Glucophage XR® Observational Study

This study has been terminated.
(The study was scheduled for completion February 2013. Because of difficulties encountered in completing the trial the study was terminated by sponsor June 2013.)
Sponsor:
Collaborator:
Merck Ltd., Thailand
Information provided by (Responsible Party):
Merck KGaA
ClinicalTrials.gov Identifier:
NCT01336673
First received: April 14, 2011
Last updated: June 18, 2014
Last verified: June 2014
  Purpose

This is a non-interventional, prospective study where no visits or additional interventions to the daily practice of the physician will be performed. Glucophage XR® has recently been available in Thailand for the treatment of patients with type 2 diabetes. A prospective observational study will be valuable to provide information on the day-to-day experience of using Glucophage XR® in the management of this patient population. The data may provide an insight into the use of Glucophage XR® in routine clinical practice in Thailand.


Condition
Diabetes Mellitus Type 2
GI Side Effect

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: An 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 patients who experience at least one gastrointestinal side effect [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Proportion of patients who discontinue Glucophage XR® prematurely, defined as less than 12 weeks, due to side effects. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Incidence of side effects [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Change of Hemoglobin A1c level from baseline after at least 12 weeks of Glucophage XR® therapy [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 518
Study Start Date: June 2011
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Detailed Description:

Metformin (Glucophage) is the standard first line therapy for patients with type 2 diabetes mellitus. The landmark UK Prospective Diabetes Study Group demonstrated significant reduction in the risk of myocardial infarction and overall mortality in overweight patients with type 2 diabetes treated with metformin and metformin was more effective in controlling blood glucose compared with lifestyle only diet-based policy. The observed improvement of blood glucose was not associated with weight gain or hypoglycaemia in contrast to treatment with either a sulphonylurea or insulin.

It is well accepted that patients' compliance with therapy tends to decrease as the dosage frequency increases and that 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®) may support the simplification of treatment for patients by allowing a once-daily administration of metformin.

Although patients taking metformin had significantly lower fasting and postprandial plasma glucose and hemoglobin A1C concentrations, they also had a higher prevalence of Gastrointestinal (GI) side effects. The most commonly reported symptoms was diarrhea (53,2 % compared to 11,7% on placebo). In a study employing self-administered questionnaires to ascertain GI symptoms in patients with type 2 diabetes approximately 20% of those taking immediate-release metformin reported diarrhea as the most common symptoms. Although less than 5% of patients discontinue metformin treatment for this reason, such adverse events can be troublesome, may limit the dosage of metformin and may impair compliance with therapy. Glucophage XR may lead to improved tolerability, by smoothing the peaks and troughs in metformin plasma concentrations and delaying the achievement of peak plasma concentration, compared with an immediate-release formulation. Initial placebo-controlled clinical trials with Glucophage XR indicate that 9,6% patients reported diarrhea (compare to 1,5% on placebo).

Thus, the use of Glucophage XR® may provide benefits in terms of improved patient management, by enabling once-daily dosing and reducing the incidence of gastrointestinal side effects for some patients. A prospective observational study will be valuable to provide information on the day-to-day experience of using Glucophage XR® in the management of this patient population. The data may provide an insight into the use of Glucophage XR® in routine clinical practice in Thailand.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patient aged > 18 and diagnosed with type 2 diabetes and considered by physician as suitable for treatment Glucophage XR®

Criteria

Inclusion Criteria:

  • Patients diagnosed with type 2 diabetes
  • Considered as suitable for treatment Glucophage XR®
  • Agreeing to maintain prior diet and exercise habits during the full course of the study
  • Patient is regularly followed by/monitored by the investigator for type II diabetes mellitus
  • Patients for whom a written informed consent has been obtained

Exclusion Criteria:

  • Contraindicated use of Glucophage XR based on local label
  • Renal disease or renal dysfunction
  • Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma
  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: NCT01336673

Locations
Thailand
Faculty of Medicine Vajira Hospital
Bangkok, Thailand
Sponsors and Collaborators
Merck KGaA
Merck Ltd., Thailand
Investigators
Study Director: Clinical Research Manager Merck Ltd., Thailand, an affiliate of Merck KGaA, Darmstadt, Germany
  More Information

No publications provided

Responsible Party: Merck KGaA
ClinicalTrials.gov Identifier: NCT01336673     History of Changes
Other Study ID Numbers: EMR200039-503
Study First Received: April 14, 2011
Last Updated: June 18, 2014
Health Authority: Thailand: Ministry of Public Health

Keywords provided by Merck KGaA:
Glucophage XR
Tolerability

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 September 18, 2014