Evaluation of a Novel Insulin Sensitizer in People With Type 1 Diabetes (WBH003)

University of Virginia

Status and phase: Not yet enrolling; Phase 2

Conditions: Glycemic Control for Diabetes Mellitus; Ketones; Type 1 Diabetes (T1D); Cardiovascular Health; Insulin

Treatments: Drug: Placebo; Drug: CIR-0602K

Study type: Interventional

Funder types: Other

Identifiers

NCT07186660

302645

3-SRA-2025-1773-M-B (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full description

Participants in the study will:

• Come to the Clinical Research Unit (CRU) at UVA Medical Center for 3 visits: Screening, Baseline (Admission 1) and End-of-Study (Admission 2).
• Complete various tests of cardiovascular health at each visit.
• Take either an experimental drug (CIR-0602K) or placebo for 12 weeks.
• Wear a study CGM with their personal insulin pump for 12 weeks.
• Be given a ketone meter and strips and be asked to take a fingerstick ketone reading every morning for 12 weeks.
• The study team will contact the participants regularly during the study to check their health and how they are tolerating the study drug/placebo.
• Return the study CGM, ketone meter, and remaining supplies, etc. at the end of the study.
• Notify the study team of any illness, injury, hypoglycemic or hyperglycemic events during the study

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups, including a placebo group

CIR-0602K

Active Comparator group

Description:

CIR-0602K 250 mg daily

Treatment:

Drug: CIR-0602K

Placebo

Placebo Comparator group

Description:

Matching Placebo Tablet

Treatment:

Drug: Placebo