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Can a common T2D drug stop ketoacidosis risk in type 1 diabetes?

NCT ID NCT07056699

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 24 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2026

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. 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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  3. A doctor treating you

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Contacts and locations

Locations

  • Texas Diabetes Institute

    RECRUITING

    San Antonio, Texas, 78229-3900, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.