Type1diabetes study: Dapagliflozin vs Pioglitazone
Official title SGLT2i, Pioglitazone, and Ketone Production in T1D
ClinicalTrials.gov ID: NCT07056699
What this study is testing
What is Dapagliflozin 10mg Tab?
An investigational oral medication being studied for use in people with type 1 diabetes. It is designed to inhibit the SGLT2 protein in the kidneys to reduce glucose reabsorption.
Also referred to as Farxiga.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to see whether pioglitazone can lower the extra liver glucose, fat breakdown, and ketone production that dapagliflozin causes in type 1 diabetes patients.
- Who it's for
- Adults with type 1 diabetes who are already taking dapagliflozin.
- What's involved
- Participants will take pioglitazone in addition to their current dapagliflozin, and will have blood tests and other routine visits to monitor glucose, ketones, and other health measures.
- Time commitment
- The study lasts several months, with regular clinic visits and blood tests as scheduled by the research team.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age \>18 years
- The abnormality is not considered clinically significant.
- The deviation does not pose a safety risk or interfere with study participation.
- The rationale for inclusion is documented in the source records.
- Fasting C-peptide concentration \<0.7 ng/ml
You likely can't join if
- Type 2 Diabetes (T2D)
- Daily insulin dose \<0.6 U/kg per day
- Fasting C-peptide \>0.7 ng/ml
- HbA1c \ 11.0%
- eGFR \< 50 ml/min
- Hematuria in urine analysis
See the full eligibility criteria
- Age \>18 years
- The abnormality is not considered clinically significant.
- The deviation does not pose a safety risk or interfere with study participation.
- The rationale for inclusion is documented in the source records.
- Fasting C-peptide concentration \<0.7 ng/ml
- Poor glycemic control (HbA1c=7.0-11.0%)
- Treatment with multiple daily insulin injections (basal plus prandial) or insulin pump
- Total daily insulin dose ≥0.6 U/kg per day
- Stable insulin dose (±4 units) in the preceding three months
- eGFR ≥ 50 ml/min
- Weight stable over the preceding 3 months (± 4 pounds)
- Positive GAD antibody (Glutamic Acid Decarboxylase antibody). \
- Testing for GAD antibodies will be performed during the screening visit. Participants who test positive for GAD antibodies will be eligible for enrollment in the study.
- Type 2 Diabetes (T2D)
- Daily insulin dose \<0.6 U/kg per day
- Fasting C-peptide \>0.7 ng/ml
- HbA1c \ 11.0%
- eGFR \< 50 ml/min
- Hematuria in urine analysis
- Pregnancy, lactating, positive pregnancy test or planning to become pregnant in the following year.
- 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
- 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
- Participants with a history of radiation exposure exceeding 5 REM within the previous 12 months will be excluded.
The study team makes the final eligibility decision.
Where it is enrolling
- San Antonio, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at San Antonio, Texas, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.