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

NCT ID: NCT01117103

Last Updated: 2014-07-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 3592 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2009-01-31

Brief Summary

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.

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.

Conditions

Type 2 Diabetes Mellitus

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck KGaA, Darmstadt, Germany

INDUSTRY

Sponsor Role: lead

Responsible Party

Merck Pte. Ltd Singapore, an affiliate of Merk KGaA, Darmstadt, Germany

Principal Investigators

Dr Marcus Klein, MD, PhD

Role: STUDY_DIRECTOR

Merck Pte. Ltd., Singapore

Locations

Kevin Tan Clinic For Diabetes, Thyroid & Hormones Pte Ltd

Mount Elizabeth, , Singapore

Countries

Singapore

Other Identifiers

200039-500

Identifier Type: -

Identifier Source: org_study_id