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New treatment option for Type 1 Diabetes
Official title Cholesterol Lowering and Residual Risk in Diabetes, Type 1
ClinicalTrials.gov ID: NCT05641753
What this study is testing
What is Evolocumab Cartridge?
Evolocumab Cartridge is an investigational medicine, given as an once-weekly pill taken by mouth, being studied as a potential treatment for type 1 diabetes.
Also referred to as REPATHA.
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
- This is a prospective, interventional, cohort study, meaning that researchers will follow and observe a group of enrolled study participants over a period of time (one to two months) to gather information and record any developments of the outcomes in question. This study will recruit 125 participants with Type 1 Diabetes (T1D) to: 1.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 89
You may be able to join if
- Participants with previous diagnosis of T1D (as defined by American Diabetes Association or judgment of physician for at least 1 year)
- American Diabetes Association Criteria for diagnosis of diabetes (Must meet at least 1 of the following criteria):
- i. FPG ≥126 mg/dL (7.0 mmol/L). Fasting is defined as no caloric intake for at least 8 hours, OR;
- ii. 2-h PG ≥200 mg/dL (11.1 mmol/L) during OGTT. The test should be performed using a glucose load containing the equivalent of 75 g anhydrous...
- iii. A1C ≥6.5% (48 mmol/mol), OR;
You likely can't join if
- Established cardiovascular disease on antithrombotic therapy
- Triglycerides \>400mg/dl
- Use of a PCSK9 inhibitor
- Recent infection in the past 30 days
- Any hospitalization in the past 30 days
- Use of immunosuppressive therapy
See the full eligibility criteria
- Participants with previous diagnosis of T1D (as defined by American Diabetes Association or judgment of physician for at least 1 year)
- American Diabetes Association Criteria for diagnosis of diabetes (Must meet at least 1 of the following criteria):
- i. FPG ≥126 mg/dL (7.0 mmol/L). Fasting is defined as no caloric intake for at least 8 hours, OR;
- ii. 2-h PG ≥200 mg/dL (11.1 mmol/L) during OGTT. The test should be performed using a glucose load containing the equivalent of 75 g anhydrous glucose dissolved in water, OR;
- iii. A1C ≥6.5% (48 mmol/mol), OR;
- iv. In a patient with classic symptoms of hyperglycemia or hyperglycemic crisis, a random plasma glucose ≥200 mg/dL (11.1 mmol/L), AND;
- History of T1D (due to autoimmune β-cell destruction, usually leading to absolute insulin deficiency, including latent autoimmune diabetes of adulthood). Autoimmune markers include islet cell autoantibodies and...
- Diagnosis of T1D and confirmed by review of records by 2 separate clinical members of the study team
- Age ≥ 18 \& \< 90
- LDL-C \>100mg/dl
- Able and willing to provide written informed consent for the study
- Established cardiovascular disease on antithrombotic therapy
- Triglycerides \>400mg/dl
- Use of a PCSK9 inhibitor
- Recent infection in the past 30 days
- Any hospitalization in the past 30 days
- Use of immunosuppressive therapy
- Use of any antithrombotic therapy
- Use of aspirin
- Use of NSAID within the past 72 hours
- Pregnancy
- Anemia (hemoglobin \ 600)
- A history of hemorrhagic diathesis
- Chronic kidney disease (CrCl \< 30ml/min)
- T2D, monogenic diabetes syndromes, or diabetes in the context of disease of the exocrine pancreas (such as pancreatitis, trauma or pancreatectomy, neoplasia, cystic fibrosis, hemochromatosis)
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, 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 to 89 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, 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.