Evaluation of Superiority of Valsartan+Celecoxib+Metformin Over Metformin Alone in Type 2 Diabetes Patients

Part of paid clinical trials in Albany, New York.

Sponsor
ARKAY Therapeutics
Study ID
NCT03686657
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Metformin — DRUG
    1000 mg metformin-HCL XR once-a-day or maintenance dose of metformin for 26 weeks
  • Val, Cel and Met XR Low — DRUG
    500 mg metformin-HCL XR plus 100 mg celecoxib once-a-day in the morning and 160 mg valsartan 6 hours later once-a-day in the afternoon for 26 weeks.
  • Val, Cel and Met XR High — DRUG
    1000 mg metformin-HCL XR plus 200 mg celecoxib once-a-day in the morning and 320 mg valsartan once-a-day 6 hours later in the afternoon for 26 weeks.

Study Details

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.

Key Dates

Start date
Oct 10, 2025
Status verified
May 2025
Primary completion
Nov 26, 2028
Completion
Jan 31, 2029

Study Design

Enrollment
115 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • No Intervention: Healthy adults with NGT
    Healthy adults with normal glucose tolerance (NGT) and beta cell function will be administered placebo.
  • Active Comparator: Metformin-Drug naive patients & Patients with inadequate glycemic control with Metformin
    Patients receive metformin once daily
  • Experimental: RK-01 Low
    Patients receive valsartan, celecoxib and metformin (low dose) once daily
  • Experimental: RK-01 High
    Patients receive valsartan, celecoxib and metformin (high dose) once daily

Primary Outcome Measure

Change in glycosylated Hemoglobin (HbA1c) for metformin background patients [ Time Frame: Baseline and 26 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Albany Medical CollegeAlbanyNew York12206
Kevin Fiesthamel, MS
[email protected]
518-264-4472
Spencer Phelps, CCRC
[email protected]
518-264-4474
Robert Busch, MD (PRINCIPAL_INVESTIGATOR)
Grimm Loretta, FNP-C (SUB_INVESTIGATOR)

Find similar trials in Albany, NY

By condition
Hypertension (high blood pressure)Obesity / overweightType 2 diabetes
By specialty
CardiologyHeart diseaseEndocrinologyMetabolic healthWeight loss
By research site
Albany Medical College· Albany, NY

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