DPP-4 Inhibition and TZD for DM Prevention

• Status: Terminated
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

Summary

To determine whether treatment with the diabetes medication, Januvia (sitagliptin), with or without another diabetes medicine, Actos (pioglitazone), will improve insulin secretion and insulin response individuals with Impaired Glucose Tolerance (IGT), a form of prediabetes.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Emory University
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Pioglitazone; Sitagliptin Phosphate

Criteria

Inclusion Criteria:

• Impaired glucose tolerance (IGT) by oral glucose tolerance test

Exclusion Criteria:

• History of diabetes mellitus

• History of congestive heart failure

• History of coronary artery disease or other macrovascular disease (stroke, peripheral vascular disease)

• History of liver disease (ALT or AST >2.5 times the upper limit of normals)

• History of renal disease (serum creatinine >1.5 mg/dl)

• History of severe osteoporosis (frequent fractures, failure on osteoporosis treatment)

• Current treatment with glucocorticoids

• History of immune disorder, including HIV

• Women of child-bearing age who are pregnant, desire to become pregnant, are breastfeeding, or who refuse to take the recommended birth control measures