Dataset Information

A comparative effectiveness study of degludec and insulin glargine 300?U/mL in insulin-naive patients with type 2 diabetes.

ABSTRACT:

Aims

To compare the real-world effectiveness of insulin degludec (degludec) and glargine 300?units/mL (glargine U300) in insulin-naïve adult patients with type 2 diabetes in routine US clinical practice.

Materials and methods

CONFIRM is a non-interventional comparative effectiveness study following US patients across the continuum of care, through electronic medical records from multiple health systems and integrated delivery networks. Propensity-score matching controlled for confounding. The primary endpoint, change in HbA1c from baseline to 180?days of follow-up, was estimated using a repeated-measure of covariance analysis with subject as random effect. Change in the rate of hypoglycaemic episodes (defined using International Classification of Diseases codes 9/10) and change in proportion of patients with hypoglycaemia were estimated using negative binomial and logistic regression, respectively. Time-to-discontinuation of the initial basal insulin/initiation with another prescribed basal insulin was analysed using a Cox Proportional Hazard model.

Results

Data concerning 4056 patients were analysed. After matching, baseline characteristics were comparable (n?=?2028 in each group). After 180?days of follow-up, degludec was associated with a larger reduction in HbA1c (estimated treatment difference, -0.27%; P?=?0.03), greater reductions in change in rate (rate ratio, 0.70; P?ConclusionsSignificantly improved HbA1c, larger reductions in rates and likelihood of hypoglycaemia and lower risk of treatment discontinuation were demonstrated with degludec vs glargine U300.

SUBMITTER: Tibaldi J

PROVIDER: S-EPMC6590449 | biostudies-literature | 2019 Apr

REPOSITORIES: biostudies-literature

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Publications

A comparative effectiveness study of degludec and insulin glargine 300 U/mL in insulin-naïve patients with type 2 diabetes.

Tibaldi Joseph J Hadley-Brown Martin M Liebl Andreas A Haldrup Steffen S Sandberg Viktor V Wolden Michael L ML Rodbard Helena W HW

Diabetes, obesity & metabolism 20190108 4

<h4>Aims</h4>To compare the real-world effectiveness of insulin degludec (degludec) and glargine 300 units/mL (glargine U300) in insulin-naïve adult patients with type 2 diabetes in routine US clinical practice.<h4>Materials and methods</h4>CONFIRM is a non-interventional comparative effectiveness study following US patients across the continuum of care, through electronic medical records from multiple health systems and integrated delivery networks. Propensity-score matching controlled for conf ...[more]

PMID: 30552800

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Project description:IntroductionFollowing pivotal trials, real-world evidence is important to assess the impact of new drugs in everyday clinical practice. The RESTORE-1 study aimed to compare effectiveness and safety of the second-generation basal insulins (2BI), i.e., insulin glargine 300 U/ml (Gla-300) vs. degludec 100 U/ml (IDeg-100), in type 1 diabetes (T1D).MethodsRetrospective, non-inferiority, multicenter study, based on electronic medical records. All patients switching to Gla-300 or IDeg-100 from first-generation basal insulins (1BI) were 1:1 propensity score matched (PSM). Changes during 6 months in HbA1c (primary endpoint), fasting plasma glucose (FPG), body weight, and insulin doses were assessed using linear mixed models for repeated measures. Incidence rates (IR) of hypoglycemic events were assessed.ResultsOverall, 19 centers provided data on 585 patients in each PSM cohort. For both groups, statistically significant reductions in HbA1c from baseline to 6 months were documented: - 0.20%; (95% CI - 0.32; - 0.08) in the Gla-300 group and - 0.14%; (95% CI - 0.24; - 0.04) in the IDeg-100 group. The non-inferiority of Gla-300 vs. IDeg-100 was confirmed (non-inferiority margin of 0.30%; upper 95% CI at 6 months, 0.09%). No statistically significant between-group differences emerged in FPG and body weight. Dose changes of basal and short-acting insulin were small in both groups, but higher in the Gla-300 group than in the Deg-100 group (p < 0.006). Incidence rates (IR) of hypoglycemia (blood glucose ≤ 70 mg/dl and < 54 mg/dl) during the 6-month follow-up by treatment were slightly lower in the Gla-300 group than in the Deg-100 group [IR ratios 0.82 (95% CI 0.55; 1.22) and 0.83; (95% CI 0.38; 1.83), respectively]. Hypoglycemic events (blood glucose < 54 mg/dl) decreased at 6 months in both groups (p = 0.01 for Gla-300 and p < 0.001 for IDeg-100). There were no severe hypoglycemic events for Gla-300 and seven events for IDeg-100 (p = 0.02).ConclusionsSwitching from 1BI to 2BI in adults with T1D was associated with similar improvements in glycemic control and overall significant decrease in hypoglycemia, with no severe events with Gla-300. Effectiveness of both insulins was limited by under-titration.