Durability of Combination Therapy With Exenatide/Pioglitazone/Metformin vs. Conventional Therapy in New Onset T2DM

Diabetes Clinical Trial

Official title:

Durability of Early Initial Combination Therapy With Exenatide/Pioglitazone/Metformin vs Conventional Therapy in New Onset Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01107717
• Other study ID #: HSC20080456H
• Secondary ID: 5R01DK103841-03
• Status: Completed
• Phase: Phase 4
• Start date: January 2009
• Est. completion date: February 3, 2023

Study information

• Verified date: January 2024
• Source: The University of Texas Health Science Center at San Antonio
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Type 2 diabetes is a systemic metabolic disease with significant morbidity and mortality due to damaging blood vessels. Increased blood sugar level is a hallmark of diabetes and is an contributes to the development of many of its complications. Multiple defects, e.g. impaired insulin secretion and impaired insulin action, contribute to the development of the disease. The aim of this study is to test the efficacy and durability of combination of drugs which correct the defects that lead to the development of diabetes on achieving adequate and durable control of blood sugar levels. Achieving adequate and durable control of blood sugar will prevent many of diabetes complications.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 521
• Est. completion date: February 3, 2023
• Est. primary completion date: February 3, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• subjects with type 2 diabetes diagnosed during the past 2 years,

• above 18 years of age,

• drug naive, or have been on metformin less than 3 months

Exclusion Criteria:

• subjects with type 1 diabetes or GAD positive subjects or subjects with long standing diabetes (>2 years) or subjects who are not drug naive or have been on metformin more than 3 months.

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus

Intervention

Drug:
• metformin\pioglitazone\exenatide
metformin (1000 mg), pioglitazone (15 mg) and exenatide (5 microgram bid) are started and dose is up titrated to achieve HbA1c < 6.5%
• metformin, glyburide and glargine
subjects are started on metformin 500 mg bid and dose is up titrated and glyburide (up to 5 mg) and glargine are sequentially added to maintain HbA1c < 6.5%

Locations

Country	Name	City	State
United States	Texas Diabetes Institute	San Antonio	Texas

Sponsors (4)

Lead Sponsor	Collaborator
The University of Texas Health Science Center at San Antonio	American Diabetes Association, Amylin Pharmaceuticals, LLC., National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in HbA1c level	subjects will be followed for 3 years and the difference in HbA1c between the two arms at 3 years is the primary outcome of the study	at the end of the study (3 years)
Secondary	treatment failure	subjects with HbA1c >6.5 at 6 months and 3 years are considered treatment failure	at 6 months and 3 years
Secondary	hypoglycemic events	asymptomatic hypoglycemic events with documented PGC < 60 mg/dl and sympotomatic hypoglycemia	during the entire study (3 years)

External Links

•   ADA Website
•   TDI site
•   UT Health San Antonio