Evaluate Adherence to Treatment With Glucophage Sachets Versus Tablets in Diabetes Type 2 Patients Previously Treated With Metformin Tablets

Study Overview
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Brief Summary
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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.

Official Title
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Evaluate Adherence to Treatment With Glucophage Sachets Versus Tablets in Diabetes Type 2 Patients, Previously Treated With Metformin Tablets

Conditions
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Diabetes Mellitus Type 2

Intervention / Treatment
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* Drug: Glucophage
* Drug: Glucophage


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Glucophage sachets<br>Patients receive Glucophage sachets, the powder formulation for oral solution in sachets. | Drug: Glucophage<br>* Glucophage Powder for oral solution in sachets (metformin hydrochloride in 850mg strengths) Dosing schedule: > 1.700mg/day for 6 month<br>* Other names: Metformin hydrochloride;|
| Active Comparator: Glucophage tablets<br>Patients received Glucophage tablets. | Drug: Glucophage<br>* Glucophage tablets (metformin hydrochloride in 850mg strengths) Dosing schedule: > 1.700mg/day for 6 month<br>* Other names: Metformin hydrochloride;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline of Patient self-reported subjective compliance as assessed by Haynes-Sackett test at Month 6 |  | Month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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%. | Month 3 and month 6 | 
| Evaluation of treatment satisfaction and preferences with the Diabetes Treatment Satisfaction Questionnaire (DTSQ) |  | Baseline, month 3 and month 6 | 
| Rate of reported adverse events |  | Month 3 and month 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes, Glucophage, Metformin, sachets, tablets