Dapagliflozin Plus Pioglitazone in T1DM (NCT03878459) | Clinical Trial Compass
Active — Not RecruitingPhase 4
Dapagliflozin Plus Pioglitazone in T1DM
United States, Israel, Kuwait120 participantsStarted 2019-08-08
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 transp…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Decrease in HbA1c
Timeframe: 28 weeks
Trial details
NCT IDNCT03878459
SponsorThe University of Texas Health Science Center at San Antonio