A retrospective study on Humalog 200 units/ml KwikP (H200) insulin
Research type
Research Study
Full title
A retrospective study of patients receiving Humalog 200 units/ml KwikPen (H200) insulin in the UK
IRAS ID
209368
Contact name
Iskandar Idris
Contact email
Sponsor organisation
University of Nottingham
Duration of Study in the UK
years, 6 months, days
Research summary
H200 is a rapid acting insulin analogue bioequivalent to the 100 units/ml formulation of Humalog but with a higher insulin concentration, thereby making the formulations therapeutically equivalent. Furthermore, the new pen holds 600 total units of insulin in the same sized pen that previously could only hold 300 total units- this mean less volume for injection resulting in an easier glide force for injection; pen lasting longer between pen changes and an improved pen device. It is expected that this will translate to treatment satisfaction, compliance as well as reduced volume for insulin absorption may hypothetically result in an improvement in glycaemic control. There is however, no post-marketing surveillance and/or real world evidence assessing how H200 is used in routine practice, its clinical effectiveness and treatment satisfaction of this insulin regimen in patients with diabetes. So we aimed to explore the characteristics of patients who are started on H200 in UK routine clinical practice; determine the effective is H200 in reducing HbA1c levels within routine clinical practice; determine the factors (clinical/demographic/treatment regimen/biochemical) that may affect or influence the effectiveness of H200 in routine clinical practice; and determine the adverse effects patients experienced with H200 or what is the reason for discontinuation; and the benefit/advantage of H200 compared with conventional insulin formulation and finally, present treatment satisfaction.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
16/LO/2073
Date of REC Opinion
2 Dec 2016
REC opinion
Further Information Favourable Opinion