Approximately 30 days after last dose of study drug (14 days for participants receiving MK0941 40 mg before each meal) |
|
|
Approximately 30 days after last dose of study drug (14 days for participants receiving MK-0941 40 mg before each meal)
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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 | MK-0941 | All participants receiving any dose of MK-0941 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (13.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme | 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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| Comparator: Placebo | Drug | Placebo 10 mg, 20 mg, 30 mg, or 40 mg before each meal or before 2 meals each day, or 60 mg before 2 meals each day |
|
| Up to 72 hours after dosing (up to 24 hours for participants receiving MK0941 60 mg before 2 meals each day) |
| Time to Maximum Concentration (Tmax) of MK-0941 After Multiple Doses of MK-0941 | Up to 72 hours after dosing (up to 24 hours for participants receiving MK0941 60 mg before 2 meals each day) |
| Apparent Terminal Elimination Half-life (T1/2) of MK-0941 After Multiple Doses of MK0941 | Up to 72 hours after dosing (up to 24 hours for participants receiving MK0941 60 mg before 2 meals each day) |
| Concentration of MK-0941 at 24 Hours (C24hr) After Multiple Doses of MK-0941 | Up to 72 hours after dosing (up to 24 hours for participants receiving MK0941 60 mg before 2 meals each day) |
| Withdrawal by Subject |
|
| Site terminated |
|
| Other |
|
| BG002 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Area Under the Concentration-time Curve (AUC0-24) of MK-0941 After Multiple Doses of MK0941 | Posted | Mean | Standard Deviation | nM-hr | Up to 72 hours after dosing (up to 24 hours for participants receiving MK0941 60 mg before 2 meals each day) |
|
|
|
| Secondary | Maximum Concentration (Cmax) of MK-0941 After Multiple Doses of MK-0941 | Posted | Mean | Standard Deviation | nM | Up to 72 hours after dosing (up to 24 hours for participants receiving MK0941 60 mg before 2 meals each day) |
|
|
|
| Secondary | Time to Maximum Concentration (Tmax) of MK-0941 After Multiple Doses of MK-0941 | Posted | Mean | Full Range | hours | Up to 72 hours after dosing (up to 24 hours for participants receiving MK0941 60 mg before 2 meals each day) |
|
|
|
| Secondary | Apparent Terminal Elimination Half-life (T1/2) of MK-0941 After Multiple Doses of MK0941 | Posted | Mean | Standard Deviation | hours | Up to 72 hours after dosing (up to 24 hours for participants receiving MK0941 60 mg before 2 meals each day) |
|
|
|
| Secondary | Concentration of MK-0941 at 24 Hours (C24hr) After Multiple Doses of MK-0941 | Posted | Mean | Standard Deviation | nM | Up to 72 hours after dosing (up to 24 hours for participants receiving MK0941 60 mg before 2 meals each day) |
|
|
|
| Primary | Participants Discontinued Because of Any Clinical Adverse Experience | Posted | Number | participants | Approximately 30 days after last dose of study drug (14 days for participants receiving MK0941 40 mg before each meal) |
|
|
|
| 0 |
| 52 |
| 27 |
| 52 |
| EG001 | Placebo | All participants receiving any dose of placebo | 0 | 18 | 11 | 18 |
| Eye pain | Eye disorders | MedDRA (13.0) | Systematic Assessment |
|
| Eye pruritus | Eye disorders | MedDRA (13.0) | Systematic Assessment |
|
| Lacrimation increased | Eye disorders | MedDRA (13.0) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
|
| Aphthous stomatitis | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
|
| Vulvovaginal mycotic infection | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (13.0) | Systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA (13.0) | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Systematic Assessment |
|
| Peripheral coldness | Vascular disorders | MedDRA (13.0) | 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. Sponsor review can be expedited to meet publication guidelines.
| D004700 | Endocrine System Diseases |