NCT01374568

Brief Summary

The purpose of this study is to determine if the use of sitagliptin increases bone formation and reduces bone turnover in postmenopausal women with type 2 diabetes.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for phase_4 type-2-diabetes-mellitus

Timeline
Completed

Started Jul 2010

Longer than P75 for phase_4 type-2-diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
terminated

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

July 1, 2010

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

June 10, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 16, 2011

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 6, 2012

Completed
3.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

May 31, 2017

Completed
Last Updated

July 24, 2017

Status Verified

June 1, 2017

Enrollment Period

2 years

First QC Date

June 10, 2011

Results QC Date

January 18, 2017

Last Update Submit

June 23, 2017

Conditions

Type 2 Diabetes Mellitus

Keywords

Type 2 diabetessitagliptinJanuvia

Outcome Measures

Primary Outcomes (2)

  • Bone Turnover in Subjects Treated With Sitagliptin When Compared to Those Treated With Placebo.

    Bone turnover assessed using change in TRACP5b over 8 weeks of treatment.

    8 weeks

  • Bone Turnover in Subjects Treated With Sitagliptin When Compared to Those Treated With Placebo

    Bone turnover assessed using change in bone-specific alkaline phosphatase (BAP) over 8 weeks of treatment.

    8 WEEKS

Study Arms (2)

sitagliptin

ACTIVE COMPARATOR

Sitagliptin

Drug: sitagliptin

Placebo

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

sitagliptinDRUG

sitagliptin 100mg daily

Also known as: Januvia
sitagliptin
PlaceboOTHER

1 pill daily

Placebo

Eligibility Criteria

Age45 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Postmenopausal women (as defined by age \>55 years old or amenorrhea for \>1years)
  • Type 2 DM currently not on diabetes-specific medication(s) or treated with monotherapy of metformin or a sulfonylurea. Patients treated with insulin monotherapy will also be eligible if the total daily dose of insulin is \<10units.
  • Hemoglobin A1c (HbA1c) of 6.5-9.0%

You may not qualify if:

  • Use of an incretin mimetic (i.e. exenatide), a DPP-4 inhibitor (i.e. sitagliptin, saxagliptin), a thiazolidinedione, or oral glucocorticoids in the 6 months prior to the study will not be eligible
  • Known osteoporosis or patients treated with an osteoporosis-specific medication (bisphosphonate, teriparatide) or estrogen (including Selective Estrogen Receptor Modulators (SERMs)) or those who anticipate imminent treatment with one of these medications will be excluded from the study
  • Chronic kidney disease (calculated GFR \<30 ml/min) or a disease known to affect bone turnover (i.e. Paget Disease, Osteogenesis Imperfecta, HIV) will be excluded from the study.
  • History of pancreatitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

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

Limitations and Caveats

Study was closed due to end of funding prior to recruitment of target participants. Small participant number limits data analysis. We were unable to obtain additional funding to complete the study.

Results Point of Contact

Title
Dr. Amy Warriner
Organization
UAB
awarriner@uabmc.edu
2059964004

Study Officials

  • Amy Warriner, MD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 10, 2011

First Posted

June 16, 2011

Study Start

July 1, 2010

Primary Completion

July 6, 2012

Study Completion

September 1, 2015

Last Updated

July 24, 2017

Results First Posted

May 31, 2017

Record last verified: 2017-06

Locations

US(1)