Health TrialsbyHealthPanel

Dapagliflozin Plus Pioglitazone in T1DM

ConditionType 1 Diabetes Mellitus
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe University of Texas Health Science Center at San Antonio

About this trial

Purpose: To examine the effect of addition of combination therapy with dapagliflozin plus pioglitazone to insulin on glucose control and plasma ketone concentration in patients with type 1 diabetes (T1DM) Research Design: 120 patients with type 1 diabetes who otherwise are healthy constitute the study population. After screening, eligible subjects will start 4 week run in. At week 4, subjects will receive dapagliflozin for 12 weeks. At week 16, subjects will be randomized to receive in a double blind fashion pioglitazone or placebo for 16 weeks.

Methods: the following techniques will be employed in the present study: (1) mixed meal tolerance test; (2) indirect calorimetry; (3) continuous glucose monitoring.

Clinical Relevance: the results of the present study will demonstrate that the addition of pioglitazone to SGLT2 inhibitor in T1DM patients produces greater reduction in the HbA1c without increasing risk of ketoacidosis and hypoglycemia.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age >18 years

T1DM

Good general health

Fasting C-peptide concentration <0.7 ng/ml

Disqualifiers

T2DM

Daily insulin dose <0.6 U/kg per day

Fasting C-peptide >0.7 ng/ml

HbA1c <7.0% or >11.0%

Trial design

Design model

Parallel

Treatments tested in this trial

  • Pioglitazone 45 mg

    Drug

    patients will be started on 15 mg and the dose escalated to the maximal tolerated dose

  • Placebo

    Drug

    PATIENTS WILL RECEIVE PLACEBO

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: InterventionExperimental treatment 1 intervention
Group B: controlPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Decrease in HbA1c

Time frame
28 weeks

Secondary outcomes

1

plasma ketones

increase in plasma ketone concentration

Time frame
28 weeks
2

insulin dose

decrease in daily insulin dose

Time frame
28 weeks

Other outcomes

Sponsors and contacts

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

The University of Texas Health Science Center at San Antonio

Lead sponsor

Source ClinicalTrials.gov
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