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DPP-4 Inhibition and TZD for DM Prevention

NCT ID: NCT01006018

Last Updated: 2013-12-05

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2011-12-31

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.

Detailed Description

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Conditions

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Prediabetic State

Keywords

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Prediabetic State

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Sitagliptin + Pioglitazone PLACEBO

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

\+ pioglitazone PLACEBO daily by mouth

Group Type EXPERIMENTAL

Sitagliptin + Pioglitazone PLACEBO

Intervention Type DRUG

Sitagliptin 100 mg tablet daily + Pioglitazone PLACEBO 15 mg capsule daily

Sitagliptin + Pioglitazone

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

\+ pioglitazone (TZD) 15 mg daily by mouth

Group Type EXPERIMENTAL

Sitagliptin + Pioglitazone

Intervention Type DRUG

Sitagliptin 100 mg tablet daily + Pioglitazone 15 mg capsule daily

PLACEBO

Sitagliptin (DPP-IV inhibitor) PLACEBO daily by mouth

\+ pioglitazone (TZD) PLACEBO daily by mouth

Group Type PLACEBO_COMPARATOR

PLACEBO

Intervention Type DRUG

Sitagliptin placebo 100 mg tablet daily + Pioglitazone placebo 15 mg capsule daily

Interventions

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Sitagliptin + Pioglitazone PLACEBO

Sitagliptin 100 mg tablet daily + Pioglitazone PLACEBO 15 mg capsule daily

Intervention Type DRUG

Sitagliptin + Pioglitazone

Sitagliptin 100 mg tablet daily + Pioglitazone 15 mg capsule daily

Intervention Type DRUG

PLACEBO

Sitagliptin placebo 100 mg tablet daily + Pioglitazone placebo 15 mg capsule daily

Intervention Type DRUG

Other Intervention Names

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Januvia (sitagliptin) Pioglitazone (Actos) Januvia (sitaglitin) Pioglitazone (Actos) Januvia (sitagliptin) PLACEBO Pioglitazone (Actos) PLACEBO

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

Emory University

OTHER

Sponsor Role lead

Responsible Party

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Dr. Mary Rhee

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mary Rhee, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

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Grady Memorial Hospital

Atlanta, Georgia, United States

Site Status

Emory University Hospital

Atlanta, Georgia, United States

Site Status

Countries

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United States

References

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Ipsen EO, Madsen KS, Chi Y, Pedersen-Bjergaard U, Richter B, Metzendorf MI, Hemmingsen B. Pioglitazone for prevention or delay of type 2 diabetes mellitus and its associated complications in people at risk for the development of type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Nov 19;11(11):CD013516. doi: 10.1002/14651858.CD013516.pub2.

Reference Type DERIVED
PMID: 33210751 (View on PubMed)

Other Identifiers

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IRB00015390

Identifier Type: -

Identifier Source: org_study_id