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| ID | Type | Description | Link |
|---|---|---|---|
| MK0431-047 | |||
| 2006_003 |
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To evaluate the effect of treatment with sitagliptin compared to placebo in elderly patients with type 2 diabetes mellitus who have poor glycemic control with diet and exercise.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | sitagliptin |
|
| 2 | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sitagliptin phosphate | Drug | Once daily (q.d.) administration of sitagliptin 100 mg tablet (or 50 mg based on creatinine clearance). For up to a 24-wk treatment period. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in HbA1c (Hemoglobin A1c) at Week 24 | Change from baseline at Week 24 is defined as Week 24 minus Week 0. | Baseline and Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in FPG (Fasting Plasma Glucose) at Week 24 | Change from baseline at Week 24 is defined as Week 24 minus Week 0. | Baseline and Week 24 |
| Change From Baseline in 2-hour PPG (Post-prandial Glucose) at Week 24 |
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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 |
|---|---|---|---|
| 21428727 | Result | Barzilai N, Guo H, Mahoney EM, Caporossi S, Golm GT, Langdon RB, Williams-Herman D, Kaufman KD, Amatruda JM, Goldstein BJ, Steinberg H. Efficacy and tolerability of sitagliptin monotherapy in elderly patients with type 2 diabetes: a randomized, double-blind, placebo-controlled trial. Curr Med Res Opin. 2011 May;27(5):1049-58. doi: 10.1185/03007995.2011.568059. Epub 2011 Mar 23. |
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Community dwelling patients ≥ 65 years of age with a diagnosis of type 2 diabetes with hemoglobin A1c (HbA1c) ≥ 7% and ≤ 10% on diet and exercise were eligible to participate. Following a variable duration screening period, patients were randomized in a 1:1 ratio to sitagliptin 100 mg q.d. (or 50 mg q.d. based on creatinine clearance) and placebo.
First Patient In: 30-MAR-2006
Last Patient Last Visit: 12-MAR-2008
60 medical clinics in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sitagliptin | Once-daily administration of sitagliptin 100 mg (or 50 mg based on creatinine clearance); Patients may be down-titrated (1 instead of 2 tablets) if there is a decrease in creatinine clearance to < 50 mL/min at any time during the study. |
| FG001 | Placebo | Sitagliptin-matching placebo tablets. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sitagliptin | Once-daily administration of sitagliptin 100 mg (or 50 mg based on creatinine clearance); Patients may be down-titrated (1 instead of 2 tablets) if there is a decrease in creatinine clearance to < 50 mL/min at any time during the study. |
| 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 HbA1c (Hemoglobin A1c) at Week 24 | Change from baseline at Week 24 is defined as Week 24 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 24, the last observed measurement was carried forward to Week 24. | Posted | Least Squares Mean | 95% Confidence Interval | Percent | Baseline and Week 24 |
|
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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 | Once-daily administration of sitagliptin 100 mg (or 50 mg based on creatinine clearance); Patients may be down-titrated (1 instead of 2 tablets) if there is a decrease in creatinine clearance to < 50 mL/min at any time during the study. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Any Cardiac disorders | Cardiac disorders | MedDRA 10.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Any Infections and Infestations | Infections and infestations | MedDRA 10.1 | 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 | 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 |
|---|---|
| D000068900 | Sitagliptin Phosphate |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
| Comparator: Placebo | Drug | sitagliptin matching placebo for up to a 24-wk treatment period. |
|
Change from baseline at Week 24 is defined as Week 24 minus Week 0.
| Baseline and Week 24 |
| Rapidity of Onset of Action as Determined by Home Glucose Monitoring After 1 Week | Fingerstick glucose measurements were taken at 4 times (pre- and 2 hours post-breakfast and dinner) at each of Days -2, 3, and 7. The average of the 4 values was computed for each day. This outcome reflects the Day 7 average minus the Day -2 average. | Week 1 |
| Lost to Follow-up |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Patient moved |
|
Sitagliptin-matching placebo tablets. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| HbA1c (Hemoglobin A1c) | Mean | Standard Deviation | Percent |
|
Sitagliptin-matching placebo tablets. |
|
|
|
| Secondary | Change From Baseline in FPG (Fasting Plasma Glucose) at Week 24 | Change from baseline at Week 24 is defined as Week 24 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 24, the last observed measurement was carried forward to Week 24. | Posted | Least Squares Mean | 95% Confidence Interval | mg/dL | Baseline and Week 24 |
|
|
|
|
| Secondary | Change From Baseline in 2-hour PPG (Post-prandial Glucose) at Week 24 | Change from baseline at Week 24 is defined as Week 24 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 24, the last observed measurement was carried forward to Week 24. | Posted | Least Squares Mean | 95% Confidence Interval | mg/dL | Baseline and Week 24 |
|
|
|
|
| Secondary | Rapidity of Onset of Action as Determined by Home Glucose Monitoring After 1 Week | Fingerstick glucose measurements were taken at 4 times (pre- and 2 hours post-breakfast and dinner) at each of Days -2, 3, and 7. The average of the 4 values was computed for each day. This outcome reflects the Day 7 average minus the Day -2 average. | 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 Day 7, the last observed measurement was carried forward to Day 7. Patients had the option to participate in self monitoring of glucose. | Posted | Least Squares Mean | 95% Confidence Interval | mg/dL | Week 1 |
|
|
|
|
| 7 |
| 4 |
| EG001 | Placebo | Sitagliptin-matching placebo tablets. | 14 | 6 |
| Coronary Artery Disease | Cardiac disorders | MedDRA 10.1 | Non-systematic Assessment |
|
| Angina Pectoris | Cardiac disorders | MedDRA 10.1 | Non-systematic Assessment |
|
| Any Gastrointestinal disorders | Gastrointestinal disorders | MedDRA 10.1 | Non-systematic Assessment |
|
| Gastroesophageal Reflux Disease | Gastrointestinal disorders | MedDRA 10.1 | Non-systematic Assessment |
|
| Lower Gastrointestinal Hemorrhage | Gastrointestinal disorders | MedDRA 10.1 | Non-systematic Assessment |
|
| Any Hepatobiliary disorders | Hepatobiliary disorders | MedDRA 10.1 | Non-systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA 10.1 | Non-systematic Assessment |
|
| Any Infections and infestations | Infections and infestations | MedDRA 10.1 | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 10.1 | Non-systematic Assessment |
|
| Diverticulitis | Infections and infestations | MedDRA 10.1 | Non-systematic Assessment |
|
| Mycobacterium Avium Complex Infection | Infections and infestations | MedDRA 10.1 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 10.1 | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 10.1 | Non-systematic Assessment |
|
| Staphylococcal Sepsis | Infections and infestations | MedDRA 10.1 | Non-systematic Assessment |
|
| Any Injury, poisoning and procedural complications | Injury, poisoning and procedural complications | MedDRA 10.1 | Non-systematic Assessment |
|
| Lumbar Vertebral Fracture | Injury, poisoning and procedural complications | MedDRA 10.1 | Non-systematic Assessment |
|
| Upper Limb Fracture | Injury, poisoning and procedural complications | MedDRA 10.1 | Non-systematic Assessment |
|
| Any Metabolism and nutrition disorders | Metabolism and nutrition disorders | MedDRA 10.1 | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 10.1 | Non-systematic Assessment |
|
| Any Neoplasms benign, malignant and unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 | Non-systematic Assessment |
|
| Basal Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 | Non-systematic Assessment |
|
| Colon Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 | Non-systematic Assessment |
|
| Malignant Melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 | Non-systematic Assessment |
|
| Squamous Cell Carcinoma Of Skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 | Non-systematic Assessment |
|
| Any Renal and urinary disorders | Renal and urinary disorders | MedDRA 10.1 | Non-systematic Assessment |
|
| Bladder Obstruction | Renal and urinary disorders | MedDRA 10.1 | Non-systematic Assessment |
|
| Renal Failure Acute | Renal and urinary disorders | MedDRA 10.1 | Non-systematic Assessment |
|
| Any Reproductive system and breast disorders | Reproductive system and breast disorders | MedDRA 10.1 | Non-systematic Assessment |
|
| Pelvic Pain | Reproductive system and breast disorders | MedDRA 10.1 | Non-systematic Assessment |
|
| Any Respiratory, thoracic and mediastinal disorders | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Non-systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Non-systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | MedDRA 10.1 | 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 |