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This study has been withdrawn prior to enrollment.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 ] [ Designated as safety issue: No ]
  • Patient self-reported subjective compliance as assessed by Haynes-Sackett test [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
  • Patient self-reported subjective compliance as assessed by Haynes-Sackett test [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Patient self-reported subjective compliance as assessed by Haynes-Sackett test [ Time Frame: Month 3 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01510522 on ClinicalTrials.gov Archive Site
  • Objective compliance to treatment [ Time Frame: Month 3 and month 6 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Rate of reported adverse events [ Time Frame: Month 3 and month 6 ] [ Designated as safety issue: Yes ]
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
Endpoint Classification: Safety/Efficacy Study
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 Names:
    • Metformin hydrochloride
    • Glucophage
  • Drug: Glucophage

    Glucophage tablets (metformin hydrochloride in 850mg strengths)

    Dosing schedule: > 1.700mg/day for 6 month

    Other Names:
    • Metformin hydrochloride
    • Glucophage
  • 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01510522
EMR200084-508, 2011-002508-34
No
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