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Completed

NCT Number: NCT01117103

A Prospective, Observational Study to Assess and Evaluate 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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Kevin Tan Clinic For Diabetes, Thyroid & Hormones Pte Ltd

Mount Elizabeth, Singapore

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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

  2. 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)

  3. 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

  4. Reasons for discontinuation

    Time frame: At the time of discontinuation before completing the 12 weeks observation of period

  5. 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)

Sponsors and collaborators

Lead sponsor

Merck KGaA, Darmstadt, Germany

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
May 5, 2010
Registry last updated
Jul 16, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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