Starting insulin in type 2 diabetes: continue oral hypoglycemic agents? A randomized trial in primary care.
OBJECTIVE
To evaluate the effects of insulin 30/70 twice daily or bedtime isophane (NPH) insulin plus continued sulfonylurea and metformin in patients with type 2 diabetes in primary care.


METHODS
Open-label, randomized trial.


METHODS
Persons younger than 76 years with type 2 diabetes whose disease had not been controlled with oral hypoglycemic agents alone. A total of 64 insulin-naive patients treated with maximal feasible dosages of sulfonylurea and metformin (baseline glycosylated hemoglobin [HbA1c]=8.5%) were randomly assigned to insulin monotherapy (IM group; n=31) or insulin in addition to unchanged oral hypoglycemic medication (IC group; n=33) for 12 months. Insulin doses were adjusted to obtain fasting glucose <7.0 mmol/L and postprandial glucose <10.0 mmol/L.


METHODS
Outcome measures included HbA1c, treatment failure, weight, hypoglycemic events and symptoms, satisfaction with treatment, general well-being, and fear of injecting insulin and testing.


RESULTS
HbA1c improved from 8.3% to 7.6% in the IC group, and from 8.8% to 7.6% in the IM group (P=NS). The IC group had 24% treatment failures, compared with 2% in the IM group (P=.09). Patients in the IC group had less weight gain than those in the IM group (1.3 vs 4.2 kg; P=.01), and they reported fewer hypoglycemic events (2.7 vs 4.3; P=.02). Increased satisfaction with treatment was equal in the 2 groups, and general well-being improved by 3.0 points more in the IC group (P=.05). Fear of self-injecting and self-testing did not differ.


CONCLUSIONS
Bedtime NPH insulin added to maximal therapy with sulfonylurea and metformin is an effective, simple, well-tolerated approach for patients with uncontrolled type 2 diabetes.
Goudswaard
Alex N
AN
University Medical Center Utrecht, Julius Center for Health Sciences and Primary Care, Koperslagersgilde 5, 3994 CH Houten, The Netherlands. lex@goudswaard.cx
Stolk
Ronald P
RP
Zuithoff
Peter
P
de Valk
Harold W
HW
Rutten
Guy E
GE
D000704:Analysis of Variance; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D004359:Drug Therapy, Combination; D005260:Female; D006442:Glycated Hemoglobin / Q000187:drug effects; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage*; D007328:Insulin / Q000008:administration & dosage*; D007336:Insulin, Isophane / Q000008:administration & dosage; D008297:Male; D008687:Metformin / Q000008:administration & dosage; D008875:Middle Aged; D013453:Sulfonylurea Compounds / Q000008:administration & dosage
D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D007328:Insulin; D007336:Insulin, Isophane; D008687:Metformin; D013453:Sulfonylurea Compounds