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| ID | Type | Description | Link |
|---|---|---|---|
| 2006_029 |
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The clinical study determines the safety and efficacy of MK0431 in patients with type 2 diabetes mellitus who have inadequate glycemic control on pioglitazone as monotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | MK0431 + pioglitazone |
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| 2 | Placebo Comparator | Placebo/MK0431 + pioglitazone |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sitagliptin phosphate | Drug | Sitagliptin (MK0431) 50 or 100 mg once daily for 52 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Hemoglobin A1c (HbA1c ) at Week 12 | Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication. | 12 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Fasting Plasma Glucose at Week 12 | Change from baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication. | 12 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in 2 Hour Postprandial Glucose at Week 12 | Change from baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication. | 12 weeks |
| Change From Baseline in Hemoglobin A1c (HbA1c ) at Week 52 |
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 |
|---|---|---|---|
| 24843518 | Background | Kashiwagi A, Kadowaki T, Tajima N, Nonaka K, Taniguchi T, Nishii M, Ferreira JC, Amatruda JM. Sitagliptin added to treatment with ongoing pioglitazone for up to 52 weeks improves glycemic control in Japanese patients with type 2 diabetes. J Diabetes Investig. 2011 Oct 7;2(5):381-90. doi: 10.1111/j.2040-1124.2011.00120.x. |
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Following a screening period of at least 4 weeks and a 2 or 8-week observation period, patients who were on pioglitazone monotherapy for at least 8 weeks and met all other entry criteria were randomized to receive: sitagliptin/sitagliptin or placebo/sitagliptin.
The starting dose of sitagliptin was 50 mg for all patients.
Phase III.
Date of first patient in: 22 August 2006. Date of last patient's last visit for Period I: 1 May 2007.
Date of last patient's last visit for Period II: 5 February 2008. Number of randomized patients: 134.
The study was conducted at 32 centers in Japan.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sitagliptin / Sitagliptin | The Sitagliptin/Sitagliptin group includes data from all patients randomized to receive treatment with sitagliptin (Weeks 0-52) and pioglitazone (Weeks 0-52) orally once daily. Includes patients who received only sitagliptin 50 mg and those who started on sitagliptin 50 mg and whose dose was subsequently up-titrated to sitagliptin 100 mg orally once daily. Uptitration of sitagliptin dose was to occur for patients with FPG >140 mg/dL at any time from Week 16 to Week 40 or HbA1c values >7.0% at any time from Week 24 to Week 40. The sitagliptin dose was to have remained stable after Week 40. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period I - Double-blind (Weeks 0-12) |
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| Comparator: sitagliptin phosphate (MK0431) | Drug | Sitagliptin (MK0431) 50 or 100 mg once daily for 40 weeks |
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| Comparator: pioglitazone | Drug | pioglitazone once daily for 52 weeks |
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| Comparator: placebo (unspecified) | Drug | Placebo once daily for 12 weeks |
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Change from the last value before receiving sitagliptin therapy: Week 0 for Sitagliptin/Sitagliptin group and Week 12 for the Placebo/Sitagliptin group. |
| Week 52 (reflecting change from Week 0) for Sitagliptin/Sitagliptin group; Weeks 52 (reflecting change from Week 12) for Placebo/Sitagliptin group. |
| FG001 | Placebo / Sitagliptin | The Placebo/Sitagliptin group includes data from all patients randomized to receive the sequence of placebo (Weeks 0-12) / sitagliptin (Weeks 12-52) and pioglitazone (Weeks 0-52) orally once daily. Includes patients who received only sitagliptin 50 mg and those who started on sitagliptin 50 mg and whose dose was subsequently up-titrated to sitagliptin 100 mg orally once daily. Uptitration of sitagliptin dose was to occur for patients with FPG >140 mg/dL at any time from Week 16 to Week 40 or HbA1c values >7.0% at any time from Week 24 to Week 40. The sitagliptin dose was to have remained stable after Week 40. |
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| NOT COMPLETED |
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| Period II - Open-label (Weeks 12-52) |
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| ID | Title | Description |
|---|---|---|
| BG000 | Sitagliptin / Sitagliptin | The Sitagliptin/Sitagliptin group includes data from all patients randomized to receive treatment with sitagliptin (Weeks 0-52) and pioglitazone (Weeks 0-52) orally once daily. Includes patients who received only sitagliptin 50 mg and those who started on sitagliptin 50 mg and whose dose was subsequently up-titrated to sitagliptin 100 mg orally once daily. Uptitration of sitagliptin dose was to occur for patients with FPG >140 mg/dL at any time from Week 16 to Week 40 or HbA1c values >7.0% at any time from Week 24 to Week 40. The sitagliptin dose was to have remained stable after Week 40. |
| BG001 | Placebo / Sitagliptin | The Placebo/Sitagliptin group includes data from all patients randomized to receive the sequence of placebo (Weeks 0-12) / sitagliptin (Weeks 12-52) and pioglitazone (Weeks 0-52) orally once daily. Includes patients who received only sitagliptin 50 mg and those who started on sitagliptin 50 mg and whose dose was subsequently up-titrated to sitagliptin 100 mg orally once daily. Uptitration of sitagliptin dose was to occur for patients with FPG >140 mg/dL at any time from Week 16 to Week 40 or HbA1c values >7.0% at any time from Week 24 to Week 40. The sitagliptin dose was to have remained stable after Week 40. |
| 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 | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Fasting Plasma Glucose | Mean | Standard Deviation | mg/dL |
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| Hemoglobin A1c (HbA1c) | 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Hemoglobin A1c (HbA1c ) at Week 12 | Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication. | Analysis in the Full Analysis Set with Last Observation Carried Forward (The Full Analysis Set population includes all randomized patients who took at least 1 dose of study medication and had both a baseline and at least one post-baseline value.) | Posted | Least Squares Mean | 95% Confidence Interval | Percent | 12 Weeks |
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| Secondary | Change From Baseline in Fasting Plasma Glucose at Week 12 | Change from baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication. | Analysis in the Full Analysis Set with Last Observation Carried Forward (The Full Analysis Set population includes all randomized patients who took at least 1 dose of study medication and had both a baseline and at least one post-baseline value.) | Posted | Least Squares Mean | 95% Confidence Interval | mg/dL | 12 Weeks |
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| Other Pre-specified | Change From Baseline in 2 Hour Postprandial Glucose at Week 12 | Change from baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication. | Analysis in the Full Analysis Set without Last Observation Carried Forward (The Full Analysis Set population includes all randomized patients who took at least 1 dose of study medication and had both a baseline and at least one post-baseline values.). | Posted | Least Squares Mean | 95% Confidence Interval | mg/dL | 12 weeks |
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| Other Pre-specified | Change From Baseline in Hemoglobin A1c (HbA1c ) at Week 52 | Change from the last value before receiving sitagliptin therapy: Week 0 for Sitagliptin/Sitagliptin group and Week 12 for the Placebo/Sitagliptin group. | The Completers Population (CP) includes all randomized patients who took at least 1 dose of sitagliptin and had [1] a baseline (Sitagliptin/Sitagliptin group) or Week 12 (Placebo/Sitagliptin group) value and [2] a value at Week 52. | Posted | Mean | 95% Confidence Interval | Percent | Week 52 (reflecting change from Week 0) for Sitagliptin/Sitagliptin group; Weeks 52 (reflecting change from Week 12) for Placebo/Sitagliptin group. |
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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/Sitagliptin (Data Through Week 12) | The Sitagliptin/Sitagliptin group includes data from all patients randomized to receive treatment with sitagliptin orally once daily (Weeks 0-52). This column of data includes only Weeks 0-12. | 3 | 21 | ||||
| EG001 | Placebo/Sitagliptin (Data Through Week 12) | The Placebo/Sitagliptin group includes data from all patients randomized to receive the sequence of placebo (Weeks 0-12) / sitagliptin (Weeks 12-52) orally once daily. This column of data includes only Weeks 0-12. | 1 | 23 | ||||
| EG002 | Pooled Sitagliptin (Data Through Week 52) | The Pooled Sitagliptin group includes data from all patients who took sitagliptin in either treatment group. Includes data from Week 0 to Week 52 for patients in the Sitagliptin/Sitagliptin group and data from Week 12 to Week 52 for patients in the Placebo/Sitagliptin group. Includes patients (from either group) who received only sitagliptin 50 mg and those who started on sitagliptin 50 mg and whose dose was subsequently up-titrated to sitagliptin 100 mg orally once daily. | 7 | 80 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coronary artery stenosis | Cardiac disorders | MedDRA 9.0 | Non-systematic Assessment |
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| Enteritis infectious | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
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| Patella fracture | Injury, poisoning and procedural complications | MedDRA 9.0 | Non-systematic Assessment |
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| Pneumothorax traumatic | Injury, poisoning and procedural complications | MedDRA 9.0 | Non-systematic Assessment |
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| Rib fracture | Injury, poisoning and procedural complications | MedDRA 9.0 | Non-systematic Assessment |
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| Ligament injury | Injury, poisoning and procedural complications | MedDRA 9.0 | Non-systematic Assessment |
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| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA 9.0 | Non-systematic Assessment |
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| Hepatic neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.0 | Non-systematic Assessment |
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| Cerebral infarction | Nervous system disorders | MedDRA 9.0 | Non-systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 9.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Periodontitis | Gastrointestinal disorders | MedDRA 9.0 | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
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| Weight increased | Investigations | MedDRA 9.0 | Non-systematic Assessment |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | Non-systematic Assessment |
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| Hypoaesthesia | Nervous system disorders | MedDRA 9.0 | Non-systematic Assessment |
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| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Non-systematic Assessment |
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| Blood creatine phosphokinase increased | Investigations | MedDRA 9.0 | Non-systematic Assessment |
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Period II (Weeks 12-52) was open-label and uncontrolled, with all patients receiving sitagliptin. Results are pooled data from both treatment groups and should be considered in the context of the Type 2 Diabetes Mellitus (T2DM) population studied.
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 |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011719 | Pyrazines |
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| Withdrawal by Subject |
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