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| ID | Type | Description | Link |
|---|---|---|---|
| 2007_623 |
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The purpose of this study is to test the safety and effectiveness of sitagliptin in patients with type 2 diabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sitagliptin | Experimental | sitagliptin 100 mg |
|
| Rosiglitazone | Active Comparator | rosiglitazone 8 mg |
|
| Placebo | Placebo Comparator | placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sitagliptin | Drug | Sitagliptin 100 mg administered as one oral tablet once daily in the morning for up to 18 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin A1C (A1C) at Week 18 | A1C is measured as percent. Thus, this change from baseline reflects the Week 18 A1C percent minus the Week 0 A1C percent. The study hypothesis comparison was between sitagliptin versus placebo. | Baseline and 18 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Fasting Plasma Glucose (FPG) at Week 18 | The change from baseline is the Week 18 FPG minus the Week 0 FPG. | Baseline and 18 Weeks |
| 2-hour Post-meal Glucose (PMG) at Week 18 | The change from baseline is the Week 18 PMG minus the Week 0 PMG. |
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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 |
|---|---|---|---|
| 18201203 | Background | Scott R, Loeys T, Davies MJ, Engel SS; Sitagliptin Study 801 Group. Efficacy and safety of sitagliptin when added to ongoing metformin therapy in patients with type 2 diabetes. Diabetes Obes Metab. 2008 Sep;10(10):959-69. doi: 10.1111/j.1463-1326.2007.00839.x. Epub 2008 Jan 14. |
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Patients 18-75 years of age with type 2 diabetes mellitus (T2DM) who were taking metformin monotherapy at a stable dose of ≥ 1500 mg/day for at least 10 weeks and had inadequate glycemic control (hemoglobin A1C ≥ 7.0% and ≤11%) were eligible to participate.
First Patient In: 16-June-2006. Last Patient Last Visit: 2-March-2007. 13 medical clinics in 3 countries in Europe and 23 in 4 countries in the rest of the world
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| ID | Title | Description |
|---|---|---|
| FG000 | Sitagliptin | The Sitagliptin group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg and placebo matching rosiglitazone q.d. (once-daily) with metformin (≥1500 mg/day). |
| FG001 | Rosiglitazone | The Rosiglitazone group includes data from patients randomized to receive treatment with oral tablets of rosiglitazone 8 mg and placebo matching sitagliptin q.d. in combination with metformin (≥1500 mg/day). |
| FG002 | Placebo | The Placebo group includes data from patients randomized to receive treatment with oral tablets of placebo matching sitagliptin and placebo matching rosiglitazone q.d. with metformin (≥1500 mg/day). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sitagliptin | The Sitagliptin group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg and placebo matching rosiglitazone q.d. (once-daily) with metformin (≥1500 mg/day). |
| BG001 | Rosiglitazone |
| 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 | Hemoglobin A1C (A1C) at Week 18 | A1C is measured as percent. Thus, this change from baseline reflects the Week 18 A1C percent minus the Week 0 A1C percent. The study hypothesis comparison was between sitagliptin versus placebo. | The all patients treated population included all patients who took at least one dose of study medication and had both a baseline measurement and at least one post-randomization measurement for this outcome. Missing data were imputed using the last observation carried forward (LOCF) method. | Posted | Least Squares Mean | 95% Confidence Interval | Percent of glycosylated hemoglobin (A1C) | Baseline and 18 Weeks |
|
Weeks 0 to 18
Safety tables are based on the All Patients as Treated (APaT) population that includes all patients who took at least one dose of study drug. One patient in the placebo group did not take any study drug. Thus, for the placebo group 92 patients are reported in the baseline characteristics and 91 patients are reported in the AE summary.
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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 | The Sitagliptin group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg and placebo matching rosiglitazone q.d. (once-daily) with metformin (≥1500 mg/day). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina unstable | Cardiac disorders | MedDRA 11.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood glucose increased | Investigations | MedDRA 11.1 | 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 |
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| 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 |
| D000077154 | Rosiglitazone |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Comparator: Rosiglitazone | Drug | Rosiglitazone 8 mg administered as two 4 mg capsules once daily in the morning for up to 18 weeks. |
|
|
| Comparator: Placebo | Drug | placebo - administered as one placebo tablet to match Sitagliptin 100 mg and two placebo capsules to match rosiglitazone 4 mg once daily in the morning for up to 18 weeks. |
|
| Comparator: Metformin | Drug | Open-label metformin was supplied by the Sponsor as 500, 850, or 1000 mg oral tablets administered at a daily dose of >= 1500 mg. |
|
| Baseline and 18 Weeks |
| Lost to Follow-up |
|
| Protocol Violation |
|
| Withdrawal by Subject and Other |
|
The Rosiglitazone group includes data from patients randomized to receive treatment with oral tablets of rosiglitazone 8 mg and placebo matching sitagliptin q.d. in combination with metformin (≥1500 mg/day). |
| BG002 | Placebo | The Placebo group includes data from patients randomized to receive treatment with oral tablets of placebo matching sitagliptin and placebo matching rosiglitazone q.d. with metformin (≥1500 mg/day). |
| BG003 | 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 (A1C) | Mean | Standard Deviation | Percent of glycosylated hemoglobin (A1C) |
|
| OG001 | Rosiglitazone | The Rosiglitazone group includes data from patients randomized to receive treatment with oral tablets of rosiglitazone 8 mg and placebo matching sitagliptin q.d. in combination with metformin (≥1500 mg/day). |
| OG002 | Placebo | The Placebo group includes data from patients randomized to receive treatment with oral tablets of placebo matching sitagliptin and placebo matching rosiglitazone q.d. with metformin (≥1500 mg/day). |
|
|
|
| Secondary | Fasting Plasma Glucose (FPG) at Week 18 | The change from baseline is the Week 18 FPG minus the Week 0 FPG. | The all patients treated population included all patients who took at least one dose of study medication and had both a baseline measurement and at least one post-randomization measurement for this outcome. Missing data were imputed using the last observation carried forward (LOCF) method. | Posted | Least Squares Mean | 95% Confidence Interval | mg/dL | Baseline and 18 Weeks |
|
|
|
|
| Secondary | 2-hour Post-meal Glucose (PMG) at Week 18 | The change from baseline is the Week 18 PMG minus the Week 0 PMG. | The all patients treated population included all patients who took at least one dose of study medication and had both a baseline measurement and at least one post-randomization measurement for this outcome. Missing data were imputed using the last observation carried forward (LOCF) method. | Posted | Least Squares Mean | 95% Confidence Interval | mg/dL | Baseline and 18 Weeks |
|
|
|
|
| 5 |
| 94 |
| 5 |
| 94 |
| EG001 | Rosiglitazone | The Rosiglitazone group includes data from patients randomized to receive treatment with oral tablets of rosiglitazone 8 mg and placebo matching sitagliptin q.d. in combination with metformin (≥1500 mg/day). | 5 | 87 | 1 | 87 |
| EG002 | Placebo | The Placebo group includes data from patients randomized to receive treatment with oral tablets of placebo matching sitagliptin and placebo matching rosiglitazone q.d. with metformin (≥1500 mg/day). | 5 | 91 | 0 | 91 |
| Coronary artery disease | Cardiac disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Intentional overdose | Injury, poisoning and procedural complications | MedDRA 11.1 | Non-systematic Assessment |
|
| Overdose | Injury, poisoning and procedural complications | MedDRA 11.1 | Non-systematic Assessment |
|
| Skin laceration | Injury, poisoning and procedural complications | MedDRA 11.1 | Non-systematic Assessment |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Endometrial hyperplasia | Reproductive system and breast disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | 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 |
| D045162 | Thiazolidinediones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |