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| ID | Type | Description | Link |
|---|---|---|---|
| MK-7079-007 | Other Identifier | Merck protocol number |
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The purpose of this study is to evaluate the effect of SCH 497079 on metabolic parameters and to determine the influence of race/ethnic origin on therapeutic response.
This study includes two parts, each part includes three consecutive 28-day treatment periods. Part 1 (to be conducted in the United States): each participant will receive the following treatments for 28 days in each of three treatment periods in an order determined by a random code: SCH 497079, or matching placebo, or metformin.
Part 2 (to be conducted in India): this part of the study will be conducted after completion of Part 1 and an analysis indicates a clinically significant decrease in blood glucose in participants with type 2 diabetes mellitus (T2DM) compared to placebo. The same procedures conducted in Part 1 will be conducted in Part 2.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment sequence 1: SCH 497079 → Placebo → Metformin | Experimental | Participants received SCH 497079 daily for 4 weeks followed by placebo daily for 4 weeks followed by metformin daily for 4 weeks. |
|
| Treatment sequence 2: Placebo → Metformin → SCH 497079 | Experimental | Participants received placebo daily for 4 weeks followed by metformin daily for 4 weeks followed by SCH 497079 daily for 4 weeks. |
|
| Treatment sequence 3: Metformin → SCH 497079 → Placebo | Experimental | Participants received metformin daily for 4 weeks followed by SCH 497079 daily for 4 weeks followed by placebo daily for 4 weeks. |
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| Treatment sequence 4: SCH 497079 → Metformin → Placebo | Experimental | Participants received SCH 497079 daily for 4 weeks followed by metformin daily for 4 weeks followed by placebo daily for 4 weeks. |
|
| Treatment sequence 5: Placebo → SCH 49709 → Metformin | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SCH 497079 | Drug | SCH 497079 100 mg capsule, administered orally, once daily for 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacodynamic: Change From Baseline in Mean 24-hour Plasma Glucose (AUC/Duration) at Week 4 (Part 1 - United States) | Change from baseline in 24-hour plasma glucose on the last day of treatment. On the day of the glucose collections (and the day prior to), standardized meals breakfast, lunch, dinner, and snack) were provided and consumed over 15 minutes. AUC/duration is presented as mg/dL and was calculated by dividing AUC (mg/dL*hr) by the duration in hours. Model-based least squares mean: ANOVA extracting the effects due to treatment, sequence, period and participant. | Pre-dose (-30 minutes), pre-standard breakfast (0 hour), 0.5, .75, 1, 2, 3, 4, 4.5, 4.75, 5, 6, 7, 8, 9, 9.5, 9.75, 10, 11, 12, 13, 14, 15, 16, and 24 hours after the beginning of the standardized breakfast on Day -1 and Day 28 |
| Pharmacodynamic: Change From Baseline in 24-hour Plasma Glucose (AUC/Duration) at Week 4 (Part 2 - India) | Change from baseline in 24-hour plasma glucose on the last day of treatment. On the day of the glucose collections (and the day prior to), standardized meals (breakfast, lunch, dinner, and snack) were provided and consumed over 15 minutes. AUC/duration is presented as mg/dL and was calculated by dividing AUC (mg/dL*hr) by the duration in hours. Model-based least squares mean: ANOVA extracting the effects due to treatment, sequence, period and participant. | Pre-dose (-30 mnutes), pre-standard breakfast (0 hour), 0.5, .75, 1, 2, 3, 4, 4.5, 4.75, 5, 6, 7, 8, 9, 9.5, 9.75, 10, 11, 12, 13, 14, 15, 16, and 24 hours after the beginning of the standardized breakfast on Day -1 and Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experienced at Least One Adverse Event (Part 1 - United States) | An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product, biologic (at any dose), or medical device, which does not necessarily have a causal relationship with the treatment. AEs may include the onset of new illness and the exacerbation of pre-existing conditions. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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Part 1 was conducted in the United States. If an analysis at the end of Part 1 demonstrated that SCH 497079 exhibited a clinically significant glucose lowering effect, Part 2 was to be conducted in India. Part 2 of the study was not conducted.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part 1/Treatment Sequence 1: SCH 497079 → Placebo → Metformin | Participants received SCH 497079 daily for 4 weeks (Period 1) followed by placebo daily for 4 weeks (Period 2) followed by metformin daily for 4 weeks (Period 3). |
| FG001 | Part 1/Treatment Sequence 2: Placebo → Metformin → SCH 497079 | Participants received placebo daily for 4 weeks (Period 1) followed by metformin daily for 4 weeks (Period 2)followed by SCH 497079 daily for 4 weeks (Period 3). |
| FG002 | Part 1/Treatment Sequence 3: Metformin → SCH 497079 → Placebo | Participants received metformin daily for 4 weeks (Period 1) followed by SCH 497079 daily for 4 weeks (Period 2)followed by placebo daily for 4 weeks (Period 3). |
| FG003 | Part 1/Treatment Sequence 4: SCH 497079 → Metformin → Placebo | Participants received SCH 497079 daily for 4 weeks (Period 1) followed by metformin daily for 4 weeks (Period 2) followed by placebo daily for 4 weeks (Period 3). |
| FG004 | Part 1/Treatment Sequence 5: Placebo → SCH 49709 → Metformin | Participants received placebo daily for 4 weeks (Period 1) followed by SCH 497079 daily for 4 weeks (Period 2) followed by metformin daily for 4 weeks (Period 3). |
| FG005 | Part 1/Treatment Sequence 6: Metformin → Placebo → SCH 497079 | Participants received metformin daily for 4 weeks (Period 1) followed by placebo daily for 4 weeks (Period 2) followed by SCH 497079 daily for 4 weeks (Period 3). |
| FG006 | Part 2/Treatment Sequence 1: SCH 497079 → Placebo → Metformin | Participants received SCH 497079 daily for 4 weeks (Period 1) followed by placebo daily for 4 weeks (Period 2) followed by metformin daily for 4 weeks (Period 3). |
| FG007 | Part 2/Treatment Sequence 2: Placebo → Metformin → SCH 497079 | Participants received placebo daily for 4 weeks (Period 1) followed by metformin daily for 4 weeks (Period 2) followed by SCH 497079 daily for 4 weeks (Period 3). |
| FG008 | Part 2/Treatment Sequence 3: Metformin → SCH 497079 → Placebo | Participants received metformin daily for 4 weeks (Period 1) followed by SCH 497079 daily for 4 weeks (Period 2) followed by placebo daily for 4 weeks (Period 3). |
| FG009 | Part 2/Treatment Sequence 4: SCH 497079 → Metformin → Placebo | Participants received SCH 497079 daily for 4 weeks (Period 1) followed by metformin daily for 4 weeks (Period 2) followed by placebo daily for 4 weeks (Period 3). |
| FG010 | Part 2/Treatment Sequence 5: Placebo → SCH 49709 → Metformin | Participants received placebo daily for 4 weeks (Period 1) followed by SCH 497079 daily for 4 weeks (Period 2) followed by metformin daily for 4 weeks (Period 3). |
| FG011 | Part 2/Treatment Sequence 6: Metformin → Placebo → SCH 497079 | Participants received metformin daily for 4 weeks (Period 1) followed by placebo daily for 4 weeks(Period 2) followed by SCH 497079 daily for 4 weeks (Period 3). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Part 1/Period 1 (United States) |
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| Part 1/Period 2 (United States) |
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| Part 1/Period 3 (United States) |
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| Part 2 (India) |
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All treated participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Treated Participants | All participants received SCH 497079 for 4 weeks, placebo for 4 weeks, and metformin for 4 weeks during one of three parts of the study. |
| 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 | Pharmacodynamic: Change From Baseline in Mean 24-hour Plasma Glucose (AUC/Duration) at Week 4 (Part 1 - United States) | Change from baseline in 24-hour plasma glucose on the last day of treatment. On the day of the glucose collections (and the day prior to), standardized meals breakfast, lunch, dinner, and snack) were provided and consumed over 15 minutes. AUC/duration is presented as mg/dL and was calculated by dividing AUC (mg/dL*hr) by the duration in hours. Model-based least squares mean: ANOVA extracting the effects due to treatment, sequence, period and participant. | All participants who completed study treatment with at least SCH 497079 and placebo. | Posted | Least Squares Mean | Standard Error | mg/dL | Pre-dose (-30 minutes), pre-standard breakfast (0 hour), 0.5, .75, 1, 2, 3, 4, 4.5, 4.75, 5, 6, 7, 8, 9, 9.5, 9.75, 10, 11, 12, 13, 14, 15, 16, and 24 hours after the beginning of the standardized breakfast on Day -1 and Day 28 |
|
Up to 14 days after last dose of study drug (up to 98 days)
Of the 17 participants who received at least one dose of study medication, 16 participants received at least one dose of placebo, 15 participants received at least one dose of SCH 497079, and 15 participants received at least one dose of metformin.
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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 received placebo daily for 4 weeks during one of 3 parts of the study. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye haemorrage | Eye disorders | MedDRA 11.1 | Systematic Assessment |
Part 2 of the study was not conducted. Part 2 of the study was to be conducted if the analysis of Part 1 indicated a clinically significant decrease in blood glucose in participants type 2 diabetes mellitus compared to placebo.
| 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 |
|---|---|
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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Participants received placebo daily for 4 weeks followed by SCH 497079 daily for 4 weeks followed by metformin daily for 4 weeks. |
|
| Treatment sequence 6: Metformin → Placebo → SCH 497079 | Experimental | Participants received metformin daily for 4 weeks followed by placebo daily for 4 weeks followed by SCH 497079 daily for 4 weeks. |
|
| Placebo | Drug | Placebo capsules matching SCH 497079, administered orally, once daily for 4 weeks |
|
| Metformin | Drug | Metformin extended release 750 mg, 2 tablets administered orally, once daily for 4 weeks (1500 mg total daily dose) |
|
| Up to 14 days after last dose of study drug (up to 98 days) |
| Number of Participants Who Experienced at Least One Adverse Event (Part 2 - India) | An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product, biologic (at any dose), or medical device, which does not necessarily have a causal relationship with the treatment. AEs may include the onset of new illness and the exacerbation of pre-existing conditions. | Up to 14 days after last dose of study drug (up to 98 days) |
| Pharmacodynamic: Change From Baseline in 12-hour Postprandial Plasma Glucose (AUC/Duration) at Week 4 (Part 1 - United States) | The postprandial period is defined as the sum of 4 hours after breakfast, 4 hours after lunch and 4 hours after dinner for a total of 12 hours. AUC/duration is presented as mg/dL and was calculated by dividing AUC (mg/dL*hr) by the duration in hours. Model-based least squares mean: ANOVA extracting the effects due to treatment, sequence, period and participant. | Pre-dose (-30 minutes), pre-standard breakfast (0 hour), 0.5, .75, 1, 2, 3, 4, 4.5, 4.75, 5, 6, 7, 8, 9, 9.5, 9.75, 10, 11, 12, 13, 14, 15, 16, and 24 hours after the beginning of the standardized breakfast on Day -1 and Day 28 |
| Pharmacodynamic: Change From Baseline in 12-hour Postprandial Plasma Glucose (AUC/Duration) at Week 4 (Part 2 - India) | The postprandial period is defined as the sum of 4 hours after breakfast, 4 hours after lunch and 4 hours after dinner for a total of 12 hours. AUC/duration is presented as mg/dL and was calculated by dividing AUC (mg/dL*hr) by the duration in hours. Model-based least squares mean: ANOVA extracting the effects due to treatment, sequence, period and participant. | Pre-dose (-30 minutes), pre-standard breakfast (0 hour), 0.5, .75, 1, 2, 3, 4, 4.5, 4.75, 5, 6, 7, 8, 9, 9.5, 9.75, 10, 11, 12, 13, 14, 15, 16, and 24 hours after the beginning of the standardized breakfast on Day -1 and Day 28 |
| Pharmacodynamic: Change From Baseline in Plasma Glucose During the 12-hour Post Absorptive State (AUC/Duration) at Week 4 (Part 1 - United States) | The post absorptive state is defined as the remaining part of day and night that is not the postprandial period. The postprandial period is defined as the sum of 4 hours after breakfast, 4 hours after lunch and 4 hours after dinner for a total of 12 hours. AUC/duration is presented as mg/dL and was calculated by dividing AUC (mg/dL*hr) by the duration in hours. Model-based least squares mean: ANOVA extracting the effects due to treatment, sequence, period and participant. | Baseline and Week 4 |
| Pharmacodynamic: Change From Baseline in Plasma Glucose During the 12-hour Post Absorptive State (AUC/Duration) at Week 4 (Part 2 - India) | The post absorptive state is defined as the remaining part of day and night that is not the postprandial period. The postprandial period is defined as the sum of 4 hours after breakfast, 4 hours after lunch and 4 hours after dinner for a total of 12 hours. AUC/duration is presented as mg/dL and was calculated by dividing AUC (mg/dL*hr) by the duration in hours. Model-based least squares mean: ANOVA extracting the effects due to treatment, sequence, period and participant. | Baseline and Week 4 |
| Pharmacokinetic: Mean Plasma Glucose (Over 24 Hours) at Week 4 (Part 1 - United States) | Blood samples for SCH 497079 pharmacokinetics will be collected at pre-dose/0-hour on Day 1 (Period 1 only) and pre-dose Day 14 and pre-dose/0-hour and at 0.5, 1, 2, 6, 12, and 24 hours post study drug administration (not breakfast) on Day 28 of the placebo and SCH 497079 periods only. In addition to these time points, a sample for metformin level will also be collected pre-dose on Day 1, Day 14, and Day 28 of the metformin administration period only. | Pre-dose (0 hour), 0.5, 1, 2, 6, 12, and 24 hours after administration of study drug |
| Pharmacokinetic: Mean Plasma Glucose (Over 24 Hours) at Week 4 (Part 2 - India) | Blood samples for SCH 497079 pharmacokinetics will be collected at pre-dose/0-hour on Day 1 (Period 1 only) and pre-dose Day 14 and pre-dose/0-hour and at 0.5, 1, 2, 6, 12, and 24 hours post study drug administration (not breakfast) on Day 28 of the placebo and SCH 497079 periods only. In addition to these time points, a sample for metformin level will also be collected pre-dose on Day 1, Day 14, and Day 28 of the metformin administration period only. | Pre-dose (0 hour), 0.5, 1, 2, 6, 12, and 24 hours after administration of study drug |
| Pharmacokinetic: Mean Maximum Observed Plasma Concentration (Cmax) (Part 1 - United States) | Blood samples for SCH 497079 pharmacokinetics will be collected at pre-dose/0-hour on Day 1 (Period 1 only) and pre-dose Day 14 and pre-dose/0-hour and at 0.5, 1, 2, 6, 12, and 24 hours post study drug administration (not breakfast) on Day 28 of the placebo and SCH 497079 periods only. In addition to these time points, a sample for metformin level will also be collected pre-dose on Day 1, Day 14, and Day 28 of the metformin administration period only. | Pre-dose (0 hour), 0.5, 1, 2, 6, 12, and 24 hours after administration of study drug |
| Pharmacokinetic: Mean Plasma Cmax (Part 2 - India) | Blood samples for SCH 497079 pharmacokinetics will be collected at pre-dose/0-hour on Day 1 (Period 1 only) and pre-dose Day 14 and pre-dose/0-hour and at 0.5, 1, 2, 6, 12, and 24 hours post study drug administration (not breakfast) on Day 28 of the placebo and SCH 497079 periods only. In addition to these time points, a sample for metformin level will also be collected pre-dose on Day 1, Day 14, and Day 28 of the metformin administration period only. | Pre-dose (0 hour), 0.5, 1, 2, 6, 12, and 24 hours after administration of study drug |
| Pharmacokinetic: Mean Time to Maximum Observed Plasma Concentration (Tmax) (Part 1 - United States) | Blood samples for SCH 497079 pharmacokinetics will be collected at pre-dose/0-hour on Day 1 (Period 1 only) and pre-dose Day 14 and pre-dose/0-hour and at 0.5, 1, 2, 6, 12, and 24 hours post study drug administration (not breakfast) on Day 28 of the placebo and SCH 497079 periods only. In addition to these time points, a sample for metformin level will also be collected pre-dose on Day 1, Day 14, and Day 28 of the metformin administration period only. | Pre-dose (0 hour), 0.5, 1, 2, 6, 12, and 24 hours after administration of study drug |
| Pharmacokinetic: Mean Plasma Tmax (Part 2 - India) | Blood samples for SCH 497079 pharmacokinetics will be collected at pre-dose/0-hour on Day 1 (Period 1 only) and pre-dose Day 14 and pre-dose/0-hour and at 0.5, 1, 2, 6, 12, and 24 hours post study drug administration (not breakfast) on Day 28 of the placebo and SCH 497079 periods only. In addition to these time points, a sample for metformin level will also be collected pre-dose on Day 1, Day 14, and Day 28 of the metformin administration period only. | Pre-dose (0 hour), 0.5, 1, 2, 6, 12, and 24 hours after administration of study drug |
| COMPLETED |
|
| NOT COMPLETED |
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| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| 24-hour plasma glucose (AUC/duration) | Mean 24-hour plasma glucose at baseline. Area under the plasma glucose curve (AUC)/duration is presented as mg/dL and was calculated by dividing AUC (mg/dL*hr) by the duration in hours. | Mean | Standard Deviation | mg/dL |
|
Participants received SCH 497079 daily for 4 weeks during one period of the study. |
| OG001 | Placebo | Participants received placebo daily for 4 weeks during one period of the study. |
| OG002 | Metformin | Participants received metformin daily for 4 weeks during one period of the study. |
|
|
|
| Primary | Pharmacodynamic: Change From Baseline in 24-hour Plasma Glucose (AUC/Duration) at Week 4 (Part 2 - India) | Change from baseline in 24-hour plasma glucose on the last day of treatment. On the day of the glucose collections (and the day prior to), standardized meals (breakfast, lunch, dinner, and snack) were provided and consumed over 15 minutes. AUC/duration is presented as mg/dL and was calculated by dividing AUC (mg/dL*hr) by the duration in hours. Model-based least squares mean: ANOVA extracting the effects due to treatment, sequence, period and participant. | No participants were randomized to treatment during Part 2 of the study. | Posted | Pre-dose (-30 mnutes), pre-standard breakfast (0 hour), 0.5, .75, 1, 2, 3, 4, 4.5, 4.75, 5, 6, 7, 8, 9, 9.5, 9.75, 10, 11, 12, 13, 14, 15, 16, and 24 hours after the beginning of the standardized breakfast on Day -1 and Day 28 |
|
|
| Secondary | Number of Participants Who Experienced at Least One Adverse Event (Part 1 - United States) | An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product, biologic (at any dose), or medical device, which does not necessarily have a causal relationship with the treatment. AEs may include the onset of new illness and the exacerbation of pre-existing conditions. | All randomized participants. | Posted | Number | Participants | Up to 14 days after last dose of study drug (up to 98 days) |
|
|
|
| Secondary | Number of Participants Who Experienced at Least One Adverse Event (Part 2 - India) | An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product, biologic (at any dose), or medical device, which does not necessarily have a causal relationship with the treatment. AEs may include the onset of new illness and the exacerbation of pre-existing conditions. | No participants were randomized to treatment during Part 2 of the study. | Posted | Up to 14 days after last dose of study drug (up to 98 days) |
|
|
| Secondary | Pharmacodynamic: Change From Baseline in 12-hour Postprandial Plasma Glucose (AUC/Duration) at Week 4 (Part 1 - United States) | The postprandial period is defined as the sum of 4 hours after breakfast, 4 hours after lunch and 4 hours after dinner for a total of 12 hours. AUC/duration is presented as mg/dL and was calculated by dividing AUC (mg/dL*hr) by the duration in hours. Model-based least squares mean: ANOVA extracting the effects due to treatment, sequence, period and participant. | All participants who completed study treatment with at least SCH 497079 and placebo. | Posted | Least Squares Mean | Standard Error | mg/dL | Pre-dose (-30 minutes), pre-standard breakfast (0 hour), 0.5, .75, 1, 2, 3, 4, 4.5, 4.75, 5, 6, 7, 8, 9, 9.5, 9.75, 10, 11, 12, 13, 14, 15, 16, and 24 hours after the beginning of the standardized breakfast on Day -1 and Day 28 |
|
|
|
|
| Secondary | Pharmacodynamic: Change From Baseline in 12-hour Postprandial Plasma Glucose (AUC/Duration) at Week 4 (Part 2 - India) | The postprandial period is defined as the sum of 4 hours after breakfast, 4 hours after lunch and 4 hours after dinner for a total of 12 hours. AUC/duration is presented as mg/dL and was calculated by dividing AUC (mg/dL*hr) by the duration in hours. Model-based least squares mean: ANOVA extracting the effects due to treatment, sequence, period and participant. | No participants were randomized to treatment during Part 2 of the study. | Posted | Pre-dose (-30 minutes), pre-standard breakfast (0 hour), 0.5, .75, 1, 2, 3, 4, 4.5, 4.75, 5, 6, 7, 8, 9, 9.5, 9.75, 10, 11, 12, 13, 14, 15, 16, and 24 hours after the beginning of the standardized breakfast on Day -1 and Day 28 |
|
|
| Secondary | Pharmacodynamic: Change From Baseline in Plasma Glucose During the 12-hour Post Absorptive State (AUC/Duration) at Week 4 (Part 1 - United States) | The post absorptive state is defined as the remaining part of day and night that is not the postprandial period. The postprandial period is defined as the sum of 4 hours after breakfast, 4 hours after lunch and 4 hours after dinner for a total of 12 hours. AUC/duration is presented as mg/dL and was calculated by dividing AUC (mg/dL*hr) by the duration in hours. Model-based least squares mean: ANOVA extracting the effects due to treatment, sequence, period and participant. | All participants who completed study treatment with at least SCH 497079 and placebo. | Posted | Least Squares Mean | Standard Error | mg/dL | Baseline and Week 4 |
|
|
|
|
| Secondary | Pharmacodynamic: Change From Baseline in Plasma Glucose During the 12-hour Post Absorptive State (AUC/Duration) at Week 4 (Part 2 - India) | The post absorptive state is defined as the remaining part of day and night that is not the postprandial period. The postprandial period is defined as the sum of 4 hours after breakfast, 4 hours after lunch and 4 hours after dinner for a total of 12 hours. AUC/duration is presented as mg/dL and was calculated by dividing AUC (mg/dL*hr) by the duration in hours. Model-based least squares mean: ANOVA extracting the effects due to treatment, sequence, period and participant. | No participants were randomized to treatment during Part 2 of the study. | Posted | Baseline and Week 4 |
|
|
| Secondary | Pharmacokinetic: Mean Plasma Glucose (Over 24 Hours) at Week 4 (Part 1 - United States) | Blood samples for SCH 497079 pharmacokinetics will be collected at pre-dose/0-hour on Day 1 (Period 1 only) and pre-dose Day 14 and pre-dose/0-hour and at 0.5, 1, 2, 6, 12, and 24 hours post study drug administration (not breakfast) on Day 28 of the placebo and SCH 497079 periods only. In addition to these time points, a sample for metformin level will also be collected pre-dose on Day 1, Day 14, and Day 28 of the metformin administration period only. | No efficacy summary or analysis was completed for this outcome measure since the Part 1 objective was not met (i.e., to determine the 24-hour glycemic profile of type 2 diabetes mellitus [T2DM] participants after four weeks of treatment with SCH 497079 vs. placebo). | Posted | Pre-dose (0 hour), 0.5, 1, 2, 6, 12, and 24 hours after administration of study drug |
|
|
| Secondary | Pharmacokinetic: Mean Plasma Glucose (Over 24 Hours) at Week 4 (Part 2 - India) | Blood samples for SCH 497079 pharmacokinetics will be collected at pre-dose/0-hour on Day 1 (Period 1 only) and pre-dose Day 14 and pre-dose/0-hour and at 0.5, 1, 2, 6, 12, and 24 hours post study drug administration (not breakfast) on Day 28 of the placebo and SCH 497079 periods only. In addition to these time points, a sample for metformin level will also be collected pre-dose on Day 1, Day 14, and Day 28 of the metformin administration period only. | No participants were randomized to treatment during Part 2 of the study. | Posted | Pre-dose (0 hour), 0.5, 1, 2, 6, 12, and 24 hours after administration of study drug |
|
|
| Secondary | Pharmacokinetic: Mean Maximum Observed Plasma Concentration (Cmax) (Part 1 - United States) | Blood samples for SCH 497079 pharmacokinetics will be collected at pre-dose/0-hour on Day 1 (Period 1 only) and pre-dose Day 14 and pre-dose/0-hour and at 0.5, 1, 2, 6, 12, and 24 hours post study drug administration (not breakfast) on Day 28 of the placebo and SCH 497079 periods only. In addition to these time points, a sample for metformin level will also be collected pre-dose on Day 1, Day 14, and Day 28 of the metformin administration period only. | No efficacy summary or analysis was completed for this outcome measure since the Part 1 objective was not met (i.e., to determine the 24-hour glycemic profile of T2DM participants after four weeks of treatment with SCH 497079 vs. placebo). | Posted | Pre-dose (0 hour), 0.5, 1, 2, 6, 12, and 24 hours after administration of study drug |
|
|
| Secondary | Pharmacokinetic: Mean Plasma Cmax (Part 2 - India) | Blood samples for SCH 497079 pharmacokinetics will be collected at pre-dose/0-hour on Day 1 (Period 1 only) and pre-dose Day 14 and pre-dose/0-hour and at 0.5, 1, 2, 6, 12, and 24 hours post study drug administration (not breakfast) on Day 28 of the placebo and SCH 497079 periods only. In addition to these time points, a sample for metformin level will also be collected pre-dose on Day 1, Day 14, and Day 28 of the metformin administration period only. | No participants were randomized to treatment during Part 2 of the study. | Posted | Pre-dose (0 hour), 0.5, 1, 2, 6, 12, and 24 hours after administration of study drug |
|
|
| Secondary | Pharmacokinetic: Mean Time to Maximum Observed Plasma Concentration (Tmax) (Part 1 - United States) | Blood samples for SCH 497079 pharmacokinetics will be collected at pre-dose/0-hour on Day 1 (Period 1 only) and pre-dose Day 14 and pre-dose/0-hour and at 0.5, 1, 2, 6, 12, and 24 hours post study drug administration (not breakfast) on Day 28 of the placebo and SCH 497079 periods only. In addition to these time points, a sample for metformin level will also be collected pre-dose on Day 1, Day 14, and Day 28 of the metformin administration period only. | No efficacy summary or analysis was completed for this outcome measure since the Part 1 objective was not met (i.e., to determine the 24-hour glycemic profile of T2DM participants after four weeks of treatment with SCH 497079 vs. placebo). | Posted | Pre-dose (0 hour), 0.5, 1, 2, 6, 12, and 24 hours after administration of study drug |
|
|
| Secondary | Pharmacokinetic: Mean Plasma Tmax (Part 2 - India) | Blood samples for SCH 497079 pharmacokinetics will be collected at pre-dose/0-hour on Day 1 (Period 1 only) and pre-dose Day 14 and pre-dose/0-hour and at 0.5, 1, 2, 6, 12, and 24 hours post study drug administration (not breakfast) on Day 28 of the placebo and SCH 497079 periods only. In addition to these time points, a sample for metformin level will also be collected pre-dose on Day 1, Day 14, and Day 28 of the metformin administration period only. | No participants were randomized to treatment during Part 2 of the study. | Posted | Pre-dose (0 hour), 0.5, 1, 2, 6, 12, and 24 hours after administration of study drug |
|
|
| 0 |
| 16 |
| 6 |
| 16 |
| EG001 | SCH 497079 | Participants received SCH 497079 daily for 4 weeks during one period of the study. | 0 | 15 | 9 | 15 |
| EG002 | Metformin | Participants received metformin daily for 4 weeks during one of 3 parts of the study. | 0 | 15 | 4 | 15 |
| Photophobia | Eye disorders | MedDRA 11.1 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Irritability | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
|
| Increased appetite | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Chromaturia | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Pruritus generalized | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
The investigator agrees not to publish or publicly present any interim results of the study without the prior written consent of the sponsor. The investigator further agrees to provide to the sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication that report any results of the study.
| D004700 | Endocrine System Diseases |
ANOVA model extracting the effect due to treatment, period, sequence and participant. |
| <0.0001 |
| Difference in least squares mean |
| -63.6 |
| 2-Sided |
| 95 |
| -80.9 |
| -46.2 |
| Superiority or Other |
ANOVA model extracting the effect due to treatment, period, sequence and participant. |
| <0.0001 |
| Difference in least squares mean |
| -26.6 |
| 2-Sided |
| 95 |
| -33.8 |
| -19.4 |
| Superiority or Other |