A Prospective, Observational Study to Assess and Evaluate the Use of Glucophage XR Therapy in the Management of Patients With Type 2 Diabetes

July 15, 2014 updated by: Merck KGaA, Darmstadt, Germany

A Prospective, Observational Study on the Use of Glucophage XR Therapy in the Management of Patients With Type 2 Diabetes

This was an observational, prospective, multicentric study conducted in a cohort of subjects with type 2 diabetes and prescribed with Glucophage XR therapy from hospitals or clinics in Hong Kong, Indonesia, Korea, Malaysia, Philippines and Singapore. Glucophage XR is being used in the Asia Pacific region for the treatment of subjects with type 2 diabetes. This study was designed to provide information on the day to-day experience of using Glucophage XR in the management of subjects with type 2 diabetes and its use in routine clinical practice in Asia Pacific region.

Study Overview

Status

Completed

Conditions

Detailed Description

Glucophage (metformin) is the standard first line therapy for subjects with type 2 diabetes mellitus (DM). The consensus statement from the American Diabetes Association and the European Association for the Study of Diabetes has recommended metformin therapy in concurrent with lifestyle intervention at diagnosis. It has been well accepted that subjects' compliance with therapy tends to decrease as the dosage frequency increases and hence the regimens should be simplified as far as possible to support good compliance with therapy. The use of an extended release formulation of metformin (Glucophage XR) supports the simplification of treatment of subjects with type 2 diabetes by allowing a once daily administration of metformin.

OBJECTIVES

Primary objective:

  • To assess the tolerability of Glucophage XR therapy when used in routine clinical practice in subjects with type 2 diabetes

Secondary objective:

  • To assess the effectiveness of Glucophage XR therapy on the maintenance of glycaemic control

The study does not involve any active involvement of the subjects and does not require any change from the standard medical management of the subjects. Each subject will be followed upon starting Glucophage XR therapy and until at least 12 weeks of treatment or discontinuation of treatment, whichever being earlier.

Study Type

Observational

Enrollment (Actual)

3592

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

  • Singapore
      • Mount Elizabeth, Singapore
        • Kevin Tan Clinic For Diabetes, Thyroid & Hormones Pte Ltd

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects diagnosed with type 2 diabetes in Asia Pacific region.

Description

Inclusion Criteria:

  • Subjects diagnosed with type 2 diabetes
  • Subjects who have been given Glucophage XR for the treatment of the type 2 diabetes

Exclusion Criteria:

  • Subjects treated with Glucophage XR before the study initiation
  • Contraindicated use of Glucophage XR based on local label
  • Subjects who plan to continue on another oral anti diabetic therapy during the course of the study

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of subjects who discontinue Glucophage XR treatment prematurely (< 12 weeks) due to side effects
Time Frame: Baseline to post-treatment visit (after at least 12 weeks of treatment from the baseline visit)
Baseline to post-treatment visit (after at least 12 weeks of treatment from the baseline visit)

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of subjects experiencing at least one gastrointestinal side effect
Time Frame: Baseline to post-treatment visit (after at least 12 weeks of treatment from the baseline visit) or discontinuation of treatment, whichever is earlier
Baseline to post-treatment visit (after at least 12 weeks of treatment from the baseline visit) or discontinuation of treatment, whichever is earlier
Proportion of subjects remaining on Glucophage XR therapy for at least 12 weeks
Time Frame: Baseline to post-treatment visit (after at least 12 weeks of treatment from the baseline visit)
Baseline to post-treatment visit (after at least 12 weeks of treatment from the baseline visit)
Incidence of side effects
Time Frame: Baseline to post-treatment visit (after at least 12 weeks of treatment from the baseline visit) or discontinuation of treatment, whichever is earlier
Baseline to post-treatment visit (after at least 12 weeks of treatment from the baseline visit) or discontinuation of treatment, whichever is earlier
Reasons for discontinuation
Time Frame: At the time of discontinuation before completing the 12 weeks observation of period
At the time of discontinuation before completing the 12 weeks observation of period
Change in glycosylated haemoglobin (HbA1c) levels from baseline after 12 weeks
Time Frame: Baseline to post-treatment visit (after at least 12 weeks of treatment from the baseline visit)
Baseline to post-treatment visit (after at least 12 weeks of treatment from the baseline visit)

Collaborators and Investigators

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

Sponsor

Merck KGaA, Darmstadt, Germany

Investigators

  • Study Director: Dr Marcus Klein, MD, PhD, Merck Pte. Ltd., Singapore

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

January 1, 2008

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

May 3, 2010

First Submitted That Met QC Criteria

May 3, 2010

First Posted (Estimate)

May 5, 2010

Study Record Updates

Last Update Posted (Estimate)

July 16, 2014

Last Update Submitted That Met QC Criteria

July 15, 2014

Last Verified

May 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 200039-500

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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