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

A Phase 1 study testing Sitagliptin phosphate in people with Type 2 Diabetes, run by Merck Sharp & Dohme LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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

Who is it for?: Ages 10 to 17 years
Conditions the study is for: Type 2 Diabetes
What is being tested?: Sitagliptin phosphate
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 35 participants
Where: No sites listed yet
Study dates: 18 Jul 2008to 14 Feb 2011
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 10 to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

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

Who cannot join

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

Show all 12Show fewer

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

About this study

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

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

Conditions: Type 2 Diabetes
Being tested: Sitagliptin phosphate, Comparator: matching placebo
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Sitagliptin phosphateDrug
Also called MK-0431, Januvia
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 placeboDrug
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.

Study groups in NCT00730275
Study group	Role	What they receive
Sitagliptin 50 mg	Experimental	Participants were randomized to sitagliptin 50 mg Receives: Drug: Sitagliptin phosphate
Sitagliptin 100 mg	Experimental	Participants were randomized to sitagliptin 100 mg Receives: Drug: Sitagliptin phosphate
Sitagliptin 200 mg	Experimental	Participants were randomized to a single dose of sitagliptin 200 mg Receives: Drug: Sitagliptin phosphate
Placebo to sitagliptin	Placebo comparator	Participants were randomized to matching placebo to sitagliptin 50 mg, 100 mg, or 200 mg Receives: Drug: Comparator: matching placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants Who Experienced at Least One Adverse Event
Measured: 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.
Measured: Pre-dose through 72 hours post-dose

Secondary outcomes (4)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Pre-dose through 24 hours post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Jul 200814 Feb 2011

First posted8 Aug 2008 (estimated)
Study start18 Jul 2008
Primary completion30 Dec 2010
Study completion14 Feb 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 35 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00730275
Sponsor's protocol ID: 0431-081
Other IDs: 2008_540
Status last verified: Apr 2017
First submitted: 6 Aug 2008
Last updated: 12 May 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final\_Updated%20July\_9\_2014.pdf http://engagezone.msd.com/ds\_documentation.php

Publications

Fraser IP, Neufeld ND, Fox LA, Kipnes MS, Miller TL, Zeitler PS, Rodriguez H, Gilmartin JH, Lee SJ, Patterson JK, Li XS, Maganti L, Luo WL, Tatosian DA, Stoch SA. A randomized clinical trial to evaluate the single-dose pharmacokinetics, pharmacodynamics, and safety of sitagliptin in pediatric patients with type 2 diabetes. Pediatr Diabetes. 2019 Feb;20(1):48-56. doi: 10.1111/pedi.12790. Epub 2018 Nov 13.
PubMed 30346099

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Type 2 Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 12 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single-Dose Study to Assess the Pharmacokinetics, Safety, and Tolerability of Sitagliptin in Adolescents
ClinicalTrials.gov ID: NCT00730275
Acronym / sponsor ID: 0431-081
Conditions: Type 2 Diabetes
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 35 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 18 Jul 2008 (actual)
Primary completion: 30 Dec 2010 (actual)
Study completion: 14 Feb 2011 (actual)
First posted: 8 Aug 2008 (estimated)
Results: Posted 30 Jan 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
Sitagliptin 50 mg	Experimental	Drug: Sitagliptin phosphateParticipants were randomized to sitagliptin 50 mg
Sitagliptin 100 mg	Experimental	Drug: Sitagliptin phosphateParticipants were randomized to sitagliptin 100 mg
Sitagliptin 200 mg	Experimental	Drug: Sitagliptin phosphateParticipants were randomized to a single dose of sitagliptin 200 mg
Placebo to sitagliptin	Placebo comparator	Drug: Comparator: matching placeboParticipants were randomized to matching placebo to sitagliptin 50 mg, 100 mg, or 200 mg

Who may qualify

Ages: 10 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (4 listed)

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

Key exclusion criteria (12 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Sitagliptin phosphateAlso: MK-0431, JanuviaParticipants 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.	Drug	Sitagliptin 100 mg, Sitagliptin 200 mg, Sitagliptin 50 mg
Comparator: matching placeboParticipants 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.	Drug	Placebo to sitagliptin

Primary outcome

Number of Participants Who Experienced at Least One Adverse Event
Time frame: 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
Time frame: Pre-dose through 72 hours post-dose
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.

4 secondary outcomes

Maximum Concentration (Cmax) Following a Single Dose of Sitagliptin
Time frame: Pre-dose through 72 hours post-dose
Time of Occurence of Maximum Concentration (Tmax) Following a Single Dose of Sitagliptin
Time frame: Pre-dose through 72 hours post-dose
Apparent Terminal Half-life (Apparent t1/2) Following a Single Dose of Sitagliptin
Time frame: Pre-dose through 72 hours post-dose
Plasma Dipeptidyl Peptidase-4 (DPP-4) Activity Following a Single Dose of Sitagliptin or Placebo
Time frame: Pre-dose through 24 hours post-dose

Results and safety

Results posted to the registry on 30 Jan 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sitagliptin 50 mg	9	9
Sitagliptin 100 mg	9	9
Sitagliptin 200 mg	8	8
Placebo	9	8

Primary outcome: Number of Participants Who Experienced at Least One Adverse Event

Time frame: Pre-study through 10 to 14 days following administration of study drug. Number. Unit: participants

Measure	Sitagliptin 50 mg n = 9	Sitagliptin 100 mg n = 9	Sitagliptin 200 mg n = 8	Placebo n = 9
Value	3	1	1	2

Population analysed: All enrolled participants.

Primary outcome: Area Under the Concentration-time Curve (AUC) From Time 0 to Infinity Following a Single Dose of Sitagliptin

Time frame: Pre-dose through 72 hours post-dose. Geometric mean (95% Confidence Interval). Unit: nM*hour

Measure	Sitagliptin 50 mg n = 9	Sitagliptin 100 mg n = 9	Sitagliptin 200 mg n = 8
Value	3438 (2881 to 4103)	5869 (4918 to 7003)	12965 (10749 to 15638)

Population analysed: All participants who received a single dose of sitagliptin 50 mg, 100 mg, or 200 mg.

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sitagliptin 50 mg	0 of 9 (0%)	3 of 9 (33.3%)	Not reported
Sitagliptin 100 mg	0 of 9 (0%)	1 of 9 (11.1%)	Not reported
Sitagliptin 200 mg	0 of 8 (0%)	1 of 8 (12.5%)	Not reported
Placebo	0 of 9 (0%)	2 of 9 (22.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 30346099Fraser IP, Neufeld ND, Fox LA, Kipnes MS, Miller TL, Zeitler PS, Rodriguez H, Gilmartin JH, Lee SJ, Patterson JK, Li XS, Maganti L, Luo WL, Tatosian DA, Stoch SA. A randomized clinical trial to evaluate the single-dose pharmacokinetics, pharmacodynamics, and safety of sitagliptin in pediatric patients with type 2 diabetes. Pediatr Diabetes. 2019 Feb;20(1):48-56. doi: 10.1111/pedi.12790. Epub 2018 Nov 13.
Individual participant dataSharing planned: Yes. http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf http://engagezone.msd.com/ds_documentation.php

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Monitor study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Sitagliptin phosphate in people with Type 2 Diabetes, run by Merck Sharp & Dohme LLC.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 May 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Jan 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Who Experienced at Least One Adverse Event (time frame: Pre-study through 10 to 14 days following administration of study drug). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00730275, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2017.