A randomized clinical trial comparing basal insulin peglispro and insulin glargine, in combination with prandial insulin lispro, in patients with type 1 diabetes: IMAGINE 1

Aims The primary objective was to demonstrate that basal insulin peglispro (BIL) was non‐inferior compared with insulin glargine (GL) for haemoglobin A1c (HbA1c) at 26 weeks with a non‐inferiority margin of 0.4%. Materials and Methods IMAGINE 1 was a Phase 3, open‐label, parallel‐arm study conducted...

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Bibliographic Details
Published in:Diabetes, obesity & metabolism obesity & metabolism, 2016-10, Vol.18 (S2), p.25-33
Main Authors: Garg, S., Dreyer, M., Jinnouchi, H., Mou, J., Qu, Y., Hartman, M. L., Rosilio, M., Jacober, S. J., Bastyr III, E. J.
Format: Article
Language:English
Subjects:
Adult
Alanine transaminase
Alanine Transaminase - metabolism
basal insulin
Blood Glucose - metabolism
Diabetes
Diabetes mellitus (insulin dependent)
Diabetes Mellitus, Type 1 - drug therapy
Diabetes Mellitus, Type 1 - metabolism
Drug Therapy, Combination
Fasting
Female
Glucose
glycaemic control
Glycated Hemoglobin A - metabolism
Hemoglobin
Humans
hypoglycaemia
Hypoglycemia
Hypoglycemia - chemically induced
Hypoglycemic Agents - therapeutic use
Injections, Subcutaneous - adverse effects
Insulin
Insulin Glargine - therapeutic use
Insulin Lispro - analogs & derivatives
Insulin Lispro - therapeutic use
Male
Meals
Middle Aged
Patients
Polyethylene Glycols - therapeutic use
randomised trial
Severity of Illness Index
Treatment Outcome
Triglycerides
type 1 diabetes
Weight Loss
Young Adult
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Summary:Aims The primary objective was to demonstrate that basal insulin peglispro (BIL) was non‐inferior compared with insulin glargine (GL) for haemoglobin A1c (HbA1c) at 26 weeks with a non‐inferiority margin of 0.4%. Materials and Methods IMAGINE 1 was a Phase 3, open‐label, parallel‐arm study conducted in nine countries. Adults with type 1 diabetes (n = 455) were randomized (2:1) to bedtime BIL or GL in combination with prandial insulin lispro for 78 weeks, with a primary endpoint of 26 weeks. An electronic diary facilitated data capture and insulin dosing calculations for intensive insulin management. Results At 26 weeks, mean HbA1c was 7.06% ± 0.04% and 7.43% ± 0.06% for patients assigned to BIL (N = 295) and GL (N = 160), respectively (difference ‐0.37% [95% CI: −0.50 to −0.23], P 
ISSN:1462-8902
1463-1326
DOI:10.1111/dom.12738