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

Primary Purpose

Diabetes

Status

Active

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

metformin\pioglitazone\exenatide

metformin, glyburide and glargine

About this trial

This is an interventional treatment trial for Diabetes focused on measuring type 2 diabetes, new onset, combination therapy, new onset type 2 diabetes

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Texas Diabetes Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Triple Therapy

conventional therapy

Arm Description

initiation a combination of metformin (1000 mg), pioglitazone (15 mg) and exenatide (5 microgram bid) at the time diabetes is diagnosed

sequential addition of metformin, glyburide and basal insulin

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

treatment failure

subjects with HbA1c >6.5 at 6 months and 3 years are considered treatment failure

hypoglycemic events

asymptomatic hypoglycemic events with documented PGC < 60 mg/dl and sympotomatic hypoglycemia

Full Information

NCT ID

NCT01107717

First Posted

April 19, 2010

Last Updated

March 20, 2023

Sponsor

The University of Texas Health Science Center at San Antonio

Collaborators

American Diabetes Association, Amylin Pharmaceuticals, LLC., National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

1. Study Identification

Unique Protocol Identification Number

NCT01107717

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

January 2009 (undefined)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The University of Texas Health Science Center at San Antonio

Collaborators

American Diabetes Association, Amylin Pharmaceuticals, LLC., National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

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

Diabetes

Keywords

type 2 diabetes, new onset, combination therapy, new onset type 2 diabetes

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

521 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Triple Therapy

Arm Type

Experimental

Arm Description

initiation a combination of metformin (1000 mg), pioglitazone (15 mg) and exenatide (5 microgram bid) at the time diabetes is diagnosed

Arm Title

conventional therapy

Arm Type

Active Comparator

Arm Description

sequential addition of metformin, glyburide and basal insulin

Intervention Type

Drug

Intervention Name(s)

metformin\pioglitazone\exenatide

Intervention Description

metformin (1000 mg), pioglitazone (15 mg) and exenatide (5 microgram bid) are started and dose is up titrated to achieve HbA1c < 6.5%

Intervention Type

Drug

Intervention Name(s)

metformin, glyburide and glargine

Intervention Description

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%

Primary Outcome Measure Information:

Title

Difference in HbA1c level

Description

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

Time Frame

at the end of the study (3 years)

Secondary Outcome Measure Information:

Title

treatment failure

Description

subjects with HbA1c >6.5 at 6 months and 3 years are considered treatment failure

Time Frame

at 6 months and 3 years

Title

hypoglycemic events

Description

asymptomatic hypoglycemic events with documented PGC < 60 mg/dl and sympotomatic hypoglycemia

Time Frame

during the entire study (3 years)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ralph DeFronzo, MD

Organizational Affiliation

The University of Texas Health Science Center at San Antonio

Official's Role

Principal Investigator

Facility Information:

Facility Name

Texas Diabetes Institute

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229-3900

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

33273042

Citation

Abdul-Ghani M, Puckett C, Adams J, Khattab A, Baskoy G, Cersosimo E, Triplitt C, DeFronzo RA. Durability of Triple Combination Therapy Versus Stepwise Addition Therapy in Patients With New-Onset T2DM: 3-Year Follow-up of EDICT. Diabetes Care. 2021 Feb;44(2):433-439. doi: 10.2337/dc20-0978. Epub 2020 Dec 3.

Results Reference

derived

Links:

URL

http://www.diabetes.org/

Description

ADA Website

URL

https://www.universityhealthsystem.com/services/diabetes

Description

TDI site

URL

http://www.uthscsa.edu

Description

UT Health San Antonio

Learn more about this trial

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

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