Dapagliflozin Plus Pioglitazone in T1DM
Recruiting
Phase 4
Interventional Study
Type 1 Diabetes Mellitus
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 120 (estimated)
- Sponsor
- The University of Texas Health Science Center at San Antonio · Other
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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…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Age \>18 years
* T1DM
* Good general health
* Fasting C-peptide concentration \<0.7 ng/ml
* Poor glycemic control (HbA1c=7.0-11.0%)
* Treatment with multiple daily insulin injections or insulin pump
* Total daily insulin dose ≥0.6 U/kg per day
* Stable insulin dose (±4 units) …
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