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

Phase 4

Withdrawn

• Conditions: Diabetes Mellitus Type 2
• Interventions: Drug: Glucophage

• Registration Number: NCT01510522
• Lead Sponsor: Merck KGaA, Darmstadt, Germany

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 Glucophage tablets.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-12-30
• Study First Submitted QC: 2012-01-11
• Study First Posted: 2012-01-16
• Study Start: 2012-06
• Primary Completion: 2012-06
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-03
• Last Update Posted: 2014-02-04

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Glucophage tablets	Glucophage	Patients received Glucophage tablets.
Glucophage sachets	Glucophage	Patients receive Glucophage sachets, the powder formulation for oral solution in sachets.

Primary Outcome Measures

Name	Time	Method
Change from Baseline of Patient self-reported subjective compliance as assessed by Haynes-Sackett test at Month 6	Month 6

Secondary Outcome Measures

Name	Time	Method
Objective compliance to treatment	Month 3 and month 6	Objective compliance to treatment is assessed by the accountability of medication returned. Patient is assessed as compliant with an adherence of over 80%.
Rate of reported adverse events	Month 3 and month 6
Evaluation of treatment satisfaction and preferences with the Diabetes Treatment Satisfaction Questionnaire (DTSQ)	Baseline, month 3 and month 6