EVALUATE THE SAFETY AND EFFICACY OF FIXED DOSE COMBINATION OF METFORMIN HCL 500 mg SR AND VOGLIBOSE 0.2mg IN DIABETIC PATIENTS

"AN OPEN LABELED,NON-RANDOMIZED,PROSPECTIVE STUDY TO EVALUATE THE SAFETY AND EFFICACY OF FIXED DOSE COMBINATION OF METFORMIN HCL 500 mg SR AND VOGLIBOSE 0.2mg IN THE MANAGEMENT OF PATIENTS WITH TYPE-IIMELLITUS DIABETES MELLITUS"

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2009/091/000922

Enrollment

200

Registered

2010-02-16

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: METFORMIN: 500MG Control Intervention1: VOGLIBOSE: 0.2MG

Eligibility

Inclusion criteria

Inclusion criteria: Patients of either sex of age greater than or equal to eighteen and less than or equal to seventy years Known patients of Type-II Diabetes Mellitus Pre menopausal women with appropriate contraception Normal Baseline LFT Normal baseline RFT Glycosylated Hemoglobin (HbA1c) level more than eight percent Patients with BSF above one hundred seventy mg/dl Patients with BSPP above two hundred fourty mg/dl All Non -IPD patients of Type-II Diabetes Mellitus Patient willing to give informed consent

Exclusion criteria

Exclusion criteria: Diabetic patients with significant renal insufficiency, including both intrinsic renal disease and renal hypo perfusion. Patients with anormal LFT and PFT. Patient with malabsorption syndrome. Patient with a history of known hypersensitivity from any one of the said medication. Patients with history of cardiac dysfunction/ cardiac surgery. Patients with symptoms of lactic acidosis. Patients with hypothyroidism. Patients with uncontrolled hypertension. Acute or chronic acidosis, including diabetic ketoacidosis. Pregnant & lactating woman.

Design outcomes

Primary

Measure	Time frame
? Proportion/ percentage reduction in blood sugar level (post prandial and fasting) after 90 days treatment with FDC. .Timepoint: 1 DAY,30 DAY,60 DAY,90 DAY	—

Secondary

Measure	Time frame
? Incidence of all adverse events.? Common solicited Unsolicited AE (including all abnormal laboratory values) SAE during the study period. Timepoint: 30 DAY,60 DAY,90 DAY	—

Countries

India

Contacts

Public ContactGAUTAM SARANNATH

CRA

sameena.k@nexuscro.com09891783557

Outcome results