Transferring type 2 diabetes patients with uncontrolled glycaemia from biphasic human insulin to biphasic insulin aspart 30: experiences from the PRESENT study.

Abstract

AIM:

The Physician's Routine Evaluation of Safety and Efficacy of NovoMix* 30 Therapy (PRESENT) aims to assess the safety and efficacy of biphasic insulin aspart (BIAsp30) used in routine clinical practice.

METHODS:

This was a large, multi-national, multi-centre, prospective, 6-month study in type 2 diabetes mellitus patients who were prescribed BIAsp30. Efficacy endpoints included changes in HbA(1c), fasting plasma glucose (FPG), postprandial plasma glucose (PPPG), and proportion who achieved target HbA(1c) < 7%. Changes from baseline were analysed using paired t-test. Safety endpoints were incidence and rate of hypoglycaemic episodes. A subgroup of patients previously uncontrolled (HbA(1c) > or = 7.0%) on biphasic human insulin (BHI) were analysed.

RESULTS:

Glycaemia improved significantly (mean +/- SD): HbA(1c) by 1.58 +/- 1.69% points (from 9.32 +/- 1.64% to 7.70 +/- 1.29%), FPG by 2.92 +/- 3.71 mmol/L and PPPG by 4.75 +/- 4.87 mmol/L. The incidence of hypoglycaemic episodes decreased over time, from 38.7% (baseline) to 20.8% (6 months). Episodes were mostly minor (reduced from 37.7 to 20.6% at 6 months), occurring during the day (reduced from 31.5 to 17.1% at 6 months). Major episodes were less frequently reported (reduced from 5.0 to 0.4% at 6 months). The rate of hypoglycaemia (episodes/patient year) from baseline to end of study decreased over time for overall (8.9-2.2), major (0.7-0.1), minor (8.2-2.2) and nocturnal (2.9-0.5) episodes.

CONCLUSIONS:

In this observational study, in the type 2 diabetes mellitus patients who were poorly controlled on BHI, glycaemia improved when transferred to BIAsp30, and a lower incidence or rate of hypoglycaemia was observed in these patients.

• Authors: M Shestakova, S K Sharma, M Almustafa, K W Min, N Ayad, S T Azar, R Danciulescu, D Khutsoane, S Guler
• Journal: Current medical research and opinion (Curr Med Res Opin) Vol. 23 Issue 12 Pg. 3209-14 (Dec 2007) ISSN: 1473-4877 [Electronic] England
• PMID: 18005503 (Publication Type: Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)

Chemical References

• Biphasic Insulins
• Blood Glucose
• Hypoglycemic Agents
• Insulin
• insulin aspart, insulin aspart protamine drug combination 30:70
• Insulin, Isophane
• Insulin Aspart

Topics

• Aged
• Biphasic Insulins
• Blood Glucose (analysis, drug effects)
• Diabetes Mellitus, Type 2 (complications, drug therapy)
• Female
• Humans
• Hyperglycemia (drug therapy, etiology)
• Hypoglycemic Agents (therapeutic use)
• Insulin (analogs & derivatives, analysis, pharmacology, therapeutic use)
• Insulin Aspart
• Insulin, Isophane
• Male
• Middle Aged
• Treatment Outcome