Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:02 PM
Ignite Modification Date:
2025-12-24 @ 3:02 PM
NCT ID:
NCT03878459
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03878459
Study Brief:
Protocol Section:
NCT03878459