NCT00888238

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1 type-2-diabetes-mellitus

Timeline
Completed

Started May 2009

Shorter than P25 for phase_1 type-2-diabetes-mellitus

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 24, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 27, 2009

Completed
15 days until next milestone

Study Start

First participant enrolled

May 12, 2009

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 21, 2009

Completed
1 year until next milestone

Results Posted

Study results publicly available

August 3, 2010

Completed
Last Updated

June 26, 2018

Status Verified

March 1, 2018

Enrollment Period

29 days

First QC Date

April 24, 2009

Results QC Date

May 24, 2010

Last Update Submit

March 29, 2018

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Glucose Infusion Rate (GIR) During 190 - 340 Minutes Post-dose

    190 minutes to 340 minutes

Study Arms (3)

Sitagliptin/Sitagliptin/Placebo

EXPERIMENTAL

Sitagliptin in 2 of 3 treatment periods and Placebo in 1 of 3 treatment periods

Drug: sitagliptinDrug: Comparator: Placebo

Sitagliptin/Placebo/Sitaglipitin

EXPERIMENTAL

Sitagliptin in 2 of 3 treatment periods and Placebo in 1 of 3 treatment periods

Drug: sitagliptinDrug: Comparator: Placebo

Placebo/Sitagliptin/Sitagliptin

EXPERIMENTAL

Sitagliptin in 2 of 3 treatment periods and Placebo in 1 of 3 treatment periods

Drug: sitagliptinDrug: Comparator: Placebo

Interventions

sitagliptinDRUG

Single oral dose of sitagliptin 100 mg (2 x 50 mg) tablets followed by the hyperglycemic clamp procedure and meal tolerance test.

Also known as: sitagliptin phosphate, MK0431
Placebo/Sitagliptin/SitagliptinSitagliptin/Placebo/SitaglipitinSitagliptin/Sitagliptin/Placebo
Comparator: PlaceboDRUG

Single oral dose of 2 tablets placebo to sitagliptin followed by the hyperglycemic clamp procedure and meal tolerance test.

Placebo/Sitagliptin/SitagliptinSitagliptin/Placebo/SitaglipitinSitagliptin/Sitagliptin/Placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Subject is an Asian Indian male between 18 to 45 years of age
  • Subject is in good health
  • Subject is a nonsmoker or has not used nicotine-containing products for six months
  • Subject is willing to avoid strenuous activity

You may not qualify if:

  • Subject has a history of stroke, seizures, or major neurological disorders
  • Subject has irritable bowel disease or recurrent nausea, vomiting, diarrhea, or abdominal pain
  • Subject has a history of high blood pressure requiring treatment
  • Subject has history of cancer
  • Subject has a history of diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 29138226RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Sitagliptin Phosphate

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrazines

Results Point of Contact

Title
Senior Vice President, Global Clinical Development
Organization
Merck Sharp & Dohme Corp
1-800-672-6372

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2009

First Posted

April 27, 2009

Study Start

May 12, 2009

Primary Completion

June 10, 2009

Study Completion

July 21, 2009

Last Updated

June 26, 2018

Results First Posted

August 3, 2010

Record last verified: 2018-03