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Diabetes Obes Metab. 2015 Apr;17(4):386-94. doi: 10.1111/dom.12438. Epub 2015 Feb 12.

New insulin glargine 300 U/ml compared with glargine 100 U/ml in insulin-naïve people with type 2 diabetes on oral glucose-lowering drugs: a randomized controlled trial (EDITION 3).

Collaborators (248)

Borissova-Ivanova AM, Levterov G, Margaritov V, Mitkov M, Temelkova M, Aronson R, Bajaj H, Campbell I, Dumas R, Elfassi E, Girard G, Goldenberg R, Hamet P, Khandwala H, Lasko B, Luton R, Shu D, Twum-Barima D, Yared Z, Belobradkova J, Horanska P, Silhova E, Turcinek R, Zak P, Faber J, Gram J, Helleberg K, Henriksen J, Lervang HH, Madsbad S, Perrild H, Rasmussen O, Torp-Pedersen C, Adojaan B, Lubi M, Past M, Kuusela M, Paul R, Piippo T, Strand J, Valle T, Beke E, Biro J, Dudas M, Hermanyi Z, Horthy R, Gombos PK, Nagy K, Oroszlan T, Petro G, Sasvari I, Somogyi A, Tabak A, Akiyama H, Fukuda S, Imamaki K, Kawakami H, Masunaga S, Matsutani A, Murata K, Nakagawa M, Ohashi M, Ono Y, Sugiyama K, Takahashi H, Yamauchi K, Akmentins A, Helda R, Pirags V, Stelmane I, Stura I, Gailiuniene S, Navickas A, Urbanaviciene E, Urbonas G, Ziukaite R, Hoogendijk J, Katerberg H, Kentgens S, Kose V, Rojas G, Voors-Pette C, van Kempen W, van de Walle V, Abreu-Feshold F, Barranco E, Colon G, Figueroa W, Irizarry C, Otero-Martinez J, Rodriguez-Vigil E, Ruiz-Rivera L, Sosa-Padilla M, Bradescu O, Cerghizan A, Cif A, Crisan C, Mot AC, Munteanu M, Musat D, Nafornita V, Negrisanu GD, Popa B, Pruna C, Vlaiculescu MV, Ambrovicova V, Dzupina A, Fabry J, Gergel V, Navratova D, Okapcova J, Tomasova L, Vargova A, Bragee B, Koskinen P, Liu B, Torstensson I, Adams A, Adams M, Adelizzi A, Allen G, Altamirano D, Anderson M, Andrawis N, Anspach R, Ares-Romero P, Aroda V, Aronoff S, Arora S, Ayesu K, Bailey T, Baker C, Bauch T, Beavins J, Berenguer R, Bernstein R, Bhargava A, Bianchi A, Bland V, Block B, Bolshoun D, Bruce T, Buchanan P, Bueso G, Burke D, Busch R, Cannon A, Carroll M, Castro M, Cha G, Chaykin L, Cheung D, Christiansen M, Cleland A, Clevinger S, Clower J, Cohen L, Connery L, Dailey G, De la Rosa R, Dempsey M, Dobratz D, Drusano M, Dunn L, Ensz D, Fiel T, Fink R, Fitz-Patrick D, Fogarty C, Fogelfeld L, Gabra N, Gonzalez G, Gorrela S, Gruener D, Hanson L, Harper L, Hart T, Hershberger V, Hershon K, Holgado M, Hollander P, Horowitz B, Jain M, Jain R, Jardula M, Jayaramaiah P, Jenkin F, Joyce J, Kaufmann R, Kerwin E, Lacour A, Lane W, Larsen D, Lerman S, Lesh K, Levinson L, Lipetz R, Lynn L, Maiquez A, Maldonado-Garcia C, Mayfield R, McCartney M, McLean B, Miers W, Nakhle S, Norwood P, Patel R, Pharr W, Plevin S, Powell S, Reeves M, Rendell M, Reynolds S, Riffer E, Colon LR, Robinson M, Rosen J, Rosenblit P, Rosenstock J, Rudolph L, Salem G, Sanchez G, Sandberg J, Sandoval J, Seaton B, Severance R, Shivaswamy V, Sial V, Smith S, Stearns P, Stegemoller R, Sugimoto D, Sussman A, Thrasher J, Tresser N, Tulloch B, Twahirwa M, Vadakekalam J, Van J, Vance C, Vargas R, Watts R, Weinstein D, Weissman P, Wise J, Wong M, Wynne A, Zeig S.

Author information

1
Department of Medicine, Perugia University Medical School, Hospital Santa Maria della Misericordia, Perugia, Italy.

Abstract

AIMS:

To compare the efficacy and safety of new insulin glargine 300 U/ml (Gla-300) with that of glargine 100 U/ml (Gla-100) in insulin-naïve people with type 2 diabetes using oral glucose-lowering drugs.

METHODS:

The EDITION 3 study was a multicentre, open-label, parallel-group study. Participants were randomized to Gla-300 or Gla-100 once daily for 6 months, discontinuing sulphonylureas and glinides, with a dose titration aimed at achieving pre-breakfast plasma glucose concentrations of 4.4-5.6 mmol/l (80-100 mg/dl). The primary endpoint was change in glycated haemoglobin (HbA1c) from baseline to month 6. The main secondary endpoint was percentage of participants with ≥1 nocturnal confirmed [≤3.9 mmol/l (≤70 mg/dl)] or severe hypoglycaemia from week 9 to month 6. Other measures of glycaemia and hypoglycaemia, weight change and insulin dose were assessed.

RESULTS:

Randomized participants (n = 878) had a mean (standard deviation) age of 57.7 (10.1) years, diabetes duration 9.8 (6.4) years, body mass index 33.0 (6.7) kg/m(2) and HbA1c 8.54 (1.06) % [69.8 (11.6) mmol/mol]. HbA1c levels decreased by equivalent amounts with the two treatments; the least squares mean difference in change from baseline was 0.04 [95% confidence interval (CI) -0.09 to 0.17] % or 0.4 (-1.0 to 1.9) mmol/mol. Numerically fewer participants reported ≥1 nocturnal confirmed (≤3.9 mmol/l) or severe hypoglycaemia from week 9 to month 6 [relative risk (RR) 0.89 (95% CI 0.66 to 1.20)] with Gla-300 versus Gla-100; a significantly lower risk of hypoglycaemia with this definition was found over the 6-month treatment period [RR 0.76 (95% CI 0.59 to 0.99)]. No between-treatment differences in adverse events were identified.

CONCLUSIONS:

Gla-300 is as effective as Gla-100 in reducing HbA1c in insulin-naïve people with type 2 diabetes, with lower hypoglycaemia risk.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT01676220.

KEYWORDS:

basal insulin analogues; basal insulin initiation; type 2 diabetes

PMID:
25641260
PMCID:
PMC4409854
DOI:
10.1111/dom.12438
[Indexed for MEDLINE]
Free PMC Article

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