Changes in Bone Turnover With Increased Incretin Hormone Exposure

Stopped early · Phase 4 · Has a placebo group

Conditions studied: Type 2 Diabetes Mellitus

In brief

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.

Key facts

Study ID

NCT01374568

Run by

University of Alabama at Birmingham

People needed

6

Starts

2010-07-01

Expected to finish

2015-09-01

Last updated by the study team

2017-07-24

Who can join

Age: 45 and older. Sex: female. Healthy volunteers: accepted.

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

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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