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| ID | Type | Description | Link |
|---|---|---|---|
| MK0431-051 | |||
| 2006_532 |
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A clinical study to determine the safety and efficacy of sitagliptin in patients with Type 2 Diabetes Mellitus who have inadequate glycemic control on insulin or insulin/metformin combination therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | sitagliptin |
|
| 2 | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sitagliptin phosphate | Drug | sitagliptin 100 mg tablet qd for a 24-wk treatment period. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in A1C at Week 24 | A1C is measured as a percent. Thus, this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent. | Baseline and Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 | Change from baseline at Week 24 is defined as Week 24 minus Week 0. | Baseline and Week 24 |
| Change From Baseline in 2-hour Post-meal Glucose (PMG) at Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in A1C at Week 24 | A1C in subset of patients on long-acting or intermediate-acting insulin. A1C is measured as a percent. Thus, this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent. | Baseline and Week 24 |
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 |
|---|---|---|---|
| 20092585 | Result | Vilsboll T, Rosenstock J, Yki-Jarvinen H, Cefalu WT, Chen Y, Luo E, Musser B, Andryuk PJ, Ling Y, Kaufman KD, Amatruda JM, Engel SS, Katz L. Efficacy and safety of sitagliptin when added to insulin therapy in patients with type 2 diabetes. Diabetes Obes Metab. 2010 Feb;12(2):167-77. doi: 10.1111/j.1463-1326.2009.01173.x. |
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Patients at least 21 years of age with type 2 diabetes mellitus with inadequate glycemic control (A1C ≥7.5 and ≤11.0%) on stable-dose insulin (alone or in combination with stable-dose metformin) were eligible to enter the 24 week study. 1-week screening, followed by a 2-week single-blind placebo run-in.
Phase III
First Patient In: 29-Jan-2007 Last Patient Last Visit: 13-Oct-2008; 100 study centers worldwide
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| ID | Title | Description |
|---|---|---|
| FG000 | Sitagliptin 100 mg q.d. | The Sitagliptin 100 mg q.d. (q.d. = once daily) 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 insulin (pre-mixed, intermediate-acting, or long-acting) alone or in combination with open-label metformin 500 mg oral tablets (≥1500 mg/day). |
| FG001 | Placebo | The Placebo group includes data from patients randomized to receive treatment with a placebo of the sitagliptin 100 mg oral tablet once daily (blinded) in addition to ongoing treatment with insulin (pre-mixed, intermediate-acting, or long-acting) alone or in combination with open-label metformin 500 mg oral tablets (≥1500 mg/day). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sitagliptin 100 mg q.d. | The Sitagliptin 100 mg q.d. (q.d. = once daily) 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 insulin (pre-mixed, intermediate-acting, or long-acting) alone or in combination with open-label metformin 500 mg oral tablets (≥1500 mg/day). |
| 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 24 | A1C is measured as a percent. Thus, this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C 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 |
|
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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. | The Sitagliptin 100 mg q.d. (q.d. = once daily) 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 insulin (pre-mixed, intermediate-acting, or long-acting) alone or in combination with open-label metformin 500 mg oral tablets (≥1500 mg/day). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Any Cardiac disorders | Cardiac disorders | MedDRA 11.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Any Metabolism and nutrition disorders | Metabolism and nutrition disorders | MedDRA 11.0 | 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 | 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 |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Comparator : placebo (unspecified) | Drug | sitagliptin 100 mg Pbo tablet qd for a 24-wk treatment period. |
|
Change from baseline at Week 24 is defined as Week 24 minus Week 0.
| Baseline and Week 24 |
| Percent Change From Baseline in Index of Static Beta-Cell Sensitivity to Glucose at Week 24 | Static sensitivity is a measure of the effect of glucose on beta-cell secretion and is the ratio between the insulin secretion rate and glucose concentration above the threshold level at steady state. (See Breda and Cobelli, Annals of Biomedical Engineering 29, 692-700 (2001) for more details.) | Baseline and Week 24 |
| Percent of Patients With A1C < 7.0% at Week 24 | 24 Weeks |
| Percent of Patients With A1C < 6.5% at Week 24 | Week 24 |
| Lost to Follow-up |
|
| Physician Decision |
|
| Protocol Violation |
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| Withdrawal by Subject |
|
| Other |
|
| BG001 | Placebo | The Placebo group includes data from patients randomized to receive treatment with a placebo of the sitagliptin 100 mg oral tablet once daily (blinded) in addition to ongoing treatment with insulin (pre-mixed, intermediate-acting, or long-acting) alone or in combination with open-label metformin 500 mg oral tablets (≥1500 mg/day). |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| A1C (Hemoglobin A1c) | Mean | Standard Deviation | Percent |
|
| OG001 | Placebo | The Placebo group includes data from patients randomized to receive treatment with a placebo of the sitagliptin 100 mg oral tablet once daily (blinded) in addition to ongoing treatment with insulin (pre-mixed, intermediate-acting, or long-acting) alone or in combination with open-label metformin 500 mg oral tablets (≥1500 mg/day). |
|
|
|
| Secondary | Change From Baseline in Fasting Plasma Glucose (FPG) 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 |
|
|
|
|
| Secondary | Change From Baseline in 2-hour Post-meal Glucose (PMG) 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 |
|
|
|
|
| Secondary | Percent Change From Baseline in Index of Static Beta-Cell Sensitivity to Glucose at Week 24 | Static sensitivity is a measure of the effect of glucose on beta-cell secretion and is the ratio between the insulin secretion rate and glucose concentration above the threshold level at steady state. (See Breda and Cobelli, Annals of Biomedical Engineering 29, 692-700 (2001) for more details.) | The Full Analysis Set (FAS) included all patients who participated in the 10-point meal tolerance test and had 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 |
|
|
|
|
| Secondary | Percent of Patients With A1C < 7.0% at Week 24 | 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 | Number | Percent | 24 Weeks |
|
|
|
|
| Secondary | Percent of Patients With A1C < 6.5% at Week 24 | 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 | Number | Percent | Week 24 |
|
|
|
|
| Other Pre-specified | Change From Baseline in A1C at Week 24 | A1C in subset of patients on long-acting or intermediate-acting insulin. A1C is measured as a percent. Thus, this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent. | The Full Analysis Set (FAS) included the subset of patients on long-acting or intermediate-acting insulin 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 |
|
|
|
|
| 20 |
| 322 |
| 49 |
| 322 |
| EG001 | Placebo | The Placebo group includes data from patients randomized to receive treatment with a placebo of the sitagliptin 100 mg oral tablet once daily (blinded) in addition to ongoing treatment with insulin (pre-mixed, intermediate-acting, or long-acting) alone or in combination with open-label metformin 500 mg oral tablets (≥1500 mg/day). | 11 | 319 | 25 | 319 |
| Acute myocardial infarction | Cardiac disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Angina unstable | Cardiac disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Coronary artery disease | Cardiac disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Trifascicular block | Cardiac disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Any Gastrointestinal Disorders | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Inguinal hernia | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Oesophageal spasm | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Any Hepatobiliary disorders | Hepatobiliary disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Cholelithiasis obstructive | Hepatobiliary disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Any Infections and Infestations | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
|
| Genital abscess | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
|
| Perianal abscess | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
|
| Pyelonephritis chronic | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
|
| Any Injury, Poisoning and Procedural Complications | Injury, poisoning and procedural complications | MedDRA 11.0 | Non-systematic Assessment |
|
| Incisional hernia | Injury, poisoning and procedural complications | MedDRA 11.0 | Non-systematic Assessment |
|
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA 11.0 | Non-systematic Assessment |
|
| Traumatic ulcer | Injury, poisoning and procedural complications | MedDRA 11.0 | Non-systematic Assessment |
|
| Any Investigations | Investigations | MedDRA 11.0 | Non-systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA 11.0 | Non-systematic Assessment |
|
| Any Metabolism and nutrition disorders | Metabolism and nutrition disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Any Neoplasms Benign, Malignant and Unspecified (Incl Cysts and Polyps) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Non-systematic Assessment |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Non-systematic Assessment |
|
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Non-systematic Assessment |
|
| Any Nervous System Disorders | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Any Psychiatric Disorders | Psychiatric disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Major depression | Psychiatric disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Any Reproductive System and Breast Disorders | Reproductive system and breast disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Balanoposthitis | Reproductive system and breast disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Any Respiratory, Thoracic and Mediastinal Disorders | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Any Skin and Subcutaneous Tissue Disorders | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Leukocytoclastic vasculitis | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Any Vascular Disorders | Vascular disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Extremity necrosis | Vascular disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 11.0 | 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 |