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New treatment option for Type 1 Diabetes (T1D)
Official title Evaluation of a Novel Insulin Sensitizer in People With Type 1 Diabetes
ClinicalTrials.gov ID: NCT07186660
What this study is testing
What is CIR-0602K?
CIR-0602K is an investigational medicine, given as an once-daily, being studied as a potential treatment for type 1 diabetes (t1d).
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 purpose of this study is to see if the study drug CIR-0602K will improve glucose time-in-range and/or lower total daily insulin dose in people with type 1 diabetes who are using closed-loop automated insulin delivery. Researchers will compare CIR-0602K to a placebo (a look-alike substance that contains no drug) to see if it achieves the investigational endpoints.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
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 45
You may be able to join if
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- History of type 1 diabetes for at least one year
- Age 18-45 years
- HbA1c \<10%
You likely can't join if
- Current Pregnancy or currently breastfeeding.
- History of smoking tobacco products within the last two years.
- History of alcohol abuse or illicit drug abuse within 6 months of screening.
- Known history of human immunodeficiency virus (HIV).
- History of other significant disease (e.g., cardiac, cerebrovascular, gastrointestinal, liver, renal, or endocrine) that could, in the investigator's...
- Any surgical or medical condition which may significantly alter the absorption of the study drug including but not limited to the following: history...
See the full eligibility criteria
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- History of type 1 diabetes for at least one year
- Age 18-45 years
- HbA1c \<10%
- BMI 18-35 kg/m2. Within this criterion, participants must have either BMI ≥25 or total daily insulin dose of ≥0.5 units/kg/day.
- Currently utilizing closed-loop AID therapy that is compatible with Dexcom G7 CGM.
- On stable regimen of non-diabetic medications for the last 6 months.
- All screening labs within normal limits or not clinically significant.
- Ability to take oral medication and be willing to adhere to the study drug/placebo for 12 weeks.
- For females and males of reproductive potential: agreement to use adequate contraception during study participation and for an additional 2 weeks after the end of CIR-0602K administration.
- For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner during study intervention.
- Agreement to adhere to Lifestyle Considerations throughout study duration.
- Current Pregnancy or currently breastfeeding.
- History of smoking tobacco products within the last two years.
- History of alcohol abuse or illicit drug abuse within 6 months of screening.
- Known history of human immunodeficiency virus (HIV).
- History of other significant disease (e.g., cardiac, cerebrovascular, gastrointestinal, liver, renal, or endocrine) that could, in the investigator's view, alter study outcomes
- Any surgical or medical condition which may significantly alter the absorption of the study drug including but not limited to the following: history of major gastrointestinal tract surgery such as gastrectomy...
- Current use of any antihyperglycemic medication beyond insulin (i.e., GLP-1 receptor agonists, SGLT2 inhibitors, etc.).
- Unstable doses (i.e., dose change within the last 4 months) of vasoactive medications (e.g., calcium-channel blockers, statins, angiotensin-converting enzyme inhibitors, diuretics, nitrates, alpha-blockers...
- Daily use of anti-inflammatory medications (e.g., ibuprofen, aspirin, prednisone, dexamethasone, etc.).
- Diagnosis of peripheral neuropathy (assessed by screening monofilament exam).
- Macroalbuminuria (i.e., urine albumin: creatinine \>300 mg per g).
- Retinopathy beyond mild, nonproliferative retinopathy.
- History of Level 3 hypoglycemia within the last 12 months.
- History of diabetic ketoacidosis (DKA) within the last 12 months.
- Screening electrocardiogram (ECG) findings indicative of arrhythmia, sinus node disease, or ischemic heart disease.
- Screening oxygen saturation \<90%
- History of hypersensitivity or prior adverse reaction to the study drug, closely-related compounds, or any of the stated ingredients.
- Use of concomitant medications with a known significant metabolism by CYP2C8 or CYP2C (including paclitaxel, phenytoin, warfarin, celecoxib, tolbutamide, or repaglinide) for the duration of the study.
- Participation in an investigational study (other than a non-treatment registry study) or received an investigational drug withing 30 days or 5 half-lives (whichever is longer) prior to randomization.
The study team makes the final eligibility decision.
Where it's taking place
- Charlottesville, Virginia, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 45 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Charlottesville, Virginia, 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.