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Valsartan + Celecoxib + Metformin for Type 2 Diabetes (RESILIENCE Trial)
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
RESILIENCE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowRESILIENCE Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.RESILIENCE Trial Design
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Who is running the clinical trial?
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- Group 1: RK-01 High
- Group 2: Metformin-Drug naive patients & Patients with inadequate glycemic control with Metformin
- Group 3: Healthy adults with NGT
- Group 4: RK-01 Low
Frequently Asked Questions
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."
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."
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."
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."
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."
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."
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."
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