Diabetes Treatment With Glucobay in Combination With Sulfonylurea

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: Acarbose (Precose/Glucobay, BAYG5421)

• Registration Number: NCT01613105
• Lead Sponsor: Bayer

Brief Summary

In this prospective, non interventional, observational Post Marketing Survelliance study data are obtained on the efficacy, safety and tolerability of Glucobay treatment on top of sulfonylurea under daily life treatment conditions.Specifically investigated is the influence of Glucobay on Post Prandial Blood Glucose and HbA1c as well as on pateint's weight when added to an already existing sulfonylurea therapy.The study is planned to carried out in 25000 - 30000 patients from 200 trial sites in India.The Post Marketing Survelliance study will be performed with commercially available medication prescribed within regular practice of the physician. No other examination will be performed than would be done without Post Marketing Survelliance study.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Study First Submitted: 2012-06-04
• Study First Submitted QC: 2012-06-05
• Study First Posted: 2012-06-06
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-24
• Last Update Posted: 2013-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4564

Inclusion Criteria

• All patient with type 2 diabetes with one of the following treatment ongoing : 1) Sulfonylurea 2) Sulfonylurea + OHA. In such patients, if investigator feels that addition of acarbose would be benficial for the patients

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Exclusion Criteria

• According to local product information

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Acarbose (Precose/Glucobay, BAYG5421)	-

Primary Outcome Measures

Name	Time	Method
Data collection on Hba1c	16 weeks
Data collection on body weight	16 weeks
Data collection on blood glucose	16 weeks
Data collection on pre treatment concomitant diseases	16 weeks

Secondary Outcome Measures

Name	Time	Method
Safety variables will be summarized using descriptive statistics based on adverse events collection	16 weeks