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

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ClinicalTrials.gov Identifier: NCT01510522
Recruitment Status : Withdrawn
First Posted : January 16, 2012
Last Update Posted : February 4, 2014
Sponsor:
Collaborator:
Merck, S.L., Spain
Information provided by (Responsible Party):
Merck KGaA

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Type 2 Drug: Glucophage Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : June 2012
Actual Primary Completion Date : June 2012

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U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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%.

  2. Evaluation of treatment satisfaction and preferences with the Diabetes Treatment Satisfaction Questionnaire (DTSQ) [ Time Frame: Baseline, month 3 and month 6 ]
  3. Rate of reported adverse events [ Time Frame: Month 3 and month 6 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01510522


Sponsors and Collaborators
Merck KGaA
Merck, S.L., Spain
Investigators
Study Director: Medical Responsible Merck, S.L., Spain
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Merck KGaA
ClinicalTrials.gov Identifier: NCT01510522     History of Changes
Other Study ID Numbers: EMR200084-508
2011-002508-34 ( EudraCT Number )
First Posted: January 16, 2012    Key Record Dates
Last Update Posted: February 4, 2014
Last Verified: February 2014

Keywords provided by Merck KGaA:
Diabetes
Glucophage
Metformin
sachets
tablets

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