IMPERIUM (IOQL)
Research type
Research Study
Full title
Protocol: F3Z-MC-IOQL An Individualized treatMent aPproach for oldER patIents: A Randomized, controlled, stUdy in type 2 diabetes Mellitus (IMPERIUM)
IRAS ID
143497
Contact name
Simon Heller
Contact email
Sponsor organisation
Eli Lilly and Company
Eudract number
2013-001473-24
Research summary
The number of older patients with Type 2 Diabetes in many developed and developing countries is increasing. Older patients with Type 2 Diabetes need more complicated care due to their frailty and the amount of them who have other long-term medical conditions in addition to their Diabetes that require treatment. At the moment there are no official guidelines allowing for treatments to be prescribed to these patients based on evidence of how well these treatments may have worked previously in this patient group.
This study will compare 2 different ways of treating Type 2 Diabetes in this patient group. ’Strategy A’ and ’strategy B’ will work in different ways to treat the participants Diabetes. Both treatment strategies will use drugs that are already approved and marketed for use in Diabetic patients. The study hopes to collect evidence on which one of these treatment strategies is most effective.
To take part in this study patients must be 65 years old or more and have a diagnosis of Type 2 Diabetes Mellitus. Each participant will be in the study for 72 weeks (about a year and a half) and the whole study is due to last for just over 4 years.
Study assessments will include: Physical examinations, completion of study diaries and questionnaires and blood and urine tests.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
14/YH/0005
Date of REC Opinion
5 Feb 2014
REC opinion
Further Information Favourable Opinion