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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
Drug naive as well as osteoarthritis patients with Type 2 diabetes receiving a non-aspirin pain reliever (e.g. acetaminophen) or an NSAID (e.g. Naproxen)
Max/maintenance dose Metformin
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 26 weeks
Awards & highlights

RESILIENCE Trial 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.Check my eligibility
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.See study design
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.

RESILIENCE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have Type 2 diabetes and take pain relievers like acetaminophen or NSAIDs for osteoarthritis.
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I am taking the highest dose of Metformin.
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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.

RESILIENCE Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
Change from baseline in Adiponectin
Change from baseline in Atherogenic Index (AI)
Change from baseline in Beta-cell function Index
+10 more

RESILIENCE 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.

Find a Location

Who is running the clinical trial?

Albany Medical CollegeOTHER
91 Previous Clinical Trials
11,382 Total Patients Enrolled
ARKAY TherapeuticsLead Sponsor
Ravi Kumar, Ph.D.Study DirectorARKAY Therapeutics

Media Library

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How can I sign up for this opportunity to test a new medication?

"This study is seeking 115 participants that have type 2 diabetes mellitus and are between 18-70 years old."

Answered by AI

Can adults of any age participate in this test?

"The age limit for patients who can enroll in this study is 70 years old, provided they are 18 or older."

Answered by AI

What are Val, Cel and Met XR Low typically employed for?

"Val, Cel and Met XR Low is a medication used to treat rheumatoid arthritis in children. It can also be used for other conditions such as left ventricular failure, uncontrolled diabetes, and therapeutic procedures."

Answered by AI

To date, how many people have signed up for this experiment?

"This particular trial is not recruiting patients at the moment. The study was created on October 11th, 2021 and last updated December 28th, 2020. However, there are other ongoing trials that might be of interest. For example, there are 3489 studies actively recruiting patients with type 2 diabetes mellitus and 260 studies for Val, Cel and Met XR Low that have open enrolment."

Answered by AI

Are there any available vacancies for this clinical trial?

"While this specific study is not currently searching for patients, it was most recently edited on 12/28/2020. There are 3489 other clinical trials regarding type 2 diabetes mellitus and 260 trials involving Val, Cel and Met XR Low that are actively enrolling participants."

Answered by AI

Are Val, Cel and Met XR Low often used in research?

"Globally, there are 260 ongoing clinical trials researching Val, Cel and Met XR Low with 58 trials in Phase 3. While many of the trials for Val, Cel and Met XR Low are running out of in Montreal, Quebec, there are 3815 locations operating studies for Val, Cel and Met XR Low."

Answered by AI

What are the hoped-for results of this clinical trial?

"The primary objective of this study is to measure the change in acute insulin response to glucose (AIRg) in metformin background patients over a period of 26 weeks. Secondary objectives include assessing the change from baseline in atherogenic index (AI) and glycosylated hemoglobin (HbA1c), as well as the percentage of subjects achieving a therapeutic glycemic response."

Answered by AI
~77 spots leftby Nov 2025