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

Launched by THE UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER AT SAN ANTONIO · Jan 30, 2024

Keywords

ClinConnect Summary

This clinical trial is studying two different combinations of medications to see how well they help manage blood sugar levels in adults who have recently been diagnosed with type 2 diabetes. Researchers want to find out if the combination of pioglitazone and tirzepatide is more effective than the combination of metformin and sitagliptin in lowering blood sugar. Participants in the trial will take pioglitazone, starting at 15 mg daily and increasing to 45 mg daily after three months.

To join the study, you need to be between 18 and 75 years old, have been diagnosed with type 2 diabetes within the last five years, and either not be on any diabetes medication or currently taking metformin alone. You should also have a specific blood sugar level (HbA1c greater than 6.5%) and be in good overall health. If you qualify, you will be part of a group that receives one of the medication combinations and will need to follow a treatment plan while also making some lifestyle changes. It's important to note that certain health conditions or recent medical issues may prevent you from participating.

Gender

ALL

Eligibility criteria

• Inclusion 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.
• Exclusion Criteria:
• • 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.