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Biguanide

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

Phase 1 & 2

Waitlist Available

Led By Robert Busch, MD

Research Sponsored by ARKAY Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Males and females, Age: >18 to 70 years at the time of screening visit

Patients with inadequate blood glucose control with Metformin defined as a central laboratory glycosylated hemoglobin (HbA1c) >8.0 and <10.5 obtained at the screening visit

Must not have

Patients with a history of Ketoacidosis

Subjects with a planned radiologic study with intravenous contrast, surgery, or other planned procedures that may predispose them to metformin-associated lactic acidosis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 26 weeks

Awards & highlights

Summary

This trial is evaluating the 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. The objective is to assess the effect of RK-01 on hemoglobin A1c (HbA1c) levels, beta cell function and insulin resistance with co-administration of valsartan, celecoxib and metformin-HCl X

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects include those related to each medication: valsartan may cause dizziness; celecoxib can increase the risk of stomach ulcers and heart issues; metformin might lead to digestive upset or a rare condition called lactic acidosis.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 70 years old.

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My blood sugar control is poor with Metformin, as my HbA1c is between 8.0 and 10.5.

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My HbA1c level was over 7.0 when first diagnosed and I haven't taken diabetes medication.

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I have high blood sugar levels and symptoms like excessive thirst, urination, or hunger.

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I have never taken RAS blocker medications.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had ketoacidosis in the past.

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I am scheduled for a procedure that could increase my risk of lactic acidosis due to metformin.

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I use insulin for my diabetes.

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I have had high blood sugar that was hard to control.

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I have COPD.

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I have complications from diabetes.

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I am not a poor metabolizer of Cyp450 2C9.

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I have had weight loss surgery in the past.

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I am currently dealing with a serious infection.

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My kidney function is reduced, with an eGFR below 60.

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I am over 70 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 26 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and 26 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 26 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from baseline in acute insulin response to glucose (AIRg) for metformin background patients

Change from baseline in acute insulin response to glucose (AIRg) for treatment naive patients

Change in glycosylated Hemoglobin (HbA1c) for metformin background patients

+1 more

Secondary study objectives

Change from baseline in Adiponectin

Change from baseline in Atherogenic Index (AI)

Change from baseline in Beta-cell function Index

+10 more

Trial Design

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.

0 / 16Eligibility criteria met

Find a Location

Who is running the clinical trial?

Albany Medical CollegeOTHER

92 Previous Clinical Trials

12,684 Total Patients Enrolled

ARKAY TherapeuticsLead Sponsor

Robert Busch, MDPrincipal InvestigatorAlbany Medical College

Media Library

Type 2 Diabetes Research Study Groups: Metformin-Drug naive patients & Patients with inadequate glycemic control with Metformin, RK-01 High, Healthy adults with NGT, RK-01 Low

~77 spots leftby Nov 2028

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