Achieve control: a pragmatic clinical trial of insulin glargine 300 U/mL versus other basal insulins in insulin-naïve patients with type 2 diabetes

Oster, Gerry; Sullivan, Sean D.; Dalal, Mehul; Kazemi, Mahmood R.; Rojeski, Maria; Wysham, Carol; Sung, Jennifer; Johnstone, Bryan M.; Cali, Anna M. G.; Wei, L. J.; Traylor, Louise; Anhalt, Henry; Hull, Michelle; Vleet, John Van; Meneghini, Luigi

doi:10.1080/00325481.2016.1241663

Cited by 14 publications

(23 citation statements)

References 36 publications

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“…However, Gla‐300 was associated with significantly better HbA1c reductions than Gla‐100 in the current study, while EDITION 3 reported similar mean HbA1c reductions at 6 months (−1.42 ± 0.05% and −1.46 ± 0.05%, respectively), meeting the study's non‐inferiority criterion . Achieve Control, a randomized, open‐label, prospective, pragmatic trial that included 3304 insulin‐naïve patients initiating Gla‐300 versus Gla‐100 or insulin detemir in real‐world clinical settings, also reported similar HbA1c reductions (−1.41% vs. –1.36%; P = 0.32) …”

Section: Discussionmentioning

confidence: 50%

Glycaemic goal attainment and hypoglycaemia outcomes in type 2 diabetes patients initiating insulin glargine 300 units/mL or 100 units/mL: Real‐world results from the DELIVER Naïve cohort study

Bailey

Zhou

Gupta

et al. 2019

Diabetes Obesity Metabolism

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Aims To compare HbA1c and hypoglycaemia in insulin‐naïve patients with type 2 diabetes (T2D) who initiated insulin glargine 300 units/mL (Gla‐300) or 100 units/mL (Gla‐100). Materials and methods This retrospective cohort study examined electronic medical records of insulin‐naïve adults with T2D who initiated Gla‐300 or Gla‐100 during March 2015 through to December 2016 with active records for ≥12 months before and ≥6 months after initiation, and ≥1 valid HbA1c value during 6‐month baseline and 90–180‐day follow‐up. Outcomes included HbA1c and hypoglycaemia. Cohorts were propensity score‐matched (1:2) on baseline demographic and clinical characteristics. Sensitivity analyses were conducted using broader inclusion criteria. Results The matched cohorts included 1004 Gla‐300 and 2008 Gla‐100 initiators (mean age 60.4 years; 53.2% male). During 6‐month follow‐up, Gla‐300 versus Gla‐100 initiators had a greater mean HbA1c decrease (−1.52 ± 2.08% vs. –1.30 ± 2.12%; P = 0.003) and more patients achieved HbA1c <7% (25.0% vs. 21.5%; P = 0.029) and <8% (55.0% vs. 49.2%; P = 0.002); and HbA1c <7% (21.9% vs. 17.4%; P = 0.003) and <8% (49.1% vs. 41.8%; P < 0.001) without hypoglycaemia. Gla‐300 initiators were similarly or less likely to have any or inpatient/emergency department‐associated hypoglycaemia during 3‐ and 6‐month follow‐up (e.g. any hypoglycaemia to 6 months: 9.7% vs. 12.5%; adjusted odds ratio 0.61; P = 0.057). Conclusions Among insulin‐naïve adults with T2D, Gla‐300 was associated with significantly better HbA1c reductions (latest value during 90–180‐day follow‐up) and similar or improved hypoglycaemia outcomes (3‐ and 6‐month follow‐up) than Gla‐100.

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Section: Discussionmentioning

confidence: 50%

Glycaemic goal attainment and hypoglycaemia outcomes in type 2 diabetes patients initiating insulin glargine 300 units/mL or 100 units/mL: Real‐world results from the DELIVER Naïve cohort study

Bailey

Zhou

Gupta

et al. 2019

Diabetes Obesity Metabolism

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“…REACH and REGAIN are the first randomized pragmatic studies in T2DM to allow for direct treatment comparisons of patient outcomes in a real-life setting, and are part of a larger real-world evidence program (including another pragmatic study, ACHIEVE-CONTROL 26 , in $3300 insulin-naïve T2DM patients in North America). In both studies, the primary outcome was non-inferiority of Gla-300 versus SoC basal insulin in terms of HbA 1c change from baseline to month 6.…”

Section: Discussionmentioning

confidence: 99%

Real-world outcomes of treatment with insulin glargine 300 U/mL versus standard-of-care in people with uncontrolled type 2 diabetes mellitus

Freemantle

Mauricio

Giaccari

et al. 2020

Current Medical Research and Opinion

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“…In conclusion, in a large and broad population of people with T2DM, Gla‐300 was associated with more sustained glycaemic control, and with a lower risk of hypoglycaemia at night and at any time of day over 12 months of treatment, compared with Gla‐100. The ongoing large‐scale real‐life, randomized, pragmatic studies of Gla‐300 vs Gla‐100 may provide more evidence about the benefits of Gla‐300 in clinical practice.…”

Section: Discussionmentioning

confidence: 99%

“…The ongoing large-scale real-life, randomized, pragmatic studies of Gla-300 vs Gla-100 [22][23][24] may provide more evidence about the benefits of Gla-300 in clinical practice.…”

Section: Number Of Participants N (%)mentioning

confidence: 99%

Better glycaemic control and less hypoglycaemia with insulin glargine 300 U/mL vs glargine 100 U/mL: 1‐year patient‐level meta‐analysis of the EDITION clinical studies in people with type 2 diabetes

Ritzel

Roussel

Giaccari

et al. 2017

Diabetes Obesity Metabolism

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AimsTo investigate the efficacy and safety of insulin glargine 300 U/mL (Gla‐300) vs insulin glargine 100 U/mL (Gla‐100) over 12 months in a patient‐level meta‐analysis, using data from the EDITION studies in people with type 2 diabetes (T2DM).Methods EDITION 1, 2 and 3 were multicentre, randomized, open‐label, 2‐arm, parallel‐group, treat‐to‐target phase IIIa studies. Similar study designs and endpoints enabled a meta‐analysis to be conducted.ResultsReductions in glycated haemoglobin (HbA1c) were better sustained over 12 months with Gla‐300 than with Gla‐100 (least squares [LS] mean difference in change from baseline: −0.10 % [95% confidence interval {CI} −0.18 to −0.02] or −1.09 mmol/mol [95% CI −2.01 to −0.20]; P = .0174). Risk of confirmed (≤3.9 mmol/L) or severe hypoglycaemia was 15% lower with Gla‐300 vs Gla‐100 at night (relative risk 0.85 [95% CI 0.77–0.92]) and 6% lower at any time of day (relative risk 0.94 [95% CI 0.90–0.98]). Rates of hypoglycaemia were 18% lower with Gla‐300 vs Gla‐100 at night (rate ratio 0.82 [95% CI 0.67–0.99]), but comparable at any time of day. HbA1c <7.0 % without nocturnal hypoglycaemia was achieved by 24% more participants with Gla‐300 than with Gla‐100 (relative risk 1.24 [95% CI 1.03–1.50]). Severe hypoglycaemia was rare; in both treatment groups the incidence of events at any time of day was ≤3.6%, while rates were ≤0.08 events per participant‐year.ConclusionsIn a broad population of people with T2DM over 12 months, use of Gla‐300 provided more sustained glycaemic control and significantly lower hypoglycaemia risk at night and at any time of day compared with Gla‐100.

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Achieve control: a pragmatic clinical trial of insulin glargine 300 U/mL versus other basal insulins in insulin-naïve patients with type 2 diabetes

Cited by 14 publications

References 36 publications

Glycaemic goal attainment and hypoglycaemia outcomes in type 2 diabetes patients initiating insulin glargine 300 units/mL or 100 units/mL: Real‐world results from the DELIVER Naïve cohort study

Glycaemic goal attainment and hypoglycaemia outcomes in type 2 diabetes patients initiating insulin glargine 300 units/mL or 100 units/mL: Real‐world results from the DELIVER Naïve cohort study

Real-world outcomes of treatment with insulin glargine 300 U/mL versus standard-of-care in people with uncontrolled type 2 diabetes mellitus

Better glycaemic control and less hypoglycaemia with insulin glargine 300 U/mL vs glargine 100 U/mL: 1‐year patient‐level meta‐analysis of the EDITION clinical studies in people with type 2 diabetes

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