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

NCT01107717 | Completed Phase 4 Results DMC

• 2 other identifiers: HSC20080456H5R01DK103841-03
• Study Type: interventional
• Target: 318
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes

Keywords

type 2 diabetes; new onset; combination therapy; new onset type 2 diabetes

Outcome Measures

Primary Outcomes (1)

• HbA1c Level

  subjects will be followed for 3 years and the HbA1c measured at this time to provide the values for each arm as defined for the primary outcome of the study

  at the end of the study (3 years)

Secondary Outcomes (2)

• Treatment Failure

  3 years

• Percentage of Patients With Reported Hypoglycemic Events

  during the entire study (3 years)

Study Arms (2)

Triple Therapy

EXPERIMENTAL

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

Drug: metformin\pioglitazone\exenatide

conventional therapy

ACTIVE COMPARATOR

sequential addition of metformin, glyburide and basal insulin

Drug: metformin, glyburide and glargine

Interventions

metformin\pioglitazone\exenatide DRUG

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

Triple Therapy

metformin, glyburide and glargine DRUG

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%

conventional therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead
• American Diabetes Association: collaborator
• Amylin Pharmaceuticals, LLC.: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Texas Diabetes Institute

San Antonio, Texas, 78229-3900, United States

Location

Related Publications (2)

• 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.

  PMID: 33273042 RESULT

• Abdul-Ghani M, Puckett C, Abdelgani S, Merovci A, Lavrynenko O, Adams J, Triplitt C, DeFronzo RA. Glycemic and non-glycemic benefits of initial triple therapy versus sequential add-on therapy in patients with new-onset diabetes: results from the EDICT study. BMJ Open Diabetes Res Care. 2025 Apr 27;13(2):e004981. doi: 10.1136/bmjdrc-2025-004981.

  PMID: 40288809 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2

Interventions

Metformin; Glyburide; Insulin Glargine

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Sulfonylurea Compounds; Urea; Amides; Sulfones; Sulfur Compounds; Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Muhammad Abdul-Ghani, MD
• Organization: University of Texas Health Science Center at San Antonio

abdulghani@uthscsa.edu

210-557-1157

Study Officials

• Ralph DeFronzo, MD

  The University of Texas Health Science Center at San Antonio

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2010
• First Posted: April 21, 2010
• Study Start: January 1, 2009
• Primary Completion: February 3, 2023
• Study Completion: February 3, 2023
• Last Updated: September 5, 2024
• Results First Posted: September 5, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: At study completion after publication in a peer review journal

Locations

US (1)