| Trial ID: | L5393 |
| Source ID: | NCT00730275
|
| Associated Drug: |
Sitagliptin Phosphate
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| Title: |
A Study to Assess the Pharmacokinetics, Safety and Tolerability of Sitagliptin in Adolescents (0431-081)
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| Acronym: |
|
| Status: |
COMPLETED
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| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT00730275/results
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| Conditions: |
Type 2 Diabetes
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| Interventions: |
DRUG: Sitagliptin phosphate|DRUG: Comparator: matching placebo
|
| Outcome Measures: |
Primary: Number of Participants Who Experienced at Least One Adverse Event, Pre-study through 10 to 14 days following administration of study drug|Area Under the Concentration-time Curve (AUC) From Time 0 to Infinity Following a Single Dose of Sitagliptin, Serum samples were used to determine the AUC from time 0 to infinity for sitagliptin. The placebo group is not included in the table below; this outcome measure only evaluated the sitagliptin groups., Pre-dose through 72 hours post-dose | Secondary: Maximum Concentration (Cmax) Following a Single Dose of Sitagliptin, Serum samples were used to determine the Cmax for sitagliptin. The placebo group is not included in the table below; this outcome measure only evaluated the sitagliptin groups., Pre-dose through 72 hours post-dose|Time of Occurence of Maximum Concentration (Tmax) Following a Single Dose of Sitagliptin, Serum samples were used to determine the Tmax for sitagliptin. The placebo group is not included in the table below; this outcome measure only evaluated the sitagliptin groups., Pre-dose through 72 hours post-dose|Apparent Terminal Half-life (Apparent t1/2) Following a Single Dose of Sitagliptin, Serum samples were used to determine the apparent t1/2 for sitagliptin. The placebo group is not included in the table below; this outcome measure only evaluated the sitagliptin groups., Pre-dose through 72 hours post-dose|Plasma Dipeptidyl Peptidase-4 (DPP-4) Activity Following a Single Dose of Sitagliptin or Placebo, Plasma DPP-4 activity was analyzed using the 24-hour weighted average inhibition (WAI) and percent inhibition at 24 hours post-dose. WAI was defined as the AUC of inhibition divided by the length of the post-dose time interval. Positive values of WAI represent a decrease in DPP-4 activity., Pre-dose through 24 hours post-dose
|
| Sponsor/Collaborators: |
Sponsor: Merck Sharp & Dohme LLC
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| Gender: |
ALL
|
| Age: |
CHILD
|
| Phases: |
PHASE1
|
| Enrollment: |
35
|
| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2008-07-18
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| Completion Date: |
2011-02-14
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| Results First Posted: |
2012-01-30
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| Last Update Posted: |
2017-05-12
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| Locations: |
|
| URL: |
https://clinicaltrials.gov/show/NCT00730275
|
