Type 2 Diabetes MellitusNCT01117103
A Prospective, Observational Study to Assess and Evaluate the Use of Glucophage XR Therapy in the Management of Patients With Type 2 Diabetes
An observational study of Type 2 Diabetes Mellitus, run by Merck KGaA, Darmstadt, Germany at 1 site in Singapore.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Type 2 Diabetes Mellitus
- How many people
- 3,592 participants
- Where
- 1 siteSingapore
- Study dates
- Jan 2008to Jan 2009
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subjects diagnosed with type 2 diabetes in Asia Pacific region.
Who may be able to join
- Subjects diagnosed with type 2 diabetes
- Subjects who have been given Glucophage XR for the treatment of the type 2 diabetes
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Singapore1 site
Kevin Tan Clinic For Diabetes, Thyroid & Hormones Pte Ltd
Mount Elizabeth
About this study
Official title: A Prospective, Observational Study on 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.
Read the 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.
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Type 2 diabetes, Diabetes Mellitus, Glucophage, Metformin
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects who discontinue Glucophage XR treatment prematurely (< 12 weeks) due to side effects
Measured: Baseline to post-treatment visit (after at least 12 weeks of treatment from the baseline visit)
Secondary outcomes (5)
Proportion of subjects experiencing at least one gastrointestinal side effect
Measured: Baseline to post-treatment visit (after at least 12 weeks of treatment from the baseline visit) or discontinuation of treatment, whichever is earlier
Proportion of subjects remaining on Glucophage XR therapy for at least 12 weeks
Measured: Baseline to post-treatment visit (after at least 12 weeks of treatment from the baseline visit)
Incidence of side effects
Measured: Baseline to post-treatment visit (after at least 12 weeks of treatment from the baseline visit) or discontinuation of treatment, whichever is earlier
Reasons for discontinuation
Measured: At the time of discontinuation before completing the 12 weeks observation of period
Change in glycosylated haemoglobin (HbA1c) levels from baseline after 12 weeks
Measured: Baseline to post-treatment visit (after at least 12 weeks of treatment from the baseline visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2010 (estimated)
- Study startJan 2008
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies 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
- 3,592 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Dr Marcus Klein, MD, PhD, Study director, Merck Pte. Ltd., Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01117103
- Sponsor's protocol ID
- 200039-500
- Status last verified
- May 2010
- First submitted
- 3 May 2010
- Last updated
- 16 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Observational Study on the Use of Glucophage XR Therapy in the Management of Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT01117103
- Acronym / sponsor ID
- 200039-500
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Type 2 diabetes, Diabetes Mellitus, Glucophage, Metformin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,592 participants (actual)
- Lead sponsor
- Merck KGaA, Darmstadt, GermanyIndustry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 5 May 2010 (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 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects diagnosed with type 2 diabetes in Asia Pacific region.
Key inclusion criteria (2 listed)
- Subjects diagnosed with type 2 diabetes
- Subjects who have been given Glucophage XR for the treatment of the type 2 diabetes
Key exclusion criteria (3 listed)
- 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
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 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)
5 secondary outcomes
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
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)
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
Reasons for discontinuation
Time frame: At the time of discontinuation before completing the 12 weeks observation of period
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2014.
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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.
Dr Marcus Klein, MD, PhD study director
Merck Pte. Ltd., Singapore
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 Type 2 Diabetes Mellitus, run by Merck KGaA, Darmstadt, Germany at 1 site in Singapore.
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 2 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: finished, as of the sponsor's last update on 16 Jul 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 Singapore. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 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)). 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 16 Jul 2014.