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

Information source: Merck KGaA
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diabetes Mellitus Type 2

Intervention: Glucophage (Drug); Glucophage (Drug)

Phase: Phase 4

Status: Withdrawn

Sponsored by: Merck KGaA

Official(s) and/or principal investigator(s):
Medical Responsible, Study Director, Affiliation: Merck, S.L., Spain


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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Change from Baseline of Patient self-reported subjective compliance as assessed by Haynes-Sackett test at Month 6

Secondary outcome:

Objective compliance to treatment

Evaluation of treatment satisfaction and preferences with the Diabetes Treatment Satisfaction Questionnaire (DTSQ)

Rate of reported adverse events


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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

Locations and Contacts

Additional Information

Starting date: June 2012
Last updated: February 3, 2014

Page last updated: August 23, 2015

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