A Short Study in older patients with tablettreateddiabetes to assess the frequency if any of low sugar levels duringroutine treatment with two commonly used treatments

Phase 1

• Conditions: Type 2 Diabetes Mellitus; MedDRA version: 20.0Level: LLTClassification code 10012594Term: DiabetesSystem Organ Class: 100000004861; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2015-003032-13-IT
• Lead Sponsor: A.O.U. Università degli Studi della Campania Luigi Vanvitelli

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-09-10
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 40

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

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 adequatelycontrolled and stable on pharmacotherapy.

Study & Design

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