DPP-4 Inhibition and TZD for DM Prevention

Not Applicable

Terminated

• Conditions: Prediabetic State
• Interventions: Drug: PLACEBO; Drug: Sitagliptin + Pioglitazone PLACEBO; Drug: Sitagliptin + Pioglitazone

• Registration Number: NCT01006018
• Lead Sponsor: Emory University

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2009-10-27
• Study First Submitted QC: 2009-10-30
• Study First Posted: 2009-11-01
• Study Start: 2011-07
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Results First Submitted: 2013-03-14
• Results First Submitted QC: 2013-05-01
• Results First Posted: 2013-06-07
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-12
• Last Update Posted: 2013-12-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PLACEBO	PLACEBO	Sitagliptin (DPP-IV inhibitor) PLACEBO daily by mouth + pioglitazone (TZD) PLACEBO daily by mouth
Sitagliptin + Pioglitazone PLACEBO	Sitagliptin + Pioglitazone PLACEBO	Sitagliptin (DPP-IV inhibitor) 100 mg daily by mouth + pioglitazone PLACEBO daily by mouth
Sitagliptin + Pioglitazone	Sitagliptin + Pioglitazone	Sitagliptin (DPP-IV inhibitor) 100 mg daily by mouth + pioglitazone (TZD) 15 mg daily by mouth

Primary Outcome Measures

Name	Time	Method
Insulin Secretion	baseline, 6 months, 9 months (after a 3 month washout)	Not measured as study was prematurely terminated due to unanticipated delays.

Trial Locations

Locations (2)

Grady Memorial Hospital; 🇺🇸 Atlanta, Georgia, United States

Emory University Hospital; 🇺🇸 Atlanta, Georgia, United States