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| ID | Type | Description | Link |
|---|---|---|---|
| 2005_009 |
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The purpose of this clinical study is 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 |
|---|---|---|---|
| Sitagliptin | Experimental | Sitagliptin 10 mg tablet daily for 54 weeks |
|
| Placebo/ Pioglitazone | Placebo Comparator | Placebo tablet daily for 24 weeks followed by Pioglitazone tablet daily for 30 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comparator: Sitagliptin | Drug | sitagliptin 10 mg tablet, once daily for 54 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in A1C at Week 24 | Hemoglobin A1C (A1C) is measured as percent. Thus this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent. | Baseline and 24 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in FPG at Week 24 | The change from baseline is the Week 24 Fasting Plasma Glucose (FPG) minus the Week 0 FPG. | Baseline and 24 Weeks |
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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 |
|---|---|---|---|
| 17593236 | Background | Hermansen K, Kipnes M, Luo E, Fanurik D, Khatami H, Stein P; Sitagliptin Study 035 Group. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor, sitagliptin, in patients with type 2 diabetes mellitus inadequately controlled on glimepiride alone or on glimepiride and metformin. Diabetes Obes Metab. 2007 Sep;9(5):733-45. doi: 10.1111/j.1463-1326.2007.00744.x. Epub 2007 Jun 26. |
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Patients 18-75 years of age with type 2 diabetes mellitus (T2DM) with inadequate glycemic control (hemoglobin A1c [A1C] ≥7.5% and ≤10.5%) at screening or after treatment with glimepiride (≥4 mg) alone or in combination with metformin (≥1500 mg) for a dose stable period of up to 10 weeks were eligible to participate.
First Patient In: 27-Apr-2005. Last Patient Last Visit: 09-Jan-2007. 27 medical clinics in the United States (US), 25 in 11 countries in Europe, and 22 in 11 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 q.d. (once daily) with glimepiride (≥4 mg/day) alone or in combination with metformin (≥1500 mg/day). |
| FG001 | Placebo/ Pioglitazone | The Placebo group includes data from patients randomized to receive treatment with placebo to sitagliptin oral tablets q.d. with glimepiride (≥4 mg/day) alone or in combination 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 q.d. (once daily) with glimepiride (≥4 mg/day) alone or in combination with metformin (≥1500 mg/day). |
| BG001 | Placebo/ Pioglitazone |
| 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 A1C at Week 24 | Hemoglobin A1C (A1C) is measured as percent. Thus this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent. | All Patients Treated included patients who received at least 1 dose of study therapy, and had a baseline value and ≥1 post-baseline value for this outcome. The last post-baseline observed measurement was carried forward to Week 24 for patients with no data at Week 24. Data obtained after glycemic rescue were considered missing. | Posted | Least Squares Mean | 95% Confidence Interval | Percent | Baseline and 24 Weeks |
|
Weeks 0 to 54
Patients received glycemic rescue medication if they met specific glycemic goals. SAEs includes events that occurred either before or after receiving rescue medication. Other AEs only includes those AEs that occurred prior to a patient receiving rescue medication.
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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 q.d. (once daily) with glimepiride (≥4 mg/day) alone or in combination with metformin (≥1500 mg/day). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina Pectoris | Cardiac disorders | MedDRA (9.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA (9.0) | 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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| Comparator: Placebo |
| Drug |
Placebo oral tablet once daily for 24 weeks |
|
| Comparator: Pioglitazone | Drug | Pioglitazone 30 mg tablet once daily for 30 weeks |
|
| Lack of Efficacy |
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| Lost to Follow-up |
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| Pregnancy |
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| Protocol Violation |
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| Withdrawal by Subject |
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| Patient moved |
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| Site terminated |
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| Planned major surgery |
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| Patient Received Glycemic Medication |
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| Unable to re-enter US |
|
| Laboratory test |
|
The Placebo group includes data from patients randomized to receive treatment with placebo to sitagliptin oral tablets q.d. with glimepiride (≥4 mg/day) alone or in combination with metformin (≥1500 mg/day). |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
|
| Fasting Plasma Glucose (FPG) | Mean | Standard Deviation | mg/dL |
|
| Hemoglobin A1C (A1C) | Mean | Standard Deviation | Percent |
|
| OG001 | Placebo/ Pioglitazone | The Placebo group includes data from patients randomized to receive treatment with placebo to sitagliptin oral tablets q.d. with glimepiride (≥4 mg/day) alone or in combination with metformin (≥1500 mg/day). |
|
|
|
| Secondary | Change From Baseline in FPG at Week 24 | The change from baseline is the Week 24 Fasting Plasma Glucose (FPG) minus the Week 0 FPG. | All Patients Treated included patients who received at least 1 dose of study therapy, and had a baseline value and ≥1 post-baseline value for this outcome. The last post-baseline observed measurement was carried forward to Week 24 for patients with no data at Week 24. Data after rescue were considered missing. | Posted | Least Squares Mean | 95% Confidence Interval | mg/dL | Baseline and 24 Weeks |
|
|
|
|
| 17 |
| 222 |
| 66 |
| 222 |
| EG001 | Placebo/ Pioglitazone | The Placebo group includes data from patients randomized to receive treatment with placebo to sitagliptin oral tablets q.d. with glimepiride (≥4 mg/day) alone or in combination with metformin (≥1500 mg/day). | 13 | 219 | 57 | 219 |
| Cardio-Respiratory Arrest | Cardiac disorders | MedDRA (9.0) | Non-systematic Assessment |
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| Coronary Artery Disease | Cardiac disorders | MedDRA (9.0) | Non-systematic Assessment |
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| Coronary Artery Occlusion | Cardiac disorders | MedDRA (9.0) | Non-systematic Assessment |
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| Ischaemic Cardiomyopathy | Cardiac disorders | MedDRA (9.0) | Non-systematic Assessment |
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| Myocardial Infarction | Cardiac disorders | MedDRA (9.0) | Non-systematic Assessment |
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| Myocardial Ischaemia | Cardiac disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
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| Drowning | General disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Multi-Organ Failure | General disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Non-Cardiac Chest Pain | General disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA (9.0) | Non-systematic Assessment |
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| Diabetic Foot Infection | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
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| Meningitis | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA (9.0) | Non-systematic Assessment |
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| Polytraumatism | Injury, poisoning and procedural complications | MedDRA (9.0) | Non-systematic Assessment |
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| Lumbar Spinal Stenosis | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
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| Glioblastoma Multiforme | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.0) | Non-systematic Assessment |
|
| Keratoacanthoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.0) | Non-systematic Assessment |
|
| Small Cell Lung Cancer Stage Unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.0) | Non-systematic Assessment |
|
| Squamous Cell Carcinoma Of Skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.0) | Non-systematic Assessment |
|
| Cerebellar Infarction | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Cerebral Infarction | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Cerebrovascular Accident | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Abortion Spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA (9.0) | Non-systematic Assessment |
|
| Completed Suicide | Psychiatric disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Endometriosis | Reproductive system and breast disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Ovarian Cyst | Reproductive system and breast disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Interstitial Lung Disease | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Deep Vein Thrombosis | Vascular disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
|
| Blood Glucose Increased | Investigations | MedDRA (9.0) | Non-systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (9.0) | 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 |