Valsartan + Celecoxib + Metformin for Type 2 Diabetes
(RESILIENCE Trial)

Recruiting in Palo Alto (17 mi)

Overseen ByRobert Busch

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: ARKAY Therapeutics

No Placebo Group

Trial Summary

What is the purpose of this trial?Evaluation of safety, tolerability and superiority of RK-01, a valsartan plus celecoxib dual add-on to metformin-HCL XR over metformin in newly diagnosed and obese adult type 2 diabetes patients with high blood pressure, arthritis and inadequate glycemic control with metformin monotherapy, diet and exercise over 26 weeks of treatment. Objective: To assess effect of RK-01 on HbA1c levels, beta cell function and insulin resistance with co-administration of valsartan, celecoxib and metformin-HCl XR relative to metformin monotherapy. Hypothesis: After 26 weeks of treatment with valsartan, celecoxib and metformin-HCl XR provides greater improvements in glycemic, inflammatory and atherogenic parameters compared to metformin monotherapy.

Eligibility Criteria

Adults aged 18-70 with newly diagnosed type 2 diabetes, obesity (BMI ≥30), high blood pressure, and arthritis. They must have poor blood glucose control on metformin alone, not be pregnant or breastfeeding, and have no history of severe kidney disease or other major health issues like heart disease or liver problems.

Inclusion Criteria

Your blood sugar level is very high 2 hours after drinking a special sugar drink.

I have Type 2 diabetes and take pain relievers like acetaminophen or NSAIDs for osteoarthritis.

I am taking the highest dose of Metformin.

+15 more

Exclusion Criteria

You have a condition where your immune system attacks your own body.

I have had ketoacidosis in the past.

I am at high risk for serious stomach or intestine problems.

+20 more

Participant Groups

The trial is testing RK-01—a combination of valsartan (for blood pressure), celecoxib (for arthritis pain), and an extended-release form of metformin—against just metformin for better control of blood sugar levels in type 2 diabetes over a period of 26 weeks.

4Treatment groups

Experimental Treatment

Active Control

Group I: RK-01 LowExperimental Treatment1 Intervention

Patients receive valsartan, celecoxib and metformin (low dose) once daily

Group II: RK-01 HighExperimental Treatment1 Intervention

Patients receive valsartan, celecoxib and metformin (high dose) once daily

Group III: Metformin-Drug naive patients & Patients with inadequate glycemic control with MetforminActive Control1 Intervention

Patients receive metformin once daily

Group IV: Healthy adults with NGTActive Control1 Intervention

Healthy adults with normal glucose tolerance (NGT) and beta cell function will be administered placebo.

Metformin is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications: