Health Condition 1: null- Non Diabetic Patients with Primary Hyperlipidemia & Type II Diabetic Patients with Primary Hyperlipidemia
Conditions
Interventions
Intervention1: Colesevelam Hydrochloride: 625mg, 3 tablets twice daily per oral for 28 Weeks
Control Intervention1: Statin & Metformin: Statin: 10mg, once daily & Metformin: 850mg, twice daily per or
Sponsors
IndSwift Ltd Head Office SCO Shivalik Enclave NAC Manimajra Chandigarh India
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion Criteria for Group A & B: 1.Male or female patients of 18 to 75 years of age (both inclusive). 2.LDL-C ≥ to 115 mg/dL and to 250 mg/dL. 3.TG ≤ to 300 mg/dL. 4.Women who are not pregnant or breast-feeding or planning to become pregnant. 5.Women of child-bearing potential had a hysterectomy or tubal-ligation, or Women of post menopausal stage or who practice the use of contraceptives other than oral contraceptives. Inclusion Criteria for Group B (in addition to that of Group A): 6.HbA1C% ≥ 7.5 and ≤ 9.5%
Exclusion criteria
Exclusion criteria: 1.Patients with known history of Type 1 Diabetes Mellitus. 2.History of acute or chronic metabolic acidosis, including diabetic ketoacidosis. 3.Patients with known history of Fredrickson Type I, III, IV and V dyslipidemias. 4.Acute coronary syndrome (e.g., myocardial infarction or unstable angina), coronary intervention (coronary artery bypass graft or percutaneous transluminal coronary angioplasty or similar procedure), congestive heart failure (requiring pharmacological treatment), or transient ischemic attack within 3 months of screening visit. 5.Patients with any vitamin deficiencies. 6.Patients with a history of bowel obstruction. 7.Patients with a history of major gastrointestinal surgery. 8.Patients with a history of Hyper Triglyceridemia-induced pancreatitis. 9.Patients with any malabsorbtion syndromes. 10.Patients suffering from seizures. 11.Patients suffering with constipation (including fecal impaction problems). 12.Patients with gastrointestinal motility disorders (including gastroparesis). 13.Patients suffering from Dyspepsia. 14.Patients suffering from Nausea. 15.Patients suffering from Dysphagia. 16.Patients suffering from esophageal obstruction. 17.Patients with serum creatinine concentration of > 2.0 mg / dl. 18.Patients with alanine transaminase concentration of > 2.5 time the upper limit of normal. 19.Patients with aspartate transaminase concentration of > 2.5 time the upper limit of normal. 20.Patients with a creatine kinase concentration > 3 time the upper limit of normal. 21.Patients currently on any drug with a narrow therapeutic index. 22.Patients currently on Thiazolidinediones. 23.Patients currently on dipeptidyl peptidase 4 indicators. 24.Patients currently on any oral vitamin supplements. 25.Patients currently on cyclosporine. 26.Patients currently on glyburide. 27.Patients currently on levothyroxine. 28.Patients currently on Warfarin. 29.Patients currently on thyroid replacement therapy. 30.Female patients currently on oral contraceptives containing ethinylestradiol and norethindrone. 31.Known hypersensitivity to Statins. 32.Known hypersensitivity to Metformin HCl. 33.Patients with a fasting plasma glucose concentration > 300 mg/dl.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Group A 1.To determine the Efficacy of Colesevelam Hydrochloride in combination with Statin when compared with Statin in patients with Primary Hyperlipidemia. Group B 1.To determine the Efficacy of Colesevelam Hydrochloride in combination with Metformin and Statin when compared with Statin and Metformin in Type II diabetic patients with Primary Hyperlipidemia.Timepoint: Group A At the end of 6-week period. Group B At the end of 26-week period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Group A 1.To determine the Safety of Colesevelam Hydrochloride in combination with Statin when compared with Statin in patients with Primary Hyperlipidemia. Group B 1.To determine the Safety of Colesevelam Hydrochloride in combination with Metformin and Statin when compared with Statin and Metformin in Type II diabetic patients with Primary Hyperlipidemia.Timepoint: Group A At the end of the 6-week period. Group B At the end of the 26 week period. | — |
Countries
India
Contacts
Public ContactMs Naga Anand
Head of R&D
Outcome results
None listed