NCT01006018

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 27, 2009

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 2, 2009

Completed
1.7 years until next milestone

Study Start

First participant enrolled

July 1, 2011

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

June 7, 2013

Completed
Last Updated

December 5, 2013

Status Verified

November 1, 2013

Enrollment Period

5 months

First QC Date

October 27, 2009

Results QC Date

March 14, 2013

Last Update Submit

November 12, 2013

Conditions

Prediabetic State

Keywords

Prediabetic State

Outcome Measures

Primary Outcomes (1)

  • Insulin Secretion

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

    baseline, 6 months, 9 months (after a 3 month washout)

Study Arms (3)

Sitagliptin + Pioglitazone PLACEBO

EXPERIMENTAL

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

Drug: Sitagliptin + Pioglitazone PLACEBO

Sitagliptin + Pioglitazone

EXPERIMENTAL

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

Drug: Sitagliptin + Pioglitazone

PLACEBO

PLACEBO COMPARATOR

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

Drug: PLACEBO

Interventions

Sitagliptin + Pioglitazone PLACEBODRUG

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

Also known as: Januvia (sitagliptin), Pioglitazone (Actos)
Sitagliptin + Pioglitazone PLACEBO
Sitagliptin + PioglitazoneDRUG

Sitagliptin 100 mg tablet daily + Pioglitazone 15 mg capsule daily

Also known as: Januvia (sitaglitin), Pioglitazone (Actos)
Sitagliptin + Pioglitazone
PLACEBODRUG

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

Also known as: Januvia (sitagliptin) PLACEBO, Pioglitazone (Actos) PLACEBO
PLACEBO

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Grady Memorial Hospital

Atlanta, Georgia, 30303, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Related Publications (1)

  • 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.

    PMID: 33210751DERIVED

MeSH Terms

Conditions

Prediabetic State

Interventions

Sitagliptin PhosphatePioglitazone

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrazinesThiazolidinedionesThiazolesSulfur CompoundsOrganic Chemicals

Results Point of Contact

Title
Mary Rhee, M.D.
Organization
Emory University
mrhee@emory.edu
404-778-1666

Study Officials

  • Mary Rhee, MD

    Emory University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 27, 2009

First Posted

November 2, 2009

Study Start

July 1, 2011

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

December 5, 2013

Results First Posted

June 7, 2013

Record last verified: 2013-11

Locations

US(2)