Changes in Bone Turnover With Increased Incretin Hormone Exposure

• Status: Terminated
• Trial end date: 2015-09-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Alabama at Birmingham
• Treatments: Gastric Inhibitory Polypeptide; Hormones; Incretins; Sitagliptin Phosphate

Criteria

Inclusion Criteria:

• 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%

Exclusion Criteria:

• 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