Can the Addition of Pioglitazone to SGLT2 Inhibitor in Type 1 Diabetic Patients Amplify the Decrease in HbA1c and Prevent the Increase in Plasma Ketone Concentration?

Launched by DASMAN DIABETES INSTITUTE · Apr 3, 2025

Keywords

ClinConnect Summary

This clinical trial is studying whether adding a medication called pioglitazone to an existing diabetes treatment, dapagliflozin, can help improve blood sugar levels in people with Type 1 Diabetes (T1D) who use automated insulin pumps. The goal is to see if this combination can lower a measure of long-term blood sugar control (called HbA1c) without causing an increase in harmful substances known as ketones in the blood.

To be eligible for this trial, participants should be over 18 years old, have Type 1 Diabetes, and be in generally good health. They should also have poor blood sugar control, indicated by an HbA1c between 7.0% and 11.0%, and be using either multiple daily insulin injections or insulin pumps. Participants can expect close monitoring of their health throughout the study, and they will be contributing to important research that could help improve treatment options for others with diabetes.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • - 1) Age \>18 years 2) T1DM 3) Other than diabetes, subjects must be in good general health as determined by physical exam, medical history, Chem 20, CBC, TSH, urinalysis, and EKG.
• • 4) Fasting C-peptide concentration \<0.7 ng/ml 5) Poor glycemic control (HbA1c=7.0-11.0%) 6) Treatment with multiple daily insulin injections (basal plus prandial) or insulin pump 7) Total daily insulin dose ≥0.6 U/kg per day 8) Stable insulin dose (±4 units) in the preceding three months. 9) eGFR≥60 ml/min. 10) Weight stable over the preceding 3 months (± 3 pounds) and who do not participate in an excessively heavy exercise program
• Exclusion Criteria:
• • 1) Age \>18 years 2) T1DM 3) Other than diabetes, subjects must be in good general health as determined by physical exam, medical history, Chem 20, CBC, TSH, urinalysis, and EKG.
• • 4) Fasting C-peptide concentration \<0.7 ng/ml 5) Poor glycemic control (HbA1c=7.0-11.0%) 6) Treatment with multiple daily insulin injections (basal plus prandial) or insulin pump 7) Total daily insulin dose ≥0.6 U/kg per day 8) Stable insulin dose (±4 units) in the preceding three months. 9) eGFR≥60 ml/min. 10) Weight stable over the preceding 3 months (± 3 pounds) and who do not participate in an excessively heavy exercise program