Insulin detemir is associated with more predictable glycemic control and reduced risk of hypoglycemia than NPH insulin in patients with type 1 diabetes on a basal-bolus regimen with premeal insulin aspart.
OBJECTIVE
Insulin detemir is a soluble basal insulin analog with a unique mechanism of protracted action designed to reduce the variability associated with conventional basal insulins. This trial compared the glycemic control, risk of hypoglycemia, and effect on body weight of insulin detemir and NPH insulin in patients with type 1 diabetes treated with rapid-acting insulin aspart at meals.


METHODS
This study was a 6-month multinational open parallel-group comparison conducted at 46 centers in five countries and included 448 patients with type 1 diabetes randomized 2:1 to insulin detemir or NPH insulin, respectively.


RESULTS
After 6 months, comparable HbA(1c) levels were found between the two treatment groups. Fasting plasma glucose tended to be lower in patients treated with insulin detemir, but this difference was not statistically significant (-0.76 mmol/l, P = 0.097). Within-subject variation in self-measured fasting blood glucose was lower with insulin detemir than with NPH insulin (SD 3.37 vs. 3.78 mmol/l, P < 0.001). Risk of hypoglycemia was 22% lower with insulin detemir than with NPH insulin (P < 0.05) and 34% lower for nocturnal (2300-0600) hypoglycemia (P < 0.005). Nightly plasma glucose profiles were smoother and more stable with insulin detemir (P = 0.05). Body weight was significantly lower with insulin detemir at the end of the trial (P < 0.001).


CONCLUSIONS
Treatment with insulin detemir resulted in more predictable glycemic control, with smoother plasma glucose profiles than NPH insulin and a significant reduction in the risk of hypoglycemia. The reduction in body weight with insulin detemir is a potential additional advantage. Regimens optimized for insulin detemir may be able to improve glycemic control beyond that possible with NPH insulin.
Vague
Philippe
P
Hôpital de la Timone, Service Nutrition Endocrinologie et Maladies Metabolique, Marseilles, France. pvague@mail.ap-hm.fr
Selam
Jean-Louis
JL
Skeie
Svein
S
De Leeuw
Ivo
I
Elte
Jan W F
JW
Haahr
Hanne
H
Kristensen
Allan
A
Draeger
Eberhard
E
D000328:Adult; D001786:Blood Glucose / Q000378:metabolism*; D001835:Body Weight; D002352:Carrier Proteins / Q000008:administration & dosage* / Q000009:adverse effects; D003922:Diabetes Mellitus, Type 1 / Q000097:blood / Q000188:drug therapy*; D004435:Eating; D005260:Female; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D007003:Hypoglycemia / Q000139:chemically induced* / Q000453:epidemiology; D007004:Hypoglycemic Agents / Q000008:administration & dosage / Q000009:adverse effects*; D015994:Incidence; D007328:Insulin / Q000008:administration & dosage* / Q000009:adverse effects* / Q000031:analogs & derivatives; D061267:Insulin Aspart; D000069057:Insulin Detemir; D007336:Insulin, Isophane / Q000008:administration & dosage / Q000009:adverse effects*; D049528:Insulin, Long-Acting; D008297:Male; D008875:Middle Aged; D012307:Risk Factors
D001786:Blood Glucose; D002352:Carrier Proteins; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D007328:Insulin; D061267:Insulin Aspart; D000069057:Insulin Detemir; D007336:Insulin, Isophane; D049528:Insulin, Long-Acting