Diabetes Mellitus Type 2NCT01336673
Glucophage XR® Observational Study
An observational study of Diabetes Mellitus Type 2 and GI Side Effect, run by Merck KGaA, Darmstadt, Germany at 1 site in Thailand.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetes Mellitus Type 2, GI Side Effect
- How many people
- 518 participants
- Where
- 1 siteThailand
- Study dates
- Jun 2011to Jun 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient aged > 18 and diagnosed with type 2 diabetes and considered by physician as suitable for treatment Glucophage XR®
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Observational Study on the Use of Glucophage XR® Therapy in the Management of Patients With Type 2 Diabetes
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.
Read the 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.
- Conditions
- Diabetes Mellitus Type 2, GI Side Effect
- Keywords
- Glucophage XR, Tolerability
- Medical subject headings
- Diabetes Mellitus, Type 2
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients who experience at least one gastrointestinal side effect
Measured: 12 weeks
Secondary outcomes (3)
Proportion of patients who discontinue Glucophage XR® prematurely, defined as less than 12 weeks, due to side effects.
Measured: 12 weeks
Incidence of side effects
Measured: 12 weeks
Change of Hemoglobin A1c level from baseline after at least 12 weeks of Glucophage XR® therapy
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2011 (estimated)
- Study startJun 2011
- Primary completionJun 2013
- Study completionJun 2013
Why it stopped: The study was scheduled for completion February 2013. Because of difficulties encountered in completing the trial the study was terminated by sponsor June 2013.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 518 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Ltd., Thailand
- Responsible party
- Sponsor
- Investigators
- Clinical Research Manager, Study director, Merck Ltd., Thailand, an affiliate of Merck KGaA, Darmstadt, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01336673
- Sponsor's protocol ID
- EMR200039-503
- Status last verified
- Jun 2014
- First submitted
- 14 Apr 2011
- Last updated
- 19 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study on the Use of Glucophage XR® Therapy in the Management of Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT01336673
- Acronym / sponsor ID
- EMR200039-503
- Conditions
- Diabetes Mellitus Type 2, GI Side Effect
- Keywords
- Glucophage XR, Tolerability
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The study was scheduled for completion February 2013. Because of difficulties encountered in completing the trial the study was terminated by sponsor June 2013.
- Enrolment
- 518 participants (actual)
- Lead sponsor
- Merck KGaA, Darmstadt, GermanyIndustry (pharma, biotech, devices)
- Collaborators
- Merck Ltd., Thailand
- Study start
- Jun 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 18 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient aged > 18 and diagnosed with type 2 diabetes and considered by physician as suitable for treatment Glucophage XR®
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of patients who experience at least one gastrointestinal side effect
Time frame: 12 weeks
3 secondary outcomes
Proportion of patients who discontinue Glucophage XR® prematurely, defined as less than 12 weeks, due to side effects.
Time frame: 12 weeks
Incidence of side effects
Time frame: 12 weeks
Change of Hemoglobin A1c level from baseline after at least 12 weeks of Glucophage XR® therapy
Time frame: 12 weeks
Results and safety
The study was stopped early (reason given: The study was scheduled for completion February 2013. Because of difficulties encountered in completing the trial the study was terminated by sponsor June 2013.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2014.
Related trials for Diabetes Mellitus Type 2
Active, not recruiting
Effect of the Thrive AI Health App on Lifestyle Behaviors and Quality of Life
Diabetes Type 2, Overweight or Obesity
Recruiting
Insulin-Mediated Glucose Uptake and Organ Perfusion Assessed by Total-Body PET During GIP and GLP-1 Infusion
Type 2 Diabetes, Healhty
RecruitingObservational study
Dietitian-Nutritionist vs. Day Hospital in the Metabolic Control of Patients With Type 2 Diabetes
Diabetes (DM)
RecruitingPhase 2
Study to Assess the Effects of ALN-ANG3 in Adult Participants With Diabetic Kidney Disease
Diabetic Kidney Disease (DKD)
RecruitingObservational study
AI-Driven Metabolic Cohort in Overweight/Obese Chinese Adults
Overweight and Obesity, Diabetes Mellitus, Type 2
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Research Manager study director
Merck Ltd., Thailand, an affiliate of Merck KGaA, Darmstadt, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus Type 2 and GI Side Effect, run by Merck KGaA, Darmstadt, Germany at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The study was scheduled for completion February 2013. Because of difficulties encountered in completing the trial the study was terminated by sponsor June 2013.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients who experience at least one gastrointestinal side effect (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2014.