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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01117103
• Other study ID #: 200039-500
• Status: Completed
• Phase: N/A
• First received: May 3, 2010
• Last updated: July 15, 2014
• Start date: January 2008
• Est. completion date: January 2009

Study information

• Verified date: May 2010
• Source: Merck KGaA
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Health Sciences Authority
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3592
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Locations

Country	Name	City	State
Singapore	Kevin Tan Clinic For Diabetes, Thyroid & Hormones Pte Ltd	Mount Elizabeth

Sponsors (1)

Lead Sponsor	Collaborator
Merck KGaA

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects who discontinue Glucophage XR treatment prematurely (< 12 weeks) due to side effects		Baseline to post-treatment visit (after at least 12 weeks of treatment from the baseline visit)	Yes
Secondary	Proportion of subjects experiencing at least one gastrointestinal side effect		Baseline to post-treatment visit (after at least 12 weeks of treatment from the baseline visit) or discontinuation of treatment, whichever is earlier	Yes
Secondary	Proportion of subjects remaining on Glucophage XR therapy for at least 12 weeks		Baseline to post-treatment visit (after at least 12 weeks of treatment from the baseline visit)	No
Secondary	Incidence of side effects		Baseline to post-treatment visit (after at least 12 weeks of treatment from the baseline visit) or discontinuation of treatment, whichever is earlier	Yes
Secondary	Reasons for discontinuation		At the time of discontinuation before completing the 12 weeks observation of period	No
Secondary	Change in glycosylated haemoglobin (HbA1c) levels from baseline after 12 weeks		Baseline to post-treatment visit (after at least 12 weeks of treatment from the baseline visit)	No