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This study has been withdrawn prior to enrollment.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

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 ]

Secondary Outcome Measures:
  • 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 ]

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 Name: Metformin hydrochloride
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 Name: Metformin hydrochloride


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01510522

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

Responsible Party: Merck KGaA Identifier: NCT01510522     History of Changes
Other Study ID Numbers: EMR200084-508
2011-002508-34 ( EudraCT Number )
Study First Received: December 30, 2011
Last Updated: February 3, 2014

Keywords provided by Merck KGaA:

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs processed this record on May 25, 2017