Diabetes Mellitus Type 2Phase 4NCT01510522
Evaluate Adherence to Treatment With Glucophage Sachets Versus Tablets in Diabetes Type 2 Patients Previously Treated With Metformin Tablets
A Phase 4 study testing Glucophage in people with Diabetes Mellitus Type 2, run by Merck KGaA, Darmstadt, Germany.
Trial summary
This is an open-label, multicenter, two-arm, parallel, randomized phase 4 study to compare the compliance in diabetes type 2 patients treated with Glucophage sachets versus patients treated with Glucophage tablets. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus Type 2
- What is being tested?
- Glucophage
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2012to Jun 2012
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diabetes mellitus type 2 diagnosed (Baseline Glycemia > 7,0 mmol/L (126 mg/dL) or overload Glycemia > 11,0 mmol/L (198 mg/dL)
- On treatment with metformin tablets
- Patients with at least 2 treated co-morbidities
- Established dose of Metformin > 1.700 mg/day
- Age > 18 years old
- Given informed consent
Who cannot join
- Patients not able to take medication orally
- According to Summary of Product Characteristics (SmPC)
- Participating in another clinical trial 30 days prior to randomization
- Any other illness or medical or psychiatric condition, severe and uncontrolled that could interfere in the patient's participation or in the assessment of the study results
About this study
Official title: Evaluate Adherence to Treatment With Glucophage Sachets Versus Tablets in Diabetes Type 2 Patients, Previously Treated With Metformin Tablets
This is an open-label, multicenter, two-arm, parallel, randomized phase 4 study to compare the compliance in diabetes type 2 patients treated with Glucophage sachets versus patients treated with Glucophage tablets.
- Conditions
- Diabetes Mellitus Type 2
- Being tested
- Glucophage
- Keywords
- Diabetes, Glucophage, Metformin, sachets, tablets
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlucophageDrug
Also called Metformin hydrochloride
Glucophage Powder for oral solution in sachets (metformin hydrochloride in 850mg strengths) Dosing schedule: > 1.700mg/day for 6 month
GlucophageDrug
Also called Metformin hydrochloride
Glucophage tablets (metformin hydrochloride in 850mg strengths)
Dosing schedule: > 1.700mg/day for 6 month
| Study group | Role | What they receive |
|---|---|---|
| Glucophage sachets | Experimental | Patients receive Glucophage sachets, the powder formulation for oral solution in sachets. Receives: Drug: Glucophage |
| Glucophage tablets | Active comparator | Patients received Glucophage tablets. Receives: Drug: Glucophage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline of Patient self-reported subjective compliance as assessed by Haynes-Sackett test at Month 6
Measured: Month 6
Secondary outcomes (3)
Objective compliance to treatment
Objective compliance to treatment is assessed by the accountability of medication returned. Patient is assessed as compliant with an adherence of over 80%.
Measured: Month 3 and month 6
Evaluation of treatment satisfaction and preferences with the Diabetes Treatment Satisfaction Questionnaire (DTSQ)
Measured: Baseline, month 3 and month 6
Rate of reported adverse events
Measured: Month 3 and month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2012 (estimated)
- Study startJun 2012
- Primary completionJun 2012
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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck, S.L., Spain
- Responsible party
- Sponsor
- Investigators
- Medical Responsible, Study director, Merck, S.L., Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01510522
- Sponsor's protocol ID
- EMR200084-508
- Other IDs
- 2011-002508-34
- Status last verified
- Feb 2014
- First submitted
- 30 Dec 2011
- Last updated
- 4 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate Adherence to Treatment With Glucophage Sachets Versus Tablets in Diabetes Type 2 Patients, Previously Treated With Metformin Tablets
- ClinicalTrials.gov ID
- NCT01510522
- Acronym / sponsor ID
- EMR200084-508
- Conditions
- Diabetes Mellitus Type 2
- Keywords
- Diabetes, Glucophage, Metformin, sachets, tablets
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Merck KGaA, Darmstadt, GermanyIndustry (pharma, biotech, devices)
- Collaborators
- Merck, S.L., Spain
- Study start
- Jun 2012
- Primary completion
- Jun 2012 (actual)
- First posted
- 16 Jan 2012 (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 an open-label, multicenter, two-arm, parallel, randomized phase 4 study to compare the compliance in diabetes type 2 patients treated with Glucophage sachets versus patients treated with Glucophage tablets.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glucophage sachets | Experimental | Drug: GlucophagePatients receive Glucophage sachets, the powder formulation for oral solution in sachets. |
| Glucophage tablets | Active comparator | Drug: GlucophagePatients received Glucophage tablets. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diabetes mellitus type 2 diagnosed (Baseline Glycemia > 7,0 mmol/L (126 mg/dL) or overload Glycemia > 11,0 mmol/L (198 mg/dL)
- On treatment with metformin tablets
- Patients with at least 2 treated co-morbidities
- Established dose of Metformin > 1.700 mg/day
- Age > 18 years old
Key exclusion criteria (4 listed)
- Patients not able to take medication orally
- According to Summary of Product Characteristics (SmPC)
- Participating in another clinical trial 30 days prior to randomization
- Any other illness or medical or psychiatric condition, severe and uncontrolled that could interfere in the patient's participation or in the assessment of the study results
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GlucophageAlso: Metformin hydrochlorideGlucophage Powder for oral solution in sachets (metformin hydrochloride in 850mg strengths) Dosing schedule: > 1.700mg/day for 6 month | Drug | Glucophage sachets |
| GlucophageAlso: Metformin hydrochlorideGlucophage tablets (metformin hydrochloride in 850mg strengths) Dosing schedule: > 1.700mg/day for 6 month | Drug | Glucophage tablets |
Primary outcome
Change from Baseline of Patient self-reported subjective compliance as assessed by Haynes-Sackett test at Month 6
Time frame: Month 6
3 secondary outcomes
Objective compliance to treatment
Time frame: Month 3 and month 6
Evaluation of treatment satisfaction and preferences with the Diabetes Treatment Satisfaction Questionnaire (DTSQ)
Time frame: Baseline, month 3 and month 6
Rate of reported adverse events
Time frame: Month 3 and month 6
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 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.
Medical Responsible study director
Merck, S.L., Spain
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Glucophage in people with Diabetes Mellitus Type 2, run by Merck KGaA, Darmstadt, Germany.
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 6 inclusion and 4 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: withdrawn, as of the sponsor's last update on 4 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Change from Baseline of Patient self-reported subjective compliance as assessed by Haynes-Sackett test at Month 6 (time frame: Month 6). 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 4 Feb 2014.