NCT03878459 · The University of Texas Health Science Center at San Antonio
Dapagliflozin Plus Pioglitazone in T1DM
What this study is about
Purpose: To examine the effect of addition of two or more treatments used together 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.
View original scientific description
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.
Interventions
DRUG
Pioglitazone 45 mg
patients will be started on 15 mg and the dose escalated to the maximal tolerated dose
DRUG
Placebo
PATIENTS WILL RECEIVE PLACEBO
Primary outcome measures
Decrease in HbA1c
Time frame: 28 weeks
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Age \>18 years
- 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
- 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
Where
- San Antonio, Texas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 1, 2025 · Source of record for eligibility and locations