Dapagliflozin Plus Pioglitazone in T1DM

Más betegség

• History of hospitalization for DKA, hypoglycemia or uncontrolled hyperglycemia in the preceding 6 month.
• History of hypersensitivity to dapagliflozin or pioglitazone

Laborértékek

• HbA1c <7.0% or >11.0%
• eGFR<60 ml/min
• 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.

Egyéb

• T2DM
• Daily insulin dose <0.6 U/kg per day
• Fasting C-peptide >0.7 ng/ml
• 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.
• Evidence of proliferative diabetic retinopathy
• Patients enrolled in a heavy exercise program
• Patients on ketogenic diet
• Presence of symptoms of poor glycemic control, e.g. polydipsia or polyurea

• 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