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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This study has been withdrawn prior to enrollment.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
History of Changes
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus Type 2
 Drug: Glucophage
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluate Adherence to Treatment With Glucophage Sachets Versus Tablets in Diabetes Type 2 Patients, Previously Treated With Metformin Tablets

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Type 2
U.S. FDA Resources

Further study details as provided by Merck KGaA:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]
Enrollment: 0
Study Start Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
  • Glucophage
Active Comparator: Glucophage tablets
Patients received Glucophage tablets.
 Drug: Glucophage

Glucophage tablets (metformin hydrochloride in 850mg strengths)

Dosing schedule: > 1.700mg/day for 6 month

Other Names:
  • Metformin hydrochloride
  • Glucophage

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01510522

Sponsors and Collaborators
Merck KGaA
Merck, S.L., Spain
Investigators
Study Director: Medical Responsible Merck, S.L., Spain
  More Information

No publications provided

Responsible Party: Merck KGaA
ClinicalTrials.gov Identifier: NCT01510522     History of Changes
Other Study ID Numbers: EMR200084-508, 2011-002508-34
Study First Received: December 30, 2011
Last Updated: February 3, 2014
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Merck KGaA:
Diabetes
Glucophage
Metformin
sachets
tablets

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
 Metformin
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 27, 2015