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| ID | Type | Description | Link |
|---|---|---|---|
| Formally-A0604T2DPT | |||
| 2006_410 |
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The purpose of this study is to determine the safety and efficacy of an investigational drug in patients with type 2 diabetes mellitus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sitagliptin 100 mg | Active Comparator | Sitagliptin 100 mg |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comparator: Sitagliptin | Drug | Sitagliptin 100 mg once daily, from Visit 4 through Visit 8. Day 1 through week 24 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in HbA1c (Hemoglobin A1C) at Week 24 | HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the Week 0 HbA1c percent. | Baseline and week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in FPG (Fasting Plasma Glucose) at Week 24 | Change from baseline at Week 24 is defined as Week 24 minus Week 0. | Baseline and week 24 |
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Inclusion Criteria:
Exclusion Criteria:
Acute coronary syndrome (e.g., MI or unstable angina), Coronary artery intervention, Stroke or transient ischemic neurological disorder.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17157112 | Background | Rosenstock J, Brazg R, Andryuk PJ, Lu K, Stein P; Sitagliptin Study 019 Group. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor sitagliptin added to ongoing pioglitazone therapy in patients with type 2 diabetes: a 24-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group study. Clin Ther. 2006 Oct;28(10):1556-68. doi: 10.1016/j.clinthera.2006.10.007. |
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Patients ≥18 years of age with type 2 diabetes mellitus and inadequate glycemic control [hemoglobin A1C
(HbA1c) ≥7.0 and ≤10.0%] who were on a stable dose of pioglitazone (≥30 mg/day) after a variable
screening period were eligible to enter the 24-week study.
First Patient In: 15-Jul-2004.
Last Patient Last Visit: 28-Sep-2005
71 study centers worldwide
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| ID | Title | Description |
|---|---|---|
| FG000 | Sitagliptin 100 mg | The Sitagliptin 100 mg 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 pioglitazone 15 mg oral tablets (total daily dose 30 to 45 mg/day). |
| FG001 | Placebo | The Placebo group includes data from patients randomized to receive treatment with placebo matching sitagliptin 100 mg tablet once daily (blinded) in addition to ongoing treatment with open-label pioglitazone 15 mg oral tablets (total daily dose 30 to 45 mg/day). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sitagliptin 100 mg | The Sitagliptin 100 mg 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 pioglitazone 15 mg oral tablets (total daily dose 30 to 45 mg/day). |
| BG001 |
| 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 HbA1c (Hemoglobin A1C) at Week 24 | HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the Week 0 HbA1c percent. | The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. For FAS patients with no data at Week 24, the last non-baseline observed measurement was carried forward to Week 24. | Posted | Least Squares Mean | 95% Confidence Interval | Percent | Baseline and week 24 |
|
Week 0 through Week 24.
Other (not including serious) adverse experience results represent those events included in the primary
safety analysis for this study (i.e., events that occurred prior to the initiation of glycemic rescue therapy).
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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 | The Sitagliptin 100 mg 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 pioglitazone 15 mg oral tablets (total daily dose 30 to 45 mg/day). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Any Gastrointestinal Disorders | Gastrointestinal disorders | MedDRA (8.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Any Infections And Infestations | Infections and infestations | MedDRA (8.0) | Non-systematic Assessment |
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| 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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| ID | Term |
|---|---|
| D000068900 | Sitagliptin Phosphate |
| D000077205 | Pioglitazone |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Comparator: Placebo | Drug | Placebo (to match Sitagliptin 100 mg) once daily, from Visit 4 through Visit 8. Day 1 through Week 24 |
|
| Comparator: Pioglitazone | Drug | Pioglitazone 30 mg or 45 mg once daily, Visit 2 through Visit 8 |
|
|
| Metformin | Drug | Metformin rescue for patients meeting pre-specified glycemic criteria. Metformin 500 mg,once daily, Visit 4 through Visit 8 |
|
| Lost to Follow-up |
|
| Physician Decision |
|
| Pregnancy |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Patient Moved |
|
| Protocol Discontinuation Criteria |
|
| Patient Accidentally Unblinded |
|
| Placebo |
The Placebo group includes data from patients randomized to receive treatment with placebo matching sitagliptin 100 mg tablet once daily (blinded) in addition to ongoing treatment with open-label pioglitazone 15 mg oral tablets (total daily dose 30 to 45 mg/day). |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| HbA1c (Hemoglobin A1c) | Mean | Standard Deviation | Percent |
|
| OG001 | Placebo | The Placebo group includes data from patients randomized to receive treatment with placebo matching sitagliptin 100 mg tablet once daily (blinded) in addition to ongoing treatment with open-label pioglitazone 15 mg oral tablets (total daily dose 30 to 45 mg/day). |
|
|
|
| Secondary | Change From Baseline in FPG (Fasting Plasma Glucose) at Week 24 | Change from baseline at Week 24 is defined as Week 24 minus Week 0. | The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. For FAS patients with no data at Week 24, the last non-baseline observed measurement was carried forward to Week 24. | Posted | Least Squares Mean | 95% Confidence Interval | mg/dL | Baseline and week 24 |
|
|
|
|
| 5 |
| 175 |
| 20 |
| 175 |
| EG001 | Placebo | The Placebo group includes data from patients randomized to receive treatment with placebo matching sitagliptin 100 mg tablet once daily (blinded) in addition to ongoing treatment with open-label pioglitazone 15 mg oral tablets (total daily dose 30 to 45 mg/day). | 8 | 178 | 13 | 178 |
| Ileitis | Gastrointestinal disorders | MedDRA (8.0) | Non-systematic Assessment |
|
| Intestinal Obstruction | Gastrointestinal disorders | MedDRA (8.0) | Non-systematic Assessment |
|
| Periodontitis | Gastrointestinal disorders | MedDRA (8.0) | Non-systematic Assessment |
|
| Any General Disorders And Administration Site Conditions | General disorders | MedDRA (8.0) | Non-systematic Assessment |
|
| Oedema Peripheral | General disorders | MedDRA (8.0) | Non-systematic Assessment |
|
| Any Hepatobiliary Disorders | Hepatobiliary disorders | MedDRA (8.0) | Non-systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA (8.0) | Non-systematic Assessment |
|
| Any Immune System Disorders | Immune system disorders | MedDRA (8.0) | Non-systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA (8.0) | Non-systematic Assessment |
|
| Any Injury, Poisoning And Procedural Complications | Injury, poisoning and procedural complications | MedDRA (8.0) | Non-systematic Assessment |
|
| Lower Limb Fracture | Injury, poisoning and procedural complications | MedDRA (8.0) | Non-systematic Assessment |
|
| Any Musculoskeletal And Connective Tissue Disorders | Musculoskeletal and connective tissue disorders | MedDRA (8.0) | Non-systematic Assessment |
|
| Intervertebral Disc Protrusion | Musculoskeletal and connective tissue disorders | MedDRA (8.0) | Non-systematic Assessment |
|
| Any Neoplasms Benign, Malignant And Unspecified (Incl Cysts And Polyps) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (8.0) | Non-systematic Assessment |
|
| Non-Small Cell Lung Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (8.0) | Non-systematic Assessment |
|
| Any Nervous System Disorders | Nervous system disorders | MedDRA (8.0) | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (8.0) | Non-systematic Assessment |
|
| Any Pregnancy, Puerperium And Perinatal Conditions | Pregnancy, puerperium and perinatal conditions | MedDRA (8.0) | Non-systematic Assessment |
|
| Abortion Spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA (8.0) | Non-systematic Assessment |
|
| Any Psychiatric Disorders | Psychiatric disorders | MedDRA (8.0) | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA (8.0) | Non-systematic Assessment |
|
| Suicide Attempt | Psychiatric disorders | MedDRA (8.0) | Non-systematic Assessment |
|
| Any Skin And Subcutaneous Tissue Disorders | Skin and subcutaneous tissue disorders | MedDRA (8.0) | Non-systematic Assessment |
|
| Angioneurotic Oedema | Skin and subcutaneous tissue disorders | MedDRA (8.0) | Non-systematic Assessment |
|
| Any Vascular Disorders | Vascular disorders | MedDRA (8.0) | Non-systematic Assessment |
|
| Atherosclerosis Obliterans | Vascular disorders | MedDRA (8.0) | Non-systematic Assessment |
|
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA (8.0) | Non-systematic Assessment |
|
| Any Nervous System Disorders | Nervous system disorders | MedDRA (8.0) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (8.0) | 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 |
| D045162 | Thiazolidinediones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |