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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
Approved for 20 Other Conditions
All Individual Drugs Already Approved
No Placebo-Only Group
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 belowSelect...
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:Select...
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.
Select...
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
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 moreSecondary study objectives
Change from baseline in Adiponectin
Change from baseline in Atherogenic Index (AI)
Change from baseline in Beta-cell function Index
+10 moreAwards & Highlights
Approved for 20 Other Conditions
This treatment demonstrated efficacy for 20 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
94 Previous Clinical Trials
12,446 Total Patients Enrolled
ARKAY TherapeuticsLead Sponsor
Robert Busch, MDPrincipal InvestigatorAlbany Medical College
Ravi Kumar, Ph.D.Study DirectorARKAY Therapeutics
Media Library
Research Study Groups:
This trial has the following groups:- Group 1: Metformin-Drug naive patients & Patients with inadequate glycemic control with Metformin
- Group 2: RK-01 High
- Group 3: Healthy adults with NGT
- Group 4: RK-01 Low