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| ID | Type | Description | Link |
|---|---|---|---|
| MK0431-044 | |||
| 2005_037 |
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The purpose of this trial is to determine the efficacy and safety of an investigational drug in patients with type 2 diabetes mellitus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Placebo Comparator | Placebo QD 12-week |
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| 2 | Experimental | 25 mg QD 12-week |
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| 3 | Experimental | 50 mg QD 12-week |
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| 4 | Experimental | 100 mg QD 12-week |
|
| 5 | Experimental | 200 mg QD 12-week |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sitagliptin phosphate | Drug | sitagliptin phosphate 25 mg, 50 mg, 100 mg QD, or 200 mg QD 12-weeks. |
|
| 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 Glycosylated Albumin at Week 12 | Change from baseline at Week 12 is defined as Week 12 minus Week 0. | Baseline and Week 12 |
| Change From Baseline in Fasting Plasma 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 |
|---|---|---|---|
| 20332588 | Result | Iwamoto Y, Taniguchi T, Nonaka K, Okamoto T, Okuyama K, Arjona Ferreira JC, Amatruda J. Dose-ranging efficacy of sitagliptin, a dipeptidyl peptidase-4 inhibitor, in Japanese patients with type 2 diabetes mellitus. Endocr J. 2010;57(5):383-94. doi: 10.1507/endocrj.k09e-272. Epub 2010 Mar 24. |
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Patients 20-75 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: 11 July 2005. Last patient, last visit: 8 March 2006.
The study was conducted at 97 centers in Japan.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sitagliptin 25 mg QD | The Sitagliptin 25 mg group includes data from all patients randomized to receive treatment with sitagliptin 25 mg orally once daily (QD=once daily). |
| FG001 | Sitagliptin 50 mg QD | The Sitagliptin 50 mg group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally once daily (QD=once daily). |
| FG002 | Sitagliptin 100 mg QD | The Sitagliptin 100 mg group includes data from all patients randomized to receive treatment with sitagliptin 100 mg orally once daily (QD=once daily). |
| FG003 | Sitagliptin 200 mg QD | The Sitagliptin 200 mg group includes data from all patients randomized to receive treatment with sitagliptin 200 mg orally once daily (QD=once daily). |
| FG004 | Placebo | The Placebo group includes data from all patients randomized to receive treatment with matching placebo orally once daily. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sitagliptin 25 mg QD | The Sitagliptin 25 mg group includes data from all patients randomized to receive treatment with sitagliptin 25 mg orally once daily (QD=once daily). |
| BG001 | Sitagliptin 50 mg QD |
| 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 | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Change From Baseline in Glycosylated Albumin at Week 12 | Change from baseline at Week 12 is defined as Week 12 minus Week 0. | The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. For FAS patients with no data at Week 12, the last non-baseline observed measurement was carried forward to Week 12. | Posted | Least Squares Mean | 95% Confidence Interval | Percent | Baseline and Week 12 |
|
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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.
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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 25 mg QD | The Sitagliptin 25 mg group includes data from all patients randomized to receive treatment with sitagliptin 25 mg orally once daily (QD=once daily). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA 8.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 8.0 | Non-systematic Assessment |
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| 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 |
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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 (unspecified) | Drug | placebo QD 12-weeks |
|
Change from baseline at Week 12 is defined as Week 12 minus Week 0.
| Baseline and Week 12 |
| Lack of Efficacy |
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| Withdrawal by Subject |
|
| Adverse event in pre-treatment period |
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The Sitagliptin 50 mg group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally once daily (QD=once daily).
| BG002 | Sitagliptin 100 mg QD | The Sitagliptin 100 mg group includes data from all patients randomized to receive treatment with sitagliptin 100 mg orally once daily (QD=once daily). |
| BG003 | Sitagliptin 200 mg QD | The Sitagliptin 200 mg group includes data from all patients randomized to receive treatment with sitagliptin 200 mg orally once daily (QD=once daily). |
| BG004 | Placebo | The Placebo group includes data from all patients randomized to receive treatment with matching placebo orally once daily. |
| BG005 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Fasting Plasma Glucose (FPG) | Mean | Standard Deviation | mg/dL |
|
| Glycosylated albumin | Mean | Standard Deviation | percent |
|
| Hemoglobin A1c (HbA1c) | Mean | Standard Deviation | percent |
|
The Sitagliptin 50 mg group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally once daily (QD=once daily).
| OG002 | Sitagliptin 100 mg QD | The Sitagliptin 100 mg group includes data from all patients randomized to receive treatment with sitagliptin 100 mg orally once daily (QD=once daily). |
| OG003 | Sitagliptin 200 mg QD | The Sitagliptin 200 mg group includes data from all patients randomized to receive treatment with sitagliptin 200 mg orally once daily (QD=once daily). |
| OG004 | Placebo | The Placebo group includes data from all patients randomized to receive treatment with matching placebo orally once daily. |
|
|
|
| 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 Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. For FAS patients with no data at Week 12, the last non-baseline observed measurement was carried forward to Week 12. | Posted | Least Squares Mean | 95% Confidence Interval | Percent | Baseline and Week 12 |
|
|
|
|
| Secondary | Change From Baseline in Fasting Plasma Glucose at Week 12 | Change from baseline at Week 12 is defined as Week 12 minus Week 0. | The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. For FAS patients with no data at Week 12, the last non-baseline observed measurement was carried forward to Week 12. | Posted | Least Squares Mean | 95% Confidence Interval | mg/dL | Baseline and Week 12 |
|
|
|
|
| 0 |
| 31 |
| EG001 | Sitagliptin 50 mg QD | The Sitagliptin 50 mg group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally once daily (QD=once daily). | 1 | 25 |
| EG002 | Sitagliptin 100 mg QD | The Sitagliptin 100 mg group includes data from all patients randomized to receive treatment with sitagliptin 100 mg orally once daily (QD=once daily). | 0 | 32 |
| EG003 | Sitagliptin 200 mg QD | The Sitagliptin 200 mg group includes data from all patients randomized to receive treatment with sitagliptin 200 mg orally once daily (QD=once daily). | 2 | 20 |
| EG004 | Placebo | The Placebo group includes data from all patients randomized to receive treatment with matching placebo orally once daily. | 0 | 29 |
| Cardiac failure chronic | Cardiac disorders | MedDRA 8.0 | Non-systematic Assessment |
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| Hypertensive heart disease | Cardiac disorders | MedDRA 8.0 | Non-systematic Assessment |
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| Myocardial ischaemia | Cardiac disorders | MedDRA 8.0 | Non-systematic Assessment |
|
| Overdose | Injury, poisoning and procedural complications | MedDRA 8.0 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 8.0 | Non-systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 8.0 | Non-systematic Assessment |
|
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 8.0 | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 8.0 | Non-systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA 8.0 | Non-systematic Assessment |
|
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 |
| Pairwise comparison based on ANCOVA |
ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used for pairwise comparison |
| <0.001 |
No multiplicity adjustment was done between trend test of primary analysis and pairwise comparisons, but the multiplicity among pairwise comparisons of sitagliptin groups against placebo was adjusted by Bonferroni method in post-hoc manner. |
| Least-squares Mean Difference |
| -1.04 |
| 95 |
| -1.21 |
| -0.86 |
ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to estimate difference of two groups and its 95% confidence interval |
| No |
| Superiority or Other |
| Pairwise comparison based on ANCOVA | ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used for pairwise comparison | <0.001 | No multiplicity adjustment was done between trend test of primary analysis and pairwise comparisons, the multiplicity among pairwise comparisons of sitagliptin groups against placebo was adjusted by Bonferroni method in post-hoc manner. | Least-squares Mean Difference | -0.96 | 95 | -1.14 | -0.79 | ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to estimate difference of two groups and its 95% confidence interval | No | Superiority or Other |
| Pairwise comparison based on ANCOVA | ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used for pairwise comparison | <0.001 | No multiplicity adjustment was done between trend test of primary analysis and pairwise comparisons, the multiplicity among pairwise comparisons of sitagliptin groups against placebo was adjusted by Bonferroni method in post-hoc manner. | Least-squares Mean Difference | -0.99 | 95 | -1.16 | -0.82 | ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to estimate difference of two groups and its 95% confidence interval | No | Superiority or Other |
| Pairwise comparison based on ANCOVA | ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used for pairwise comparison | <0.001 | No multiplicity adjustment was done between trend test of primary analysis and pairwise comparisons, the multiplicity among pairwise comparisons of sitagliptin groups against placebo was adjusted by Bonferroni method in post-hoc manner. | Least-squares Mean Difference | -0.69 | 95 | -0.85 | -0.52 | ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to estimate difference of two groups and its 95% confidence interval | No | Superiority or Other |
| Pairwise comparison based on ANCOVA | ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used for pairwise comparison | <0.001 | Multiplicity among pairwise comparisons of sitagliptin groups against placebo was adjusted by Bonferroni method in post-hoc manner. | Least-squares Mean Difference | -20.8 | 95 | -27.4 | -14.3 | ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to estimate difference of two groups and its 95% confidence interval | No | Superiority or Other |
| Pairwise comparison based on ANCOVA | ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used for pairwise comparison | <0.001 | Multiplicity among pairwise comparisons of sitagliptin groups against placebo was adjusted by Bonferroni method in post-hoc manner. | Least-squares Mean Difference | -17.7 | 95 | -24.2 | -11.2 | ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to estimate difference of two groups and its 95% confidence interval | No | Superiority or Other |
| Pairwise comparison based on ANCOVA | ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used for pairwise comparison | <0.001 | Multiplicity among pairwise comparisons of sitagliptin groups against placebo was adjusted by Bonferroni method in post-hoc manner. | Least-squares Mean Difference | -15.9 | 95 | -22.3 | -9.6 | ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to estimate difference of two groups and its 95% confidence interval | No | Superiority or Other |