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| ID | Type | Description | Link |
|---|---|---|---|
| 2008_503 |
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A study to see if better control of type 2 diabetes can occur in patients taking a stable dose of metformin when they are also provided either sitagliptin or glimepiride. This study will also see if this treatment is safe and tolerable.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | sitagliptin |
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| 2 | Active Comparator | glimepiride |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sitagliptin | Drug | Sitagliptin 100 mg q.d. (q.d. = once daily); Duration of Treatment: 30 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in HbA1c at Week 30 | Patient-level HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 30 HbA1c percent minus the Week 0 HbA1c percent. | Week 0 to Week 30 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in FPG (Fasting Plasma Glucose) at Week 30 | Change from baseline at Week 30 was defined as Week 30 minus Week 0. | Week 0 to Week 30 |
| Percent of Patients With at Least One Hypoglycemia Episode of Any Type at Week 30 |
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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 |
|---|---|---|---|
| 21199268 | Result | Arechavaleta R, Seck T, Chen Y, Krobot KJ, O'Neill EA, Duran L, Kaufman KD, Williams-Herman D, Goldstein BJ. Efficacy and safety of treatment with sitagliptin or glimepiride in patients with type 2 diabetes inadequately controlled on metformin monotherapy: a randomized, double-blind, non-inferiority trial. Diabetes Obes Metab. 2011 Feb;13(2):160-8. doi: 10.1111/j.1463-1326.2010.01334.x. | |
| 25633134 |
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Patients at least 18 years of age with type 2 diabetes mellitus with inadequate glycemic control (A1C ≥6.5 and ≤9.0%) on a stable dose of metformin (at a dose of at least 1500 mg per day for at least 12 weeks) were eligible to enter the 30 week study. Up to a 2 week screening period, followed by a 2-week placebo run-in.
Phase III
First Patient In: 14-May-2008; Last Patient Last Visit: 27-Oct-2009; 109 study centers worldwide
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| ID | Title | Description |
|---|---|---|
| FG000 | Sitagliptin | The Sitagliptin 100 mg q.d. (q.d. = once daily) 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 metformin oral tablets (≥1500 mg/day). |
| FG001 | Glimepiride |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Comparator: glimepiride | Drug | glimepiride 1 mg per day to be up-titrated (up to week 18 of the double-blind treatment period) as considered appropriate by the investigator, based upon the results of patient's self blood glucose monitoring (SBGM). The maximum dose of glimepiride must not be higher than 6 mg/day. |
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| open-label metformin | Drug | open-label metformin oral tablets (≥1500 mg/day) in addition to Glimepiride or Sitagliptin treatment. |
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| Week 0 to Week 30 |
| Change From Baseline in Body Weight at Week 30 | Change from baseline at Week 30 was defined as Week 30 minus Week 0. | Week 0 to Week 30 |
| Percent of Patients With A1C <7.0% at Week 30 | Week 30 |
| Percent of Patients With A1C <6.5% at Week 30 | Week 30 |
| Derived |
| Ommen ES, Xu L, O'Neill EA, Goldstein BJ, Kaufman KD, Engel SS. Comparison of treatment with sitagliptin or sulfonylurea in patients with type 2 diabetes mellitus and mild renal impairment: a post hoc analysis of clinical trials. Diabetes Ther. 2015 Mar;6(1):29-40. doi: 10.1007/s13300-015-0098-y. Epub 2015 Jan 30. |
The Glimepiride group includes data from patients randomized to receive treatment starting with 1 mg oral tablets of glimepiride (blinded) up-titrated until Week 18 as needed to a maximum dose of 6 mg q.d. in addition to ongoing treatment with open-label metformin oral tablets (≥1500 mg/day). |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Sitagliptin | The Sitagliptin 100 mg q.d. (q.d. = once daily) 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 metformin oral tablets (≥1500 mg/day). |
| BG001 | Glimepiride | The Glimepiride group includes data from patients randomized to receive treatment starting with 1 mg oral tablets of glimepiride (blinded) up-titrated until Week 18 as needed to a maximum dose of 6 mg q.d. in addition to ongoing treatment with open-label metformin oral tablets (≥1500 mg/day). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| A1C (Hemoglobin A1c) | Mean | Standard Deviation | Percent |
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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Change From Baseline in HbA1c at Week 30 | Patient-level HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 30 HbA1c percent minus the Week 0 HbA1c percent. | The per protocol population included all patients with a baseline value, a measurement at Week 30, and no major protocol violations (i.e., drug compliance <85%, use of prohibited medications, change of Metformin dose, incorrect double-blind study medication). | Posted | Least Squares Mean | 95% Confidence Interval | Percent | Week 0 to Week 30 |
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| Secondary | Change From Baseline in FPG (Fasting Plasma Glucose) at Week 30 | Change from baseline at Week 30 was defined as Week 30 minus Week 0. | The per protocol population included all patients with a baseline value, a measurement at Week 30, and no major protocol violations (i.e., drug compliance <85%, use of prohibited medications, change of Metformin dose, incorrect double-blind study medication). | Posted | Least Squares Mean | 95% Confidence Interval | mg/dL | Week 0 to Week 30 |
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| Secondary | Percent of Patients With at Least One Hypoglycemia Episode of Any Type at Week 30 | All patients who took at least one dose of study therapy. | Posted | Number | Percentage of Participants | Week 0 to Week 30 |
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| Secondary | Change From Baseline in Body Weight at Week 30 | Change from baseline at Week 30 was defined as Week 30 minus Week 0. | All patients who took at least one dose of study therapy and had body weight measurements at both baseline and Week 30. | Posted | Least Squares Mean | 95% Confidence Interval | Kilograms | Week 0 to Week 30 |
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| Secondary | Percent of Patients With A1C <7.0% at Week 30 | The per protocol population included all patients with a baseline value, a measurement at Week 30, and no major protocol violations (i.e., drug compliance <85%, use of prohibited medications, change of Metformin dose, incorrect double-blind study medication). | Posted | Number | Percentage of Participants | Week 30 |
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| Secondary | Percent of Patients With A1C <6.5% at Week 30 | The per protocol population included all patients with a baseline value, a measurement at Week 30, and no major protocol violations (i.e., drug compliance <85%, use of prohibited medications, change of Metformin dose, incorrect double-blind study medication). | Posted | Number | Percentage of Participants | Week 30 |
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Particpants analyzed are those who received at least 1 dose of study medication. One participant in the Glimepiride group did not receive any study medication and is not included in the analysis.
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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 100 mg q.d. (q.d. = once daily) 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 metformin oral tablets (≥1500 mg/day). | 16 | 516 | 58 | 519 | ||
| EG001 | Glimepiride | The Glimepiride group includes data from patients randomized to receive treatment starting with 1 mg oral tablets of glimepiride (blinded) up-titrated until Week 18 as needed to a maximum dose of 6 mg q.d. in addition to ongoing treatment with open-label metformin oral tablets (≥1500 mg/day). | 11 | 518 | 134 | 518 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (12.1) | Non-systematic Assessment |
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| Acute coronary syndrome | Cardiac disorders | MedDRA (12.1) | Non-systematic Assessment |
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| Coronary artery disease | Cardiac disorders | MedDRA (12.1) | Non-systematic Assessment |
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| Myocardial ischaemia | Cardiac disorders | MedDRA (12.1) | Non-systematic Assessment |
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| Inguinal hernia | Gastrointestinal disorders | MedDRA (12.1) | Non-systematic Assessment |
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| Non-cardiac chest pain | General disorders | MedDRA (12.1) | Non-systematic Assessment |
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| Pain | General disorders | MedDRA (12.1) | Non-systematic Assessment |
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| Anal abscess | Infections and infestations | MedDRA (12.1) | Non-systematic Assessment |
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| Infection | Infections and infestations | MedDRA (12.1) | Non-systematic Assessment |
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| Mastitis | Infections and infestations | MedDRA (12.1) | Non-systematic Assessment |
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| Peritonsillar abscess | Infections and infestations | MedDRA (12.1) | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA (12.1) | Non-systematic Assessment |
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| Typhoid fever | Infections and infestations | MedDRA (12.1) | Non-systematic Assessment |
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| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA (12.1) | Non-systematic Assessment |
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| Humerus fracture | Injury, poisoning and procedural complications | MedDRA (12.1) | Non-systematic Assessment |
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| Patella fracture | Injury, poisoning and procedural complications | MedDRA (12.1) | Non-systematic Assessment |
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| Skin laceration | Injury, poisoning and procedural complications | MedDRA (12.1) | Non-systematic Assessment |
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| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA (12.1) | Non-systematic Assessment |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Non-systematic Assessment |
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| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.1) | Non-systematic Assessment |
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| Lung squamous cell carcinoma stage unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.1) | Non-systematic Assessment |
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| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.1) | Non-systematic Assessment |
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| Autonomic neuropathy | Nervous system disorders | MedDRA (12.1) | Non-systematic Assessment |
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| Cerebrovascular accident | Nervous system disorders | MedDRA (12.1) | Non-systematic Assessment |
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| Haemorrhagic stroke | Nervous system disorders | MedDRA (12.1) | Non-systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA (12.1) | Non-systematic Assessment |
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| Prostatitis | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Non-systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA (12.1) | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA (12.1) | Non-systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (12.1) | Non-systematic Assessment |
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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.
| 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 |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000068900 | Sitagliptin Phosphate |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011719 | Pyrazines |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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