Status:
NOT_YET_RECRUITING
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?
Lead Sponsor:
Dasman Diabetes Institute
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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...
Detailed Description
Insulin Pumps Participants The interim analysis of our previous study has demonstrated that the combination of dapagliflozin plus pioglitazone cause robust decrease in the plasma glucose concentration...
Eligibility Criteria
Inclusion
- \- 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
- 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
Key Trial Info
Start Date :
September 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 15 2027
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06922656
Start Date
September 15 2025
End Date
January 15 2027
Last Update
August 29 2025
Active Locations (3)
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1
Dasman Diabetes Institute
Kuwait City, Kuwait, 1180
2
Hamad Medical Corporation
Doha, Qatar
3
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