Type 2 diabetes MedDRA version: 14.0 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Trade Name: DIANBEN 850 mg para solución oral
Pharmaceutical Form: Powder for oral solution
INN or Proposed INN: METFORMIN HYDROCHLORIDE
CAS Number: 1115-70-4
Concentration unit: mg milligram(s)
Conce
Sponsors
MERCK, S.L.
Eligibility
Sex/Gender
All
Inclusion criteria
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 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the compliance in both treatment arms;Secondary Objective: - Patient objetive adherence - To asses patient satisfaction with the treatment - To evaluate patients preferences - Safety of the treatments ;Primary end point(s): Patient self-reported subjetive compliance. Haynes Sackett test;Timepoint(s) of evaluation of this end point: 6 months of treatment after randomization | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Objetive compliance to treatment is assesed by the accountability of medication returned. Patient compliant over 80% of adherence. - Treatment satisfaction and preferences are evaluated with the diabetes Treatment Satisfaction Questionnaire (DTSQ) - Rate of reported adverse events ;Timepoint(s) of evaluation of this end point: 6 months of treatment after randomization | — |
Countries
Spain
Contacts
Public ContactDEPARTAMENTO MÉDICO
MERCK, S.L.
Outcome results
None listed