Status:
WITHDRAWN
Evaluate Adherence to Treatment With Glucophage Sachets Versus Tablets in Diabetes Type 2 Patients Previously Treated With Metformin Tablets
Lead Sponsor:
Merck KGaA, Darmstadt, Germany
Collaborating Sponsors:
Merck, S.L., Spain
Conditions:
Diabetes Mellitus Type 2
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 Gluco...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01510522
Start Date
June 1 2012
Last Update
February 4 2014
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