DPP-4 Inhibition and TZD for DM Prevention

Prediabetic State Clinical Trial

— DInT DM  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01006018
• Other study ID #: IRB00015390
• 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

• Prediabetic State

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