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

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.

Conditions

Type 2 Diabetes (Adult Onset)

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Type 2 Diabetes (Adult Onset)
Intervention / Treatment

-

Contacts and Locations

San Antonio

University Health System Texas Diabetic Institute, San Antonio, Texas, United States, 78207

San Antonio

UT Health Science Center, San Antonio, Texas, United States, 78229

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

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

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

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

2029-06-30