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

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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 Glucophage tablets.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck KGaA; Merck KGaA, Darmstadt, Germany
• Collaborator: Merck, S.L., Spain
• Treatments: Metformin

Criteria

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