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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01006018
Other study ID # IRB00015390
Secondary ID
Status Terminated
Phase N/A
First received October 27, 2009
Last updated November 12, 2013
Start date July 2011
Est. completion date December 2011

Study information

Verified date November 2013
Source Emory University
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 3
Est. completion date December 2011
Est. primary completion date December 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 80 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Drug:
Sitagliptin + Pioglitazone PLACEBO
Sitagliptin 100 mg tablet daily + Pioglitazone PLACEBO 15 mg capsule daily
Sitagliptin + Pioglitazone
Sitagliptin 100 mg tablet daily + Pioglitazone 15 mg capsule daily
PLACEBO
Sitagliptin placebo 100 mg tablet daily + Pioglitazone placebo 15 mg capsule daily

Locations

Country Name City State
United States Emory University Hospital Atlanta Georgia
United States Grady Memorial Hospital Atlanta Georgia

Sponsors (2)

Lead Sponsor Collaborator
Emory University Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Insulin Secretion Not measured as study was prematurely terminated due to unanticipated delays. baseline, 6 months, 9 months (after a 3 month washout) No
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