Status:
RECRUITING
Dapagliflozin Plus Pioglitazone in T1DM
Lead Sponsor:
The University of Texas Health Science Center at San Antonio
Conditions:
Type 1 Diabetes Mellitus
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 (T...
Detailed Description
Insulin deficiency, due to autoimmune destruction of beta cells, is the primary factor responsible for the development of T1DM, and insulin replacement therapy is the mainstay for the management of hy...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 8 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT03878459
Start Date
August 8 2019
End Date
December 1 2027
Last Update
July 1 2025
Active Locations (3)
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1
University Health System Texas Diabetic Institute
San Antonio, Texas, United States, 78207
2
Endocrinology and Diabetes Center, Rambam Medical Center
Haifa, Israel
3
Dasman Diabetes Institute
Kuwait City, Kuwait