Can a common T2D drug stop ketoacidosis risk in type 1 diabetes?
NCT ID NCT07056699
First seen Jun 27, 2026 · Last updated Jul 21, 2026 · Updated 3 times
Summary
This study looks at whether adding pioglitazone (a type 2 diabetes drug) to dapagliflozin (an SGLT2 inhibitor) can reduce the liver's glucose production, fat breakdown, and ketone production in people with type 1 diabetes. These effects from dapagliflozin can raise the risk of ketoacidosis, a dangerous condition. The study will involve 24 adults with type 1 diabetes and poor blood sugar control, using tracer infusions to measure changes over 16 weeks.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 24 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2026
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
INCLUSION CRITERIA 1. Age \>18 years 2. T1D 3. Other than diabetes, subjects must be in good general health as determined by the investigator based on physical exam, medical history and screening labs. Minor deviations may be permitted if: * The abnormality is not considered clinically significant. * The deviation does not pose a safety risk or interfere with study participation. * The rationale for inclusion is documented in the source records. 4. Fasting C-peptide concentration \<0.7 ng/ml 5. Poor glycemic control (HbA1c=7.0-11.0%) 6. Treatment with multiple daily insulin injections (basal plus prandial) or insulin pump 7. Total daily insulin dose ≥0.6 U/kg per day 8. Stable insulin dose (±4 units) in the preceding three months 9. eGFR ≥ 50 ml/min 10. Weight stable over the preceding 3 months (± 4 pounds) 11. Positive GAD antibody (Glutamic Acid Decarboxylase antibody). \* * Testing for GAD antibodies will be performed during the screening visit. Participants who test positive for GAD antibodies will be eligible for enrollment in the study. Over time, these antibodies may disappear, reducing the likelihood of a positive result during screening. If participant tests negative for GAD antibodies, their medical history will be reviewed to determine whether testing for GAD antibodies was performed at an earlier stage of Type 1 Diabetes (T1D). If prior positive results are confirmed, the participant may be enrolled. If a participant tests positive for antibodies other than GAD, an exception request will be submitted to the Institutional Review Board (IRB) for approval. EXCLUSION CRITERIA 1. Type 2 Diabetes (T2D) 2. Daily insulin dose \<0.6 U/kg per day 3. Fasting C-peptide \>0.7 ng/ml 4. HbA1c \<7.0% or \>11.0% 5. eGFR \< 50 ml/min 6. Hematuria in urine analysis 7. Pregnancy, lactating, positive pregnancy test or planning to become pregnant in the following year. Women of child-bearing potential will be required to undergo a pregnancy test prior to enrollment and must agree to use effective contraception (at least two barrier methods) for the duration of the study. 8. 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. 9. Evidence of proliferative diabetic retinopathy 10. Patients enrolled in a heavy exercise program 11. Patients on ketogenic diet 12. History of hospitalization for DKA, hypoglycemia or uncontrolled hyperglycemia in the preceding 6 month. 13. Presence of symptoms of poor glycemic control, e.g. polydipsia or polyurea 14. History of hypersensitivity to dapagliflozin or pioglitazone 15. Participants with a history of radiation exposure exceeding 5 REM within the previous 12 months will be excluded. Prior to the screening period, potential participants will be pre-screened either by phone or in person at the Texas Diabetes Institute. Individuals with prior significant radiation exposure will be excluded.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Texas Diabetes Institute
RECRUITINGSan Antonio, Texas, 78229-3900, United States
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