Health Condition 1: E785- Hyperlipidemia, unspecified
Conditions
Interventions
Intervention1: ZYH1: 2mg or 4mg once daily (OD)Oral
Control Intervention1: Pioglitazone: 45mg OD
Oral
Sponsors
Cadila Healthcare Limited
Eligibility
Inclusion criteria
Inclusion criteria: INCLUSION CRITERIA (S ) FOR SCREENING: 1) Age 18- 65 years 2) Subjects of either gender, males and females 3) Subjects on sulphonylurea and/or metformin for the treatment of type 2 diabetes mellitus (DM) for at least last 3 months and documented history of type 2 diabetes mellitus as per American Diabetes Association (ADA). 3) Triglycerides > 200 up to 400 mg/dl on screening visit. 4) Subject having HbA1c > 7 up to 9% 5) Body mass index (BMI) > 23 kg/m2 6) Subject has given informed consent for participation in this trial INCLUSION CRITERIA (S ) FOR ENROLMENT: 1) Age 18- 65 years 2) Subjects of either gender, males and females 3) Subjects on sulphonylurea and/or metformin for the treatment of type 2 diabetes mellitus (DM) for at least last 3 months and documented history of type 2 diabetes mellitus as per American Diabetes Association (ADA). 4) Subjects with type 2 diabetes and dyslipidemia which is inadequately controlled by the life-style modifications 5) Triglycerides > 200 to 400 mg/dl on enrolment visit. 6) Body mass index (BMI) > 23 kg/m2 7) Subject has given informed consent for participation in this trial
Exclusion criteria
Exclusion criteria: EXCLUSION CRITERIA(S) FOR SCREENING: 1) History of > 5% weight loss in past 6 months 2) Subjects on insulin and/or glitazone / glitazar therapy 3) BMI less than 23 kg/m2 4) Pregnancy and lactation 5) Subjects with history of myocardial infarction (MI), Coronary artery bypass graft (CABG), Percutaneous transluminal coronary angioplasty (PTCA), unstable angina or New York Heart Association (NYHA) heart failure of Class (III-IV) regardless of therapy 6) BP > 150/100mmHg 7) History of thyroid disorder 8) Subjects with history of active liver disease 9) Subjects with history of gall stone 10) Subjects with renal dysfunction (serum creatinine > 1.2 mg %) 11) Subjects with history of myopathies or evidence of active muscle diseases 12) Subject on concomitant medications known to affect the lipid level in past 1-2 weeks. 13) Subjects with history of any other concurrent serious illness ( e.g. tuberculosis, HIV, malignancy) 14) Subject with history of alcohol and/or drug abuse 15) Known allergy, sensitivity or intolerance to the study drugs and their formulation ingredients. 16) Participation in any other clinical trial in past 3 months 17) Subjects who are unwilling or unable to give informed consent EXCLUSION CRITERIA FOR ENROLMENT: 1) History of > 5% weight loss in past 6 months 2) Subjects on insulin and/or glitazone / glitazar therapy 3) Presence of ketonuria 4) BMI less than 23 kg/m2 5) Pregnancy and lactation 6) Subjects with history of myocardial infarction (MI), Coronary artery bypass graft (CABG), Percutaneous transluminal coronary angioplasty (PTCA), unstable angina or New York Heart Association (NYHA) heart failure of any Class (III-IV) regardless of therapy 7) BP > 150/100mmHg 8) Subjects with active liver disease 9) Hepatic dysfunction demonstrated by aspartate aminotransferase (AST) and alanine aminotransferase (ALT) greater than or equal to 2.5 times of upper limits of normal or Bilirubin more than 2 times UNL. 10) Thyroid dysfunction demonstrated by abnormal TSH value 11) Presence of gall stone 12) Subjects with renal dysfunction (serum creatinine > 1.2 mg %) 13) Subjects with history of myopathies or evidence of active muscle diseases 14) Subject on concomitant medications known to affect the lipid level in past 2 weeks. 15) Subjects with history of any other concurrent serious illness ( e.g. tuberculosis, HIV, malignancy) 16) Subject with history of alcohol and/or drug abuse 17) Known allergy, sensitivity or intolerance to the study drugs and their formulation ingredients 18) Participation in any other clinical trial in past 3 months 19) Subjects who are unwilling or unable to give informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Efficacy TG Timepoint: Time frame 12 and 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Efficacy : LDL,VLDL,HDL,Total cholesterol,Apo(a), Apo B,HbA1c,Fasting plasma glucose(FPG),C-peptide test and fasting insulin for HOMA beta and HOMA IR, hs-CRP,Post prandial triglyceride (PPTG) at selected centres Timepoint: Time frame 12 and 24 weeks | — |
Countries
India
Contacts
Public ContactDrRHJani
Cadila Healthcrae Limited
Outcome results
None listed