A randomized clinical trial comparing breakfast, dinner, or bedtime administration of insulin glargine in patients with type 1 diabetes.
OBJECTIVE
Insulin glargine (Lantus), a long-acting human insulin analog, provides effective glycemic control when administered at bedtime. This open-label, randomized, parallel group, multicenter study investigated whether insulin glargine is equally effective if administered before breakfast, before dinner, or at bedtime.


METHODS
Patients with type 1 diabetes on basal-bolus therapy (n = 378, 18-68 years, HbA(1c) 5.5-9.8%) were treated with once-daily individually titrated insulin glargine in combination with prandial insulin lispro for 24 weeks.


RESULTS
Baseline characteristics were similar in the three groups (overall age 40.9 +/- 11.9 years, diabetes duration 17.3 +/- 11.5 years). Median total daily insulin dose was similar at baseline (0.65, 0.65, and 0.66 IU/kg for breakfast, dinner, and bedtime, respectively) and remained relatively constant over the study period; however, the insulin glargine-to-total insulin dose ratio increased more in the breakfast group than in the dinner and bedtime groups. A similar reduction of adjusted mean HbA(1c) from baseline to end point occurred in all patients (7.6-7.4, 7.6-7.5, and 7.6-7.5% for breakfast, dinner, and bedtime, respectively), and a similar percentage achieved HbA(1c) <7.0% at end point in all groups (29.5, 29.8, and 25.8%, respectively). The 24-h blood glucose profiles in relation to injection time were similar in all groups. The incidences of total symptomatic and severe hypoglycemia did not differ between the three treatment groups; however, nocturnal hypoglycemia occurred in significantly fewer patients in the breakfast group (59.5%) compared with the dinner (71.9%) and bedtime (77.5%) groups (P = 0.005).


CONCLUSIONS
These data suggest that insulin glargine, in combination with insulin lispro, is safe and effective when administered before breakfast, before dinner, or at bedtime.
Hamann
Andreas
A
Division of Endocrinology and Metabolism, Department of Medicine, University Hospital Heidelberg, Heidelberg, Germany. andreas_hamann@med.uni-heidelberg.de
Matthaei
Stephan
S
Rosak
Christoph
C
Silvestre
Louise
L
D000293:Adolescent; D000328:Adult; D000368:Aged; D001786:Blood Glucose / Q000032:analysis / Q000187:drug effects / Q000378:metabolism*; D015992:Body Mass Index; D003922:Diabetes Mellitus, Type 1 / Q000188:drug therapy* / Q000503:physiopathology / Q000523:psychology*; D004334:Drug Administration Schedule; D004435:Eating; D005215:Fasting; 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 / Q000627:therapeutic use*; D007328:Insulin / Q000008:administration & dosage* / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D000069036:Insulin Glargine; D049528:Insulin, Long-Acting; D008297:Male; D008875:Middle Aged; D018579:Patient Selection; D011788:Quality of Life; D012449:Safety; D013997:Time Factors
D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D007328:Insulin; D000069036:Insulin Glargine; D049528:Insulin, Long-Acting