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| ID | Type | Description | Link |
|---|---|---|---|
| 2006_051 |
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The 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 |
|---|---|---|---|
| Sitagliptin 50 mg QD | Experimental | sitagliptin 50 mg orally once daily (QD=once daily) |
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| Voglibose 0.2 mg TID | Active Comparator | voglibose 0.2 mg orally three times daily (TID= three times daily) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sitagliptin phosphate | Drug | sitagliptin 50 mg orally once daily QD. Duration of Treatment: 12 Weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in HbA1c at Week 12 | HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the Week 0 HbA1c percent. | Baseline and Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Fasting Plasma Glucose at Week 12 | Change from baseline at Week 12 is defined as fasting plasma glucose at Week 12 minus fasting plasma glucose at Week 0. | Baseline and Week 12 |
| Change From Baseline in 2 Hour Postprandial Glucose at 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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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20590736 | Result | Iwamoto Y, Tajima N, Kadowaki T, Nonaka K, Taniguchi T, Nishii M, Arjona Ferreira JC, Amatruda JM. Efficacy and safety of sitagliptin monotherapy compared with voglibose in Japanese patients with type 2 diabetes: a randomized, double-blind trial. Diabetes Obes Metab. 2010 Jul;12(7):613-22. doi: 10.1111/j.1463-1326.2010.01197.x. |
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Patients at least 20 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 III.
First patient in: 6 January 2007. Last patient, last visit: 15 August 2007.
The study was conducted at 71 centers in Japan.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sitagliptin 50 mg QD | The Sitagliptin group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally once daily (QD=once daily). |
| FG001 | Voglibose 0.2 mg TID |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Comparator: voglibose | Drug | voglibose 0.2 mg orally three times daily TID. Duration of Treatment: 12 Weeks |
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Change from baseline at Week 12 is defined as 2-hour postprandial glucose Week 12 minus 2-hour postprandial glucose Week 0. |
| Baseline and Week 12 |
The Voglibose group includes data from all patients randomized to receive treatment with voglibose 0.2 mg orally three times daily (TID= three times daily).
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| ID | Title | Description |
|---|---|---|
| BG000 | Sitagliptin 50 mg QD | The Sitagliptin group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally once daily (QD=once daily). |
| BG001 | Voglibose 0.2 mg TID | The Voglibose group includes data from all patients randomized to receive treatment with voglibose 0.2 mg orally three times daily (TID= three times daily). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Fasting Plasma Glucose (FPG) | Mean | Standard Deviation | mg/dL |
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| Hemoglobin A1c (HbA1c) | Mean | Standard Deviation | percent |
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| 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Change From Baseline in HbA1c at Week 12 | HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the Week 0 HbA1c percent. | The Per Protocol Population included patients with baseline and Week 12 (i.e., final primary timepoint) values for this outcome and excluded patients who met predefined criteria for major protocol violations. | Posted | Least Squares Mean | 95% Confidence Interval | Percent | Baseline and Week 12 |
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| Secondary | Change From Baseline in Fasting Plasma Glucose at Week 12 | Change from baseline at Week 12 is defined as fasting plasma glucose at Week 12 minus fasting plasma glucose at Week 0. | The Per Protocol Population included patients with baseline and Week 12 (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 12 |
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| Secondary | Change From Baseline in 2 Hour Postprandial Glucose at Week 12 | Change from baseline at Week 12 is defined as 2-hour postprandial glucose Week 12 minus 2-hour postprandial glucose Week 0. | The Per Protocol Population included patients with baseline and Week 12 (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 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 | Sitagliptin 50 mg QD | The Sitagliptin group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally once daily (QD=once daily). | 1 | 32 | ||||
| EG001 | Voglibose 0.2 mg TID | The Voglibose group includes data from all patients randomized to receive treatment with voglibose 0.2 mg orally three times daily (TID= three times daily). | 2 | 62 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cellulitis | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
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| Foot fracture | Injury, poisoning and procedural complications | MedDRA 9.1 | Non-systematic Assessment |
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| Crohn's disease | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
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| Abdominal distension | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
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| Flatulence | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA 9.1 | Non-systematic Assessment |
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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 |
| 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 |
|---|---|
| D000068900 | Sitagliptin Phosphate |
| C102817 | voglibose |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011719 | Pyrazines |
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| Male |
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| Non-Inferiority or Equivalence |
Non-inferiority margin (Sitagliptin minus Voglibose) = 0.2 percent |
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