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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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|
- Change from Baseline of Patient self-reported subjective compliance as assessed by Haynes-Sackett test at Month 6 [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
- Objective compliance to treatment [ Time Frame: Month 3 and month 6 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]
- Rate of reported adverse events [ Time Frame: Month 3 and month 6 ] [ Designated as safety issue: Yes ]
|Study Start Date:||June 2012|
|Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
Experimental: Glucophage sachets
Patients receive Glucophage sachets, the powder formulation for oral solution in sachets.
Glucophage Powder for oral solution in sachets (metformin hydrochloride in 850mg strengths) Dosing schedule: > 1.700mg/day for 6 month
Active Comparator: Glucophage tablets
Patients received Glucophage tablets.
Glucophage tablets (metformin hydrochloride in 850mg strengths)
Dosing schedule: > 1.700mg/day for 6 month
Please refer to this study by its ClinicalTrials.gov identifier: NCT01510522
|Study Director:||Medical Responsible||Merck, S.L., Spain|