Evaluation of a Novel Insulin Sensitizer in People With Type 1 Diabetes
Evaluation of a Novel Insulin Sensitizer on Glycemic Control, Insulin Usage, and Cardiovascular Biomarkers in People With Type 1 Diabetes Who Use Closed-loop Automated Insulin Delivery
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 45 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether CIR-0602K helps people with type 1 diabetes keep blood sugar in their target range or use less insulin each day. It is for adults ages 18–45 who use an automated insulin delivery system. Researchers will compare the drug with a placebo, a look-alike pill with no drug.
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. If the study results show that the drug works to increase time-in-range and lower insulin doses, this will lead to further studies which may then make the drug available to the public.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be 18–45 years old and have had type 1 diabetes for at least 1 year.
- Have an HbA1c below 10%. This blood test shows your average blood sugar over the past few months.
- Have a BMI of 18–35, a measure of weight compared with height. You must also have either a BMI of at least 25 or use at least 0.5 units of insulin per kilogram of body weight each day.
- Use a closed-loop automated insulin delivery system that works with the Dexcom G7 blood sugar sensor.
- Have no changes to your medicines for conditions other than diabetes for 6 months. Screening lab results must be normal or have no medically important problems.
- Be able and willing to take the study drug or placebo by mouth for 12 weeks.
- If you or your partner could become pregnant, agree to use effective birth control during the study and for 2 weeks after stopping CIR-0602K. Men who could father a child must use condoms or another effective method with their partner.
- Sign and date the consent form. Be available for the whole study and agree to follow study procedures and lifestyle rules.
Who can't join
- Are pregnant or breastfeeding; smoked tobacco in the past 2 years; or had alcohol or illegal drug abuse in the 6 months before screening.
- Have HIV or another major illness that the study doctor thinks could affect results. Have a condition or past surgery that could greatly change how your body absorbs the drug, such as major stomach or bowel surgery or active inflammatory bowel syndrome.
- Use a blood sugar medicine other than insulin, take anti-inflammatory medicines daily, or changed the dose of certain heart, blood pressure, or cholesterol medicines in the past 4 months.
- Have nerve damage in your arms or legs; a urine albumin-to-creatinine ratio above 300 mg/g, showing high protein in urine; or diabetes-related eye damage beyond the mild, early stage.
- Had severe low blood sugar needing help from someone else or diabetic ketoacidosis, a dangerous buildup of acids in the blood, in the past 12 months.
- Have screening heart-test results showing an abnormal heartbeat, a problem with the heart's natural pacemaker, or poor blood flow to the heart. Have a blood oxygen level below 90%.
- Have had an allergy or bad reaction to the study drug, similar drugs, or its ingredients. Use medicines processed heavily by certain liver enzymes, called CYP2C8 or CYP2C, such as warfarin, phenytoin, or celecoxib.
- Took part in another research study, other than a registry with no treatment, or received a research drug too recently before study group assignment. The waiting period is at least 30 days or 5 drug half-lives, whichever is longer. A half-life is the time it takes the body to clear half of a drug.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: 1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. History of type 1 diabetes for at least one year 4. Age 18-45 years 5. 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. Exclusion Criteria: * 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, gastroenterostomy, bowel resection, gastric bypass, gastric stapling, or gastric banding, currently active inflammatory bowel syndrome. * 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, beta-blockers, etc.). * 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.
Study sites (1)
VA
- University of Virginia · Charlottesville, VA 22908Horton B Horton, MD · Study contact · (434) 924-1828 · WBH2N@VIRGINIA.EDUMore trials in Charlottesville