A prospective, multicentric, single arm clinical study to evaluate the effect of saroGlitazar on non HDL-ChoLesterol in patIents with Diabetic Dyslipidaemia inadequately controllEd with diet, exeRcise and statin.(Glidder) - GLIDDER

Dr Upendra Kaul0 sites104 target enrollmentTBD

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Health Condition 1: E136- Other specified diabetes mellituswith other specified complicationsHealth Condition 2: null- patients with diabetic dyslipidaemia inadequately controlled with diet, exercise and statin.
Sponsor: Dr Upendra Kaul
Enrollment: 104
Status: Completed
Last Updated: 4 years ago

No summary available.

Registry

who.int

Start Date

TBD

End Date

January 29, 2018

Last Updated

4 years ago

Study Type

Observational

Sponsor

Dr Upendra Kaul

•1\.Type 2 Diabetes Mellitus patients (as per ADA 2015 criteria) age above 18 years, inclusive of either sex
•2\.Patients with triglyceride \>\=200 mg/dL after diet, exercise and stable statin therapy for at least 3 months
•3\.Patient with ability to understand and provide written informed consent form, which must have been obtained prior to study procedure
•4\.Patients willing to comply with the protocol requirements.

•1\.Known cases of type 1 diabetes mellitus
•2\.Diabetic complications such as diabetic nephropathy, diabetic ketoacidosis, diabetic coma, hyperglycaemia hyperosmolar state, retinopathy, neuropathy or other diabetic complications of sufficient severity to require treatment like severe peripheral neuropathy, foot ulcers, gastric stasis
•3\.Uncontrolled hypertension and its complications such as malignant hypertension, resistant hypertension
•4\.Urinary retention
•5\.History of \>\=5% weight change due to unknown reason in the preceding 6 months
•6\.History of unstable angina, acute myocardial infarction in the preceding 3 months, heart failure classified as New York Heart Association Class IIIâ??IV, Patients with history of arrhythmias, Torsades de pointes or using antiarrhythmic drugs, patients with edema suggestive of cardiac involvement.
•7\.Patients receiving glitazones, insulin, lipid\-modifying therapy (e.g., fenofibrate) other than statin or glitazar
•8\.Uncontrolled thyroid disorders
•9\.Patients having gallstones
•10\.Patients having impaired liver (aspartate aminotransferase and alanine aminotransferase â?¡2\.5 times the upper normal limit \[UNL] or bilirubin â?¡2 times the UNL)