DiaFrail: A Short Duration Study in Older People ( DIAFRAIL Study)

• Status: Withdrawn
• Trial end date: 2016-11-01
• Target enrollment: 0
• Participant gender: All

Summary

1. Many patients with type 2 diabetes are not at glycaemic goal and require additional therapy in order to reduce vascular risk and improve symptom control

2. Sulphonylurea therapy is a commonly prescribed 2nd-line glucose -lowering agent and its use is recommended in major clinical guidelines for diabetes and also in the recently presented IDF (International Diabetes Federation) guidelines for older people.

3. Older people with diabetes are not a homogeneous group and as many as 25% are frail.

4. Frailty is a PRE-DISABILITY state but may increase the 'vulnerability' of many older people to having a fall, admission into hospital, or perhaps increasing their risk of hypoglycaemia

5. As a consequence of their glucose-lowering ability, sulphonylureas may increase the risk of hypoglycaemia in older people and those who have features of frailty may be at increased risk.

6. The investigators therefore need to estimate the risk of hypoglycaemia in moderately frail older subjects with type 2 diabetes who are taking sulphonylurea therapy as this is a commonly prescribed class of agent used routinely in clinical practice

7. Thus, this short term project wishes to assess the frequency of hypoglycaemia in subjects with some evidence of frailty with type 2 diabetes by a series of glucose monitoring techniques with excellent research team support to minimize any safety issues. An identical study at the Second University of Naples, Italy under the supervision of Professor Giuseppe Paolisso is planned and is the second study site for this PILOT project.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Diabetes Frail Ltd
• Collaborators: Merck Sharp & Dohme Corp.; Second University of Naples; University of Campania "Luigi Vanvitelli"
• Treatments: Glimepiride; Metformin

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).

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.

Exclusion Criteria:

1. BMI >32 Kg/m2.

2. Patient has hypersensitivity or intolerance to glimepiride or any component of this 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 (self blood glucose monitoring) and/or CBGM

6. Patient routinely consumes more than 2 alcoholic drinks per day.

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.

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