Health Condition 1: E785- Hyperlipidemia, unspecified Health Condition 2: null- In hypertriglyceridemia with type II diabetes not controlled with Atorvastatin therapy.
Conditions
Interventions
Intervention1: ZYH1 2mg &
4mg: once orally in the morning before breakfast, for 12 weeks.
Control Intervention1: Placebo: once orally in the morning before breakfast, for 12 weeks.
Sponsors
Cadila Healthcare Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1) Age 18- 65 years 2) Subjects of either gender, males or females 3) Subjects on treatment of type 2 diabetes mellitus (DM) for at least last 3 months or documented history of type 2 diabetes mellitus as per American Diabetes Association (ADA). 4) Patient on stable Atorvastatin therapy (10 mg) for at least 4 weeks with LDL greater than or equal to 100mg%. 5) Triglycerides > 200 up to 500 mg/dl on screening visit. 6) Body mass index (BMI) > 23 kg/m2 7) Subject has given informed consent for participation in this trial
Exclusion criteria
Exclusion criteria: 1) Pregnancy and lactation 2) History of > 5% weight loss in past 6 months 3) Subjects on insulin 4) Subjects on glitazone / glitazar therapy in the past 1 month 5) Subjects having unstable angina, Acute Myocardial Infarction in past 3 months or heart failure of NYHA class (III-IV). 6) Uncontrolled hypertension 7) History of clinically significant edema. 8) History of thyroid disorder (abnormal TSH value) or subjects on any thyroid modulating drugs 9) History of active liver disease or gall stones or hepatic dysfunction demonstrated by AST and ALT greater than or equal to 2.5 times of upper normal limit (UNL) or bilirubin greater than or equal to 2 times UNL. 10) History of myopathies or evidence of active muscle diseases demonstrated by CPK greater than or equal 10 times UNL. 11) History of any other concurrent serious illness ( e.g. tuberculosis, HIV, malignancy) 12) History of alcohol and/or drug abuse 13) History of known allergy, sensitivity or intolerance to the study drugs and their formulation ingredients. 14) Renal dysfunction demonstrated by abnormal serum creatinine levels (> 1.2 mg %) or presence of ketonuria. 15) Subjects on concomitant medications known to affect the lipid level other than Atorvastatin 10 mg in past 4 weeks. 16) History of contraceptive, hormone replacement therapy (HRT) or steroids since last 3 months. 17) History of long term use of Non steroidal anti- inflammatory drugs for any treatment such as osteoarthritis, rheumatoid arthritis etc. 18) Participation in any other clinical trial in the past 3 months 19) Unable to give informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Efficacy : TG Timepoint: Time frame 6 and 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Efficacy:1)LDL,2)VLDL,3)HDL, 4)Total cholesterol,5)Non HDL-C,6)Apo (a),7)Apo B,8)hs-CRP Timepoint: Time frame 6 and 12 weeks | — |
Countries
India
Contacts
Public ContactDrRHJani
Cadila Healthcare Limited
Outcome results
None listed