NCT02444364

Brief Summary

Participants will be persons with Type 2 Diabetes who are likely to have increased risk of bone fractures. The investigators believe this medication will enhance bone turnover. The investigators will use DXA measurements to evaluate bone density before and after subjects take the medication.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started May 2015

Shorter than P25 for early_phase_1 type-2-diabetes

Geographic Reach
1 country

1 active site

Status
withdrawn

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

May 1, 2015

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

May 11, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 14, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

June 1, 2017

Status Verified

May 1, 2017

Enrollment Period

8 months

First QC Date

May 11, 2015

Last Update Submit

May 30, 2017

Conditions

Type 2 Diabetes

Keywords

diabetesbone lossBone Density

Outcome Measures

Primary Outcomes (1)

  • Change in Bone Turnover

    Six Months

Study Arms (1)

Sitagliptin

EXPERIMENTAL

Subjects will receive 90 tablets of 100mg sitagliptin

Drug: Sitagliptin

Interventions

SitagliptinDRUG

Subjects will receive 90 tablets of 100mg sitagliptin

Also known as: Januvia
Sitagliptin

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 diabetes mellitus.
  • Hemoglobin A1c \>6.5% and \<10%.
  • Estimated GFR greater than 60 mL per minute per meter squared.
  • Between 18 and 70 years of age.
  • On oral antihyperglycemic agents with stable dose at least for last 2 months.
  • Females: minimum of two years postmenopausal, surgically sterile, or using an acceptable contraceptive regimen (OCP, IUD, double barrier, Depo-Provera or subcutaneous progestin implant) and negative urine pregnancy test at trial start.

You may not qualify if:

  • Pregnancy, breast feeding or planning pregnancy during the study period
  • Any medical condition expected to be terminal within one year
  • Active mental illness or other condition which in the opinion of the investigator would prevent informed consent or adherence with study protocol
  • Use of any PPAR agonist within three months prior to enrollment
  • Daily insulin use
  • Vitamin D level \< 20
  • Allergy or intolerance of sitagliptin or other DPP-4 inhibitor
  • Use of DPP-4 inhibitor or GLP-1 analog within three months prior to enrollment
  • Significant alcohol use defined as \>3 standard servings of alcohol per day for men and \>2 for women
  • History of bariatric surgery in the last 3 years or planned bariatric surgery during the study period
  • Receipt of another study drug within 30 days of screening.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Missouri-Columbia: Diabetes Center

Columbia, Missouri, 65212, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes MellitusBone Diseases, Metabolic

Interventions

Sitagliptin Phosphate

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBone DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrazines

Study Officials

  • Muhammed T Sarmini, MD

    University of Missouri-Columbia

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2015

First Posted

May 14, 2015

Study Start

May 1, 2015

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

June 1, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)