Takashi Kadowaki1, Hideaki Jinnouchi2, Kohei Kaku3, Malene L Hersløv4, Jacob Hyllested-Winge5, Shuji Nakamura6. 1. 1Department of Metabolic Diseases, Graduate School of Medicine and Faculty of Medicine, The University of Tokyo, Tokyo, Japan. 2. Iryo Houjin Shadan Jinnouchikai, Jinnouchi Hospital, Kumamoto, Japan. 3. 3Department of Internal Medicine, Kawasaki Medical School, Okayama, Japan. 4. 4Medical and Science, Novo Nordisk A/S, Søborg, Denmark. 5. Medical and Scientific Affairs, Novo Nordisk Pharma Ltd, Tokyo, Japan. 6. Iryo Houjin Shadan Kowakai, Heiwadai Hospital, Miyazaki, Japan.
Abstract
AIMS: Managing insulin therapy is a challenge for both patients and healthcare providers.The primary aim of this trial was to compare the efficacy and safety of insulin degludec (IDeg) in a fixed versus flexible dosing schedule. The secondary aim and subject of this manuscript was to compare a simple versus a stepwise titration algorithm. MATERIALS AND METHODS: This was a 26-week, controlled, multicenter, open-label, randomized, treat-to-target phase 3b trial of Japanese patients with type 2 diabetes inadequately treated with insulin glargine and with/without antidiabetic drugs orally. The trial had a 2 × 2 factorial design whereby 458 patients were randomized 1:1:1:1 to one of two titration algorithms and one of two dosing schedules. IDeg dose was adjusted weekly using a clinician-led, treat-to-target approach in order to ensure optimal insulin titration and glycemic control following self-measured blood glucose (SMBG) readings. RESULTS: Mean insulin dose at the end of the trial was similar in both simple and stepwise titration algorithms. Glycemic control improved in both titration algorithms, with noninferiority in glycated hemoglobin (HbA1c) reduction confirmed when comparing simple and stepwise titration algorithms and no significant differences in fasting plasma glucose or SMBG at 26 weeks. No safety concerns were observed in terms of adverse events, and rates of hypoglycemia were not significantly different between the two algorithms. CONCLUSIONS: This trial demonstrated comparable efficacy with noninferior HbA1c and comparable safety of once-daily IDeg using either a simple or stepwise titration algorithm in Japanese patients with type 2 diabetes inadequately controlled with insulin glargine.
AIMS: Managing insulin therapy is a challenge for both patients and healthcare providers.The primary aim of this trial was to compare the efficacy and safety of insulin degludec (IDeg) in a fixed versus flexible dosing schedule. The secondary aim and subject of this manuscript was to compare a simple versus a stepwise titration algorithm. MATERIALS AND METHODS: This was a 26-week, controlled, multicenter, open-label, randomized, treat-to-target phase 3b trial of Japanese patients with type 2 diabetes inadequately treated with insulin glargine and with/without antidiabetic drugs orally. The trial had a 2 × 2 factorial design whereby 458 patients were randomized 1:1:1:1 to one of two titration algorithms and one of two dosing schedules. IDeg dose was adjusted weekly using a clinician-led, treat-to-target approach in order to ensure optimal insulin titration and glycemic control following self-measured blood glucose (SMBG) readings. RESULTS: Mean insulin dose at the end of the trial was similar in both simple and stepwise titration algorithms. Glycemic control improved in both titration algorithms, with noninferiority in glycated hemoglobin (HbA1c) reduction confirmed when comparing simple and stepwise titration algorithms and no significant differences in fasting plasma glucose or SMBG at 26 weeks. No safety concerns were observed in terms of adverse events, and rates of hypoglycemia were not significantly different between the two algorithms. CONCLUSIONS: This trial demonstrated comparable efficacy with noninferior HbA1c and comparable safety of once-daily IDeg using either a simple or stepwise titration algorithm in Japanese patients with type 2 diabetes inadequately controlled with insulin glargine.
Entities:
Keywords:
Basal insulin; Insulin degludec; Titration algorithm; Type 2 diabetes
Authors: David S Oyer; Mark D Shepherd; Franklin C Coulter; Anuj Bhargava; Jason Brett; Pei-Ling Chu; Bruce S Trippe Journal: Am J Med Date: 2009-11 Impact factor: 4.965