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| ID | Type | Description | Link |
|---|---|---|---|
| MK0431-064-10 | |||
| 2009_003 |
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A 30-week extension to a 24-week study assessing the hemoglobin A1c (HbA1c)- and fasting plasma glucose (FPG)-lowering efficacy of the combination of sitagliptin and pioglitazone in patients with type 2 diabetes mellitus (T2DM) with inadequate glycemic control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sitagliptin + Pioglitazone | Experimental |
| |
| Pioglitazone + Placebo | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sitagliptin 100 mg q.d.+ Pioglitazone 45 mg q.d. | Drug | Patients will receive combination therapy with blinded sitagliptin 100 mg q.d. (q.d. = once daily) and open-label pioglitazone 45 mg q.d. during the up to 30 week extension study. Sitagliptin 100 mg q.d. and pioglitazone 45 mg q.d. will be administered as oral tablets. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline (i.e., Week 0 of the 24-week Base Study) in Hemoglobin A1c (HbA1c) at Week 54 | HbA1c is measured as percent. Thus this change from baseline reflects the Week 54 HbA1c percent minus the Week 0 HbA1c percent. | Baseline and 54 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline (i.e., Week 0 of the 24-week Base Study) in Fasting Plasma Glucose (FPG) at Week 54 | Change from baseline at Week 54 is defined as Week 54 minus Week 0. | Baseline and Week 54 |
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Inclusion 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 |
|---|---|---|---|
| 21235696 | Result | Yoon KH, Shockey GR, Teng R, Golm GT, Thakkar PR, Meehan AG, Williams-Herman DE, Kaufman KD, Amatruda JM, Steinberg H. Effect of initial combination therapy with sitagliptin, a dipeptidyl peptidase-4 inhibitor, and pioglitazone on glycemic control and measures of beta-cell function in patients with type 2 diabetes. Int J Clin Pract. 2011 Feb;65(2):154-64. doi: 10.1111/j.1742-1241.2010.02589.x. | |
| 22405352 |
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Patients ≥18 years with type 2 diabetes mellitus (T2DM) and hemoglobin A1c (HbA1c) of 8-12% on diet/exercise meeting all other entry criteria were eligible for participation in the 24-week base study.
Patients who completed the base study with >75% study drug compliance were eligible to enter the 30-week extension study at participating sites.
First patient in the 30-week extension study: 21-Sep-2007.
Last patient last visit of the 30-week extension
study: 23-Jan-2009; 53 study centers worldwide.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sitagliptin 100 mg q.d. + Pioglitazone 45 mg q.d. | The Sitagliptin 100 mg q.d. + Pioglitazone 45 mg q.d. (q.d. = once daily) group includes extension study data from patients who received once-daily coadministered treatment with oral tablets of sitagliptin 100 mg and pioglitazone 45 mg. During the 24-week base study (prior to the entering the extension study), these patients received once-daily coadministered treatment with oral tablets of sitagliptin 100 mg and pioglitazone 30 mg. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Pioglitazone 45 mg q.d. + Sitagliptin 100 mg placebo q.d. | Drug | Patients will receive placebo to match sitagliptin 100 mg q.d. (blinded) and open-label pioglitazone 45 mg q.d. during the up to 30 week extension study. The placebo to match sitagliptin 100 mg q.d. (blinded) and open-label pioglitazone 45 mg q.d. will be administered as oral tablets. |
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| Metformin | Drug | Patients not meeting specific glycemic goals during the 30-week extension study will receive open-label metformin at a dose determined by the investigator. |
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| Derived |
| Yoon KH, Steinberg H, Teng R, Golm GT, Lee M, O'Neill EA, Kaufman KD, Goldstein BJ. Efficacy and safety of initial combination therapy with sitagliptin and pioglitazone in patients with type 2 diabetes: a 54-week study. Diabetes Obes Metab. 2012 Aug;14(8):745-52. doi: 10.1111/j.1463-1326.2012.01594.x. Epub 2012 Apr 17. |
| FG001 | Pioglitazone 45 mg q.d. | The Pioglitazone 45 mg q.d. (q.d. = once daily) group includes extension study data from patients who received once-daily coadministered treatment with oral tablets of placebo to sitagliptin 100 mg and pioglitazone 45 mg. During the 24-week base study (prior to entering the extension study), these patients received once-daily coadministered treatment with oral tablets of placebo to sitagliptin 100 mg and pioglitazone 30 mg. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Sitagliptin 100 mg q.d. + Pioglitazone 45 mg q.d. | The Sitagliptin 100 mg q.d. + Pioglitazone 45 mg q.d. (q.d. = once daily) group includes extension study data from patients who received once-daily coadministered treatment with oral tablets of sitagliptin 100 mg and pioglitazone 45 mg. During the 24-week base study (prior to the entering the extension study), these patients received once-daily coadministered treatment with oral tablets of sitagliptin 100 mg and pioglitazone 30 mg. |
| BG001 | Pioglitazone 45 mg q.d. | The Pioglitazone 45 mg q.d. (q.d. = once daily) group includes extension study data from patients who received once-daily coadministered treatment with oral tablets of placebo to sitagliptin 100 mg and pioglitazone 45 mg. During the 24-week base study (prior to entering the extension study), these patients received once-daily coadministered treatment with oral tablets of placebo to sitagliptin 100 mg and pioglitazone 30 mg. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| 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 | These data reflect the patients' ages at the beginning of the 24-week base study | 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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| Hemoglobin A1c (HbA1c) | These data reflect the baseline measurement at the beginning of the 24- week base study. The number of patients with data for HbA1c at this time point were N=163 (sitagliptin+pioglitazone), N=151 (pioglitazone), and N=314 (total). | 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 (i.e., Week 0 of the 24-week Base Study) in Hemoglobin A1c (HbA1c) at Week 54 | HbA1c is measured as 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 value for this outcome during the 30-week extension study. For FAS patients with no data at Week 54, the last observed measurement during the 30-week extension study was carried forward to Week 54. | Posted | Least Squares Mean | 95% Confidence Interval | Percent HbA1c | Baseline and 54 Weeks |
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| Secondary | Change From Baseline (i.e., Week 0 of the 24-week Base Study) in Fasting Plasma Glucose (FPG) 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 value for this outcome during the extension study. For FAS patients with no data at Week 54, the last observed measurement during extension study was carried forward to Week 54. | Posted | Least Squares Mean | 95% Confidence Interval | mg/dL | Baseline and Week 54 |
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Weeks 24 to 54 (i.e., the entire 30-week extension study)
Non-serious adverse experience results represent those events included in the prespecified primary analysis of safety (i.e., excluding events that occurred following the initiation of glycemic rescue therapy) for this study.
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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 q.d. + Pioglitazone 45 mg q.d. | The Sitagliptin 100 mg q.d. + Pioglitazone 45 mg q.d. (q.d. = once daily) group includes extension study data from patients who received once-daily coadministered treatment with oral tablets of sitagliptin 100 mg and pioglitazone 45 mg. During the 24-week base study (prior to the entering the extension study), these patients received once-daily coadministered treatment with oral tablets of sitagliptin 100 mg and pioglitazone 30 mg. | 5 | 164 | 8 | 164 | ||
| EG001 | Pioglitazone 45 mg q.d. | The Pioglitazone 45 mg q.d. (q.d. = once daily) group includes extension study data from patients who received once-daily coadministered treatment with oral tablets of placebo to sitagliptin 100 mg and pioglitazone 45 mg. During the 24-week base study (prior to entering the extension study), these patients received once-daily coadministered treatment with oral tablets of placebo to sitagliptin 100 mg and pioglitazone 30 mg. | 3 | 153 | 8 | 153 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| All Cardiac Disorders | Cardiac disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Coronary artery insufficiency | Cardiac disorders | MedDRA 12.0 | Non-systematic Assessment |
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| All Infections and Infestations | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
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| Appendicitis | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
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| Gastroenteritis viral | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
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| Lobar pneumonia | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
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| Pyelonephritis chronic | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
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| All Nervous System Disorders | Nervous system disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Cerebrovascular accident | Nervous system disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Presyncope | Nervous system disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| All Infections and Infestations | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 12.0 | 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 |
| 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 |
| D000077205 | Pioglitazone |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011719 | Pyrazines |
| D045162 | Thiazolidinediones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
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