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| ID | Type | Description | Link |
|---|---|---|---|
| MK0431-045 | |||
| 2008_026 |
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A clinical study determines the safety and efficacy of sitagliptin (MK0431) in patients with Type 2 diabetes mellitus who have inadequate glycemic control on diet/exercise therapy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Placebo Comparator | Placebo |
|
| 2 | Experimental | Sitagliptin 100 mg |
|
| 3 | Experimental | Sitagliptin 50 mg |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sitagliptin phosphate | Drug | 100 mg once daily (QD), taken orally for 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in 24-hour Weighted Mean Plasma Glucose | Change from baseline at Week 4 is defined as 24-hour weighted mean glucose (24hr-WMG) at Week 4 minus 24hr-WMG at Week 0. | Baseline and Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Plasma Glucose | Change from baseline at Week 4 is defined as fasting plasma glucose at Week 4 minus fasting plasma glucose at Week 0. | 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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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19253204 | Background | Nonaka K, Tsubouchi H, Okuyama K, Fukao Y, Johnson-Levonas AO, Amatruda JM. Effects of once-daily sitagliptin on 24-h glucose control following 4 weeks of treatment in Japanese patients with type 2 diabetes mellitus. Horm Metab Res. 2009 Mar;41(3):232-7. doi: 10.1055/s-0028-1100413. Epub 2009 Feb 27. |
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| ID | Type | URL | Comment |
|---|---|---|---|
| CSR Synopsis | View IPD |
Patients 20-69 years of age with type 2 diabetes mellitus and inadequate glycemic control (HbA1c ≥6.5% and <10% at Week -2) were eligible for randomization following at least 8 weeks of diet/exercise and antihyperglycemic agent (AHA) wash-off (for patients previously on an AHA), including a 2-week placebo run-in.
Phase II.
First patient in: 31 July 2005. Last patient, last visit: 13 February 2006.
The study was conducted at 8 centers in Japan.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sitagliptin 100 mg QD | The Sitagliptin 100 mg QD group includes data from all patients randomized to receive treatment with sitagliptin 100 mg orally once daily (QD=once daily). |
| FG001 | Sitagliptin 50 mg BID | The Sitagliptin 50 mg BID group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally twice daily (BID=twice daily). |
| FG002 | Placebo | The Placebo group includes data from all patients randomized to receive treatment with matching placebo orally. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sitagliptin 100 mg QD | The Sitagliptin 100 mg QD group includes data from all patients randomized to receive treatment with sitagliptin 100 mg orally once daily (QD=once daily). |
| BG001 | Sitagliptin 50 mg BID |
| 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 in 24-hour Weighted Mean Plasma Glucose | Change from baseline at Week 4 is defined as 24-hour weighted mean glucose (24hr-WMG) at Week 4 minus 24hr-WMG at Week 0. | The Per Protocol population included patients with baseline and Week 4 (i.e., final primary timepoint) values for this outcome and excluded patients who met predefined criteria for protocol violations. | Posted | Least Squares Mean | 95% Confidence Interval | mg/dL | Baseline and Week 4 |
|
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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 | Sitagliptin 100 mg QD | The Sitagliptin 100 mg QD group includes data from all patients randomized to receive treatment with sitagliptin 100 mg orally once daily (QD=once daily). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Overdose | Injury, poisoning and procedural complications | MedDRA 8.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 8.0 | Non-systematic Assessment |
Reported overdoses, regardless of association with reported adverse events, were considered as serious adverse events in this study. The patients for whom the event of overdose was reported had no concomitant AEs with the overdose.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp | 1-800-672-6372 |
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| 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 |
|---|---|
| D000068900 | Sitagliptin Phosphate |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Comparator: Placebo | Drug | Placebo tablet, QD, taken orally for 4 weeks |
|
| Comparator: Sitagliptin | Drug | 50 mg twice daily (BID), taken orally for 4 weeks |
|
|
The Sitagliptin 50 mg BID group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally twice daily (BID=twice daily).
| BG002 | Placebo | The Placebo group includes data from all patients randomized to receive treatment with matching placebo orally. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| 24-hour weighted mean plasma glucose (24hr-WMG) | The 24hr-WMG is the weighted mean of the blood glucose weighted by the intervals between time points for a day [i.e. the area under curve in glucose-time profile through 24-hours (AUC0-24 hr) divided by 24]. | Mean | Standard Deviation | mg/dL |
|
| Fasting Plasma Glucose (FPG) | Mean | Standard Deviation | mg/dL |
|
The Sitagliptin 50 mg BID group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally twice daily (BID=twice daily). |
| OG002 | Placebo | The Placebo group includes data from all patients randomized to receive treatment with matching placebo orally. |
|
|
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| Secondary | Change From Baseline in Plasma Glucose | Change from baseline at Week 4 is defined as fasting plasma glucose at Week 4 minus fasting plasma glucose at Week 0. | The Per Protocol population included patients with baseline and Week 4 (i.e., final primary timepoint) values for this outcome and excluded patients who met predefined criteria for protocol violations. | Posted | Least Squares Mean | 95% Confidence Interval | mg/dL | Baseline and Week 4 |
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| 1 |
| 1 |
| EG001 | Sitagliptin 50 mg BID | The Sitagliptin 50 mg BID group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally twice daily (BID=twice daily). | 2 | 1 |
| EG002 | Placebo | The Placebo group includes data from all patients randomized to receive treatment with matching placebo orally. | 0 | 2 |
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.
| D004700 | Endocrine System Diseases |
| D011719 |
| Pyrazines |
| ANCOVA | ANCOVA model with terms of treatment as a factor and baseline value as a covariate was used for pairwise comparison | <0.001 | No multiplicity adjustment among the pairwise comparisons of sitagliptin against placebo | Least-squares Mean Difference | -12.9 | 95 | -20.4 | -5.4 | ANCOVA model with terms of treatment as a factor and baseline value as a covariate was used to estimate difference of two groups and its 95% confidence interval | Superiority or Other |