Step-up therapy with biphasic insulin aspart-70/30--Sapporo 1-2-3 study.
The effectiveness of BIAsp 30 step-up therapy in achieving glycemic control in Japanese patients with type 2 diabetes mellitus was investigated. Study subjects were 99 patients with type 2 diabetes mellitus aged over 20 years who were judged to require insulin therapy due to poor glucose control (HbA1c level of > or =7.5%). BIAsp 30 dosage was determined by the patient's attending physician; coadministration of hypotensive agents and antilipemic agents was permitted, but OAD coadministration was limited to patients already receiving such drugs at the start of the study. Patients who did not achieve HbA1c <6.5% after 16+/-5 weeks with QD (Phase 1) were stepped up to BID (Phase 2). If patients still had not achieved HbA1c <6.5% after 16+/-5 weeks with BID, they were stepped up to TID (Phase 3). 55 of the 99 enrolled subjects completed the study and the rates of achievement of HbA1c <6.5% and HbA1c <7.0% were 45.5% and 74.5%, respectively. Of all registered subjects, 5.1% (5/99) achieved HbA1c <6.5% in QD, 19.5% (16/82) in BID, and 20.6% (7/34) in TID. Statistically significant reductions in HbA1c levels were recorded at the conclusion of each phase, with no incidents requiring intervention, indicating that BIAsp 30 step-up therapy is a safe, simple therapy that can be useful in achieving better glycemic control for Japanese patients with type 2 diabetes mellitus.
Department of Medicine II, Hokkaido University Graduate School of Medicine, Kita 15 jyo, Nishi 7 cho-me, Kita-ku, Sapporo, Hokkaido, 060-8638, Japan. n-yoshi@med.hokudai.ac.jp
N
N
Yoshioka
Y
Y
Kurihara
N
N
Manda
K
K
Komori
M
M
Kato
H
H
Kijima
N
N
Wada
K
K
Yanagisawa
S
S
Aoki
Y
Y
Ono
T
T
Koike
D000284:Administration, Oral; D000328:Adult; D000368:Aged; D061265:Biphasic Insulins; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D003927:Diet, Diabetic; D004334:Drug Administration Schedule; D015444:Exercise; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage / Q000627:therapeutic use; D007328:Insulin / Q000031:analogs & derivatives* / Q000627:therapeutic use; D061267:Insulin Aspart; D007336:Insulin, Isophane; D007564:Japan; D008297:Male; D008875:Middle Aged; D012449:Safety; D055815:Young Adult
D061265:Biphasic Insulins; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D007328:Insulin; D061267:Insulin Aspart; D007336:Insulin, Isophane; C557564:insulin aspart, insulin aspart protamine drug combination 30:70