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| ID | Type | Description | Link |
|---|---|---|---|
| MK0431-040 | |||
| 2005_094 |
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This is a clinical study to determine the safety and efficacy of an investigational drug in patients with type 2 diabetes mellitus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | sitagliptin 100 mg |
|
| 2 | Placebo Comparator | placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sitagliptin phosphate | Drug | Sitagliptin 100 mg administered as one oral tablet once daily before the morning meal for up to 18 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Hemoglobin A1c (HbA1c) at Week 18 | A1C was measured as a percent. Thus, this change from baseline reflects the Week 18 A1C percent minus the Week 0 A1C percent. | Baseline and Week 18 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Fasting Plasma Glucose (FPG) at Week 18 | Change from baseline at Week 18 is defined as Week 18 FPG minus Week 0 FPG. | Baseline and Week 18 |
| Change From Baseline in 2-hr Post-Meal Glucose (PMG) at Week 18 |
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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 |
|---|---|---|---|
| 19097665 | Background | Mohan V, Yang W, Son HY, Xu L, Noble L, Langdon RB, Amatruda JM, Stein PP, Kaufman KD. Efficacy and safety of sitagliptin in the treatment of patients with type 2 diabetes in China, India, and Korea. Diabetes Res Clin Pract. 2009 Jan;83(1):106-16. doi: 10.1016/j.diabres.2008.10.009. Epub 2008 Dec 20. | |
| 33914296 | Derived |
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Patients not on an antihyperglycemic agent (AHA) or on oral single AHA or low dose dual combination therapy could participate. After an up to 6-week diet/exercise (and wash-off period for patients on AHA), patients with hemoglobin A1C 7.5-11% and fasting plasma glucose 130-280 mg/dL entered a 2-week placebo run-in period prior to randomization.
First Patient In: 27-Apr-2006; Last Patient Last Visit: 30-Mar-2007; Twenty-eight medical clinics (9 in China, 9 in India, and 10 in Korea).
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| ID | Title | Description |
|---|---|---|
| FG000 | Sitagliptin 100 mg | The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily. |
| FG001 | Placebo | The Placebo group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo once daily. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sitagliptin 100 mg | The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily. |
| BG001 | Placebo |
| 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 Hemoglobin A1c (HbA1c) at Week 18 | A1C was measured as a percent. Thus, this change from baseline reflects the Week 18 A1C percent minus the Week 0 A1C percent. | The full-analysis-set (FAS) population included all patients with at least one dose of double-blind study therapy, and with a baseline value and ≥1 post-baseline value for this outcome. Missing data were handled using the last observation carrying forward (LOCF) method. | Posted | Least Squares Mean | 95% Confidence Interval | Percent | Baseline and Week 18 |
|
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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 | The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Any Cardiac Disorders | Cardiac disorders | MedDRA 9.1 | 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 | Drug | placebo to match Sitagliptin 100 mg administered as one oral tablet once daily before the morning meal for up to 18 weeks |
|
Change from baseline at Week 18 is defined as Week 18 minus Week 0.
| Baseline and Week 18 |
| Singh B, Sims H, Trueheart I, Simpson K, Wang KC, Patzkowsky K, Wegman T, Soma JM, Dixon R, Jayes F, Voegltine K, Yenokyan G, Su SC, Leppert P, Segars JH. A Phase I Clinical Trial to Assess Safety and Tolerability of Injectable Collagenase in Women with Symptomatic Uterine Fibroids. Reprod Sci. 2021 Sep;28(9):2699-2709. doi: 10.1007/s43032-021-00573-8. Epub 2021 Apr 29. |
| Lack of Efficacy |
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| Lost to Follow-up |
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| Protocol Violation |
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| Withdrawal by Subject |
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| Patient Moved |
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| Open-Label AHA Treatment Requested |
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The Placebo group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo once daily.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Fasting Plasma Glucose (FPG) | Mean | Standard Deviation | mg/dL |
|
| Hemoglobin A1C (HbA1C; A1C) | Mean | Standard Deviation | Percent |
|
The Placebo group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo once daily. |
|
|
|
| Secondary | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 18 | Change from baseline at Week 18 is defined as Week 18 FPG minus Week 0 FPG. | The full-analysis-set (FAS) population included all patients with at least one dose of double-blind study therapy, and with a baseline value and ≥1 post-baseline value for this outcome. Missing data were handled using the last observation carrying forward (LOCF) method. | Posted | Least Squares Mean | 95% Confidence Interval | mg/dL | Baseline and Week 18 |
|
|
|
|
| Secondary | Change From Baseline in 2-hr Post-Meal Glucose (PMG) at Week 18 | Change from baseline at Week 18 is defined as Week 18 minus Week 0. | The full-analysis-set (FAS) population included all patients with at least one dose of double-blind study therapy, and with a baseline value and ≥1 post-baseline value for this outcome. Missing data were handled using the last observation carrying forward (LOCF) method. | Posted | Least Squares Mean | 95% Confidence Interval | mg/dL | Baseline and Week 18 |
|
|
|
|
| 6 |
| 352 |
| 0 |
| 352 |
| EG001 | Placebo | The Placebo group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo once daily. | 2 | 178 | 0 | 178 |
| Acute Myocardial Infarction | Cardiac disorders | MedDRA 9.1 | Systematic Assessment |
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| Myocardial Infarction | Cardiac disorders | MedDRA 9.1 | Systematic Assessment |
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| Myocardial Ischaemia | Cardiac disorders | MedDRA 9.1 | Systematic Assessment |
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| Any Hepatobiliary Disorders | Hepatobiliary disorders | MedDRA 9.1 | Systematic Assessment |
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| Bile Duct Stone | Hepatobiliary disorders | MedDRA 9.1 | Systematic Assessment |
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| Cholecystitis Acute | Hepatobiliary disorders | MedDRA 9.1 | Systematic Assessment |
|
| Any Neoplasms Benign, Malignant And Unspecified (Incl Cysts & Polyps) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.1 | Systematic Assessment |
|
| Carcinoid Tumour Of The Gastrointestinal Tract | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.1 | Systematic Assessment |
|
| Ovarian Epithelial Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.1 | Systematic Assessment |
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| Any Nervous System Disorders | Nervous system disorders | MedDRA 9.1 | Systematic Assessment |
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| Cerebrovascular Accident | Nervous system disorders | MedDRA 9.1 | Systematic Assessment |
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| Any Psychiatric Disorders | Psychiatric disorders | MedDRA 9.1 | Systematic Assessment |
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| Alcoholism | Psychiatric disorders | MedDRA 9.1 | Systematic Assessment |
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| Any Respiratory, Thoracic And Mediastinal Disorders | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | Systematic Assessment |
|
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | 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 |