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New treatment option for Type1diabetes
Official title SGLT2i, Pioglitazone, and Ketone Production in T1D
ClinicalTrials.gov ID: NCT07056699
What this study is testing
What is Dapagliflozin 10mg Tab?
Dapagliflozin 10mg Tab is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for type1diabetes.
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
- Participants are being asked to be in a research study. Scientists do research to answer important questions which might help change or improve treatment of participants disease in the future.
- 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
- Other than diabetes, people must be in good general health as determined by the investigator based on physical exam, medical history and screening...
- 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.
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
- Other than diabetes, people must be in good general health as determined by the investigator based on physical exam, medical history and screening labs. Minor deviations may be permitted if:
- 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. Over time, these antibodies may disappear...
- 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. Women of child-bearing potential will be required to undergo a pregnancy test prior to enrollment and must agree to use...
- 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...
- 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. Prior to the screening period, potential participants will be pre-screened either by phone or in person...
The study team makes the final eligibility decision.
Where it's taking place
- 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 - 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?
Study sites include San Antonio, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.