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| ID | Type | Description | Link |
|---|---|---|---|
| MK0431-049 | |||
| 2006_561 |
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A study to evaluate the efficacy and safety of sitagliptin in comparison to a commonly used medication in patients with type 2 diabetes
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Drug |
|
| 2 | Active Comparator | Active comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sitagliptin phosphate | Drug | (1) sitagliptin 100mg tablet once daily (q.d.) for a 24-wk treatment period |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24 | HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the Week 0 HbA1c percent. | Baseline and 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Who Reported 1 or More Episodes of the Adverse Experience of Diarrhea | Baseline to Week 24 | |
| Number of Patients Who Reported 1 or More Episodes of the Adverse Experience of Nausea | Baseline to Week 24 |
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General Inclusion Criteria:
General 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 |
|---|---|---|---|
| 20070351 | Result | Aschner P, Katzeff HL, Guo H, Sunga S, Williams-Herman D, Kaufman KD, Goldstein BJ; Sitagliptin Study 049 Group. Efficacy and safety of monotherapy of sitagliptin compared with metformin in patients with type 2 diabetes. Diabetes Obes Metab. 2010 Mar;12(3):252-61. doi: 10.1111/j.1463-1326.2009.01187.x. Epub 2009 Nov 25. |
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Patients 18-78 years of age with Type 2 diabetes mellitus (T2DM) who were not on anti-hyperglycemic agents for at least 4 months (16 weeks) and with a hemoglobin A1c (HbA1c) of ≥ 6.5 and ≤9.0%
First patient In: 04-Apr-2007
Last Patient Last Visit: 25-Jul-2008
113 study centers worldwide
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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 tablet of sitagliptin once daily. |
| FG001 | Metformin | The Metformin group includes data from patients randomized to receive treatment with metformin initiated at a dose of 1 tablet (500 mg) per day. Patients were then to be up-titrated over a maximum of 5 weeks to a total daily dose of 2 tablets twice daily (1000 mg b.i.d). |
| 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 tablet of sitagliptin once daily. |
| BG001 | Metformin |
| 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 24 | HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the Week 0 HbA1c percent. | The per protocol population required that a patient had measurements both at baseline and at Week 24, and did not have any major protocol violations (e.g. drug compliance <85%, addition of prohibited antihyperglycemic agent, incorrect double-blind study medication). No missing data were imputed. | Posted | Least Squares Mean | 95% Confidence Interval | Percent | Baseline and 24 weeks |
|
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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 tablet of sitagliptin once daily. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Any Cardiac disorders | Cardiac disorders | MedDRA 11.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Any Gastrointestinal disorders | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
Site 0490125 was non-compliant with Good Clinical Practice (GCP). Data from the 8 patients at this site were removed from all analyses.
| 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: metformin hydrochloride | Drug | (4) Metformin 500mg tablets once daily (q.d.) for a 24-wk treatment period. |
|
| Number of Patients Who Reported 1 or More Episodes of the Adverse Experience of Abdominal Pain | Baseline to Week 24 |
| Number of Patients Who Reported 1 or More Episodes of the Adverse Experience of Vomiting | Baseline to Week 24 |
| Lack of Efficacy |
|
| Lost to Follow-up |
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| Physician Decision |
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| Protocol Violation |
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| Withdrawal by Subject |
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| Glycemic discontinuation criteria |
|
The Metformin group includes data from patients randomized to receive treatment with metformin initiated at a dose of 1 tablet (500 mg) per day. Patients were then to be up-titrated over a maximum of 5 weeks to a total daily dose of 2 tablets twice daily (1000 mg b.i.d).
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Body Weight | Mean | Standard Deviation | Kilograms |
|
| Hemoglobin A1c (HbA1c) | Mean | Standard Deviation | Percent |
|
| Metformin |
The Metformin group includes data from patients randomized to receive treatment with metformin initiated at a dose of 1 tablet (500 mg) per day. Patients were then to be up-titrated over a maximum of 5 weeks to a total daily dose of 2 tablets twice daily (1000 mg b.i.d). |
|
|
|
| Secondary | Number of Patients Who Reported 1 or More Episodes of the Adverse Experience of Diarrhea | All randomized patients who received at least 1 dose of the double-blind study therapy. | Posted | Number | Participants | Baseline to Week 24 |
|
|
|
|
| Secondary | Number of Patients Who Reported 1 or More Episodes of the Adverse Experience of Nausea | All randomized patients who received at least 1 dose of the double-blind study therapy. | Posted | Number | Participants | Baseline to Week 24 |
|
|
|
|
| Secondary | Number of Patients Who Reported 1 or More Episodes of the Adverse Experience of Abdominal Pain | All randomized patients who received at least 1 dose of the double-blind study therapy. | Posted | Number | Participants | Baseline to Week 24 |
|
|
|
|
| Secondary | Number of Patients Who Reported 1 or More Episodes of the Adverse Experience of Vomiting | All randomized patients who received at least 1 dose of the double-blind study therapy. | Posted | Number | Participants | Baseline to Week 24 |
|
|
|
|
| 10 |
| 19 |
| EG001 | Metformin | The Metformin group includes data from patients randomized to receive treatment with metformin initiated at a dose of 1 tablet (500 mg) per day. Patients were then to be up-titrated over a maximum of 5 weeks to a total daily dose of 2 tablets twice daily (1000 mg b.i.d). | 8 | 57 |
| Acute myocardial infarction | Cardiac disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Coronary artery disease | Cardiac disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Tachyarrhythmia | Cardiac disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Any Congenital, familial and genetic disorders | Congenital, familial and genetic disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Multiple endocrine adenomatosis Type II | Congenital, familial and genetic disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Any General disorders and administration site conditions | General disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Any Infections and infestations | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
|
| Appendicitis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
|
| Any Injury, poisoning and procedural complications | Injury, poisoning and procedural complications | MedDRA 11.0 | Non-systematic Assessment |
|
| Intervertebral disc injury | Injury, poisoning and procedural complications | MedDRA 11.0 | Non-systematic Assessment |
|
| Joint injury | Injury, poisoning and procedural complications | MedDRA 11.0 | Non-systematic Assessment |
|
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA 11.0 | Non-systematic Assessment |
|
| Any Metabolism and nutrition disorders | Metabolism and nutrition disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Any Neoplasms benign, malignant and unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Non-systematic Assessment |
|
| Lung carcinoma cell type unspecified stage IV | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Non-systematic Assessment |
|
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Non-systematic Assessment |
|
| Metastases to bone | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Non-systematic Assessment |
|
| Any Nervous system disorders | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Facial palsy | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Any Renal and urinary disorders | Renal and urinary disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Any Reproductive system and breast disorders | Reproductive system and breast disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Hydrometra | Reproductive system and breast disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 11.0 | 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 |