Try our beta test site

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

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
Merck, S.L., Spain
Information provided by (Responsible Party):
Merck KGaA
ClinicalTrials.gov Identifier:
NCT01510522
First received: December 30, 2011
Last updated: February 3, 2014
Last verified: February 2014

December 30, 2011
February 3, 2014
June 2012
June 2012   (Final data collection date for primary outcome measure)
Change from Baseline of Patient self-reported subjective compliance as assessed by Haynes-Sackett test at Month 6 [ Time Frame: Month 6 ]
  • Patient self-reported subjective compliance as assessed by Haynes-Sackett test [ Time Frame: Baseline ]
  • Patient self-reported subjective compliance as assessed by Haynes-Sackett test [ Time Frame: Month 3 ]
  • Patient self-reported subjective compliance as assessed by Haynes-Sackett test [ Time Frame: Month 6 ]
Complete list of historical versions of study NCT01510522 on ClinicalTrials.gov Archive Site
  • 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%.
  • Evaluation of treatment satisfaction and preferences with the Diabetes Treatment Satisfaction Questionnaire (DTSQ) [ Time Frame: Baseline, month 3 and month 6 ]
  • Rate of reported adverse events [ Time Frame: Month 3 and month 6 ]
Same as current
Not Provided
Not Provided
 
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
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes Mellitus Type 2
  • Drug: Glucophage
    Glucophage Powder for oral solution in sachets (metformin hydrochloride in 850mg strengths) Dosing schedule: > 1.700mg/day for 6 month
    Other Name: Metformin hydrochloride
  • Drug: Glucophage

    Glucophage tablets (metformin hydrochloride in 850mg strengths)

    Dosing schedule: > 1.700mg/day for 6 month

    Other Name: Metformin hydrochloride
  • Experimental: Glucophage sachets
    Patients receive Glucophage sachets, the powder formulation for oral solution in sachets.
    Intervention: Drug: Glucophage
  • Active Comparator: Glucophage tablets
    Patients received Glucophage tablets.
    Intervention: Drug: Glucophage
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
Not Provided
June 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
Spain
 
NCT01510522
EMR200084-508, 2011-002508-34
No
Not Provided
Not Provided
Not Provided
Merck KGaA
Merck KGaA
Merck, S.L., Spain
Study Director: Medical Responsible Merck, S.L., Spain
Merck KGaA
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP