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Search / Trial NCT06922656

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

Trial Information

Current as of July 09, 2025

Not yet recruiting

Keywords

Ketoacidosis, Hypoglycemia, Glucose Control, Sglt2 Inhibitors, Tzd, Pioglitazone, T1 D

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

About Dasman Diabetes Institute

Dasman Diabetes Institute (DDI) is a leading research and clinical organization dedicated to advancing diabetes care and management through innovative research, education, and community outreach. Established to address the growing prevalence of diabetes, DDI focuses on conducting high-quality clinical trials aimed at developing effective prevention and treatment strategies. The institute collaborates with local and international partners to enhance understanding of diabetes and its complications, fostering a multidisciplinary approach that integrates clinical practice with cutting-edge research. With a commitment to improving patient outcomes, DDI serves as a vital resource for healthcare professionals, researchers, and individuals affected by diabetes.

Locations

Kuwait City, , Kuwait

Qatar, Doha, Qatar

Riyadh, , Saudi Arabia

Patients applied

0 patients applied

Trial Officials

Fahd Al-Mulla, MD, PhD

Study Chair

Dasman Diabetes Institute

Muhammed Abdul Ghani, MD, PhD

Principal Investigator

Texas Diabetes Institute, Dasman Diabetes Institute

Mohamed Abu-Farha, PhD

Study Director

Dasman Diabetes Institute

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported