Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT06922656
PHASE4

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

View on ClinicalTrials.gov

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

DRUG

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.

DRUG

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.

DRUG

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