Actively Recruiting
Dapagliflozin Plus Pioglitazone in T1DM
Led by The University of Texas Health Science Center at San Antonio · Updated on 2025-07-01
120
Participants Needed
3
Research Sites
433 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Purpose: To examine the effect of addition of combination therapy with dapagliflozin plus pioglitazone to insulin on glucose control and plasma ketone concentration in patients with type 1 diabetes (T1DM) Research Design: 120 patients with type 1 diabetes who otherwise are healthy constitute the study population. After screening, eligible subjects will start 4 week run in. At week 4, subjects will receive dapagliflozin for 12 weeks. At week 16, subjects will be randomized to receive in a double blind fashion pioglitazone or placebo for 16 weeks. Methods: the following techniques will be employed in the present study: (1) mixed meal tolerance test; (2) indirect calorimetry; (3) continuous glucose monitoring. Clinical Relevance: the results of the present study will demonstrate that the addition of pioglitazone to SGLT2 inhibitor in T1DM patients produces greater reduction in the HbA1c without increasing risk of ketoacidosis and hypoglycemia.
CONDITIONS
Official Title
Dapagliflozin Plus Pioglitazone in T1DM
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age greater than 18 years
- Diagnosed with type 1 diabetes mellitus
- Good general health
- Fasting C-peptide concentration less than 0.7 ng/ml
- Poor glycemic control with HbA1c between 7.0% and 11.0%
- Using multiple daily insulin injections or an insulin pump
- Total daily insulin dose of at least 0.6 units per kilogram per day
- Stable insulin dose within plus or minus 4 units in the last three months
- Estimated glomerular filtration rate (eGFR) of 60 ml/min or higher
- Weight stable within plus or minus 3 pounds in the last three months
- Not participating in an excessively heavy exercise program
You will not qualify if you...
- Diagnosis of type 2 diabetes mellitus
- Daily insulin dose less than 0.6 units per kilogram per day
- Fasting C-peptide concentration greater than 0.7 ng/ml
- HbA1c less than 7.0% or greater than 11.0%
- Estimated glomerular filtration rate (eGFR) less than 60 ml/min
- Presence of hematuria in urine analysis
- Pregnancy, lactating, positive pregnancy test, or planning pregnancy within the next year
- Women of childbearing potential not using at least two barrier contraceptive methods
- Major organ system diseases including malignancy, heart disease, chronic liver disease, alcohol or drug abuse, chronic lung disease, rheumatic disease, chronic pancreatitis or pancreatic surgery, stroke or transient ischemic attack, HIV infection or immune-compromised disease, or history of organ transplantation
- Use of medications other than insulin that affect glucose metabolism (e.g., prednisone)
- Evidence of proliferative diabetic retinopathy
- Enrollment in a heavy exercise program
- Following a ketogenic diet
- Hospitalization for diabetic ketoacidosis, hypoglycemia, or uncontrolled hyperglycemia within the last six months
- Symptoms of poor glycemic control, such as excessive thirst or urination
- Known hypersensitivity to dapagliflozin or pioglitazone
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
University Health System Texas Diabetic Institute
San Antonio, Texas, United States, 78207
Active, Not Recruiting
2
Endocrinology and Diabetes Center, Rambam Medical Center
Haifa, Israel
Active, Not Recruiting
3
Dasman Diabetes Institute
Kuwait City, Kuwait
Actively Recruiting
Research Team
M
Muhammad Abdul-Ghani, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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