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Dapagliflozin Plus Pioglitazone for Type 1 Diabetes

This study is looking at how adding two medications, dapagliflozin and pioglitazone, to insulin therapy affects blood sugar control in people with type 1 diabetes (T1DM). Researchers want to see if this combination can help lower your HbA1c (a measure of average blood sugar over 2-3 months). You might be able to join if you are over 18, have T1DM, are in good general health, and have poor blood sugar control (HbA1c between 7.0-11.0%). You also need to be taking multiple daily insulin injections or using an insulin pump. The study plans to enroll 120 participants, but its current status is unclear.

Study design
This is an interventional study involving 120 participants. After an initial period, participants will receive dapagliflozin, and then be randomly assigned to receive either pioglitazone or a placebo (an inactive substance) in a double-blind fashion.
What's involved
You would participate in a 4-week run-in period, followed by 12 weeks of dapagliflozin, and then 16 weeks of either pioglitazone or placebo. The study involves mixed meal tolerance tests, indirect calorimetry, and continuous glucose monitoring.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, decrease in HbA1c, is measured at 28 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03878459

Dapagliflozin Plus Pioglitazone in T1DM

Active, Not Recruiting
PHASE4Ages 18+InterventionalTreatment
The University of Texas Health Science Center at San Antonio
~120 participants
Updated 2026-07-29 on ClinicalTrials.gov
What's tested:Pioglitazone 45 mgPlacebo

At a glance

Recruiting sites
0 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Decrease in HbA1c
Measured over 28 weeks

Conditions

Type 1 Diabetes Mellitus

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Where it's being run

3 sites across 3 states
Texas1
Israel1
Kuwait1

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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) in the preceding three months.
eGFR≥60 ml/min
Weight stable over the preceding 3 months (± 3 pounds)
Do not participate in an excessively heavy exercise program

Exclusion

T2DM
Daily insulin dose \<0.6 U/kg per day
Fasting C-peptide \>0.7 ng/ml
HbA1c \<7.0% or \>11.0%
eGFR\<60 ml/min
Hematuria in urine analysis
Pregnancy, lactating, positive pregnancy test or planning to become pregnant in the following year.
Women of child-bearing potential will be requested to use at least two barrier methods before being enrolled in the study.
Major organ system disease which includes: (i) malignancy or history of malignancy including bladder cancer; (ii) Congestive heart failure or history of coronary heart disease or any other cardiac disease; (iii) chronic liver disease or LFT \>3 times the upper normal level; (iv) History of alcohol or drug abuse; (v) History of chronic lung disease (e.g., COPD, asthma); (vi) history of rheumatic disease; (vii) History of chronic pancreatitis or pancreatic surgery; (viii) History of CVA or TIA (ix) Planned surgery during the study; (x) history of HIV infection or other immune compromised disease; and history of organ transplantation; (xi) patients who take medications, other than insulin, known to affect glucose metabolism, e.g., prednisone.
Evidence of proliferative diabetic retinopathy
Patients enrolled in a heavy exercise program
Patients on ketogenic diet
History of hospitalization for DKA, hypoglycemia or uncontrolled hyperglycemia in the preceding 6 month.
Presence of symptoms of poor glycemic control, e.g. polydipsia or polyurea
History of hypersensitivity to dapagliflozin or pioglitazone

What this trial measures

  • Decrease in HbA1c28 weeks