FIAsp versus aspart in type 2 diabetes - ONSET2
Research type
Research Study
Full title
Efficacy and Safety of FIAsp compared to insulin aspart in Combination with insulin glargine and metformin in adults with Type 2 Diabetes
IRAS ID
128057
Contact name
Thozhukat Sathyapalan
Contact email
Sponsor organisation
Novo Nordisk A/S
Eudract number
2010-024051-93
Clinicaltrials.gov Identifier
Research summary
This is a 26-week multinational, randomised, double-blind, active controlled, treat-to-target parallel group trial with a 8-week run-in period, comparing the efficacy and safety of mealtime FIAsp insulin with mealtime insulin aspart, both in combination with once daily basal insulin glargine and metformin in a basal-bolus regimen, in patients with type 2 diabetes.
During the run-in eligible Subjects who are at study entry treated with once daily basal insulin and metformin, possibly in combination with some other oral diabetes medicine, will receive glargine insulin and metformin treatment. After the 8 week run-in period suitable subjects will be randomised in a 1:1 ratio to have either mealtime FIAsp or insulin aspart added to their treatment.
In the 8-week run-in period the basal insulin glargine will be titrated weekly in connection with visits or telephone contacts. Titration will be based on the mean of three fasting self measured plasma glucose measurements, with the target of 4.0-5.0 mmol/L. After bolus insulin is added at randomisation, the aim is to optimise the dose by titrating daily, based on self measured plasma glucose values before two main meals and at bedtime on the previous day. The glycaemic pre-prandial target for bolus insulin is 4.0-6.0 mmol/L.
Subjects will be in the study for approximately 37 weeks in total. There will be weekly contacts, either by telephone, 25 times, or clinic visits, 12 times.
A total of 1074 subjects with type 2 diabetes are expected to be screened into the study worldwide, with 752 entering run-in and 676 randomised to study treatment.
REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
13/YH/0111
Date of REC Opinion
23 May 2013
REC opinion
Further Information Favourable Opinion