[The efficacy and safety of insulin degludec versus insulin glargine in insulin-naive subjects with type 2 diabetes: results of a Chinese cohort from a multinational randomized controlled trial].

Sep 6, 2017Zhonghua nei ke za zhi

Effectiveness and safety of insulin degludec compared to insulin glargine in Chinese adults with type 2 diabetes starting insulin

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Abstract

In a study of 560 Chinese subjects with type 2 diabetes, mean glycosylated hemoglobin (HbA1c) decreased from 8.2% to 6.9% with insulin degludec (IDeg).

IDeg and insulin glargine (IGlar) both combined with metformin resulted in HbA1c reductions after 26 weeks.
The estimated treatment difference in HbA1c change between IDeg and IGlar was -0.10% points.
56.3% of subjects using IDeg achieved HbA1c levels below 7.0%, compared to 49.7% with IGlar.
IDeg was associated with a numerically lower overall rate of confirmed hypoglycemia and a statistically significantly lower rate of nocturnal hypoglycemia compared to IGlar.
No significant differences in other safety parameters were observed between IDeg and IGlar.

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To compare the safety and efficacy of insulin degludec (IDeg) with those of insulin glargine (IGlar) in insulin-naive subjects with type 2 diabetes (T2DM).This was a 26-week, randomized, open-label, parallel-group, treat-to-target trial in 560 Chinese subjects with T2DM (men/women: 274/263, mean age 56 years, mean diabetes duration 7 years) inadequately controlled on oral antidiabetic drugs (OADs). Subjects were randomized 2∶1 to once-daily IDeg (373 subjects) or IGlar(187 subjects), both in combination with metformin. The primary endpoint was changes from baseline in glycosylated hemoglobin(HbA1c) after 26 weeks.Mean HbA1c decreased from 8.2% in both groups to 6.9% in IDeg and 7.0% in IGlar, respectively. Estimated treatment difference (ETD) of IDeg-IGlar in change from baseline was -0.10% points (95%-0.25-0.05). The proportion of subjects achieving HbA1c<7.0% was 56.3%and 49.7% with IDeg and IGlar, respectively [estimated odds ratio of IDeg/IGlar: 1.26(95%0.88-1.82)]. Numerically lower rateof overall confirmed hypoglycaemia and statistically significantly lower nocturnal confirmed hypoglycemia were associated with IDeg compared with IGlar, respectively [estimated rateratio of IDeg/IGlar 0.69(95%0.46-1.03), and 0.43(95%0.19-0.97)]. No differences in other safety parameters were found between the two groups.IDeg was non-inferior to IGlar in terms of glycaemic control, and was associated with a statistically significantly lower rate of nocturnal confirmed hypoglycaemia. IDeg is considered to be suitable for initiating insulin therapy in Chinese T2DM patients on OADs requiring intensified treatment.Clinicaltrials.gov, NCT01849289. Objective: Methods: Results: Conclusions: Clinical trail registration: CI CI CI CI

[The efficacy and safety of insulin degludec versus insulin glargine in insulin-naive subjects with type 2 diabetes: results of a Chinese cohort from a multinational randomized controlled trial].

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