Health Condition 1: E115- Type 2 diabetes mellitus with circulatory complications
Conditions
Interventions
Intervention1: Azelniidpine and Telmisartan: Dose:Azelniidpine 8-16 mg & Telmisartan 20/40/80 mg
Route of administration: Oral
Duration: 5 months
Control Intervention1: NIL: NIL
Sponsors
Torrent Pharmaceuticals Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male or Female patients 18 to 65 years. 2.Known cases of T2DM with HTN as Treatment naïve or uncontrolled receiving background ARB therapy for at least four weeks 3.Patients with systemic Blood pressure =140/90 mm/Hg.
Exclusion criteria
Exclusion criteria: 1.Patients with T1DM. 2.Patients with impaired hepatic function with liver enzymes 5X ULN 3.Current state as pregnant or breast-feeding 4.Patients not willing for follow –up during the course of the study @ 8W and 24W
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in Blood Pressure (SBP/DBP) at 4W and 12W Change from baseline in Resting Heart Rate (RHR) at 4W and 12W Timepoint: Baseline, 4 weeks and 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in Blood Pressure at 4W and 12W with at least one additional risk factor (Dyslipidemia, Smoking, Family history) or Comorbidity (Left ventricular dysfunction, chronic kidney disease with proteinuria) OR 10y QRISK3 score less than 10 percentageTimepoint: Baseline, 4 weeks and 12 weeks;Change from baseline in eGFR at 4W and 12W for cases with Diabetic Kidney DiseaseTimepoint: Baseline, 4 weeks and 12 weeks;Change from baseline in LDL-C & Non-HDL-C levels at 4W and 12WTimepoint: Baseline, 4 weeks and 12 weeks ;Change from baseline in Resting Heart Rate at 4W and 12W for cases with 10y- QRISK3 score less than 10 percentageTimepoint: Baseline, 4 weeks and 12 weeks;Change in HbA1c at 12W.Timepoint: Baseline, 4 weeks and 12 weeks | — |
Countries
India
Contacts
Public ContactDr Rathish Nair PhD MBA
Torrent Pharmaceuticals Ltd
Outcome results
None listed