Long-term glycaemic control with insulin glargine in Type 2 diabetes.
OBJECTIVE
This study examined the long-term glycaemic control and safety of insulin glargine (LANTUS) in patients with Type 2 diabetes.


METHODS
This <or=28-month, long-term extension of a multinational, multicentre, open-label 52-week study enrolled patients from the original study to continue taking insulin glargine at bedtime plus previous oral hypoglycaemic agents (OHAs). Efficacy and safety were assessed by HbA(1c) and adverse events, symptomatic hypoglycaemia and selected clinical and laboratory variables.


RESULTS
Two hundred and thirty-nine treated patients from the original study entered the extension study and 198 completed the extension study. There was a 1.02% reduction in mean HbA(1c) from baseline of the original study (9.44%) to endpoint of the extension study (8.42%). No new or unexpected adverse events were observed with longer term exposure to insulin glargine over a treatment period of<or=39 months. Treatment-emergent adverse events were reported for 152 patients (63.6%), four of which (1.7%) were considered to be possibly treatment-related. Mean weight gain observed during the original study was +2.12 kg with an absence of further weight gain at the end of the extension study (+2.02 kg).


CONCLUSIONS
Long-term insulin glargine treatment plus OHAs provides continued glycaemic control and is well tolerated in patients with Type 2 diabetes. Therefore, insulin glargine appears to be suitable for the long-term management of Type 2 diabetes.
Kacerovsky-Bielesz
Gertrud
G
First Department of Medicine, Hanusch Hospital, Vienna, Austria. gertrud.kacerovsky@wgkk.sozvers.at
Dressler
Ansgar
A
Freunscht
Regina
R
D000368:Aged; D001786:Blood Glucose / Q000187:drug effects / Q000378:metabolism*; D003924:Diabetes Mellitus, Type 2 / Q000097:blood* / Q000188:drug therapy*; D005006:Ethnicity; D005260:Female; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use; D007328:Insulin / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000069036:Insulin Glargine; D049528:Insulin, Long-Acting; D008297:Male; D008875:Middle Aged; D018579:Patient Selection
D001786:Blood Glucose; D007004:Hypoglycemic Agents; D007328:Insulin; D049528:Insulin, Long-Acting; D000069036:Insulin Glargine