A Multinational, Randomized, Open-label, Treat-to-Target Trial Comparing Insulin Degludec and Insulin Glargine in Insulin-Naïve Patients with Type 2 Diabetes Mellitus

Apr 22, 2016Drugs in R&D

Comparing Two Long-Acting Insulins in People with Type 2 Diabetes Starting Insulin Treatment

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Abstract

In a trial with 833 subjects, insulin degludec (IDeg) demonstrated non-inferiority to insulin glargine (IGlar) in reducing glycosylated hemoglobin (HbA1c) levels.

Mean HbA1c decreased from 8.3% to 7.0% in both IDeg and IGlar groups after 26 weeks.
54.2% of subjects using IDeg achieved HbA1c levels below 7.0%, compared to 51.4% with IGlar.
Numerically lower rates of overall and nocturnal hypoglycemia were observed with IDeg compared to IGlar.
Subjects reported higher satisfaction with the IDeg device than with the IGlar device.
No significant differences in safety parameters were found between IDeg and IGlar.

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INTRODUCTION: To lower the barrier for initiating insulin treatment and obtain adequate glycemic control in type 2 diabetes mellitus (T2DM), new basal insulin preparations with improved pharmacological properties and consequently a lower risk of hypoglycemia are needed. The objective of this trial was to confirm the efficacy and compare the safety of insulin degludec (IDeg) with insulin glargine (IGlar) in a multinational setting with two thirds of subjects enrolled in China.

METHODS: This was a 26-week, randomized, open-label, parallel-group, treat-to-target, non-inferiority trial in 833 subjects with T2DM (48 % were female, mean age 56 years, diabetes duration 8 years), inadequately controlled on oral antidiabetic drugs (OADs). Subjects were randomized 2:1 to once-daily IDeg (555 subjects) or IGlar (278 subjects), both with metformin. The primary endpoint was the change from baseline in glycosylated hemoglobin (HbA1c) after 26 weeks.

RESULTS: The completion rate was high (IDeg 94.2 %; IGlar 91.4 %). Mean HbA1c decreased from 8.3 to 7.0 % in both groups. Estimated treatment difference (ETD) [95 % confidence interval (CI)] IDeg-IGlar in change from baseline was -0.05 % points [-0.18 to 0.08], confirming the non-inferiority of IDeg to IGlar. The proportion of subjects achieving HbA1c <7.0 % was 54.2 and 51.4 % with IDeg and IGlar, respectively (estimated odds ratio [95 % CI] IDeg/IGlar: 1.14 [0.84 to 1.54]). The mean decrease in fasting plasma glucose, self-measured plasma glucose profiles, and insulin dose were similar between groups. Numerically lower rates of overall (estimated rate ratio [95 % CI] IDeg/IGlar: 0.80 [0.59 to 1.10]) and nocturnal (0.77 [0.43 to 1.37]) confirmed hypoglycemia were observed with IDeg compared with IGlar. No treatment differences in other safety parameters were found. Subjects were more satisfied with the IDeg device compared with the IGlar device as reflected by the total Treatment Related Impact Measures-Diabetes Device score (ETD [95 % CI] IDeg-IGlar: 2.2 [0.2 to 4.3]).

CONCLUSION: IDeg provided adequate glycemic control non-inferior to IGlar and a tendency for a lower hypoglycemia rate. IDeg is considered suitable for initiating insulin therapy in T2DM patients on OADs requiring intensified treatment.

TRIAL REGISTRATION: Clinicaltrials.gov NCT01849289.

Key numbers

54.2%

Proportion Achieving HbA1c <7.0%

54.2% of subjects with IDeg achieved HbA1c <7.0% compared to 51.4% with IGlar.

-0.05 percentage points

Estimated Treatment Difference in HbA1c Change

The estimated treatment difference in HbA1c change was -0.05 percentage points.

20%

Overall Hypoglycemia Rate Reduction

Numerically lower rates of overall confirmed hypoglycemia were observed with IDeg.

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A Multinational, Randomized, Open-label, Treat-to-Target Trial Comparing Insulin Degludec and Insulin Glargine in Insulin-Naïve Patients with Type 2 Diabetes Mellitus

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