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

February 3, 2014 updated by: Merck KGaA, Darmstadt, Germany

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Glucophage sachets
Patients receive Glucophage sachets, the powder formulation for oral solution in sachets.
Drug: Glucophage
Glucophage Powder for oral solution in sachets (metformin hydrochloride in 850mg strengths) Dosing schedule: > 1.700mg/day for 6 month
Other Names:
  • Metformin hydrochloride
Drug: Glucophage

Glucophage tablets (metformin hydrochloride in 850mg strengths)

Dosing schedule: > 1.700mg/day for 6 month

Other Names:
  • Metformin hydrochloride
Active Comparator: Glucophage tablets
Patients received Glucophage tablets.
Drug: Glucophage
Glucophage Powder for oral solution in sachets (metformin hydrochloride in 850mg strengths) Dosing schedule: > 1.700mg/day for 6 month
Other Names:
  • Metformin hydrochloride
Drug: Glucophage

Glucophage tablets (metformin hydrochloride in 850mg strengths)

Dosing schedule: > 1.700mg/day for 6 month

Other Names:
  • Metformin hydrochloride

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective compliance to treatment
Time Frame: 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%.
Month 3 and month 6
Evaluation of treatment satisfaction and preferences with the Diabetes Treatment Satisfaction Questionnaire (DTSQ)
Time Frame: Baseline, month 3 and month 6
Baseline, month 3 and month 6
Rate of reported adverse events
Time Frame: Month 3 and month 6
Month 3 and month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck KGaA, Darmstadt, Germany

Collaborators

Merck, S.L., Spain

Investigators

  • Study Director: Medical Responsible, Merck, S.L., Spain

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

December 30, 2011

First Submitted That Met QC Criteria

January 11, 2012

First Posted (Estimate)

January 16, 2012

Study Record Updates

Last Update Posted (Estimate)

February 4, 2014

Last Update Submitted That Met QC Criteria

February 3, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EMR200084-508
  • 2011-002508-34 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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