Status:
UNKNOWN
Bone Turnover in Type 2 Diabetes Patients
Lead Sponsor:
University of Vermont
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
Background: Incretin hormones are hormones produced by the gut in response to food intake. These hormones help the body to control the metabolism of glucose (sugar). In particular, two incretin hormo...
Eligibility Criteria
Inclusion
- Type 2 diabetes treated with diet/exercise or metformin
- HbA1c less than or equal to 7%
- Men and women aged 45-80 years old
- If female, must be post-menopausal (natural or surgical)
Exclusion
- Endocrine disorders (acromegaly, anorexia, Cushings, type 2 diabetes, hyperparathyroidism, hyperthyroidism, hypercalcemia)
- GI conditions (celiac sprue, gastric bypass/gastrectomy, active inflammatory bowel disease, cirrhosis)
- Cancer (including multiple myeloma) within 3 years of the study (except local non-melanoma skin cancers and cervical carcinoma in situ)
- Active alcoholism or drug abuse
- Chronic kidney disease with a GFR \< 60
- HIV/AIDS
- History of hypersensitivity reaction to sitagliptin or other DPP-4 inhibitors
- Hemoglobin \< 12 mg/dL for men and \< 10 for women
- Taking medications that could affect bone turnover (estrogen, progesterone, testosterone, bisphosphonates, SERMS, calcitonin, teriparatide cyclosporine glucocorticoids, methotrexate or phenothiazines), thiazolidinediones, sulfonylureas, dipeptidyl peptidase-4 inhibitors, exenatide, insulin, weight loss drugs
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2010
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00732121
Start Date
August 1 2008
End Date
August 1 2010
Last Update
June 28 2010
Active Locations (1)
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1
University of Vermont
South Burlington, Vermont, United States, 05403