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

NCT ID: NCT01510522

Last Updated: 2014-02-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Brief Summary

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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

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Conditions

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Diabetes Mellitus Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Glucophage sachets

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

Group Type EXPERIMENTAL

Glucophage

Intervention Type DRUG

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

Glucophage tablets

Patients received Glucophage tablets.

Group Type ACTIVE_COMPARATOR

Glucophage

Intervention Type DRUG

Glucophage tablets (metformin hydrochloride in 850mg strengths)

Dosing schedule: \> 1.700mg/day for 6 month

Interventions

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Glucophage

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

Intervention Type DRUG

Glucophage

Glucophage tablets (metformin hydrochloride in 850mg strengths)

Dosing schedule: \> 1.700mg/day for 6 month

Intervention Type DRUG

Other Intervention Names

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Metformin hydrochloride Metformin hydrochloride

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck, S.L., Spain

INDUSTRY

Sponsor Role collaborator

Merck KGaA, Darmstadt, Germany

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Responsible

Role: STUDY_DIRECTOR

Merck, S.L., Spain

Other Identifiers

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2011-002508-34

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

EMR200084-508

Identifier Type: -

Identifier Source: org_study_id

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