Diabetes Metab J.  2013 Jun;37(3):181-189. 10.4093/dmj.2013.37.3.181.

Safety and Efficacy of Modern Insulin Analogues

Affiliations
  • 1Department of Internal Medicine, Korea University College of Medicine, Seoul, Korea. 103hyun@korea.ac.kr
  • 2Department of Internal Medicine, Konyang University College of Medicine, Daejeon, Korea.
  • 3Department of Internal Medicine, Eulji University School of Medicine, Daejeon, Korea.
  • 4Department of Internal Medicine, Kyung Hee University School of Medicine, Seoul, Korea.
  • 5Department of Internal Medicine, Eulji University School of Medicine, Seoul, Korea.
  • 6Department of Internal Medicine, Inje University College of Medicine, Busan, Korea.
  • 7Department of Internal Medicine, The Catholic University of Korea College of Medicine, Seoul, Korea.
  • 8Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea.
  • 9Department of Internal Medicine, Inha University School of Medicine, Incheon, Korea.
  • 10Department of Internal Medicine, Chungbuk National University College of Medicine, Cheongju, Korea.
  • 11Department of Internal Medicine, University of Ulsan College of Medicine, Ulsan, Korea.
  • 12Department of Internal Medicine, Hongik Hospital, Seoul, Korea.
  • 13Department of Internal Medicine, Keimyung University School of Medicine, Daegu, Korea.
  • 14Department of Internal Medicine, Kosin University College of Medicine, Busan, Korea.
  • 15Department of Internal Medicine, Hanyang University College of Medicine, Seoul, Korea.
  • 16Novo Nordisk Pharma Korea, Seoul, Korea.

Abstract

BACKGROUND
A1chieve(R) was a noninterventional study evaluating the clinical safety and efficacy of biphasic insulin aspart 30, insulin detemir, and insulin aspart.
METHODS
Korean type 2 diabetes patients who have not been treated with the study insulin or have started it within 4 weeks before enrollment were eligible for the study. The patient selection and the choice of regimen were at the discretion of the physician. The safety and efficacy information was collected from the subjects at baseline, week 12, and week 24. The number of serious adverse drug reactions (SADRs) was the primary endpoint. The changes of clinical diabetic markers at week 12 and/or at week 24 compared to baseline were the secondary endpoints.
RESULTS
Out of 4,058 exposed patients, 3,003 completed the study. During the study period, three SADRs were reported in three patients (0.1%). No major hypoglycemic episodes were observed and the rate of minor hypoglycemic episodes marginally decreased during 24 weeks (from 2.77 to 2.42 events per patient-year). The overall quality of life score improved (from 66.7+/-15.9 to 72.5+/-13.5) while the mean body weight was slightly increased (0.6+/-3.0 kg). The 24-week reductions in glycated hemoglobin, fasting plasma glucose and postprandial plasma glucose were 1.6%+/-2.2%, 2.5+/-4.7 mmol/L, and 4.0+/-6.4 mmol/L, respectively.
CONCLUSION
The studied regimens showed improvements in glycemic control with low incidence of SADRs, including no incidence of major hypoglycemic episodes in Korean patients with type 2 diabetes.

Keyword

Diabetes mellitus, type 2; Insulin; Republic of Korea; Safety; Treatment outcome

MeSH Terms

Biphasic Insulins
Body Weight
Diabetes Mellitus, Type 2
Drug Toxicity
Fasting
Glucose
Hemoglobins
Humans
Incidence
Insulin
Insulin Aspart
Insulin, Isophane
Insulin, Long-Acting
Patient Selection
Plasma
Quality of Life
Republic of Korea
Treatment Outcome
Insulin Detemir
Biphasic Insulins
Glucose
Hemoglobins
Insulin
Insulin Aspart
Insulin, Isophane
Insulin, Long-Acting

Figure

  • Fig. 1 Participant disposition by the study group. All data are presented as number of patients. The number of the withdrawn patients is presented by the reason: adverse drug reaction/lost contact/other. OAD, oral antidiabetic drug.

  • Fig. 2 The change in the rate of hypoglycemic episode by the types of episode and the study visit.


Cited by  1 articles

Characteristics Predictive for a Successful Switch from Insulin Analogue Therapy to Oral Hypoglycemic Agents in Patients with Type 2 Diabetes
Gyuri Kim, Yong-ho Lee, Eun Seok Kang, Bong-Soo Cha, Hyun Chul Lee, Byung-Wan Lee
Yonsei Med J. 2016;57(6):1395-1403.    doi: 10.3349/ymj.2016.57.6.1395.


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