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| ID | Type | Description | Link |
|---|---|---|---|
| 2009_584 | Other Identifier | Merck Registration Number | |
| CTRI/2009/091/000457 | Registry Identifier | CTRI |
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This study will evaluate the effect of a single dose of sitagliptin on glucose dependent insulin secretion using a meal tolerance test (MTT) during a hyperglycemic clamp (HCG) procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sitagliptin/Sitagliptin/Placebo | Experimental | Sitagliptin in 2 of 3 treatment periods and Placebo in 1 of 3 treatment periods |
|
| Sitagliptin/Placebo/Sitaglipitin | Experimental | Sitagliptin in 2 of 3 treatment periods and Placebo in 1 of 3 treatment periods |
|
| Placebo/Sitagliptin/Sitagliptin | Experimental | Sitagliptin in 2 of 3 treatment periods and Placebo in 1 of 3 treatment periods |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sitagliptin | Drug | Single oral dose of sitagliptin 100 mg (2 x 50 mg) tablets followed by the hyperglycemic clamp procedure and meal tolerance test. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Insulin Secretion Rate (ISR) During 190 - 340 Minutes Post-dose | ISR was estimated by the deconvolution of peripheral C-peptide concentrations using a 2-compartment model that utilizes population C-peptide kinetic parameters. | 190 minutes to 340 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Glucose Infusion Rate (GIR) During 190 - 340 Minutes Post-dose | Glucose Infusion Rate required to maintain the target glucose level of 160 milligrams / deciliter (mg/dL) ; GIR was normalized to subject's body weight (kg). | 190 minutes to 340 minutes |
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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 |
|---|---|---|---|
| 29138226 | Result | Shankar SS, Shankar RR, Mixson LA, Miller DL, Steinberg HO, Beals CR, Kelley DE. Insulin secretory effect of sitagliptin: assessment with a hyperglycemic clamp combined with a meal challenge. Am J Physiol Endocrinol Metab. 2018 Apr 1;314(4):E406-E412. doi: 10.1152/ajpendo.00238.2017. Epub 2017 Nov 14. |
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Subjects screened over a 1 week period.
Subjects were recruited at Veeda Clinical Research Pvt. Ltd. in May 2009.
First Patient Screened: 20-May-2009.
Last Patient, Last Visit: 21-Jul-2009.
1 site
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| ID | Title | Description |
|---|---|---|
| FG000 | Sitagliptin / Sitagliptin / Placebo | Single oral dose Sitagliptin 100 mg (administered as 2 X 50 mg tablet) / Single oral dose Sitagliptin 100 mg (administered as 2 X 50 mg tablet) / Matching Placebo |
| FG001 | Sitagliptin / Placebo / Sitagliptin | Single oral dose Sitagliptin 100 mg (administered as 2 X 50 mg tablet) / Matching Placebo / Single oral dose Sitagliptin 100 mg (administered as 2 X 50 mg tablet) |
| FG002 | Placebo / Sitagliptin / Sitagliptin | Matching Placebo / Single oral dose Sitagliptin 100 mg (administered as 2 X 50 mg tablet) / Single oral dose Sitagliptin 100 mg (administered as 2 X 50 mg tablet) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Period of Treatment Intervention |
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| Washout Period After Period 1 |
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| Second Period of Treatment Intervention |
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| Washout Period After Period 2 |
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| Third Period of Treatment Intervention |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Patients | All Randomized patients |
| 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 | Insulin Secretion Rate (ISR) During 190 - 340 Minutes Post-dose | ISR was estimated by the deconvolution of peripheral C-peptide concentrations using a 2-compartment model that utilizes population C-peptide kinetic parameters. | All subjects who completed a hyperglycemic clamp in each period were included in the analysis. | Posted | Least Squares Mean | Standard Deviation | ng/min | 190 minutes to 340 minutes |
|
Adverse experiences were collected from the time the consent was signed through the 14 day follow up period, after all treatment periods were completed.
Subjects were queried at each visit for any adverse experiences since the previous visit.
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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 | 11 subjects received a single-dose of sitagliptin 100 mg in 2 periods; 1 subject received a single dose of sitagliptin 100 mg in 1 period only. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blister | Skin and subcutaneous tissue disorders | MedDRA 12.0 | 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 |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
| Comparator: Placebo | Drug | Single oral dose of 2 tablets placebo to sitagliptin followed by the hyperglycemic clamp procedure and meal tolerance test. |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Body Mass Index | Mean | Standard Deviation | kg/m2 |
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| Secondary | Glucose Infusion Rate (GIR) During 190 - 340 Minutes Post-dose | Glucose Infusion Rate required to maintain the target glucose level of 160 milligrams / deciliter (mg/dL) ; GIR was normalized to subject's body weight (kg). | All subjects who completed a hyperglycemic clamp in each period were included in the analysis. | Posted | Least Squares Mean | Standard Deviation | mg / kg / min | 190 minutes to 340 minutes |
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|
| 0 |
| 12 |
| 1 |
| 12 |
| EG001 | Placebo | 12 subjects received a single-dose of placebo in 1 period. | 0 | 12 | 0 | 12 |
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 |