Diabetes Treatment With Glucobay in Combination With Metformin

July 7, 2014 updated by: Bayer

Prospecitve, Non Interventional, Non Controlled, Post Marketing Survelliance Study to Evaluate Efficacy, Safety, Tolerability of Glucobay on Top of Metformin Under Daily Life Treatment Conditions

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 metformin 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 metformin therapy.The study is planned to carried out in 25000 - 30000 patients from 200 trial sites in India.The PMS 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

19509

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • Many Locations, India

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Type 2 diabetes

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • According to local product information

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
Drug: Acarbose (Precose/Glucobay, BAYG5421)
Oral Glucobay 25 titrated to Glucobay 50 three times a day with meals or as per investigators descretion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Data collection on body weight
Time Frame: 16 weeks
16 weeks
Data collection on blood glucose
Time Frame: 16 weeks
16 weeks
Data collection on Hba1c
Time Frame: 16 weeks
16 weeks
Data collection on pre treatment concomitant diseases
Time Frame: 16 weeks
16 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety variables will be summarized using descriptive statistics based on adverse events collection
Time Frame: 16 weeks
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

June 4, 2012

First Submitted That Met QC Criteria

June 4, 2012

First Posted (Estimate)

June 6, 2012

Study Record Updates

Last Update Posted (Estimate)

July 8, 2014

Last Update Submitted That Met QC Criteria

July 7, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13925
  • GB0711IN (Other Identifier: company internal)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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