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

Primary Purpose

Prediabetic State

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sitagliptin + Pioglitazone PLACEBO
Sitagliptin + Pioglitazone
PLACEBO
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Prediabetic State focused on measuring Prediabetic State

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Grady Memorial Hospital
  • Emory University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Sitagliptin + Pioglitazone PLACEBO

Sitagliptin + Pioglitazone

PLACEBO

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Insulin Secretion
Not measured as study was prematurely terminated due to unanticipated delays.

Secondary Outcome Measures

Full Information

First Posted
October 27, 2009
Last Updated
November 12, 2013
Sponsor
Emory University
Collaborators
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT01006018
Brief Title
DPP-4 Inhibition and TZD for DM Prevention
Acronym
DInT DM
Official Title
DPP-4 Inhibition and Thiazolidinedione for Diabetes Mellitus Prevention (DInT DM Study)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Terminated
Why Stopped
Unanticipated delays due to sterilization/stabilization testing of GLP-1.
Study Start Date
July 2011 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
Collaborators
Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prediabetic State
Keywords
Prediabetic State

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sitagliptin + Pioglitazone PLACEBO
Arm Type
Experimental
Arm Description
Sitagliptin (DPP-IV inhibitor) 100 mg daily by mouth + pioglitazone PLACEBO daily by mouth
Arm Title
Sitagliptin + Pioglitazone
Arm Type
Experimental
Arm Description
Sitagliptin (DPP-IV inhibitor) 100 mg daily by mouth + pioglitazone (TZD) 15 mg daily by mouth
Arm Title
PLACEBO
Arm Type
Placebo Comparator
Arm Description
Sitagliptin (DPP-IV inhibitor) PLACEBO daily by mouth + pioglitazone (TZD) PLACEBO daily by mouth
Intervention Type
Drug
Intervention Name(s)
Sitagliptin + Pioglitazone PLACEBO
Other Intervention Name(s)
Januvia (sitagliptin), Pioglitazone (Actos)
Intervention Description
Sitagliptin 100 mg tablet daily + Pioglitazone PLACEBO 15 mg capsule daily
Intervention Type
Drug
Intervention Name(s)
Sitagliptin + Pioglitazone
Other Intervention Name(s)
Januvia (sitaglitin), Pioglitazone (Actos)
Intervention Description
Sitagliptin 100 mg tablet daily + Pioglitazone 15 mg capsule daily
Intervention Type
Drug
Intervention Name(s)
PLACEBO
Other Intervention Name(s)
Januvia (sitagliptin) PLACEBO, Pioglitazone (Actos) PLACEBO
Intervention Description
Sitagliptin placebo 100 mg tablet daily + Pioglitazone placebo 15 mg capsule daily
Primary Outcome Measure Information:
Title
Insulin Secretion
Description
Not measured as study was prematurely terminated due to unanticipated delays.
Time Frame
baseline, 6 months, 9 months (after a 3 month washout)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary Rhee, MD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Grady Memorial Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Facility Name
Emory University Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
33210751
Citation
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.
Results Reference
derived

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DPP-4 Inhibition and TZD for DM Prevention

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