DPP-4 Inhibition and TZD for DM Prevention (DInT DM)

Emory University

Status: Terminated

Conditions: Prediabetic State

Treatments: Drug: PLACEBO; Drug: Sitagliptin + Pioglitazone; Drug: Sitagliptin + Pioglitazone PLACEBO

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01006018

IRB00015390

Details and patient eligibility

About

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.

Enrollment: 3 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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3 participants in 3 patient groups, including a placebo group

Sitagliptin + Pioglitazone PLACEBO

Experimental group

Description:

Sitagliptin (DPP-IV inhibitor) 100 mg daily by mouth + pioglitazone PLACEBO daily by mouth

Treatment:

Drug: Sitagliptin + Pioglitazone PLACEBO

Sitagliptin + Pioglitazone

Experimental group

Description:

Sitagliptin (DPP-IV inhibitor) 100 mg daily by mouth + pioglitazone (TZD) 15 mg daily by mouth

Treatment:

Drug: Sitagliptin + Pioglitazone

PLACEBO

Placebo Comparator group

Description:

Sitagliptin (DPP-IV inhibitor) PLACEBO daily by mouth + pioglitazone (TZD) PLACEBO daily by mouth

Treatment:

Drug: PLACEBO