4228: DUAL™ VIII – Durability, IDegLira vs IGlar in Type 2 diabetes
Research type
Research Study
Full title
A 104 week clinical trial comparing long term glycaemic control of insulin degludec/liraglutide (IDegLira) versus insulin glargine therapy in subjects with type 2 diabetes mellitus
IRAS ID
188418
Contact name
Thozhukat Sathyapalan
Contact email
Sponsor organisation
Novo Nordisk A/S
Eudract number
2014-005639-15
Duration of Study in the UK
2 years, 8 months, 24 days
Research summary
Insulin degludec/liraglutide (IDegLira) is a blood sugar lowering medication being developed for the treatment of type 2 diabetes. It is a combination of insulin degludec (a long-acting insulin) and liraglutide (a modified form of the body´s own natural gut hormone called glucagon-like peptide 1) administered in a pen for once daily injection under the skin.
DUAL VIII™ is a study comparing long term glycaemic (blood sugar) control of IDegLira to insulin glargine in insulin naïve patients with Type 2 diabetes that are in need of treatment intensification.
The study duration is approximately 111 weeks, consisting of a 2 week screening period, a 104 week treatment period and approximately a 5 week follow-up period. If eligible, participants will be randomised to either the IDegLira treatment group or the insulin glargine treatment group. At the start of the study participants will receive training and instructions on how to administer and adjust their trial product doses according to their daily self-measured blood sugar readings.
The study consists of a 13 clinic visits and 2 telephone contact visits.
The study plan is to include a total of 1000 randomised participants across 16 countries including the UK. In the UK the planned number of participants is 80 across 10 sites.
REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
15/YH/0428
Date of REC Opinion
20 Oct 2015
REC opinion
Further Information Favourable Opinion