Diabetes Unmet Need with Basal Insulin Evaluation
Research type
Research Study
Full title
Multinational, Prospective, Observational study to assess the unmet medical needs associated with Basal Insulin Use in Patients with Type 2 Diabetes Newly or Recently initiated Basal Insulin treatment
IRAS ID
169299
Contact name
James Clark
Contact email
Sponsor organisation
Sanofi
Research summary
This study is an observational study and its purpose is to collect data that will reflect current clinical practices in the management of patients with type 2 diabetes (T2D) who have started with basal insulin (insulin with a long duration of action) for less than 12 months or newly/recently initiated basal insulin treatment.
It is important for patients with T2D to maintain their blood sugar levels in the ‘normal’ range (glycaemia target) to try to prevent the onset of diabetes complications. One of the reasons why target achievement is limited in diabetes patients is the potential impact of hypoglacemia (low blood sugar levels) associated to basal insulin treatment.
The aim of the study is to investigate the association between failure to achieve glycemic target and hypoglycaemia events during insulin titration.
The study also aims to reliably detect hypoglycaemia events in uncontrolled T2D patients. Since hypoglycaemia might be associated with other unfavourable clinical and health economical outcomes there are multiple secondary objectives to describe the potential impact of hypoglycaemia (weight gain, fear of hypoglycaemia, and health care resource utilization, etc).
After patient consent, demographics, information on the prescribed basal insulin and relevant past or concomitant medical conditions will be collected. A diary will be provided to patients, to collect blood glucose values, obtained from patients own blood glucose meter, the insulin doses and hypoglycaemia events.
Last available laboratory results, HbA1c (glycohemoglobin) and fasting blood sugar to determine blood sugar levels are well controlled, will be collected.
Hypoglycemia Fear Survey questionnaire, about patient’s concerns about low blood sugar and what patients do routinely to avoid low blood sugar, will be provided.
After 3 months, information on current antidiabetic treatment and more specifically on the modifications, especially concerning insulin treatment and the same laboratory results than for the first visit will be collected.REC name
South Central - Hampshire A Research Ethics Committee
REC reference
15/SC/0062
Date of REC Opinion
28 Jan 2015
REC opinion
Further Information Favourable Opinion