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
Study ID
NCT06922656
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dapagliflozin (DAPA) — DRUG
    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 — DRUG
    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 — DRUG
    Placebo

Study Details

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 Dates

Start date
Sep 15, 2025
Status verified
Mar 2025
Primary completion
Sep 1, 2026
Completion
Jan 15, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Pioglitazone and Dapagliflozin
    Group 1 will be started on dapagliflozin 10 mg per day plus 30 mg pioglitazone.
  • Placebo Comparator: Placebo
    Group 2 will receive matching placebo

Primary Outcome Measure

HbA1C Reduction [ Time Frame: 16 weeks ]

Central Contacts

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