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Diabetes Care. 2014 Dec;37(12):3235-43. doi: 10.2337/dc14-0990. Epub 2014 Sep 5.

New insulin glargine 300 units/mL versus glargine 100 units/mL in people with type 2 diabetes using oral agents and basal insulin: glucose control and hypoglycemia in a 6-month randomized controlled trial (EDITION 2).

Collaborators (186)

Tellier G, Jones M, Leiter L, Perron P, Punthakee Z, Rizvi Q, Shu D, Ho K, Vitug G, Woo V, Morrison D, Berlingieri J, Gottesman I, Lahsen R, Soto N, Aravena M, Godoy G, Solis C, Larenas G, Palma J, Aburto MF, Valderas JP, Fajardo G, Gutierrez V, Romero C, Yki-Järvinen H, Gouet D, Krempf M, Serusclat P, Clavel S, Lopez I, Hochner I, Böckmann U, Klein C, Sauter J, Wenzl-Bauer V, Chen-Stute A, Kosch C, Kis-Gombos P, Kiss J, Lengyel Z, Nyirati G, Plés Z, Poór F, Taller A, Garza J, Villezca DL, Morales-De TM, Frenk P, Aguilar-Orozco R, Calvo-Vargas C, Leguizamo-Dimas A, Pelayo S, Nicolau A, Bradescu O, Cristescu J, Musat D, Negrisanu G, Avram RI, Cif A, Nafornita V, Ferariu I, Popa B, Pavel MF, Munteanu M, Onaca A, Cerghizan A, Pintilei E, Shustov S, Rodionova T, Vorokhobina N, Zhdanova E, Karpova I, Dreval A, Alpenidze D, Feofanova S, Petunina N, Lantseva O, Zalevskaya A, Morugova T, Badat A, Joshi S, Padayachee T, Ellis G, Bester F, Subias D, Rivas M, Tinahones FJ, Ferrer GJ, Gonzalbez J, Masmiquel L, Rosenstock J, Hsieh R, Burr R, Kasper JF, Mandry J, Selam JL, Thrasher J, Lai C, Adkins K, Mikell F, Maheshwari H, Wilson J, Cohen L, Johnson DM, Powell S, Rodbard H, Larocque J, Aroda V, Harris M, Reeves M, Lovell C, De La Rosa R, Wakefield P, O'connor T, Webster B, Palmer J, Blair-Britt L, Vance C, Nakhle S, Bernstein R, Meyers P, Alzohaili O, Lillestol M, Gonzalez-Campoy J, Riffer E, Bauch T, Evans P, Hughes G, Winkle P, Mayfield R, Stegemoller R, Moore P, Hoffman A, Kerwin E, Bergenstal R, Matfin G, Mcknight T, Allen D, Adelizzi A, Condit J, Moretto T, Kwon E, Beavins J, Riveland B, Arif A, Daniel J, Arora S, Kreutter F, Jardula M, Uusinarkaus K, Stringam S, Daboul N, Hsu C, Martin P, Boehm T, Hollander P, Ball E, Reyes H, Houser P, Bauman J, Earl J, Plevin S, Oates S, Simon H, Levinson L, Passaro M, Kessel J, Aronoff S, Welch M, Kulick D, Fogelfeld L, Broker R, Buchanan P, Salem G, Larsen D, Stearns P, Iguh B, Lorch D, Sandoval J, Delgado B, Klein E, Denham D, Fishman N, Fishman N, Wong M.

Author information

1
Department of Medicine, University of Helsinki, and Minerva Foundation Institute for Medical Research, Helsinki, Finland ykijarvi@cc.helsinki.fi.
2
International Diabetes Center at Park Nicollet, Minneapolis, MN.
3
Sanofi-Aventis Deutschland GmbH, Frankfurt am Main, Germany.
4
Sanofi, Warsaw, Poland.
5
Sanofi, Paris, France.
6
Oregon Health & Science University, Portland, OR.

Abstract

OBJECTIVE:

To compare the efficacy and safety of new insulin glargine 300 units/mL (Gla-300) with glargine 100 units/mL (Gla-100) in people with type 2 diabetes using basal insulin (≥42 units/day) plus oral antihyperglycemic drugs (OADs).

RESEARCH DESIGN AND METHODS:

EDITION 2 was a multicenter, open-label, two-arm study. Adults receiving basal insulin plus OADs were randomized to Gla-300 or Gla-100 once daily for 6 months. The primary end point was change in HbA1c. The main secondary end point was percentage of participants with one or more nocturnal confirmed (≤3.9 mmol/L [≤70 mg/dL]) or severe hypoglycemic events from week 9 to month 6.

RESULTS:

Randomized participants (n = 811) had a mean (SD) HbA₁c of 8.24% (0.82) and BMI of 34.8 kg/m(2) (6.4). Glycemic control improved similarly with both basal insulins; least squares mean (SD) reduction from baseline was -0.57% (0.09) for Gla-300 and -0.56% (0.09) for Gla-100 (mean difference -0.01% [95% CI -0.14 to 0.12]), with 10% higher dose of Gla-300. Less nocturnal confirmed (≤3.9 mmol/L [≤70 mg/dL]) or severe hypoglycemia was observed with Gla-300 from week 9 to month 6 (relative risk 0.77 [95% CI 0.61-0.99]; P = 0.038) and during the first 8 weeks. Fewer nocturnal and any time (24 h) hypoglycemic events were reported during the entire 6-month period. Weight gain was lower with Gla-300 than with Gla-100 (P = 0.015). No between-treatment differences in safety parameters were identified.

CONCLUSIONS:

Gla-300 was as effective as Gla-100 and associated with a lower risk of hypoglycemia during the night and at any time of the day.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT01499095.

PMID:
25193531
DOI:
10.2337/dc14-0990
[Indexed for MEDLINE]

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