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| ID | Type | Description | Link |
|---|---|---|---|
| 2007_526 |
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Sufficient data regarding the dose-response to MK-0893 had been obtained from the first cohort of the study to assess the safety and efficacy
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A study to compare MK0893 to metformin or placebo for patients with Type 2 diabetes (Diabetes Mellitus).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MK0893 80 mg | Experimental | MK0893 tablets totaling 80 mg once daily. |
|
| MK0893 60 mg | Experimental | MK0893 tablets totaling 60 mg once daily. |
|
| MK0893 40 mg | Experimental | MK0893 40 mg tablet once daily. |
|
| MK0893 20 mg | Experimental | MK0893 20 mg tablet once daily. |
|
| Metformin | Active Comparator | Metformin HCL 500 mg tablet twice daily BID titrating up to 1000 mg twice daily over 3 weeks. |
|
| Placebo |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK0893 | Drug | MK0893 taken orally once daily; 20 mg and 40 mg tablets used in combination according to dose. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Week 12 in Fasting Plasma Glucose (FPG) | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Week 12 in Hemoglobin A1c (HbA1c) | Week 12 | |
| Change From Baseline to Week 12 in 2-Hour Post Prandial Glucose (PPG) | Week 12 |
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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 | |
| FG001 | MK0893 20 mg | |
| FG002 | MK0893 40 mg | |
| FG003 | MK0893 60 mg | |
| FG004 | MK0893 80 mg | |
| FG005 | Metformin HCL |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | |
| BG001 | MK0893 20 mg | |
| BG002 | MK0893 40 mg |
| 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 | Change From Baseline to Week 12 in Fasting Plasma Glucose (FPG) | All participants who received at least one dose of study therapy, had a baseline measurement, and had at least one post-randomization measurement. | Posted | Least Squares Mean | 95% Confidence Interval | mg/dL | Week 12 |
|
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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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina unstable | Cardiac disorders | MedDRA 12.0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 12.0 |
Sufficient data regarding the dose-response to MK-0893 had been obtained from the first cohort of the study to assess the safety and efficacy, thus the study was discontinued.
| 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 |
|---|---|
| C575263 | N-((4-(1-(3-(3,5-dichlorophenyl)-5-(6-methoxynaphthalen-2-yl)-1H-pyrazol-1-yl)ethyl)phenyl)carbonyl)-beta-alanine |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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PLA tablets. 12 week treatment period. |
|
| Metformin | Drug | Metformin HCL 500 mg tablet twice daily titrating up to 1000 mg twice daily over 3 weeks. |
|
| Placebo to MK0893 | Drug | Dose-matched placebo tablets to MK0893; taken orally once daily. |
|
| Placebo to Metformin | Drug | Dose-matched placebo tablets to metformin (500 mg); taken orally twice daily. |
|
| Hyperglycemia |
|
| Lack of Efficacy |
|
| Lost to Follow-up |
|
| Physician Decision |
|
| Pregnancy |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| BG003 | MK0893 60 mg |
| BG004 | MK0893 80 mg |
| BG005 | Metformin HCL |
| BG006 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG004 | MK0893 80 mg |
| OG005 | Metformin HCL |
|
|
|
| Secondary | Change From Baseline to Week 12 in Hemoglobin A1c (HbA1c) | All participants who received at least one dose of study therapy, had a baseline measurement, and had at least one post-randomization measurement. | Posted | Least Squares Mean | 95% Confidence Interval | mg/dL | Week 12 |
|
|
|
|
| Secondary | Change From Baseline to Week 12 in 2-Hour Post Prandial Glucose (PPG) | All participants who received at least one dose of study therapy, had a baseline measurement, and had at least one post-randomization measurement. | Posted | Least Squares Mean | 95% Confidence Interval | mg/dL | Week 12 |
|
|
|
|
| 5 |
| 57 |
| 16 |
| 57 |
| EG001 | MK0893 20 mg | 0 | 57 | 11 | 57 |
| EG002 | MK0893 40 mg | 1 | 57 | 22 | 57 |
| EG003 | MK0893 60 mg | 0 | 58 | 16 | 58 |
| EG004 | MK0893 80 mg | 2 | 56 | 12 | 56 |
| EG005 | Metformin HCL | 0 | 57 | 13 | 57 |
| Inguinal hernia | Gastrointestinal disorders | MedDRA 12.0 |
|
| Chest pain | General disorders | MedDRA 12.0 |
|
| Pulmonary tuberculosis | Infections and infestations | MedDRA 12.0 |
|
| Blood bilirubin increased | Investigations | MedDRA 12.0 |
|
| Cerebral haemorrhage | Nervous system disorders | MedDRA 12.0 |
|
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 12.0 |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 12.0 |
|
| Nausea | Gastrointestinal disorders | MedDRA 12.0 |
|
| Influenza | Infections and infestations | MedDRA 12.0 |
|
| Nasopharyngitis | Infections and infestations | MedDRA 12.0 |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 12.0 |
|
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA 12.0 |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 12.0 |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 12.0 |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 12.0 |
|
| Dizziness | Nervous system disorders | MedDRA 12.0 |
|
| Headache | Nervous system disorders | MedDRA 12.0 |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 |
|
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| D004700 | Endocrine System Diseases |
| Mean Difference (Final Values) |
| -1.53 |
| 2-Sided |
| 95 |
| -1.91 |
| -1.15 |
| No |
| Superiority or Other |
| ANCOVA | <0.001 | Mean Difference (Final Values) | -1.69 | 2-Sided | 95 | -2.07 | -1.31 | No | Superiority or Other |
| ANCOVA | <0.001 | Mean Difference (Final Values) | -2.06 | 2-Sided | 95 | -2.45 | -1.68 | No | Superiority or Other |
| ANCOVA | <0.001 | Mean Difference (Final Values) | -1.32 | 2-Sided | 95 | -1.70 | -0.95 | No | Superiority or Other |
| Mean Difference (Final Values) |
| -70.0 |
| 2-Sided |
| 95 |
| -91.8 |
| -48.2 |
| No |
| Superiority or Other |
| ANCOVA | <0.001 | Mean Difference (Final Values) | -87.4 | 2-Sided | 95 | -109.4 | -65.3 | No | Superiority or Other |
| ANCOVA | <0.001 | Mean Difference (Final Values) | -101.6 | 2-Sided | 95 | -124.2 | -79.1 | No | Superiority or Other |
| ANCOVA | <0.001 | Mean Difference (Final Values) | -60.8 | 2-Sided | 95 | -82.7 | -38.8 | No | Superiority or Other |