RECRUITING

Dapagliflozin Plus Pioglitazone in T1DM

Conditions

Type 1 Diabetes Mellitus T1DM,ketoacidosis, dapagliflozin, pioglitazone

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Can Addition of Pioglitazone to SGLT2 Inhibitor in Type 1 Diabetic Patients Amplify the Decrease in HbA1c and Prevent the Increase in Plasma Ketone Concentration?

Quick Facts

Study Start:2019-08-08

Study Completion:2025-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03878459

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Muhammad Abdul-Ghani, MD, PhD

CONTACT

210 567 2391

ABDULGHANI@UTHSCSA.EDU

Study Locations (Sites)

University Health System Texas Diabetic Institute

San Antonio, Texas, 78207

United States

Collaborators and Investigators

Sponsor: The University of Texas Health Science Center at San Antonio

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-08-08

Study Completion Date2025-01

Study Record Updates

Study Start Date2019-08-08

Study Completion Date2025-01

Terms related to this study

Keywords Provided by Researchers

T1DM,ketoacidosis, dapagliflozin, pioglitazone

Additional Relevant MeSH Terms

Type 1 Diabetes Mellitus