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| ID | Type | Description | Link |
|---|---|---|---|
| 2009_541 |
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Study was terminated due to inability to recruit patients.
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A study to assess the safety and efficacy of MK8245 as monotherapy compared to placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MK8245 5 mg b.i.d. | Experimental | MK8245 |
|
| MK8245 50 mg b.i.d. | Experimental | MK8245 |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK8245 5 mg (twice a day) b.i.d. | Drug | All patients will receive placebo capsules 2 weeks prior to treatment period to be taken twice daily. Patients randomized to the 5 mg b.i.d. treatment group took 2 capsules of MK8245 2.5 mg in the morning and 2 capsules of MK8245 2.5 mg in the evening. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in 24-hour Weighted Mean Glucose (WMG) at Week 4 | The 24-hour WMG is derived from multiple glucose values collected during both fasting and post-meal periods. A "weighted" rather than a "simple" mean is used to avoid overrepresentation of post-meal glucose values. Blood samples for glucose were to be collected immediately prior to (sample -10 minutes), and 0, 15, 30, 60, 90, 120, and 180 minutes after each meal, and overnight (at midnight, 3 AM, and 5 AM) and fasting at 7 AM. Patients were to be domiciled for approximately 26 hours at the site where standard meals were provided and physical activity monitored. | Baseline and Week 4 |
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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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Patients 18-65 yrs not on antihyperglycemic agent (AHA) (A1C 7-10%),or single AHA (A1C 7-9.5%),or low dose dual AHA therapy (A1C 6.5-9.5%) with type 2 diabetes mellitus entered a 4-wk diet/exercise period (AHA wash-off if on AHA),after which,those with fasting glucose of 130-250 mg/dL were eligible for randomization (after a 2 wk pbo run-in period)
First Patient In:10-Feb-2009
Early Termination*:11-Aug-2009
Last Patient Last Visit:19-Aug-2009
10 Centers Worldwide
*Study was terminated due to inability to recruit patients. Because it was not terminated for safety concerns, sites were to see patients for early termination visit at earliest convenience. The last patient was seen 19-Aug-2009.
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| ID | Title | Description |
|---|---|---|
| FG000 | MK8245 5 mg b.i.d. | Patients randomized to the 5 mg (twice a day) b.i.d. treatment group took 2 capsules of MK8245 2.5 mg in the morning and 2 capsules of MK8245 2.5 mg in the evening. |
| FG001 | MK8245 50 mg b.i.d. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| MK8245 50 mg b.i.d. | Drug | All patients will receive placebo capsules 2 weeks prior to treatment period to be taken twice daily. Patients randomized to the 50 mg b.i.d. treatment group took 2 capsules of MK8245 25 mg in the morning and 2 capsules of MK8245 25 mg in the evening. |
|
|
| Placebo | Drug | All patients will receive placebo capsules 2 weeks prior to treatment period to be taken twice daily. Patients randomized to the placebo treatment group took 2 capsules of placebo matching MK8245 capsules in the morning and 2 placebo capsules matching MK8245 capsules in the evening. |
|
Patients randomized to the 50 mg b.i.d. treatment group took 2 capsules of MK8245 25 mg in the morning and 2 capsules of MK8245 25 mg in the evening.
| FG002 | Placebo | Patients randomized to the placebo treatment group took 2 capsules of placebo matching MK8245 capsules in the morning and 2 placebo capsules matching MK8245 capsules in the evening. |
| COMPLETED |
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| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | MK8245 5 mg b.i.d. | Patients randomized to the 5 mg (twice a day) b.i.d. treatment group took 2 capsules of MK8245 2.5 mg in the morning and 2 capsules of MK8245 2.5 mg in the evening. |
| BG001 | MK8245 50 mg b.i.d. | Patients randomized to the 50 mg b.i.d. treatment group took 2 capsules of MK8245 25 mg in the morning and 2 capsules of MK8245 25 mg in the evening. |
| BG002 | Placebo | Patients randomized to the placebo treatment group took 2 capsules of placebo matching MK8245 capsules in the morning and 2 placebo capsules matching MK8245 capsules in the evening. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
|
| 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 in 24-hour Weighted Mean Glucose (WMG) at Week 4 | The 24-hour WMG is derived from multiple glucose values collected during both fasting and post-meal periods. A "weighted" rather than a "simple" mean is used to avoid overrepresentation of post-meal glucose values. Blood samples for glucose were to be collected immediately prior to (sample -10 minutes), and 0, 15, 30, 60, 90, 120, and 180 minutes after each meal, and overnight (at midnight, 3 AM, and 5 AM) and fasting at 7 AM. Patients were to be domiciled for approximately 26 hours at the site where standard meals were provided and physical activity monitored. | The analysis population included all patients with a baseline value and Week 4 value for this outcome. | Posted | Mean | Standard Deviation | mg/dL | Baseline and Week 4 |
|
|
|
Adverse experiences were collected from Visit 2 (Week -6) through Visit 6 (Week 4). Serious adverse experiences were collected for up to 14 days after the last dose of study medication.
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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 | MK8245 5 mg b.i.d. | Patients randomized to the 5 mg (twice a day) b.i.d. treatment group took 2 capsules of MK8245 2.5 mg in the morning and 2 capsules of MK8245 2.5 mg in the evening. | 0 | 4 | 3 | 4 | ||
| EG001 | MK8245 50 mg b.i.d. | Patients randomized to the 50 mg b.i.d. treatment group took 2 capsules of MK8245 25 mg in the morning and 2 capsules of MK8245 25 mg in the evening. | 0 | 4 | 1 | 4 | ||
| EG002 | Placebo | Patients randomized to the placebo treatment group took 2 capsules of placebo matching MK8245 capsules in the morning and 2 placebo capsules matching MK8245 capsules in the evening. | 0 | 6 | 3 | 6 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Punctate keratitis | Eye disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA (12.0) | Non-systematic Assessment |
| |
| Headadache | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
|
This study was terminated due to the continuing inability to recruit patients. No efficacy analysis was performed because of insufficient sample size for meaningful analysis due to early study termination and insufficient sample size.
Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| 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 |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C561635 | (5-(3-(4-(2-bromo-5-fluorophenoxy)piperidin-1-yl)isoxazol-5-yl)-2H-tetrazol-2-yl)acetic acid |
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| Male |
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| Not Hispanic or Latino |
|
| Unknown or Not Reported |
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| Multi-Racial |
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| White |
|