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

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

Status

Withdrawn

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01510522

Enrollment

Registered

2012-01-16

Start date

2012-06-30

Completion date

Unknown

Last updated

2014-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus Type 2

Keywords

Diabetes, Glucophage, Metformin, sachets, tablets

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.

Interventions

DRUGGlucophage

Glucophage Powder for oral solution in sachets (metformin hydrochloride in 850mg strengths) Dosing schedule: \> 1.700mg/day for 6 month

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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%.
Evaluation of treatment satisfaction and preferences with the Diabetes Treatment Satisfaction Questionnaire (DTSQ)	Baseline, month 3 and month 6	—
Rate of reported adverse events	Month 3 and month 6	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026