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

This study has been completed.
Sponsor:
Information provided by:
Merck KGaA
ClinicalTrials.gov Identifier:
NCT01117103
First received: May 3, 2010
Last updated: July 15, 2014
Last verified: May 2010
  Purpose

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.


Condition
Type 2 Diabetes Mellitus

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective, Observational Study on the Use of Glucophage XR Therapy in the Management of Patients With Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by Merck KGaA:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • 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) ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Reasons for discontinuation [ Time Frame: At the time of discontinuation before completing the 12 weeks observation of period ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Plasma


Enrollment: 3592
Study Start Date: January 2008
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subjects diagnosed with type 2 diabetes in Asia Pacific region.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01117103

Locations
Singapore
Kevin Tan Clinic For Diabetes, Thyroid & Hormones Pte Ltd
Mount Elizabeth, Singapore
Sponsors and Collaborators
Merck KGaA
Investigators
Study Director: Dr Marcus Klein, MD, PhD Merck Pte. Ltd., Singapore
  More Information

No publications provided

Responsible Party: Marcus Klein, Regional Medical Director, Merck Pte. Ltd Singapore, an affiliate of Merk KGaA, Darmstadt, Germany
ClinicalTrials.gov Identifier: NCT01117103     History of Changes
Other Study ID Numbers: 200039-500
Study First Received: May 3, 2010
Last Updated: July 15, 2014
Health Authority: Singapore: Health Sciences Authority

Keywords provided by Merck KGaA:
Type 2 diabetes
Diabetes Mellitus
Glucophage
Metformin

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014