NCT00364377

Brief Summary

People with high fasting glucose can develop type 2 diabetes with the passage of time. This study is being done to determine the effect of a novel medication in people with this elevated fasting glucose. Sitagliptin is a substance that raises levels of a hormone normally found in the blood. This hormone, called glucagon-like peptide-1 (GLP-1), is normally released by the intestine in response to the presence of food. This hormone acts like a messenger between the intestine and the pancreas to raise insulin levels, and therefore, lower blood sugars. Sitagliptin is effective in people with diabetes, however, this study is being done to determine if Sitagliptin is effective in people with high fasting glucose who do not yet have diabetes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Aug 2006

Typical duration for phase_4

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

August 1, 2006

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

August 14, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 15, 2006

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
3 years until next milestone

Results Posted

Study results publicly available

December 6, 2011

Completed
Last Updated

December 6, 2011

Status Verified

November 1, 2011

Enrollment Period

2.3 years

First QC Date

August 14, 2006

Results QC Date

April 4, 2011

Last Update Submit

November 1, 2011

Conditions

Pre-diabetes

Outcome Measures

Primary Outcomes (1)

  • Lowering of Fasting Glucose

    fasting glucose taken as the mean of blood glucose measured at -30, -20, -10 and 0 minutes prior to each inpatient meal study

    8 weeks

Study Arms (2)

Sitagliptin

ACTIVE COMPARATOR

People with impaired fasting glucose randomized to treatment with sitagliptin 100 mg once daily.

Drug: Sitagliptin

Placebo

PLACEBO COMPARATOR

People with impaired fasting glucose randomized to treatment with placebo once daily.

Other: Placebo

Interventions

SitagliptinDRUG

100 mg once daily

Also known as: Januvia
Sitagliptin
PlaceboOTHER

once daily for duration of the study

Placebo

Eligibility Criteria

Age35 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males and females between the ages of 35-70.
  • Good health as determined by past medical history,physical examination, vital signs, electrocardiogram and laboratory tests at the time of screening.
  • Patients on diuretics or thyroid hormone therapy must be on a stable dose (at least 3 months prior to screening) and the maintenance dose may not be adjusted during the study.

You may not qualify if:

  • Individuals with a body mass index less than 19 or greater than 40 kg/m\^2, or a total weight \> 130 kg, will be excluded from study.
  • Subjects less than 35 years will not be studied in order to minimize the possibility of studying subjects with type 1 diabetes.
  • No history of a) significant nephropathy, (i.e., plasma creatinine \> 1.4 mg/dl in women and 1.5 mg/dl in men, and/or proteinuria); b) clinically significant atherosclerotic vascular disease (e.g., history of heart attack or angina); c) a known systemic illness.
  • Pregnant or lactating females.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

  • Bock G, Dalla Man C, Micheletto F, Basu R, Giesler PD, Laugen J, Deacon CF, Holst JJ, Toffolo G, Cobelli C, Rizza RA, Vella A. The effect of DPP-4 inhibition with sitagliptin on incretin secretion and on fasting and postprandial glucose turnover in subjects with impaired fasting glucose. Clin Endocrinol (Oxf). 2010 Aug;73(2):189-96. doi: 10.1111/j.1365-2265.2009.03764.x. Epub 2009 Dec 18.

    PMID: 20039889RESULT

MeSH Terms

Conditions

Glucose Intolerance

Interventions

Sitagliptin Phosphate

Condition Hierarchy (Ancestors)

HyperglycemiaGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrazines

Results Point of Contact

Title
Adrian Vella
Organization
Mayo Clinic
vella.adrian@mayo.edu
507-284-3754

Study Officials

  • Adrian Vella, M.D.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of medicine

Study Record Dates

First Submitted

August 14, 2006

First Posted

August 15, 2006

Study Start

August 1, 2006

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

December 6, 2011

Results First Posted

December 6, 2011

Record last verified: 2011-11

Locations

US(1)