A Study to Assess the Pharmacokinetics, Safety and Tolerability of Sitagliptin in Adolescents (0431-081)

Type 2 Diabetes Clinical Trial

Official title:

A Single-Dose Study to Assess the Pharmacokinetics, Safety, and Tolerability of Sitagliptin in Adolescents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00730275
• Other study ID #: 0431-081
• Secondary ID: 2008_540
• Status: Completed
• Phase: Phase 1
• First received: August 6, 2008
• Last updated: August 7, 2015
• Start date: July 2008
• Est. completion date: February 2011

Study information

• Verified date: August 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study will assess the safety, tolerability and pharmacokinetics of sitagliptin in 10 to 17 year old diabetic patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: February 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 17 Years

Eligibility

Inclusion Criteria:

• Males or females who are 10 - 17 years of age

• History of type 2 diabetes

• Nonsmoker

• No clinical or laboratory evidence to indicate a diagnosis of type 1 diabetes

Exclusion Criteria:

• History of diabetic ketoacidosis

• History of stroke, chronic seizures or major neurological disorder

• Consumes alcohol

• Consume more than 6 servings (1 serving is approximately equivalent to 120 mg of caffeine) of coffee, tea, cola or other beverages containing caffeine per day

• Unable to swallow tablets

• Has had surgery, donated or lost 1 unit of blood, or participated in another investigational study within a minimum of 4 weeks prior to starting the study

• History of multiple and/or severe allergies or has had an allergic reaction to or significant intolerability to prescription or non-prescription drugs or food

• Currently a regular user of any illicit drugs or has a history of drug or alcohol abuse

• History of clinically significant endocrine, gastrointestinal,

cardiovascular, hematological, hepatic, immunological, renal, respiratory, or

genitourinary abnormalities or diseases

• Has an estimated creatinine clearance of less than or equal to 80 mL/min

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Type 2 Diabetes

Intervention

Drug:
• Sitagliptin phosphate
Participants will fast 8 hours prior to dosing. All doses will be given with 240 ml of water. Participants received either a single oral dose of sitagliptin 50 mg tablet, sitagliptin 100 mg tablet, or sitagliptin 200 mg.
• Comparator: matching placebo
Participants will fast 8 hours prior to dosing. All doses will be given with 240 ml of water. Participants received either a single oral dose of matching placebo to sitagliptin 50 mg, 100 mg, or 200 mg.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Who Experienced at Least One Adverse Event		Pre-study through 10 to 14 days following administration of study drug	Yes
Primary	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	No
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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No