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Effects of DPP-4 Inhibition on Calcium and Bone Metabolism in Type 2 Diabetes Mellitus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02444364
Recruitment Status : Withdrawn (Funding withdrawn; no participants enrolled.)
First Posted : May 14, 2015
Last Update Posted : June 1, 2017
Sponsor:
Information provided by (Responsible Party):
University of Missouri-Columbia

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.


Condition or disease Intervention/treatment Phase
Type 2 Diabetes Drug: Sitagliptin Early Phase 1

Detailed Description:

Type 2 Diabetes Mellitus (T2DM) is associated with an increased risk of bone fractures even when there is not decreased bone density via DXA measurements. This appears primarily related to impaired bone quality and abnormal bone architecture. Although the exact pathophysiologic mechanisms remain unclear, low bone turnover is considered one of the key defects. Emerging evidence suggests that dipeptidyl peptidase (DPP) inhibition is associated with improved bone quality and reduction in fracture risk.

While animal studies have shown an improvement in bone mineral density and trabecular architecture with sitagliptin treatment, no such studies in humans have yet been undertaken. We are proposing to extend these animal studies with a pilot clinical trial that seeks to use serum markers of bone turn-over and calcaneal quantitative ultrasound to evaluate the effect of DPP-4 inhibition on bone metabolism. Our hypothesis is that DPP-4 inhibition with sitagliptin will enhance bone turn over and quality in persons with T2DM.

This project project seeks to examine the impact of six months of therapy on sitagliptin, a DPP-4 inhibitor, on bone metabolism and bone quality in subjects with T2DM. The proposed study is intended to be a pilot investigation for providing preliminary data for submission of a more definitive national grant proposal with a larger patient population, blinded randomized control design and high resolution CT imaging of the lumbar spine.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Project Evaluation of the DPP-4 Inhibition With Sitagliptin on Calcium and Bone Metabolism in Patients With Type 2 Diabetes Mellitus
Study Start Date : May 2015
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sitagliptin
Subjects will receive 90 tablets of 100mg sitagliptin
Drug: Sitagliptin
Subjects will receive 90 tablets of 100mg sitagliptin
Other Name: Januvia




Primary Outcome Measures :
  1. Change in Bone Turnover [ Time Frame: Six Months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Type 2 diabetes mellitus.
  2. Hemoglobin A1c >6.5% and <10%.
  3. Estimated GFR greater than 60 mL per minute per meter squared.
  4. Between 18 and 70 years of age.
  5. On oral antihyperglycemic agents with stable dose at least for last 2 months.
  6. 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.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02444364


Locations
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United States, Missouri
University of Missouri-Columbia: Diabetes Center
Columbia, Missouri, United States, 65212
Sponsors and Collaborators
University of Missouri-Columbia
Investigators
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Principal Investigator: Muhammed T Sarmini, MD University of Missouri-Columbia
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Responsible Party: University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT02444364    
Other Study ID Numbers: MERCK-200379
First Posted: May 14, 2015    Key Record Dates
Last Update Posted: June 1, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of Missouri-Columbia:
diabetes
bone loss
Bone Density
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sitagliptin Phosphate
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action