Can a common diabetes pill make insulin therapy safer and more effective for type 1 diabetes?
NCT ID NCT03878459
First seen Jul 29, 2026 · Last updated Jul 30, 2026 · Updated 1 time
Summary
This phase 4 trial tests whether adding pioglitazone to an SGLT2 inhibitor (dapagliflozin) and insulin can lower blood sugar more effectively in people with type 1 diabetes while preventing a rise in ketones, which can lead to a dangerous condition called ketoacidosis. About 120 adults with type 1 diabetes and poor blood sugar control will receive dapagliflozin for 12 weeks, then be randomly assigned to pioglitazone or a placebo for another 16 weeks. Researchers will track changes in HbA1c, ketone levels, and insulin needs.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- pioglitazone
- What this could lead to
- If it works, this combination could offer a new way to improve blood sugar control in type 1 diabetes while reducing the risk of a dangerous side effect called ketoacidosis.
- What could go wrong
- This is a mid-stage trial with 120 participants, so results may not apply to everyone. Pioglitazone can cause side effects like weight gain and fluid retention.
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 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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120 people
The number who actually took part.
- Started
-
Aug 2019
- Expected to finish
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Dec 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
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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: * 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 Criteria: * 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
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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.
Contacts and locations
Locations
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Dasman Diabetes Institute
Kuwait City, Kuwait
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Endocrinology and Diabetes Center, Rambam Medical Center
Haifa, Israel
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University Health System Texas Diabetic Institute
San Antonio, Texas, 78207, United States
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Other studies related to the condition(s) this trial covers.
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