Health Condition 1: E115- Type 2 diabetes mellitus with circulatory complications
Conditions
Interventions
Intervention1: FDC of Rosuvastatin 5 mg plus Teneligliptin 20 mg Tablets: One tablet once a day orally in
the morning after breakfast
every day for 84 days (12
weeks)
Intervention2: FDC of Rosuvastati
Sponsors
Synokem Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female patients aged between 18 to 65 years (both inclusive). 2. Patient diagnosed with Dyslipidemia and Type 2 diabetes defined as: LDL-C >= 100 mg/dl and = 7% and 3. Patients who had receiving a stable dose of Metformin (>= 1000 mg /day) for at least 3 months prior to screening. 4. Patient with ability to understand and provide written informed consent form, which must have been obtained prior to screening. 5. Patients willing to comply with the protocol requirements.
Exclusion criteria
Exclusion criteria: 1. Any known contraindications to Rosuvastatin or Teneligliptin or related class of drugs. 2. Has clinical laboratory evaluations (including biochemistry and hematology) are not within the reference range for the testing laboratory and the results are deemed clinically significant by the investigator. 3. Patients with known case of type 1 diabetes mellitus. 4. Patients with glycosylated hemoglobin (HbA1c) >8.5%. 5. Patients with Body mass index (BMI) higher than 40 kg/m2. 6. Patients with clinically significant impaired hepatic function [SGOT & SGPT more than 2.5X the UNL and/or Total bilirubin more than 1.5X the UNL]. 7. Patients with estimated glomerular filtration rate (eGFR) 8. Patients with the history of severe heart disease (angioplasty, stent placement, bypass surgery, myocardial infarction, unstable angina pectoris, New York Heart Association class III, IV congestive heart failure, or ventricular arrhythmia within 6 months before screening). 9. Patients with known cases of diabetic nephropathy, diabetic ketoacidosis, diabetic coma, hyperglycemia hyperosmolar state, retinopathy, neuropathy. 10. Female subjects who are pregnant or lactating or planning to become pregnant during the study period. 11. Females who are not ready to use acceptable contraceptive methods during the course of study. 12. Patients with known case of clinically significant cerebrovascular disease, cardiovascular disease, gastric dysfunction, thyroid dysfunction, chronic uncontrolled systemic diseases like asthma, hypertension or other medical illness that may affect patient safety or difficult to evaluate the efficacy of the product. 13. Patients who have participated in any clinical trial in the past 3 months. 14. Patients who are known cases of HIV, Hepatitis B or Hepatitis C. 15. Patients who have a recent history or who are currently known to abuse alcohol or drugs. 16. Patients with medical history of Oncological Conditions since last 5 years. 17. Currently taking prohibited medications(s) listed and inability/unwillingness to discontinue them for the entire study period. 18. Suspected inability or unwillingness to comply with the study procedures. 19. 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 |
|---|---|
| 1. Mean change in Low-Density Lipoprotein (LDL-C) from baseline to end of the study. 2. Mean change in glycosylated hemoglobin (HbA1c) from baseline to end of the study. Timepoint: For LDL-C - At Week 4, Week 8 and Week 12 For HbA1c - At Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in fasting plasma glucose (FPG) & 2-hr post prandial glucose (PPG) from baseline to end of the study.Timepoint: At Week 4, Week 8 and Week 12 | — |
Countries
India
Contacts
Public ContactRahul Vij
Synokem Pharmaceuticals Ltd.
Outcome results
None listed