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| ID | Type | Description | Link |
|---|---|---|---|
| MK0431-052 | |||
| 2006_507 |
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A clinical study to determine the safety and efficacy of sitagliptin in patients with Type 2 Diabetes Mellitus who have inadequate glycemic control on metformin/peroxisome proliferator-activated receptor gamma (PPARg) agonist combination therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Sitagliptin |
|
| 2 | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sitagliptin | Drug | Sitagliptin 100mg tablet each day for 54 weeks. All subjects will be given placebo to sitagliptin for a 2 week period. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in HbA1c (Hemoglobin A1C) at Week 18 | HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the Week 0 HbA1c percent. | Baseline and 18 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in FPG (Fasting Plasma Glucose) at Week 18 | Change from baseline at Week 18 is defined as Week 18 minus Week 0 | Baseline and 18 Weeks |
| Change From Baseline in 2-hour PMG (Post-meal Glucose) 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 |
|---|---|---|---|
| 22742523 | Derived | Dobs AS, Goldstein BJ, Aschner P, Horton ES, Umpierrez GE, Duran L, Hill JS, Chen Y, Golm GT, Langdon RB, Williams-Herman DE, Kaufman KD, Amatruda JM, Ferreira JC. Efficacy and safety of sitagliptin added to ongoing metformin and rosiglitazone combination therapy in a randomized placebo-controlled 54-week trial in patients with type 2 diabetes. J Diabetes. 2013 Mar;5(1):68-79. doi: 10.1111/j.1753-0407.2012.00223.x. |
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Patients 18-78 years of age with T2DM and inadequate glycemic control (HbA1c ≥7.5 and ≤11.0%) who were on stable doses of rosiglitazone (≥4 mg/day) and metformin (≥1500 mg/day) after an up to 20-week dose-titration and stabilization period were eligible to enter the 54-week study.
Phase III
First Patient In: 29-Aug-06. Last Patient Enrolled: 23-Mar-07. Last Patient Last Visit: 27-May-08; 41 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 tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with open-label rosiglitazone 4 mg oral tablets (4 to 8 mg/day) and open-label metformin 500 mg oral tablets (≥1500 mg/day). |
| FG001 | Placebo | The Placebo group includes data from patients randomized to receive treatment with placebo to sitagliptin 100 mg tablet once daily (blinded) in addition to ongoing treatment with open-label rosiglitazone 4 mg oral tablets (4 to 8 mg/day) and open-label metformin 500 mg oral tablets (≥1500 mg/day). |
| 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 (blinded) in addition to ongoing treatment with open-label rosiglitazone 4 mg oral tablets (4 to 8 mg/day) and open-label metformin 500 mg oral tablets (≥1500 mg/day). |
| BG001 |
| 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 18 | HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 18 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. Data following glycemic rescue were treated as missing. For FAS patients with no data at Week 18, the last non-baseline observed measurement was carried forward to Week 18. | Posted | Least Squares Mean | 95% Confidence Interval | Percent | Baseline and 18 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 Data Through Week 18 | The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with open-label rosiglitazone 4 mg oral tablets (4 to 8 mg/day) and open-label metformin 500 mg oral tablets (≥1500 mg/day). |
| 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 |
Non-serious adverse event results represent those events included in the primary safety analysis for this study (events occurred prior to initiation of glycemic rescue therapy). Site 0520039 was non-compliant with GDP, data was removed from analyses.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclsoure@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 |
| D000077154 | Rosiglitazone |
| D008687 | Metformin |
| D005913 | Glipizide |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Comparator: Placebo | Drug | Placebo to sitagliptin 100mg tablet each day for 54 weeks. |
|
| rosiglitazone | Drug | Subjects taking 4mg or greater rosiglitazone at screening will enter a 6 week stable dose period followed by a 54 week treatment period. Subjects who are taking less than 4mg/day or no rosiglitazone at screening will be titrated to a stable dose of at least 4mg over a a maximum of 8 weeks followed by a dose stable period of up to 12 weeks then a 54 week treatment period. Total treatment will be up to 77 weeks. |
|
|
| metformin | Drug | Subjects taking 1500mg or greater metformin at screening will enter a 6 week stable dose period followed by a 54 week treatment period. Subjects who are taking less than 1500mg/day or no metformin at screening will be titrated to a stable dose of at least 1500mg over a a maximum of 8 weeks followed by a dose stable period of up to 12 weeks then a 54 week treatment period. Total treatment will be up to 77 weeks. |
|
| glipizide | Drug | Subjects not meeting specific glycemic controls during the 54-week treatment period will use glipizide as rescue therapy. Glipizide will be titrated in 5mg doses up to a maximum 40mg each day. (In Canada, the rescue therapy will be a sulfonylurea agent marketed in that country.) |
|
|
Change from baseline at Week 18 is defined as Week 18 minus Week 0
| Baseline and Week 18 |
| Change From Baseline in HbA1c (Hemoglobin A1C) at Week 54 | HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 54 HbA1c percent minus the Week 0 HbA1c percent. | Baseline and Week 54 |
| Change From Baseline in FPG (Fasting Plasma Glucose) at Week 54 | Change from baseline at Week 54 is defined as Week 54 minus Week 0 | Baseline and Week 54 |
| Change From Baseline in 2-hour PMG (Post-meal Glucose) at Week 54 | Change from baseline at Week 54 is defined as Week 54 minus Week 0. | Baseline and Week 54 |
| Lost to Follow-up |
|
| Physician Decision |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Patient Moved |
|
| Non-compliance with study procedures |
|
| Placebo |
The Placebo group includes data from patients randomized to receive treatment with placebo to sitagliptin 100 mg tablet once daily (blinded) in addition to ongoing treatment with open-label rosiglitazone 4 mg oral tablets (4 to 8 mg/day) and open-label metformin 500 mg oral tablets (≥1500 mg/day). |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity | Number | participants |
|
| HbA1c (Hemoglobin A1c) | Mean | Standard Deviation | Percent |
|
| OG001 | Placebo | The Placebo group includes data from patients randomized to receive treatment with placebo to sitagliptin 100 mg tablet once daily (blinded) in addition to ongoing treatment with open-label rosiglitazone 4 mg oral tablets (4 to 8 mg/day) and open-label metformin 500 mg oral tablets (≥1500 mg/day). |
|
|
|
| Secondary | Change From Baseline in FPG (Fasting Plasma Glucose) at Week 18 | Change from baseline at Week 18 is defined as Week 18 minus Week 0 | The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. For FAS patients with no data at Week 18, the last non-baseline observed measurement was carried forward to Week 18. | Posted | Least Squares Mean | 95% Confidence Interval | mg/dL | Baseline and 18 Weeks |
|
|
|
|
| Secondary | Change From Baseline in 2-hour PMG (Post-meal Glucose) at Week 18 | Change from baseline at Week 18 is defined as Week 18 minus Week 0 | The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. For FAS patients with no data at Week 18, the last non-baseline observed measurement was carried forward to Week 18. | Posted | Least Squares Mean | 95% Confidence Interval | mg/dL | Baseline and Week 18 |
|
|
|
|
| Secondary | Change From Baseline in HbA1c (Hemoglobin A1C) at Week 54 | HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 54 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. Data following glycemic rescue were treated as missing. For FAS patients with no data at Week 54, the last non-baseline observed measurement was carried forward to Week 54. | Posted | Least Squares Mean | 95% Confidence Interval | Percent | Baseline and Week 54 |
|
|
|
|
| Secondary | Change From Baseline in FPG (Fasting Plasma Glucose) at Week 54 | Change from baseline at Week 54 is defined as Week 54 minus Week 0 | The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. For FAS patients with no data at Week 54, the last non-baseline observed measurement was carried forward to Week 54. | Posted | Least Squares Mean | 95% Confidence Interval | mg/dL | Baseline and Week 54 |
|
|
|
|
| Secondary | Change From Baseline in 2-hour PMG (Post-meal Glucose) at Week 54 | Change from baseline at Week 54 is defined as Week 54 minus Week 0. | The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. For FAS patients with no data at Week 54, the last non-baseline observed measurement was carried forward to Week 54. | Posted | Least Squares Mean | 95% Confidence Interval | mg/dL | Baseline and Week 54 |
|
|
|
|
| 2 |
| 20 |
| EG001 | Placebo Data Through Week 18 | The Placebo group includes data from patients randomized to receive treatment with placebo to sitagliptin 100 mg tablet once daily (blinded) in addition to ongoing treatment with open-label rosiglitazone 4 mg oral tablets (4 to 8 mg/day) and open-label metformin 500 mg oral tablets (≥1500 mg/day). | 2 | 14 |
| EG002 | Sitagliptin 100 mg Data Through Week 54 | 14 | 70 |
| EG003 | Placebo Data Through Week 54 | 4 | 35 |
| Myocardial Infarction | Cardiac disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Any Ear And Labyrinth Disorders | Ear and labyrinth disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Any Hepatobiliary Disorders | Hepatobiliary disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Biliary Colic | Hepatobiliary disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Any Infections And Infestations | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
|
| Urinary 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 |
|
| Lower Limb Fracture | Injury, poisoning and procedural complications | MedDRA 11.0 | Non-systematic Assessment |
|
| Any Musculoskeletal And Connective Tissue Disorders | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Intervertebral Disc Protrusion | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Pain In Extremity | Musculoskeletal and connective tissue 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 |
|
| Astrocytoma Malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Non-systematic Assessment |
|
| Basal Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Non-systematic Assessment |
|
| Breast Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Non-systematic Assessment |
|
| Neurilemmoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Non-systematic Assessment |
|
| Prostate Cancer | 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 |
|
| Cerebrovascular Accident | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Diabetic Neuropathy | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Any Psychiatric Disorders | Psychiatric disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Suicidal Ideation | Psychiatric disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Any Renal And Urinary Disorders | Renal and urinary disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Renal Colic | Renal and urinary disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Any General Disorders And Administration Site Conditions | General disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Oedema Peripheral | General disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Any Infections And Infestations | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
|
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
|
| Any Musculoskeletal And Connective Tissue Disorders | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Any Nervous System Disorders | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Any Respiratory, Thoracic And Mediastinal Disorders | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal 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 |
| D045162 | Thiazolidinediones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D013453 | Sulfonylurea Compounds |
| D013450 | Sulfones |