Abstract | INTRODUCTION: Basal-bolus insulin therapy is a standard method of intensifying diabetes treatment. A common adverse effect of such treatment is hypoglycemia. Data on frequency of hypoglycemia when fast-acting insulin analogue is used in everyday clinical practice is scarce. OBJECTIVES: PATIENTS AND METHODS: It was a multicenter, open-label, noninterventional study. It involved 950 patients with type 1 and 1332 patients with type 2 diabetes who started preprandial insulin aspart in basal-bolus regimen. Patients were followed for 13 weeks. The primary endpoint was the incidence of major daytime and nocturnal hypoglycemic events assessed on the basis of patients' self-reports during follow-up compared with a 4-week period before the baseline visit. Secondary endpoints were: incidence of minor daytime and nocturnal hypoglycemia, hemoglobin A1c (HbA1c), fasting and postprandial glycemia. RESULTS: The rate of major hypoglycemia decreased in patients with type 1 diabetes--the incidence rate ratio ( IRR) was 0.14 for daytime and 0.03 for nocturnal episodes (P <0.0001) and did not change in patients with type 2 diabetes. The rate of minor episodes decreased in patients with type 1 diabetes ( IRR = 0.44 for daytime and IRR = 0.24 for nocturnal episodes, P <0.0001) and in patients with type 2 diabetes ( IRR= 0.57, P <0.0001 for daytime and IRR = 0.89, P <0.05 for nocturnal episodes). HbA1c decreased by 1.28 ± 1.64% in type 1 and 1.25 ± 1.10% in type 2 diabetes (both P <0.0001). Self-measured fasting and postprandial blood glucose levels were significantly lower at the final visit compared with baseline, irrespective of diabetes type. CONCLUSIONS: In clinical practice, treatment with insulin aspart in basal-bolus regimen is associated with low risk of hypoglycemia and leads to a significant improvement in glucose control, irrespective of diabetes type.
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Authors | Janusz Krzymień, Teresa Kobli, Maciej Nazar |
Journal | Polskie Archiwum Medycyny Wewnetrznej
(Pol Arch Med Wewn)
Vol. 120
Issue 11
Pg. 444-50
(Nov 2010)
Poland |
PMID | 21102380
(Publication Type: Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
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Chemical References |
- Blood Glucose
- Glycated Hemoglobin A
- Hypoglycemic Agents
- Insulin
- Insulin Aspart
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Topics |
- Adolescent
- Adult
- Aged
- Blood Glucose
(analysis)
- Comorbidity
- Diabetes Mellitus, Type 1
(drug therapy, epidemiology)
- Diabetes Mellitus, Type 2
(drug therapy, epidemiology)
- Dose-Response Relationship, Drug
- Drug Administration Schedule
- Female
- Glycated Hemoglobin
(analysis)
- Humans
- Hypoglycemia
(chemically induced, epidemiology)
- Hypoglycemic Agents
(administration & dosage, adverse effects)
- Incidence
- Insulin
(administration & dosage, adverse effects, analogs & derivatives)
- Insulin Aspart
- Male
- Middle Aged
- Poland
(epidemiology)
- Treatment Outcome
- Young Adult
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