Study to Assess the Dietary Carbohydrate Content of Indian Diabetics With Special Therapeutic View on Effectiveness of Acarbose and Metformin Monotherapy (STARCH AM)

Bayer

Status: Withdrawn

Conditions: Diabetes Mellitus

Treatments: Drug: Bay G5421 Glucobay; Drug: Metformin

Study type: Observational

Funder types: Industry

Identifiers

NCT01961388

GB1311IN (Other Identifier)

16667

Details and patient eligibility

About

The study is designed as non interventional to collect data on the effectiveness of acarbose and metformin monotherapy, respectively, in terms of change from baseline in post prandial blood glucose level at the end of 16 weeks in drug-naïve type 2 diabetic patients within each carbohydrates consumption subgroup under real-life treatment condition in large sample of type-2 diabetes patients in India. The study will begin after the study approval by ethics committee.All drug naïve patients in whom decision to administer acarbose or metformin monotherapy for type 2 diabetes management has been made will be included in study after taking the informed consent.Patients will be observed for up to 16 weeks (2 weeks).The study involves general examination of patients, collection of data like history of disease, concomitant medication, drug dose , 24 hr dietary recall etc. The study is planned to enroll 12250 subjects from multiple study centers spread across India. The study data will be analyzed with appropriate statistical methods.

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Drug-naïve (i.e., the patients should never be treated with anti-diabetic drugs before screening) patients in whom decision to administer monotherapy with either acarbose or metformin for type-2 diabetes management has been made by the attending physician on the basis of best clinical practice and medical patient needs, and who consent to participate in study will be included

Exclusion criteria

• Patients receiving any anti-diabetic medication at the time of enrollment in the study will be excluded. However, during observation period, patients may receive any additional anti-diabetics medication at the decision of investigator.
• Exclusion criteria should be read in conjunction with local product information. All contra-indications according to the local marketing authorization should be considered

Trial design

0 participants in 2 patient groups

Group 1

Description:

Acarbose_BAY G5421

Treatment:

Drug: Bay G5421 Glucobay

Group 2

Description:

Metformin

Treatment:

Drug: Metformin