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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This study has been withdrawn prior to enrollment.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:

ClinicalTrials.gov Identifier:

NCT01510522

First Posted: January 16, 2012

Last Update Posted: February 4, 2014

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Collaborator:

Merck, S.L., Spain

Information provided by (Responsible Party):

Merck KGaA

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 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

Resource links provided by NLM:

Drug Information available for: Metformin Metformin hydrochloride

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 ]

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

Eligibility

Information from the National Library of Medicine

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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

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


Responsible Party:	Merck KGaA
ClinicalTrials.gov Identifier:	NCT01510522 History of Changes
Other Study ID Numbers:	EMR200084-508 2011-002508-34 ( EudraCT Number )
First Submitted:	December 30, 2011
First Posted:	January 16, 2012
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

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