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

• Status: Withdrawn
• Trial end date: 2016-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Missouri-Columbia
• Treatments: Sitagliptin Phosphate

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.