DiaFrail: A Short Duration Study in Older People ( DIAFRAIL Study)
Status:
Withdrawn
Trial end date:
2016-11-01
Target enrollment:
Participant gender:
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
Details
Lead Sponsor:
Diabetes Frail Ltd
Collaborators:
Merck Sharp & Dohme Corp. Second University of Naples University of Campania "Luigi Vanvitelli"