NCT01510522

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.

Trial Health

10
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 30, 2011

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 16, 2012

Completed
5 months until next milestone

Study Start

First participant enrolled

June 1, 2012

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Last Updated

February 4, 2014

Status Verified

February 1, 2014

Enrollment Period

Same day

First QC Date

December 30, 2011

Last Update Submit

February 3, 2014

Conditions

Diabetes Mellitus Type 2

Keywords

DiabetesGlucophageMetforminsachetstablets

Outcome Measures

Primary Outcomes (1)

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

    Month 6

Secondary Outcomes (3)

  • Objective compliance to treatment

    Month 3 and month 6

  • 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

Study Arms (2)

Glucophage sachets

EXPERIMENTAL

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

Drug: Glucophage

Glucophage tablets

ACTIVE COMPARATOR

Patients received Glucophage tablets.

Drug: Glucophage

Interventions

GlucophageDRUG

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

Also known as: Metformin hydrochloride
Glucophage sachets

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Interventions

Metformin

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Medical Responsible

    Merck, S.L., Spain

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 30, 2011

First Posted

January 16, 2012

Study Start

June 1, 2012

Primary Completion

June 1, 2012

Last Updated

February 4, 2014

Record last verified: 2014-02