Evaluation of Superiority of Valsartan+Celecoxib+Metformin Over Metformin Alone in Type 2 Diabetes Patients
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorARKAY Therapeutics
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Males and females, Age: >18 to 70 years at the time of screening visit.
Women of childbearing potential (WOCBP) must have negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent of HCG) within 24 hours prior to the start of the study.
Women must not be breastfeeding.
HbA1c≥8.0
Disqualifiers
Age >70
Patients with Type 1 diabetes, Screen for GAD (Glutamic acid decarboxylase) antibodies at the time of screening visit. To rule out latent autoimmune diabetes in adults (LADA), screening for other diabetes-related antibodies, such as insulinoma-associated protein (IA-2 and IA-2 beta), zinc transporter-8 (ZnT8), islet cell antibodies (ICA) or insulin autoantibody (IAA) will also be considered.
Pregnant women
Patients with a history of Ketoacidosis.
Trial design
Design model
Parallel
Treatments tested in this trial
Metformin
Drug1000 mg metformin-HCL XR once-a-day or maintenance dose of metformin for 26 weeks
Val, Cel and Met XR Low
Drug500 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
Drug1000 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.
Treatment groups
115 Participants
are divided into 4 treatment groupsGroup A: Healthy adults with NGTNo intervention 0 interventions
Group B: Metformin-Drug naive patients & Patients with inadequate glycemic control with MetforminActive comparator 1 intervention
Group C: RK-01 LowExperimental treatment 1 intervention
Group D: RK-01 HighExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in glycosylated Hemoglobin (HbA1c) for metformin background patients
Glycosylated hemoglobin (HbA1c) is a measurement of the percentage of hemoglobin that is glycated. The change from baseline is calculated as the week 26 HbA1c minus the baseline HbA1c. Since HbA1c is measured as a percentage, the change from baseline is also a percentage.
Time frame
Baseline and 26 weeks2
Change in glycosylated Hemoglobin (HbA1c) for treatment naive patients
Glycosylated hemoglobin (HbA1c) is a measurement of the percentage of hemoglobin that is glycated. The change from baseline is calculated as the week 26 HbA1c minus the baseline HbA1c. Since HbA1c is measured as a percentage, the change from baseline is also a percentage.
Time frame
Baseline and 26 weeks3
Change from baseline in acute insulin response to glucose (AIRg) for metformin background patients
Change in baseline in acute insulin response to glucose at week 26
Time frame
Baseline and 26 weeks4
Change from baseline in acute insulin response to glucose (AIRg) for treatment naive patients
Change in baseline in acute insulin response to glucose at week 26
Time frame
Baseline and 26 weeksSecondary outcomes
1
Change in glycosylated Hemoglobin (HbA1c) to <7.0%
Glycosylated hemoglobin (HbA1c) is a measurement of the percentage of hemoglobin that is glycated. The change from baseline is calculated as the week 26 HbA1c minus the baseline HbA1c. Since HbA1c is measured as a percentage, the change from baseline is also a percentage. Percentage of subjects achieving a therapeutic glycemic response, defined as HbA1c \<7.0%.
Time frame
Baseline and 26 weeks2
Change from baseline in Body weight
Change in body weight at week 26
Time frame
Baseline and 26 weeks3
Change from baseline in fasting plasma glucose
Change in baseline in fasting plasma glucose at week 26
Time frame
Baseline and 26 weeks4
Change from baseline in Beta-cell function Index
Change in baseline in beta cell function index at week 26. Beta-cell function Index is a measure of their capacity to respond to elevated blood glucose levels
Time frame
Baseline and 26 weeksSponsors and contacts
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Source ClinicalTrials.gov
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