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Deprecated: Implicit conversion from float 298.79999999999995 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Diabetes+Obes+Metab 2016 ; 18 (11): 1081-8 Nephropedia Template TP
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Randomized, double?blind clinical trial comparing basal insulin peglispro and insulin glargine, in combination with prandial insulin lispro, in patients with type 1 diabetes: IMAGINE 3 #MMPMID27265390
Diabetes Obes Metab 2016[Nov]; 18 (11): 1081-8 PMID27265390show ga
Aims: To compare the efficacy and safety of basal insulin peglispro (BIL), which has a flat pharmacokinetic and pharmacodynamic profile and a long duration of action, with insulin glargine (GL) in patients with type 1 diabetes. Materials and methods: In this phase III, 52?week, blinded study, we randomized 1114 adults with type 1 diabetes in a 3?:?2 distribution to receive either BIL (n?=?664) or GL (n?=?450) at bedtime, with preprandial insulin lispro, using intensive insulin management. The primary objective was to compare glycated haemoglobin (HbA1c) in the groups at 52?weeks, with a non?inferiority margin of 0.4%. Results: At 52?weeks, mean (standard error) HbA1c was 7.38 (0.03)% with BIL and 7.61 (0.04)% with GL {difference ?0.22% [95% confidence interval (CI) ?0.32, ?0.12]; p?0.001}. At 52?weeks more BIL?treated patients reached HbA1c <7% (35% vs 26%; p?0.001), the nocturnal hypoglycaemia rate was 47% lower (p?0.001) and the total hypoglycaemia rate was 11% higher (p?=?0.002) than in GL?treated patients, and there was no difference in severe hypoglycaemia rate. Patients receiving BIL lost weight, while those receiving GL gained weight [difference ?1.8?kg (95% CI ?2.3, ?1.3); p?0.001]. Treatment with BIL compared with GL at 52?weeks was associated with greater increases from baseline in levels of serum triglyceride [difference 0.19?mmol/l (95% CI 0.11, 0.26); p?0.001] and alanine aminotransferase (ALT) levels [difference 6.5 IU/l (95% CI 4.1, 8.9), p?0.001], and more frequent injection site reactions. Conclusions: In patients with type 1 diabetes, treatment with BIL compared with GL for 52?weeks resulted in a lower HbA1c, more patients with HbA1c levels <7%, and reduced nocturnal hypoglycaemia, but more total hypoglycaemia and injection site reactions and higher triglyceride and ALT levels.