DPP-4 Inhibition and TZD for DM Prevention

Study Overview
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Brief Summary
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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.

Official Title
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DPP-4 Inhibition and Thiazolidinedione for Diabetes Mellitus Prevention (DInT DM Study)

Conditions
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Prediabetic State

Intervention / Treatment
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* Drug: Sitagliptin + Pioglitazone PLACEBO
* Drug: Sitagliptin + Pioglitazone
* Drug: PLACEBO


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sitagliptin + Pioglitazone PLACEBO<br>Sitagliptin (DPP-IV inhibitor) 100 mg daily by mouth + pioglitazone PLACEBO daily by mouth | Drug: Sitagliptin + Pioglitazone PLACEBO<br>* Sitagliptin 100 mg tablet daily + Pioglitazone PLACEBO 15 mg capsule daily<br>* Other names: Pioglitazone (Actos);|
| Experimental: Sitagliptin + Pioglitazone<br>Sitagliptin (DPP-IV inhibitor) 100 mg daily by mouth + pioglitazone (TZD) 15 mg daily by mouth | Drug: Sitagliptin + Pioglitazone<br>* Sitagliptin 100 mg tablet daily + Pioglitazone 15 mg capsule daily<br>* Other names: Pioglitazone (Actos);|
| Placebo Comparator: PLACEBO<br>Sitagliptin (DPP-IV inhibitor) PLACEBO daily by mouth + pioglitazone (TZD) PLACEBO daily by mouth | Drug: PLACEBO<br>* Sitagliptin placebo 100 mg tablet daily + Pioglitazone placebo 15 mg capsule daily<br>* Other names: Pioglitazone (Actos) PLACEBO;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin Secretion | Not measured as study was prematurely terminated due to unanticipated delays. | baseline, 6 months, 9 months (after a 3 month washout) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prediabetic State