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

NCT01961388 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2016-06-15

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Bay G5421 Glucobay

Oral, dosage of Acarbose as per the directions of treating physician

DRUG

Metformin

Oral, dosage of Metformin as per the directions of treating physician

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2016-12-31
Completion
2017-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01961388 on ClinicalTrials.gov