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

Diabetes Mellitus Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01510522
• Other study ID #: EMR200084-508
• Secondary ID: 2011-002508-34
• Status: Withdrawn
• Phase: Phase 4
• First received: December 30, 2011
• Last updated: February 3, 2014
• Start date: June 2012

Study information

• Verified date: February 2014
• Source: Merck KGaA
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus Type 2
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Glucophage
Glucophage Powder for oral solution in sachets (metformin hydrochloride in 850mg strengths) Dosing schedule: > 1.700mg/day for 6 month
• Glucophage
Glucophage tablets (metformin hydrochloride in 850mg strengths) Dosing schedule: > 1.700mg/day for 6 month

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Merck KGaA	Merck, S.L., Spain

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline of Patient self-reported subjective compliance as assessed by Haynes-Sackett test at Month 6		Month 6	No
Secondary	Objective compliance to treatment	Objective compliance to treatment is assessed by the accountability of medication returned. Patient is assessed as compliant with an adherence of over 80%.	Month 3 and month 6	No
Secondary	Evaluation of treatment satisfaction and preferences with the Diabetes Treatment Satisfaction Questionnaire (DTSQ)		Baseline, month 3 and month 6	No
Secondary	Rate of reported adverse events		Month 3 and month 6	Yes