GLucobay M - Evaluation Of Safety and Effectiveness in Type 2 Diabetes Not Well Controlled on Monotherapy in Real Life Practice

Withdrawn

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: Acarbose/Metformin (Glucobay M, BAY81-9783)

• Registration Number: NCT01915264
• Lead Sponsor: Bayer

Brief Summary

The study is designed as non interventional to collect data on the safety especially, severe hypoglycemia or documented symptomatic hypoglycemic episodes and effectiveness of acarbose/metformin fixed-dose combination under real-life treatment condition in large sample of type-2 diabetes patients in India. The study objective is to evaluate severe hypoglycemia or documented symptomatic or asymptomatic hypoglycemic events reported as adverse events. The study will begin after the study approval by ethics committee. All patients with type 2 diabetes on acarbose or metformin monotherapy and prescribed Glucobay M will be included in study after taking the informed consent. Patients will be observed for up to 24 weeks (2 weeks).The study involves general examination of patients, collection of data like history of disease, concomitant medication, drug dose etc. The study is planned to enroll 10000 subjects from multiple study centers spread across India. The study data will be analyzed with appropriate statistical methods.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-07-25
• Study First Submitted QC: 2013-08-01
• Study First Posted: 2013-08-02
• Study Start: 2015-08
• Status Verified: 2016-03
• Last Update Submitted: 2016-04-22
• Last Update Posted: 2016-04-25
• Primary Completion: 2016-12
• Study Completion: 2017-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Patient will be enrolled after the decision to administer acarbose/metformin fixed dose combination for type-2 diabetes management has been made by the attending physician on the basis of best clinical practice and patient needs.
• Willing to give informed consent for participating in this study

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Exclusion Criteria

• Patients receiving anti-diabetic medication other than acarbose, or metformin monotherapy at the time of enrollment in the study will be excluded. However, during observation period, any additional anti-diabetics medication administered by the attending physician will be allowed & recorded in case record form.
• Patient receiving acarbose/metformin fixed dose combination during 3-months prior to enrollment.
• Exclusion criteria should be read in conjunction with local product information

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Acarbose/Metformin (Glucobay M, BAY81-9783)	-

Primary Outcome Measures

Name	Time	Method
Incidence of severe hypoglycemia or documented symptomatic or asymptomatic hypoglycemic events reported as adverse events	24 weeks

Secondary Outcome Measures

Name	Time	Method
Mean change in HbA1c level	baseline and 24 weeks
Incidence of adverse events other than hypoglycemia reported	24 weeks
Mean change in serum LDL(low-density lipoprotein) cholesterol	baseline and 24 weeks
Change in percent satisfaction to the therapy from baseline as measured by 5 point satisfaction scale	baseline and 24 weeks
Mean change in fasting blood sugar	baseline and 24 weeks
Mean change in postprandial blood sugar	baseline and 24 weeks
Mean change in body weight	baseline and 24 weeks
Mean change in serum triglyceride	baseline and 24 weeks
Mean change in serum HDL (High density lipoproteins) cholesterol	baseline and 24 weeks
Number of patient with adverse event (Tolerability)	Baseline and 24 weeks