Health Condition 1: null- Type-II Diabetes
Conditions
Interventions
Intervention1: Voglibose 0.3mg + Metformin SR 500mg: Then newly diagnosed type2 diabetes patients will be allocated treatment with fixed dose combination of Voglibose 0.3 mg + Metformin (SR) 500mg one
Sponsors
Abbott Healthcare Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.18 years of age, upper limit at the discretion of Investigator. 2.Patients diagnosed of type 2 diabetes as defined by the Expert Committee on the Diagnosis and Classification of Diabetes Mellitus (Appendix B) at least 6 months prior to screening 3.Newly diagnosed Type 2 diabetes mellitus patients 4.Patients with type 2 diabetes mellitus who had previously received at least 3 months of continuous treatment with oral therapy of Metformin 1000 mg alone and is inadequately controlled [HbA1c 8% and HbA1c 11 %] during screening visit 5.Patient with BMI between 20 ? 35 Kg/m2 6.Patients whose baseline fasting plasma venous glucose (FPG) concentration ranging from 126mg/dl but 200mg/dl 7.Patients whose venous plasma glucose concentration is 200 mg/dl at 2hr postprandial (after a meal) but 300mg/dl 8.Patients with stable dietary and exercise pattern since three month and willing to follow the same for entire trial duration. 9.Ability to understand and the willingness to sign and date a written informed consent document at the screening visit before any protocol-specific procedures are performed.
Exclusion criteria
Exclusion criteria: 1.Type-1 diabetes mellitus 2.Stroke, myocardial infarction, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, or angina pectoris, within the last 12 months 3.Cardiac status New York Heart Association (NYHA) III-IV 4.Uncontrolled Blood pressure [ 140 Systolic and 90 Diastolic] 5.Impaired renal function as shown by, but not limited to, serum creatinine ¡Ý 1.5 mg/dL for males, or ¡Ý 1.4 mg/dL for females 6.Clinically significant peripheral edema 7.Acute infection 8.Acute or chronic history of metabolic acidosis, including diabetic ketoacidosis 9.Clinical evidence of active liver disease, or serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) 2.5 times the upper limit of the normal range 10.Patients on steroids 11.Patient with anticipated need of surgery within study period. 12.Patient known to be suffering from any bleeding disorder. 13.Pregnancy or lactating women 14.Known hypersensitivity to any of the study drugs. 15.Any malignancy within the last 5 years, with the exception of adequately treated basal or squamous cell carcinoma of the skin or adequately treated cervical carcinoma in situ 16.Current addiction or current alcohol abuse, or history of substance or alcohol abuse within the last 2 years 17.Diagnosis of dementia 18.Subject is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol 19.Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study. Subject unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study 20.Any disease or condition that in the opinion of the investigator may interfere with the completion of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -No. of patients achieving HbA1C 7% -Percentage reduction of fasting plasma glucose (FPG) from baseline. Timepoint: Baseline Day30 Day90 and Day180 | — |
Secondary
| Measure | Time frame |
|---|---|
| -Percentage of subjects achieving an HbA1C decrease by 1% -Percentage reduction of PPG from baseline. -Change in lipid parameters from baseline to Day 180 -Global assessment for efficacy and tolerability by investigator and patients at day 180. -The adverse effects of the study drug will be assessed by monitoring adverse events, vital signs, physical examination and clinically significant changes in laboratory parameters. Timepoint: Baseline Day30 Day90 and Day 180 | — |
Countries
India
Contacts
Public ContactMrManoj Prabhu
Abbott Healthcare Private Limited
Outcome results
None listed