Insulin detemir improves glycaemic control with less hypoglycaemia and no weight gain in patients with type 2 diabetes who were insulin naive or treated with NPH or insulin glargine: clinical practice experience from a German subgroup of the PREDICTIVE study.

Abstract

AIM:

The Predictable Results and Experience in Diabetes through Intensification and Control to Target: An International Variability Evaluation (PREDICTIVE) Study is a large, multi-centre, observational study assessing the safety and efficacy of insulin detemir in everyday clinical practice.

METHODS:

This subgroup analysis of the German cohort of PREDICTIVE evaluates over 3 months, patients with type 2 diabetes who were transferred to insulin detemir +/- oral antidiabetic drugs (OADs) from an OAD-only regimen (n = 1321), NPH insulin +/- OADs (n = 251) or insulin glargine +/- OADs (n = 260).

RESULTS:

Among all groups, 3 months after starting treatment with insulin detemir, total, daytime and nocturnal hypoglycaemic events/patient were reduced by 84, 80 and 90%, respectively, from baseline. No major hypoglycaemic events were reported during treatment with insulin detemir. HbAlc was significantly reduced from baseline in each of the subgroups (-1.29,-0.60 and-0.59% for patients previously taking OADs only, NPH insulin +/- OADs and insulin glargine +/- OADs respectively; p < 0.0001), as was fasting blood glucose (FBG) (-58.1,-29.1 and-24.6 mg/dl; p < 0.0001) and FBG variability-8.2 mg/dl,-5.7 mg/dl; p < 0.0001 and -5.1 mg/dl; p = 0.0008). All subgroups combined lost an average of 0.9 kg of body weight (p < 0.0001) during the study. Total daily basal insulin dose increased slightly from baseline for those patients on a prior insulin regimen, and in this study 79% of patients used insulin detemir once daily.

CONCLUSIONS:

These data confirm the short-term safety and efficacy of insulin detemir +/- OADs in a real-world scenario and support the findings of randomized controlled clinical trials with insulin detemir, including its limited effects on body weight.

• Authors: L F Meneghini, K H Rosenberg, C Koenen, M J Merilainen, H-J Lüddeke
• Journal: Diabetes, obesity & metabolism (Diabetes Obes Metab) Vol. 9 Issue 3 Pg. 418-27 (May 2007) ISSN: 1462-8902 [Print] England
• PMID: 17391170 (Publication Type: Journal Article, Multicenter Study)

Chemical References

• Blood Glucose
• Glycated Hemoglobin A
• Hypoglycemic Agents
• Insulin
• Insulin, Long-Acting
• Insulin Glargine
• Insulin Detemir
• Insulin, Isophane

Topics

• Administration, Oral
• Blood Glucose (drug effects)
• Cohort Studies
• Diabetes Mellitus, Type 2 (complications, drug therapy, physiopathology)
• Drug Administration Schedule
• Female
• Glycated Hemoglobin (analysis)
• Humans
• Hypoglycemia (complications, physiopathology)
• Hypoglycemic Agents (administration & dosage, adverse effects, therapeutic use)
• Insulin (administration & dosage, adverse effects, agonists, analogs & derivatives, therapeutic use)
• Insulin Detemir
• Insulin Glargine
• Insulin, Isophane (therapeutic use)
• Insulin, Long-Acting
• Male
• Middle Aged
• Treatment Outcome
• Weight Loss (drug effects)