Insulin degludec/insulin aspart versus biphasic insulin aspart 30 twice daily in insulin-experienced Japanese subjects with uncontrolled type 2 diabetes: Subgroup analysis of a Pan-Asian, treat-to-target Phase 3 Trial.

Abstract

BACKGROUND:

The present study was a subgroup analysis of a Pan-Asian Phase 3 open-label randomized treat-to-target trial evaluating insulin degludec/insulin aspart (IDegAsp) and biphasic insulin aspart 30 (BIAsp 30) in Japanese subjects with type 2 diabetes inadequately controlled on insulin.

METHODS:

Eligible subjects (n = 178) were randomized (2: 1) to twice-daily (b.i.d.) IDegAsp or BIAsp 30 with or without metformin for 26 weeks, titrated to a blood glucose target of between 3.9 and <5.0 mmol/L. Changes in HbA1c , the proportion of responders reaching the HbA1c target, and changes in fasting plasma glucose, nine-point self-monitored plasma glucose profiles, and body weight were assessed.

RESULTS:

At 26 weeks, the decrease in HbA1c was similar in both groups. Fasting plasma glucose was lower with IDegAsp than BIAsp 30 (estimated treatment difference -1.50 mmol/L; 95 % confidence interval [CI] -1.98, -1.01). Overall confirmed hypoglycemia rates were similar; the nocturnal confirmed hypoglycemia rate was lower with IDegAsp than BIAsp 30 (estimated rate ratio 0.44; 95 % CI 0.20, 0.99). No severe hypoglycemic episodes were reported.

CONCLUSIONS:

The results indicate that IDegAsp b.i.d. improves glycemic control and, compared with BIAsp 30, lowers the rate of nocturnal confirmed hypoglycemia.

• Authors: Shinji Taneda, Jacob Hyllested-Winge, Mari-Anne Gall, Shizuka Kaneko, Koichi Hirao
• Journal: Journal of diabetes (J Diabetes) Vol. 9 Issue 3 Pg. 243-247 (Mar 2017) ISSN: 1753-0407 [Electronic] Australia
• Vernacular Title: 在既往使用胰岛素治疗血糖未得到控制的日本2型糖尿病受试者中比较德谷胰岛素/门冬胰岛素与每日2次双相门冬胰岛素30:泛亚达标治疗3期试验亚组分析.
• PMID: 27059529 (Publication Type: Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial)
• Copyright: © 2016 The Authors. Journal of Diabetes published John Wiley & Sons Australia, Ltd and Ruijin Hospital, Shanghai Jiaotong University School of Medicine.

Chemical References

• Biphasic Insulins
• Blood Glucose
• Glycated Hemoglobin A
• Hypoglycemic Agents
• Insulin, Long-Acting
• insulin aspart, insulin aspart protamine drug combination 30:70
• Insulin, Isophane
• insulin degludec
• Metformin
• Insulin Aspart

Topics

• Aged
• Asian People
• Biphasic Insulins (adverse effects, therapeutic use)
• Blood Glucose (metabolism)
• Diabetes Mellitus, Type 2 (blood, drug therapy, ethnology)
• Diabetic Retinopathy (chemically induced)
• Drug Administration Schedule
• Drug Therapy, Combination
• Female
• Glycated Hemoglobin (metabolism)
• Humans
• Hypertension (chemically induced)
• Hypoglycemic Agents (adverse effects, therapeutic use)
• Insulin Aspart (adverse effects, therapeutic use)
• Insulin, Isophane (adverse effects, therapeutic use)
• Insulin, Long-Acting (adverse effects, therapeutic use)
• Male
• Metformin (adverse effects, therapeutic use)
• Middle Aged
• Nasopharyngitis (chemically induced)
• Treatment Outcome