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

Merck KGaA (EMD Serono)

Status and phase: Withdrawn; Phase 4

Conditions: Diabetes Mellitus Type 2

Treatments: Drug: Glucophage

Study type: Interventional

Funder types: Industry

Identifiers

NCT01510522

2011-002508-34 (EudraCT Number)

EMR200084-508

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Glucophage sachets

Experimental group

Description:

Patients receive Glucophage sachets, the powder formulation for oral solution in sachets.

Treatment:

Drug: Glucophage

Drug: Glucophage

Glucophage tablets

Active Comparator group

Description:

Patients received Glucophage tablets.

Treatment:

Drug: Glucophage

Drug: Glucophage