Evaluate adherence to treatment with Glucophage sachets versus tablets in diabetes type 2 patients, previously treated with metformin tablets

• Conditions: Type 2 diabetes; MedDRA version: 14.0Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2011-002508-34-ES
• Lead Sponsor: MERCK, S.L.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10-13
• Last Update Posted: 22 October 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- Type 2 Diabetes diagnosed. Baseline Glycaemia > 7,0 mmol/L (126 mg/dL) or overload Glycemia > 11,0 mmol/L (198 mg/dL)
- On treatment with metformin tablets
- To fulfill at any time at least one of the following criteria for cardio-vascular risk:
• BP sistolic > 180 mmHg and/or >110 mmHg diastolic.
or
BP sistolic > 160 mmHg and <70 mmHg diastolic.
or
> 3 CV risk factors
or
Stablished CV disease or nephropathy
- Stablished dose of Metformin > 1.700 mg/day
- Age > 18 years old
- Given informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 140
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- not able to take medication orally
- According to SmPC:
Known hypersensitivity to metformin or any of its excipients
Diabetic ketoacidosis or diabetic precoma in the previous week
Renal impairment or dysfunction (Creatinine clearance < 60 mL/min)
Acute disease which may produce renal dysfunction, tissue hypoxia as dehydration, severe infection, shock, administration of iodinated contrast.
Acute or chronic disease which may produce tissue hypoxia as cardiovascular or respiratory collapse, recent myocardial infarction, shock.
Liver impairment, alcohol poisoning o alcoholism
Lactating
- Participating in other clinical trial in the 30 days prior to randomisation.
- Any other illnes or medical or psiquiatric condition, severe and uncontrolled that could interfere in the patient's participation or in the assesment of the study results.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified