Type 2 Diabetes Mellitus MedDRA version: 20.0 Level: LLT Classification code 10012594 Term: Diabetes System Organ Class: 100000004861
Conditions
Interventions
Trade Name: GLUCOPHAGE - 500 MG COMPRESSE RIVESTITE 30 COMPRESSE
Pharmaceutical Form: Tablet
INN or Proposed INN: METFORMINA
CAS Number: 657-24-9
Current Sponsor code: MF1
Other descriptive name: METF
Sponsors
A.O.U. Università degli Studi della Campania "Luigi Vanvitelli"
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Frail older patients with type 2 diabetes without adequate glycemic control (HbA1c >8.0%, >64 mmol/mol) while on metformin treatment. A previous diagnosis of type 2 diabetes mellitus will have met ADA criteria. Frailty will be identified by using the easy to use Clinical Frailty Scale (see appendix) with patients being described as point 4 (vulnerable), or point 5 (mildly frail), or point 6 (moderately frail (18): Research staff will be instructed how to assess for the frailty criteria using this tool. 2. Patient understands the study procedures, alternative treatments available, and risks involved with the study, and voluntarily agrees to participate by giving written informed consent. 3. Patient is a male or female and >70 years of age on the day of signing informed consent. 4. Patient is willing to maintain their standard diet based on previous diabetes education advice for the duration of the study. 5. Female patients who are receiving non-cyclical hormone therapy (including non cyclical hormone replacement therapy or any oestrogen antagonist/agonist) have been maintained on a stable dose and regimen for at least 8 weeks prior to Visit 1 and patient is willing to continue the same regimen throughout the study. 6. Each patient (or carer) will be able to engage in self-blood glucose monitoring (SBGM) of the patient 7. Each patient (including carer as appropriate) chosen to be in the continuous blood glucose monitoring (CGM) subgroup is able and willing to have a glucose sensor applied and is prepared for continuous recording of the patient’s subcutaneous glucose levels for three 72h periods during the study period of CGM Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: 1. BMI >32 Kg/m2. 2. Patient has hypersensitivity or intolerance to glimepiride or and metformin any component of these medication. 3. Patient treated with insulin. 4. Patient with severe evidence of frailty (Clinical Frailty Scale –point 7-9) 5. Patient (or carer) unable to manage SBGM and/or CGM 6. Patient does not routinely consume more than 14 units per week (women) or 21 units per week (men). 7. Patient is currently participating or has participated in a study with an investigational compound or device within 30 days of signing informed consent. 8. Patient's glycaemia are >300 mg/dL (>16.7 mmol/l) at Visit 2. 9. Patient has uncontrolled endocrine or metabolic disease known to influence glycaemia (i.e., secondary causes of hyperglycaemia). 10. Patient has a history or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study, or interfere with the patient's participation for the full duration of the study, such that it is not in the best interest of the patient to participate. 11. Patients with an established diagnosis of dementia 12. Patients with a memory disorder, those needing an interpreter, or those with severe visual impairment (unable to complete the tests) 13. Patient has congestive heart failure defined by NYHA (New York Heart Association) Class III or IV. 14. Patient has unstable angina pectoris. 15. Patient has had a myocardial infarction, coronary artery bypass surgery. Angioplasty or uncontrolled or severe peripheral artery disease within previous 6 months 16. Patient has had a partial ileal bypass gastric bypass, or other significant intestinal malabsorption. 17. Patient has uncontrolled hypertension (treated or untreated) with systolic blood pressure >180 mm Hg or diastolic >100 mm Hg at Visit 1. Investigators are encouraged to maximize blood pressure control according to current guidelines prior to randomization. 18. Patient has estimated glomerular filtration rate (eGFR) <45 mL/min/1.73 m2 based on the 4-variable MDRD (Modification of Diet in Renal Disease) equation, nephrotic syndrome or other clinically significant renal disease at baseline.. 19. Patient has a history of malignancy < 5 years prior to signing informed consent. 20. Patient is, at the time of signing informed consent, a user of recreational or illicit drugs or has had a recent history (within the last year) of drug or alcohol abuse or dependence. 21. Patient has a history major psychiatric illness not adequately controlled and stable on pharmacotherapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: We wish to determine if in older moderately frail patients treated with metformin for their diabetes the addition of a commonly prescribed treatment for diabetes, glimepiride, at a modest dose only leads to an increase in the risk of a low blood sugar state (a 'hypo').;Secondary Objective: Using a method of continuous subcutaneous blood glucose monitoring using an approved userfriendly device called the Dexcom G4 Platinum, we wish to determine if in patients given glimepiride there is evidence of hypoglycaemia occurring and in particular we wish to record any levels of sugar (glucose) that are less than 4 mmol/l and also if levels fall below 3 mmol/l.;Primary end point(s): The primary outcomes will be the differences between glimepiride, as add on to metformin, Episodes of symptomatic hypoglycaemia (i.e. a recorded blood sugar less than 70mg/dl (3.9 mmol/l)), or symptoms or signs attributed to low blood glucose and responding to appropriate treatment. -Documented episodes of hypoglycaemia (irrespective of symptoms) recorded via continuous subcutaneous glucose monitoring (CGM) in the defined study recording periods ;Timepoint(s) of evaluation of this end point: 16 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 0,8 and 16 weeks | — |
Countries
Italy
Contacts
Public ContactVI DIVISIONE DI MEDICINA INTERNA
Dipartimento di Scienze mediche, Chirurgiche,Neurologiche, Metaboliche e dell'Invecchiamento
Outcome results
None listed