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| ID | Type | Description | Link |
|---|---|---|---|
| 2007_510 |
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A study to evaluate the efficacy and safety of MK0431A in comparison to a commonly used medication in patients with type 2 diabetes
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Sitagliptin phosphate (+) metformin hydrochloride |
|
| 2 | Active Comparator | pioglitazone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sitagliptin phosphate (+) metformin hydrochloride | Drug | sitagliptin phosphate (+) metformin hydrochloride 50/500 mg tablet bid, titrating up to sitagliptin phosphate (+) metformin hydrochloride 50/1000 mg tablet for an ~32 wk treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in A1C at Week 32 | A1C is measured as a percent. Thus this change from baseline reflects the Week 32 A1C percent minus the baseline A1C percent | Baseline and Week 32 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Fasting Plasma Glucose (FPG) at Week 1 | Change from baseline reflects the Week 1 FPG minus the baseline FPG. At Week 1, the dose was 50/500 mg b.i.d. for Sita/Met FDC and 30 mg q.d. for pioglitazone | Baseline and Week 1 |
| Change From Baseline in 2-hour Post-Meal Glucose (PMG) at Week 32 |
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General Inclusion Criteria:
General 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 |
|---|---|---|---|
| 22059736 | Result | Wainstein J, Katz L, Engel SS, Xu L, Golm GT, Hussain S, O'Neill EA, Kaufman KD, Goldstein BJ. Initial therapy with the fixed-dose combination of sitagliptin and metformin results in greater improvement in glycaemic control compared with pioglitazone monotherapy in patients with type 2 diabetes. Diabetes Obes Metab. 2012 May;14(5):409-18. doi: 10.1111/j.1463-1326.2011.01530.x. Epub 2011 Dec 22. |
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Patients 18-78 years old with Type 2 Diabetes Mellitus (T2DM), drug-naïve (off antihyperglycemic agent
[AHA] for at least 3 months prior to screening, and a maximum 4 weeks cumulative AHA therapy over the
previous 3 years), hemoglobin A1C 7.5 to 12% were eligible. Eligible patients underwent a 2-week placebo
run-in period prior to randomization.
First Patient In: 19-Mar-2008
Last Patient Last Visit: 23-Oct-2009
Seventy-four medical clinics worldwide (19 sites in the United States, 31 in Eastern Europe, and 24 in the rest of the world).
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| ID | Title | Description |
|---|---|---|
| FG000 | Sitagliptin/Metformin Fixed-Dose Combination | The Sitagliptin/Metformin Fixed-Dose Combination (Sita/Met FDC) group includes data from patients randomized to receive treatment with oral tablets of Sita/Met FDC 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. Patients were discontinued if they were considered clinically inappropriate for up-titration or could not be up-titrated or maintained on the up-titrated dose. |
| FG001 | Pioglitazone | The Pioglitazone group includes data from patients randomized to receive treatment with oral tablets of pioglitazone initiated at a dose of 30 mg once daily (q.d.). The dose was to have been up-titrated over 4 weeks to 45 mg q.d. Patients were discontinued if they were considered clinically inappropriate for up-titration or could not be up-titrated or maintained on the up-titrated dose. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sitagliptin/Metformin Fixed-Dose Combination | The Sitagliptin/Metformin Fixed-Dose Combination (Sita/Met FDC) group includes data from patients randomized to receive treatment with oral tablets of Sita/Met FDC 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. Patients were discontinued if they were considered clinically inappropriate for up-titration or could not be up-titrated or maintained on the up-titrated dose. |
| 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 32 | A1C is measured as a percent. Thus this change from baseline reflects the Week 32 A1C percent minus the baseline A1C percent | The Full Analysis Set (FAS) included all patients who received at least one dose of double-blind study drug and had both a baseline value and ≥ 1 post-baseline value for this outcome. For FAS patients with no data at Week 32, the last non-baseline observed measurement was carried forward to Week 32. | Posted | Least Squares Mean | 95% Confidence Interval | Percent of glycosylated hemoglobin (A1C) | Baseline and Week 32 |
|
Week 0 through Week 32
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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/Metformin Fixed-Dose Combination | The Sitagliptin/Metformin Fixed-Dose Combination (Sita/Met FDC) group includes data from patients randomized to receive treatment with oral tablets of Sita/Met FDC 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. Patients were discontinued if they were considered clinically inappropriate for up-titration or could not be up-titrated or maintained on the up-titrated dose. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctivitis allergic | Eye disorders | MedDRA (12.1) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA (12.1) | Non-systematic Assessment |
Unknown to the Sponsor and the investigators, two patients in the study were randomized twice (each at two different sites). Data for these patients were deemed unreliable and excluded from all analyses (efficacy and safety).
| 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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| ID | Term |
|---|---|
| D000068900 | Sitagliptin Phosphate |
| D008687 | Metformin |
| D000068899 | Sitagliptin Phosphate, Metformin Hydrochloride Drug Combination |
| D000077205 | Pioglitazone |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
| Comparator: pioglitazone | Drug | pioglitazone 30 mg tablet qd, titrating up to 45 mg qd for an ~32-wk treatment period. |
|
|
Change from baseline reflects the Week 32 2-hour PMG minus the baseline 2-hour PMG |
| Baseline and Week 32 |
| Change From Baseline in FPG at Week 32 | Change from baseline reflects the Week 32 FPG minus the baseline FPG | Baseline and Week 32 |
| Percent of Participants With A1C <7.0% at Week 32 | Week 32 |
| Lost to Follow-up |
|
| Physician Decision |
|
| Pregnancy |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Protocol Specific Criteria |
|
| BG001 | Pioglitazone | The Pioglitazone group includes data from patients randomized to receive treatment with oral tablets of pioglitazone initiated at a dose of 30 mg once daily (q.d.). The dose was to have been up-titrated over 4 weeks to 45 mg q.d. Patients were discontinued if they were considered clinically inappropriate for up-titration or could not be up-titrated or maintained on the up-titrated dose. |
| 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 of glycosylated hemoglobin (A1C) |
|
| Fasting Plasma Glucose (FPG) | Mean | Standard Deviation | mg/dL |
|
| 2-Hour Post-Meal Glucose (2-HR PMG) | Mean | Standard Deviation | mg/dL |
|
| OG001 | Pioglitazone | The Pioglitazone group includes data from patients randomized to receive treatment with oral tablets of pioglitazone initiated at a dose of 30 mg once daily (q.d.). The dose was to have been up-titrated over 4 weeks to 45 mg q.d. Patients were discontinued if they were considered clinically inappropriate for up-titration or could not be up-titrated or maintained on the up-titrated dose. |
|
|
|
| Secondary | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 1 | Change from baseline reflects the Week 1 FPG minus the baseline FPG. At Week 1, the dose was 50/500 mg b.i.d. for Sita/Met FDC and 30 mg q.d. for pioglitazone | The Full Analysis Set (FAS) included all patients who received at least one dose of double-blind study drug and had both a baseline value and ≥ 1 post-baseline value for this outcome. | Posted | Least Squares Mean | 95% Confidence Interval | mg/dL | Baseline and Week 1 |
|
|
|
|
| Secondary | Change From Baseline in 2-hour Post-Meal Glucose (PMG) at Week 32 | Change from baseline reflects the Week 32 2-hour PMG minus the baseline 2-hour PMG | The Full Analysis Set (FAS) included all patients who received at least one dose of double-blind study drug and had both a baseline value and ≥ 1 post-baseline value for this outcome. For FAS patients with no data at Week 32, the last non-baseline observed measurement was carried forward to Week 32. | Posted | Least Squares Mean | 95% Confidence Interval | mg/dL | Baseline and Week 32 |
|
|
|
|
| Secondary | Change From Baseline in FPG at Week 32 | Change from baseline reflects the Week 32 FPG minus the baseline FPG | Full Analysis Set (FAS) included all patients who received at least one dose of double-blind study drug and had both a baseline value and ≥ 1 post-baseline value for this outcome. For FAS patients with no data at Week 32, the last non-baseline observed measurement was carried forward to Week 32. | Posted | Least Squares Mean | 95% Confidence Interval | mg/dL | Baseline and Week 32 |
|
|
|
|
| Secondary | Percent of Participants With A1C <7.0% at Week 32 | The Full Analysis Set (FAS) included all patients who received at least one dose of double-blind study drug and had both a baseline value and ≥ 1 post-baseline value for this outcome. For FAS patients with no data at Week 32, the last non-baseline observed measurement was carried forward to Week 32. | Posted | Number | Percent Participants | Week 32 |
|
|
|
|
| 11 |
| 261 |
| 94 |
| 261 |
| EG001 | Pioglitazone | The Pioglitazone group includes data from patients randomized to receive treatment with oral tablets of pioglitazone initiated at a dose of 30 mg once daily (q.d.). The dose was to have been up-titrated over 4 weeks to 45 mg q.d. Patients were discontinued if they were considered clinically inappropriate for up-titration or could not be up-titrated or maintained on the up-titrated dose. | 8 | 256 | 68 | 256 |
| Ulcerative keratitis | Eye disorders | MedDRA (12.1) | Non-systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | MedDRA (12.1) | Non-systematic Assessment |
|
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (12.1) | Non-systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA (12.1) | Non-systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA (12.1) | Non-systematic Assessment |
|
| Hepatitis | Hepatobiliary disorders | MedDRA (12.1) | Non-systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA (12.1) | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (12.1) | Non-systematic Assessment |
|
| Femur fracture | Injury, poisoning and procedural complications | MedDRA (12.1) | Non-systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Non-systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Non-systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Non-systematic Assessment |
|
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.1) | Non-systematic Assessment |
|
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.1) | Non-systematic Assessment |
|
| Renal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.1) | Non-systematic Assessment |
|
| Brain stem infarction | Nervous system disorders | MedDRA (12.1) | Non-systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA (12.1) | Non-systematic Assessment |
|
| Abortion spontaneous complete | Pregnancy, puerperium and perinatal conditions | MedDRA (12.1) | Non-systematic Assessment |
|
| Urine flow decreased | Renal and urinary disorders | MedDRA (12.1) | Non-systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (12.1) | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA (12.1) | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (12.1) | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (12.1) | Non-systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (12.1) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (12.1) | 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 |
| D045162 | Thiazolidinediones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |