Health Condition 1: E136- Other specified diabetes mellituswith other specified complications Health Condition 2: null- patients with diabetic dyslipidaemia inadequately controlled with diet, exercise and statin.
Conditions
Interventions
None listed
Sponsors
Dr Upendra Kaul
Fortis Escorts Heart InstituteOkhla
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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) 11. Patients having renal (serum creatinine 1.5 mg/dL) function, ketonuria 12. Patients having myopathies or active muscle diseases (creatinine phosphokinase [CPK] ±10 times UNL) 13. Patients having severe illness such as tuberculosis, human immunodeficiency infection & malignancy 14. Patients with continuing history of alcohol and / or drug abuse 15. Patients having allergy, sensitivity or intolerance to the study drugs and their formulation ingredients 16. Patients who have participated in any other clinical trial in the preceding 3 months at the time of enrolment. 17. Female subjects were excluded if they were pregnant or breast feeding or had initiated hormonal treatment (e.g., hormonal contraceptive, hormone replacement therapy) in the preceding 3 months. 18. Any other condition that in the opinion of the Investigator that does not justify the patientâ??s participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy variable will be: 1) The mean change in non HDL-C level at the end of therapy (Week 24) as compared to baseline (Visit 1) Timepoint: Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary efficacy variables will be: 1) The mean change in TG, total cholesterol, VLDL, LDL, HDL, sd-LDL at the end of therapy (Week 24) as compared to baseline (Visit 1) 2) The mean change in HbA1c, FPG and PPG the end of therapy (Week 24) as compared to baseline (Visit 1) Timepoint: 24 week | — |
Countries
India
Contacts
Public ContactDr Upendra Kaul
Fortis Escorts Heart Institute
Outcome results
None listed