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| ID | Type | Description | Link |
|---|---|---|---|
| MK0431A-079 | |||
| 2007_548 |
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The purpose of this study is to investigate the efficacy and safety of an investigational treatment for type 2 diabetes mellitus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Arm 1: drug |
|
| 2 | Active Comparator | Arm 2: active comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sitagliptin phosphate (+) metformin hydrochloride | Drug | sitagliptin/Metformin HCl 50/500 mg tablet bid, titrating up to sitagliptin/Metformin HCl 50/1000 mg tablet over 4 weeks; for a 44-wk treatment period. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in 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. | Baseline and Week 18 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With A1C < 7.0% at Week 18 | Week 18 | |
| Change From Baseline in Fasting Plasma Glucose (FPG) at Week 18 | FPG is measured as mg/dL. Thus, this change from baseline reflects the Week 18 FPG mg/dL minus the Week 0 FPG mg/dL. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in A1C at Week 44 | A1C is measured as percent. Thus, this change from baseline reflects the Week 44 A1C percent minus the Week 0 A1C percent. | Baseline and Week 44 |
| Number of Patients With A1C < 7.0% at Week 44 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21410627 | Result | Reasner C, Olansky L, Seck TL, Williams-Herman DE, Chen M, Terranella L, Johnson-Levonas AO, Kaufman KD, Goldstein BJ. The effect of initial therapy with the fixed-dose combination of sitagliptin and metformin compared with metformin monotherapy in patients with type 2 diabetes mellitus. Diabetes Obes Metab. 2011 Jul;13(7):644-52. doi: 10.1111/j.1463-1326.2011.01390.x. | |
| 21535346 |
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Patients 18-78 years of age with type 2 diabetes mellitus (T2DM) with inadequate glycemic control (hemoglobin A1c [A1C] >7.5% at screening visit) who were appropriate for treatment with oral antihyperglycemic therapy and had not been on an anti-hyperglycemic agent (AHA) in the last 4 months were eligible to participate.
First Patient In: 26-Jun-2007; Last Patient Last Visit for end of study: 28-Apr-2009; Two-hundred four medical clinics in the United States (US) and 5 in Puerto Rico.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sita/Met FDC | The Sitagliptin/Metformin Fixed Dose Combination (Sita/Met FDC) group includes data from patients randomized to receive treatment with oral tablets of Sita/Met initiated at a dose of 50/500 mg twice a day (b.i.d.) The dose was to have been up-titrated over 4 weeks to 50/1000 mg b.i.d.; however, patients could stay in the study on a minimum dose of Sita/Met 50/500 mg b.i.d. if a higher dose was not tolerated. |
| FG001 | Metformin | The Metformin group includes data from patients randomized to receive treatment with oral tablets of metformin initiated at a dose of 500 mg twice a day (b.i.d.) The dose was to have been up-titrated over 4 weeks to 1000 mg b.i.d. ; however, patients could stay in the study on a minimum dose of Sita/Met 50/500 mg b.i.d. if a higher dose was not tolerated. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | Sita/Met FDC | The Sitagliptin/Metformin Fixed Dose Combination (Sita/Met FDC) group includes data from patients randomized to receive treatment with oral tablets of Sita/Met initiated at a dose of 50/500 mg twice a day (b.i.d.) The dose was to have been up-titrated over 4 weeks to 50/1000 mg b.i.d.; however, patients could stay in the study on a minimum dose of Sita/Met 50/500 mg b.i.d. if a higher dose was not tolerated. |
| 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 (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 Full Analysis Set (FAS) included all patients who received at least 1 dose of double-blind study therapy, had a baseline value and ≥ 1 post-baseline value for this outcome. Data after initiation of additional AHA were treated as missing. For FAS with no data at Week 18, the last post-baseline observed measurement was carried forward to Week 18. | Posted | Least Squares Mean | 95% Confidence Interval | Percent | Baseline and Week 18 |
|
Week 0 through Week 44
1 patient in the Sita/Met FDC group and 3 patients in the Metformin group from Site 079011301, which was identified as non-compliant with some of the requirements of Good Clinical Practice. For this reason, data from all four randomized patients at this site were deemed unreliable and were excluded from the primary efficacy and safety analysis.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sita/Met FDC | The Sitagliptin/Metformin Fixed Dose Combination (Sita/Met FDC) group includes data from patients randomized to receive treatment with oral tablets of Sita/Met initiated at a dose of 50/500 mg twice a day (b.i.d.) The dose was to have been up-titrated over 4 weeks to 50/1000 mg b.i.d.; however, patients could stay in the study on a minimum dose of Sita/Met 50/500 mg b.i.d. if a higher dose was not tolerated. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Any Cardiac Disorders | Cardiac disorders | MedDRA 11.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Any Gastrointestinal Disorders | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
Site 079011301 was non-compliant with Good Clinical Practice (GCP). Data from the 4 patients at this site are included in the Participant Flow summary, but are excluded from all other summaries and 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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Not provided
| ID | Term |
|---|---|
| D000068900 | Sitagliptin Phosphate |
| D008687 | Metformin |
| D000068899 | Sitagliptin Phosphate, Metformin Hydrochloride Drug Combination |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
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Not provided
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|
| metformin | Drug | metformin 500 mg tablet bid, titrating up to 1000 mg tablets bid for a 44-wk treatment period |
|
| Baseline and Week 18 |
| Week 44 |
| Olansky L, Reasner C, Seck TL, Williams-Herman DE, Chen M, Terranella L, Mehta A, Kaufman KD, Goldstein BJ. A treatment strategy implementing combination therapy with sitagliptin and metformin results in superior glycaemic control versus metformin monotherapy due to a low rate of addition of antihyperglycaemic agents. Diabetes Obes Metab. 2011 Sep;13(9):841-9. doi: 10.1111/j.1463-1326.2011.01416.x. |
| Hyperglycemia Criteria |
|
| Lack of Efficacy |
|
| Lost to Follow-up |
|
| Physician Decision |
|
| Pregnancy |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| BG001 | Metformin | The Metformin group includes data from patients randomized to receive treatment with oral tablets of metformin initiated at a dose of 500 mg twice a day (b.i.d.) The dose was to have been up-titrated over 4 weeks to 1000 mg b.i.d. ; however, patients could stay in the study on a minimum dose of Sita/Met 50/500 mg b.i.d. if a higher dose was not tolerated. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | Participants |
|
| Hemoglobin A1c (A1C) | Mean | Standard Deviation | Percent |
|
| OG001 | Metformin | The Metformin group includes data from patients randomized to receive treatment with oral tablets of metformin initiated at a dose of 500 mg twice a day (b.i.d.) The dose was to have been up-titrated over 4 weeks to 1000 mg b.i.d. ; however, patients could stay in the study on a minimum dose of Sita/Met 50/500 mg b.i.d. if a higher dose was not tolerated. |
|
|
|
| Secondary | Number of Patients With A1C < 7.0% at Week 18 | The Full Analysis Set (FAS) included all patients who received at least 1 dose of double-blind study therapy, had a baseline value and ≥1 post-baseline value for this outcome. Data after initiation of additional AHA were treated as missing. For FAS with no data at Week 18, the last post-baseline observed measurement was carried forward to Week 18. | Posted | Number | Participants | Week 18 |
|
|
|
|
| Secondary | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 18 | FPG is measured as mg/dL. Thus, this change from baseline reflects the Week 18 FPG mg/dL minus the Week 0 FPG mg/dL. | The Full Analysis Set (FAS) included all patients who received at least 1dose of double-blind study therapy, had a baseline value and ≥1 post-baseline value for this outcome. Data after initiation of additional AHA were treated as missing. For FAS with no data at Week 18, the last post-baseline observed measurement was carried forward to Week 18. | Posted | Least Squares Mean | 95% Confidence Interval | mg/dL | Baseline and Week 18 |
|
|
|
|
| Other Pre-specified | Change From Baseline in A1C at Week 44 | A1C is measured as percent. Thus, this change from baseline reflects the Week 44 A1C percent minus the Week 0 A1C percent. | The Full Analysis Set (FAS) included all patients who received at least 1 dose of double-blind study therapy, had a baseline value and ≥1 post-baseline value for this outcome. Data after initiation of additional AHA were included. For FAS with no data at Week 44, the last post-baseline observed measurement was carried forward to Week 44. | Posted | Least Squares Mean | 95% Confidence Interval | Percent | Baseline and Week 44 |
|
|
|
|
| Other Pre-specified | Number of Patients With A1C < 7.0% at Week 44 | The Full Analysis Set (FAS) included all patients who received at least 1dose of double-blind study therapy, had a baseline value and ≥1 post-baseline value for this outcome. Data after initiation of additional AHA were included. For FAS with no data at Week 44, the last post-baseline observed measurement was carried forward to Week 44. | Posted | Number | Participants | Week 44 |
|
|
|
|
| 28 |
| 625 |
| 173 |
| 625 |
| EG001 | Metformin | The Metformin group includes data from patients randomized to receive treatment with oral tablets of metformin initiated at a dose of 500 mg twice a day (b.i.d.) The dose was to have been up-titrated over 4 weeks to 1000 mg b.i.d. ; however, patients could stay in the study on a minimum dose of Sita/Met 50/500 mg b.i.d. if a higher dose was not tolerated. | 38 | 621 | 185 | 621 |
| Acute coronary syndrome | Cardiac disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Acute myocardial infarction | Cardiac disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Atrial flutter | Cardiac disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Coronary artery disease | Cardiac disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Myocardial ischaemia | Cardiac disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Any Gastrointestinal Disorders | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Food poisoning | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Pancreatitis chronic | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Any General Disorders and Administration site Conditions | General disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Adverse drug reaction | General disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Electrocution | General disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Any Hepatobiliary disorders | Hepatobiliary disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Any Infections and Infestations | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
|
| Appendicitis | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
|
| Enterocolitis infectious | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
|
| Hepatitis C | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
|
| Pneumonia streptococcal | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
|
| Pyelonephritis acute | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
|
| Any Injury, Poisoning and Procedural Complications | Injury, poisoning and procedural complications | MedDRA 11.1 | Non-systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 11.1 | Non-systematic Assessment |
|
| Pneumothorax traumatic | Injury, poisoning and procedural complications | MedDRA 11.1 | Non-systematic Assessment |
|
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 11.1 | Non-systematic Assessment |
|
| Skull fractured base | Injury, poisoning and procedural complications | MedDRA 11.1 | Non-systematic Assessment |
|
| Any Metabolism and Nutrition Disorders | Metabolism and nutrition disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Diabetic foot | Metabolism and nutrition disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Any Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Non-systematic Assessment |
|
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Non-systematic Assessment |
|
| Endometrial cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Non-systematic Assessment |
|
| Laryngeal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Non-systematic Assessment |
|
| Lung adenocarcinoma metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Non-systematic Assessment |
|
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Non-systematic Assessment |
|
| Metastatic renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Non-systematic Assessment |
|
| Ovarian adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Non-systematic Assessment |
|
| Prostate cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Non-systematic Assessment |
|
| Any Nervous System Disorders | Nervous system disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Carotid artery disease | Nervous system disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Any Pregnancy, puerperium and perinatal conditions | Pregnancy, puerperium and perinatal conditions | MedDRA 11.1 | Non-systematic Assessment |
|
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 11.1 | Non-systematic Assessment |
|
| Any Psychiatric Disorders | Psychiatric disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Panic attack | Psychiatric disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Schizophrenia | Psychiatric disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Suicidal ideation | Psychiatric disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Any Renal and Urinary Disorders | Renal and urinary disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Neurogenic bladder | Renal and urinary disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Postrenal failure | Renal and urinary disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Renal colic | Renal and urinary disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Any Respiratory, Thoracic and Mediastinal Disorders | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Any Vascular Disorders | Vascular disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Aneurysm | Vascular disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Aortic aneurysm | Vascular disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Aortic stenosis | Vascular disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Thrombophlebitis | Vascular disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Any Infections and infestations | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
|
| Any Nervous system disorders | Nervous system disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Headache | Nervous system 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 |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |