NCT03878459 Dapagliflozin Plus Pioglitazone in T1DM

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.

This trial targets 120 participants in total. It began in 2019-08-08 with a primary completion date of 2027-06.

Brief 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.

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

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