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| ID | Type | Description | Link |
|---|---|---|---|
| 2008_601 |
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A study to assess the safety and efficacy of the addition of sitagliptin compared to placebo in patients with Type 2 Diabetes Mellitus who have inadequate glycemic control on metformin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sitagliptin | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comparator: Sitagliptin phosphate | Drug | All participants will receive placebo tablets two weeks prior to treatment period. Participants will receive sitagliptin phosphate 100 mg tablets once daily (q.d.) and continue on stable dose of metformin therapy (500 or 850 mg twice daily). Treatment period of 24 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Hemoglobin A1c (A1C) at Week 24 | A1C is measured as 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 Hemoglobin A1c (A1C) at Week 24 for Participants on Metformin 1000 mg/Day | A1C is measured as percent. Thus, this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent. | Baseline and Week 24 |
| Change From Baseline in Hemoglobin A1c (A1C) at Week 24 for Participants on Metformin 1700 mg/Day |
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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 |
|---|---|---|---|
| 22672586 | Derived | Yang W, Guan Y, Shentu Y, Li Z, Johnson-Levonas AO, Engel SS, Kaufman KD, Goldstein BJ, Alba M. The addition of sitagliptin to ongoing metformin therapy significantly improves glycemic control in Chinese patients with type 2 diabetes. J Diabetes. 2012 Sep;4(3):227-37. doi: 10.1111/j.1753-0407.2012.00213.x. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sitagliptin | Sitagliptin phosphate 100 mg tablets once daily (q.d.) and a stable dose of metformin therapy for 24 weeks. |
| FG001 | Placebo | Placebo tablets q.d. and a stable dose of metformin therapy for 24 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sitagliptin | Sitagliptin phosphate 100 mg tablets once daily (q.d.) and a stable dose of metformin therapy for 24 weeks. |
| BG001 | Placebo | Placebo tablets q.d. and a stable dose of metformin therapy for 24 weeks. |
| 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 Hemoglobin A1c (A1C) at Week 24 | A1C is measured as percent. Thus, this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent. | Full Analysis Set (defined as a subset of all randomized participants who received at least one dose of double-blind study medication, and had both a baseline [randomization] measurement and a post-randomization measurement) using last observation carried forward for missing data. | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| POST PROCEDURAL HAEMORRHAGE | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 13.0 | 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 |
|---|---|
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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|
|
| Comparator: Placebo | Drug | All participants will receive placebo tablets two weeks prior to treatment period. Participants will receive sitagliptin phosphate placebo tablets q.d. and continue on stable dose of metformin therapy (500 or 850 mg twice daily). Treatment period of 24 weeks. |
|
|
A1C is measured as percent. Thus, this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent. |
| Baseline and Week 24 |
| 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. | Baseline and Week 24 |
| 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 |
| Lack of Efficacy |
|
| Lost to Follow-up |
|
| Other reason |
|
| Protocol Violation |
|
| Subject moved |
|
| Withdrawal by Subject |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Hemoglobin A1c (HbA1c) | Mean | Standard Deviation | Percent |
|
| 2-hour Post-meal Glucose | 392 participants with available data: sitagliptin, n=192; placebo, n=196 | Mean | Standard Deviation | mg/dL |
|
| Fasting Plasma Glucose | Mean | Standard Deviation | mg/dL |
|
Placebo tablets q.d. and a stable dose of metformin therapy for 24 weeks. |
|
|
|
| Secondary | Change From Baseline in Hemoglobin A1c (A1C) at Week 24 for Participants on Metformin 1000 mg/Day | A1C is measured as percent. Thus, this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent. | Full Analysis Set (defined as a subset of all randomized participants who received at least one dose of double-blind study medication, and had both a baseline [randomization] measurement and a post-randomization measurement) using last observation carried forward for missing data. | Posted | Least Squares Mean | 95% Confidence Interval | Percent | Baseline and Week 24 |
|
|
|
| Secondary | Change From Baseline in Hemoglobin A1c (A1C) at Week 24 for Participants on Metformin 1700 mg/Day | A1C is measured as percent. Thus, this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent. | Full Analysis Set (defined as a subset of all randomized participants who received at least one dose of double-blind study medication, and had both a baseline [randomization] measurement and a post-randomization measurement) using last observation carried forward for missing data. | Posted | Least Squares Mean | 95% Confidence Interval | Percent | 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. | Full Analysis Set (defined as a subset of all randomized participants who received at least one dose of double-blind study medication, and had both a baseline [randomization] measurement and a post-randomization measurement) using last observation carried forward for missing data. | Posted | Least Squares Mean | 95% Confidence Interval | mg/dL | Baseline and Week 24 |
|
|
|
| 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. | Full Analysis Set (defined as a subset of all randomized participants who received at least one dose of double-blind study medication, and had both a baseline [randomization] measurement and a post-randomization measurement) using last observation carried forward for missing data. | Posted | Least Squares Mean | 95% Confidence Interval | mg/dL | Baseline and Week 24 |
|
|
|
| 7 |
| 197 |
| 10 |
| 197 |
| EG001 | Placebo | 5 | 198 | 13 | 198 |
| SPINAL CORD INJURY CERVICAL | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
|
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 13.0 | Systematic Assessment |
|
| DIABETES MELLITUS | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
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| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
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| TENOSYNOVITIS | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
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| COLON CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
|
| LIP AND/OR ORAL CAVITY CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
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| CEREBRAL INFARCTION | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| IIIrd NERVE PARALYSIS | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
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| TRANSIENT ISCHAEMIC ATTACK | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| EPIGLOTTIC CYST | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
Following the multicenter publication or 24 months after study completion, whichever comes first, an investigator may publish the results for their study site independently. The SPONSOR must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the SPONSOR as confidential must be deleted prior to submission.
| D004700 | Endocrine System Diseases |