Evaluate Adherence to Treatment With Glucophage Sachets Versus Tablets in Diabetes Type 2 Patients Previously Treated With Metformin Tablets
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ClinicalTrials.gov Identifier: NCT01510522 |
Recruitment Status
:
Withdrawn
First Posted
: January 16, 2012
Last Update Posted
: February 4, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diabetes Mellitus Type 2 | Drug: Glucophage | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Evaluate Adherence to Treatment With Glucophage Sachets Versus Tablets in Diabetes Type 2 Patients, Previously Treated With Metformin Tablets |
Study Start Date : | June 2012 |
Actual Primary Completion Date : | June 2012 |

Arm | Intervention/treatment |
---|---|
Experimental: Glucophage sachets
Patients receive Glucophage sachets, the powder formulation for oral solution in sachets.
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Drug: Glucophage
Glucophage Powder for oral solution in sachets (metformin hydrochloride in 850mg strengths) Dosing schedule: > 1.700mg/day for 6 month
Other Name: Metformin hydrochloride
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Active Comparator: Glucophage tablets
Patients received Glucophage tablets.
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Drug: Glucophage
Glucophage tablets (metformin hydrochloride in 850mg strengths) Dosing schedule: > 1.700mg/day for 6 month Other Name: Metformin hydrochloride
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- Change from Baseline of Patient self-reported subjective compliance as assessed by Haynes-Sackett test at Month 6 [ Time Frame: Month 6 ]
- Objective compliance to treatment [ Time Frame: Month 3 and month 6 ]Objective compliance to treatment is assessed by the accountability of medication returned. Patient is assessed as compliant with an adherence of over 80%.
- 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01510522
Study Director: | Medical Responsible | Merck, S.L., Spain |
Responsible Party: | Merck KGaA |
ClinicalTrials.gov Identifier: | NCT01510522 History of Changes |
Other Study ID Numbers: |
EMR200084-508 2011-002508-34 ( EudraCT Number ) |
First Posted: | January 16, 2012 Key Record Dates |
Last Update Posted: | February 4, 2014 |
Last Verified: | February 2014 |
Keywords provided by Merck KGaA:
Diabetes Glucophage Metformin sachets tablets |
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 |