Dapagliflozin Plus Pioglitazone in T1DM

Launched by THE UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER AT SAN ANTONIO · Mar 15, 2019

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a new combination therapy for people with Type 1 Diabetes Mellitus (T1DM). The researchers want to see if adding two medications, dapagliflozin and pioglitazone, to a patient’s insulin treatment can help improve blood sugar control without increasing the risk of serious side effects, like ketoacidosis (a dangerous condition caused by high ketone levels) or low blood sugar. The study will include 120 healthy adults aged 18 and older who struggle to manage their blood sugar levels despite using insulin.

Participants in the trial will first go through a 4-week period to assess their health, followed by 12 weeks of taking dapagliflozin. After that, they will be randomly assigned to receive either pioglitazone or a placebo (a treatment that looks like the real drug but has no active ingredients) for an additional 16 weeks. During the study, researchers will monitor participants' blood sugar levels and overall health using various tests. This trial is currently recruiting participants, and eligible individuals should have specific criteria, such as poor blood sugar control and a stable insulin dose. If you're interested or think you might qualify, it’s a good idea to talk to your healthcare provider for more information.

Gender

ALL

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