RECRUITING

Comparative Effectiveness of Two Initial Combination Therapies in Patients With Recent Onset Diabetes

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Conditions

Type 2 Diabetes (Adult Onset)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The primary purpose of this study is to evaluate the efficacy, durability, and mechanism of HbA1c reduction produced by the combination of pioglitazone plus tirzepatide compared to metformin plus sitagliptin in patients with recently diagnosed type 2 diabetes mellitus.

Official Title

Comparative Effectiveness of Two Initial Combination Therapies in Patients With New Onset Diabetes

Quick Facts

Study Start:2024-11-07
Study Completion:2029-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06246799

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Ability of subject to understand and the willingness to sign a written informed consent document.
  2. 2. Males and females; Age 18-75 years
  3. 3. Recently (within 5 years) diagnosed Type 2 Diabetes Mellitus (T2DM) patients
  4. 4. Drug naïve or receiving metformin monotherapy
  5. 5. HbA1c \>6.5% (no limit on upper HbA1c value);
  6. 6. Willingness to adhere to the investigational product regimen
  7. 7. Good general health
  8. 8. Stable body weight over the preceding 3 months
  9. 9. Agreement to adhere to Lifestyle Considerations throughout study duration.
  1. 1. positive anti-GAD (antibodies to glutamic acid decarboxylase)
  2. 2. pregnancy or plan of becoming pregnant
  3. 3. evidence of proliferative diabetic retinopathy,
  4. 4. plasma creatinine \>1.4 females or \>1.5 males;
  5. 5. presence of congestive heart failure (CHF);
  6. 6. history of cancer (\<5 years);
  7. 7. prior history of pancreatitis,
  8. 8. bladder cancer or family history of thyroid tumors;
  9. 9. presence of hematuria in the urine analysis.

Contacts and Locations

Study Contact

Muhammad Abdul-Ghani, MD
CONTACT
210-567-6691
abdulghani@uthscsa.edu
Gozde Baskoy, PhD
CONTACT
210-358-7200
baskoy@uthscsa.edu

Principal Investigator

Muhammad Abdul-Ghani, MD
PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center at San Antonio

Study Locations (Sites)

University Health System Texas Diabetic Institute
San Antonio, Texas, 78207
United States
UT Health Science Center
San Antonio, Texas, 78229
United States

Collaborators and Investigators

Sponsor: The University of Texas Health Science Center at San Antonio

  • Muhammad Abdul-Ghani, MD, PRINCIPAL_INVESTIGATOR, The University of Texas Health Science Center at San Antonio

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-07
Study Completion Date2029-06-30

Study Record Updates

Study Start Date2024-11-07
Study Completion Date2029-06-30

Terms related to this study

Additional Relevant MeSH Terms

  • Type 2 Diabetes (Adult Onset)