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
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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Kuwait City, , Kuwait
Qatar, Doha, Qatar
Riyadh, , Saudi Arabia
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