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?

ConditionType 1 Diabetes

Trial statusNot yet recruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age18+

SponsorDasman Diabetes Institute

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

60 Participants

are divided into 2 treatment groups

Group A: Pioglitazone and DapagliflozinActive comparator 2 interventions

Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

HbA1C Reduction

1\) The primary objective of the study is to examine the decrease in HbA1c caused by pioglitazone plus dapagliflozin versus placebo in T1DM patients receiving automated insulin delivery (780 pump).

Time frame

16 weeks

Secondary outcomes

Time in Range

Secondary objectives of the study are to examine the effect of pioglitazone plus dapagliflozin on plasma ketone concentration, time in range, body weight and rate of hypoglycemia.

Time frame

16 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Dasman Diabetes Institute

Lead sponsor

Source ClinicalTrials.gov

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