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| ID | Type | Description | Link |
|---|---|---|---|
| 2006_511 |
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A clinical study to determine the safety, efficacy and the way sitagliptin works in patients with Type 2 Diabetes Mellitus who have inadequate glycemic (blood sugar) control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sitagliptin | Experimental | Participants randomized to this arm will be administered sitagliptin 100mg daily, for six weeks. |
|
| Placebo | Placebo Comparator | Participants randomized to this arm will be administered matching placebo, daily for six weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comparator: sitagliptin phosphate | Drug | Sitagliptin tablet 100 mg, administered once daily before the morning meal. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Glucose 5-Hour Incremental AUC at Week 6 | Participants underwent the 5-hour meal test prior to randomization (baseline) and was repeated at the conclusion of the 6-week double-blind study period. The change from baseline in Glucose 5-Hour Incremental AUC at Week 6 is computed as the difference between the Week 6 measurement and the baseline measurement. | Baseline and Week 6 |
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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 |
|---|---|---|---|
| 22685234 | Derived | Muscelli E, Casolaro A, Gastaldelli A, Mari A, Seghieri G, Astiarraga B, Chen Y, Alba M, Holst J, Ferrannini E. Mechanisms for the antihyperglycemic effect of sitagliptin in patients with type 2 diabetes. J Clin Endocrinol Metab. 2012 Aug;97(8):2818-26. doi: 10.1210/jc.2012-1205. Epub 2012 Jun 8. |
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57 participants were enrolled in this study. Of these, 7 participants with normal fasting glucose (NFG) only underwent pre-randomization experiments and did not receive an allocation number, were not randomized to one of the treatment groups, and did not receive double-blind study medication.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sitagliptin | Participants were administered sitagliptin 100 mg tablet once daily before the morning meal for six weeks. |
| FG001 | Placebo | Participants were administered sitagliptin matching placebo tablet once daily before the morning meal for six weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sitagliptin | Participants were administered sitagliptin 100 mg tablet once daily before the morning meal for six weeks. |
| BG001 | Placebo | Participants were administered sitagliptin matching placebo tablet once daily before the morning meal for six weeks. |
| 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, Customized | Number |
| 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 Glucose 5-Hour Incremental AUC at Week 6 | Participants underwent the 5-hour meal test prior to randomization (baseline) and was repeated at the conclusion of the 6-week double-blind study period. The change from baseline in Glucose 5-Hour Incremental AUC at Week 6 is computed as the difference between the Week 6 measurement and the baseline measurement. | Full-Analysis-Set (FAS) population, which includes all randomized participants who had a baseline value, received at least one dose of randomized treatment, and had a measurement at Week 6. | Posted | Least Squares Mean | 95% Confidence Interval | mg*hr/dL | Baseline and Week 6 |
|
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The analyses for all safety outcomes used the All Patients as Treated (APaT) approach. The APaT population used all randomized participants who received at least 1 dose of study 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 | Participants were administered sitagliptin 100 mg tablet once daily before the morning meal for six weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vertigo positional | Ear and labyrinth disorders | MedDRA 12.2 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 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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| Comparator: placebo (unspecified) | Drug | Matching placebo tablet, administered once daily before the morning meal. |
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| Withdrawal by Subject |
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| BG002 | Total | Total of all reporting groups |
| participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| OG001 |
| Placebo |
Participants were administered sitagliptin matching placebo tablet once daily before the morning meal for six weeks. |
|
|
|
| 1 |
| 26 |
| 0 |
| 26 |
| EG001 | Placebo | Participants were administered sitagliptin matching placebo tablet once daily before the morning meal for six weeks. | 0 | 24 | 0 | 24 |
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. SPONSOR review can be expedited to meet publication guidelines.
| D004700 | Endocrine System Diseases |