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NCT03878459Active, not recruitingPhase 4

Dapagliflozin Plus Pioglitazone in T1DM

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?

Source: ClinicalTrials.gov · Last updated 29 Jul 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
120 (actual)
First submitted
14 Mar 2019
Start date
8 Aug 2019
Primary completion date
15 Mar 2026
Lead sponsor
The University of Texas Health Science Center at San Antonio
NCT number
NCT03878459

What you commit to

  • Study type: Interventional · Phase 4
  • Participants enrolled: 120
  • From 8 Aug 2019 to the primary completion date, 15 Mar 2026
  • 3 sites in 3 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

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

Lab values

  • 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.

Other

  • 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

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (3)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Endocrinology and Diabetes Center, Rambam Medical Center
Coordinator of this site? Confirm its status
HaifaIsraelUnknown status
Dasman Diabetes Institute
Coordinator of this site? Confirm its status
Kuwait CityKuwaitUnknown status
University Health System Texas Diabetic Institute
Coordinator of this site? Confirm its status
San AntonioUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.