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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?
Sponsor: Dasman Diabetes Institute
Summary
Previous data from our clinical trial has demonstrated that the combination of dapagliflozin plus pioglitazone cause robust decrease in the plasma glucose concentration without significant increase in plasma ketone concentration in subjects with T1DM receiving multiple insulin injections or insulin pump. Although patients receiving insulin therapy with pump have participated in the study, none has insulin delivered in automated pump (780 pump) which automatically adjusts the rate of insulin infusion based upon the measured plasma glucose concentration. Although automated insulin pumps have been introduced to practice only last year, they are gaining popularity in the care of T1DM patients worldwide. The aim of this amendment is to demonstrate the efficacy (decrease in HbA1c) and safety (no significant increase in plasma ketone concentration) of combination of dapagliflozin plus pioglitazone in T1DM patients receiving insulin therapy with automated insulin pump.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2025-09-15
Completion Date
2027-01-15
Last Updated
2025-08-29
Healthy Volunteers
No
Conditions
Interventions
Dapagliflozin (DAPA)
The hypothesis tested in the original study was whether the addition of pioglitazone in patients with type 1 diabetes mellitus (T1DM) receiving therapy with dapagliflozin would amplify the decrease in HbA1c and prevent the increase in plasma ketone concentration caused by dapagliflozin.
Pioglitazone 45 mg
The hypothesis tested in the original study was whether the addition of pioglitazone in patients with type 1 diabetes mellitus (T1DM) receiving therapy with dapagliflozin would amplify the decrease in HbA1c and prevent the increase in plasma ketone concentration caused by dapagliflozin.
Placebo
Placebo
Locations (3)
Dasman Diabetes Institute
Kuwait City, Kuwait
Hamad Medical Corporation
Doha, Qatar
Diabetes and Endocrine Treatment Center, Prince Sultan Military Medical City. Kidney & Pancreas Health Centre, Organ Transplant Centre of Excellence, King Faisal Specialist Hospital & Research Centre, Alfaisal Univeristy, Riyadh, Kingdom of Saudi Arabia
Riyadh, Saudi Arabia