Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
24 participants
INTERVENTIONAL
2026-01-30
2027-06-30
Brief Summary
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In patients with Type 1 Diabetes (T1D), Dapagliflozin a Selective Glucose Transporter 2 Inhibitor (SGLT2i) is known to increase production of glucose in the liver, increase breakdown of fats (lipolysis), and increase production of ketones (ketogenesis). Ketones are chemicals produced by the liver when the body breaks down fat for energy instead of glucose. When the level of ketones in the body becomes too high, a condition called ketoacidosis develops. In this study, the study team will investigate whether adding pioglitazone (a medication commonly used to treat type 2 diabetes), can reduce the Dapagliflozin - induced liver glucose production, fat break down (lipolysis) and ketone body production (ketogenesis) in patients with Type 1 Diabetes (T1D).
Detailed Description
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Dapagliflozin is in a class of drugs known as Selective Glucose Cotransporter 2 inhibitors (SGLT2i) and has been shown to effectively lower blood sugar concentration in type 1 diabetes mellitus (T1DM) patients. These drugs lower blood glucose levels by preventing or reducing the re-absorption of glucose in the kidneys. This results in the release of glucose into the urine. At the same time, Selective Glucose Transporter 2 Inhibitor (SGLT2i) drugs stimulate glucose production by the liver, which helps compensate for the loss of glucose into the urine. Also, the use of dapagliflozin in patients with type 1 diabetes was associated with increased risk of ketoacidosis. Ketoacidosis is a serious condition that occurs when the body produces high levels of ketones, leading to increased acidity in the blood. Pioglitazone is in a class of thiazolidinediones and is commonly used to treat high blood sugar levels caused by type 2 diabetes. The investigators believe that the addition of pioglitazone, to dapagliflozin will prevent the risk of ketoacidosis associated with dapagliflozin, and will cause a large reduction in plasma glucose concentration in type 1 diabetes (T1DM) patients.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Experimental study drug for T1D
Dapagliflozin (10 mg/day) + Pioglitazone (15 mg/day for 2 weeks, then 30 mg/day for 14 weeks)
Dapagliflozin 10mg Tab
Dapagliflozin (10 mg/day)
Pioglitazone 15 MG and 30mg
Pioglitazone (15 mg/day for 2 weeks, then 30 mg/day for 14 weeks)
Placebo Group for T1D
Dapagliflozin (10 mg/day) + Placebo (for 16 weeks)
Dapagliflozin 10mg Tab
Dapagliflozin (10 mg/day)
Placebo
Inert placebo for Pioglitazone
Interventions
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Dapagliflozin 10mg Tab
Dapagliflozin (10 mg/day)
Pioglitazone 15 MG and 30mg
Pioglitazone (15 mg/day for 2 weeks, then 30 mg/day for 14 weeks)
Placebo
Inert placebo for Pioglitazone
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. T1DM
3. Other than diabetes, subjects must be in good general health as determined by physical exam, medical history, Chem 20, CBC, TSH, urinalysis, and EKG.
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≥60 ml/min
10. Weight stable over the preceding 3 months (± 3 pounds) and who do not participate in an excessively heavy exercise program
Exclusion Criteria
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\<60 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 requested to use at least two barrier methods before being enrolled in 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
18 Years
ALL
No
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
The University of Texas Health Science Center at San Antonio
OTHER
Responsible Party
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Principal Investigators
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Muhammad Abdul-Ghani, MD
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center at San Antonio
Ralph DeFronzo, MD
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center at San Antonio
Locations
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Texas Diabetes Institute
San Antonio, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Ralph Defronzo, MD
Role: primary
Aurora Merovci, MD, MPH
Role: backup
Other Identifiers
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STUDY00001633 - 504078
Identifier Type: -
Identifier Source: org_study_id