- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02444364
Effects of DPP-4 Inhibition on Calcium and Bone Metabolism in Type 2 Diabetes Mellitus
Pilot Project Evaluation of the DPP-4 Inhibition With Sitagliptin on Calcium and Bone Metabolism in Patients With Type 2 Diabetes Mellitus
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.
Study Overview
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.
Study Type
Phase
- Early Phase 1
Contacts and Locations
Study Locations
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Missouri
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Columbia, Missouri, United States, 65212
- University of Missouri-Columbia: Diabetes Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Sitagliptin
Subjects will receive 90 tablets of 100mg sitagliptin
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Subjects will receive 90 tablets of 100mg sitagliptin
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in Bone Turnover
Time Frame: Six Months
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Six Months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Muhammed T Sarmini, MD, University of Missouri-Columbia
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Endocrine System Diseases
- Diabetes Mellitus
- Diabetes Mellitus, Type 2
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Protease Inhibitors
- Incretins
- Dipeptidyl-Peptidase IV Inhibitors
- Sitagliptin Phosphate
Other Study ID Numbers
- MERCK-200379
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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