Comparison of insulin detemir and insulin glargine using a basal-bolus regimen in a randomized, controlled clinical study in patients with type 2 diabetes.
BACKGROUND
This treat-to-target study compared the efficacy and safety of insulin detemir (IDet) and insulin glargine (IGla) in a basal-bolus (insulin aspart) regimen in type 2 diabetes.


METHODS
385 patients were randomized 2 : 1 (IDet : IGla). Non-inferiority of IDet to IGla was determined by HbA(1c) 95% CI upper limit <0.4.


RESULTS
IDet and IGla showed similar efficacy in HbA(1c) reduction at 26 weeks, as the non-inferiority criterion was met at 26 weeks (LS mean [Det-Gla]: 0.207; 95% CI: 0.0149,0.3995). It appeared that IGla in some cases did better than IDet in terms of HbA(1c), but the difference (0.207%) was not clinically meaningful. Based on the CONSORT guideline, non-inferiority analysis using the LOCF approach was inconclusive regarding possible inferiority of delta 0.4 (LS mean of [Det-Gla]: 0.307; 95% CI: 0.1023, 0.5109). HbA(1c) decreased significantly from baseline in IDet (-1.1% [26 weeks], -0.9% [LOCF], p < 0.001) and in IGla (-1.3% [26 weeks, LOCF], p < 0.001). Final HbA(1c) were 7.1% (26 weeks) and 7.3% (LOCF) in IDet, and 6.9% (26 weeks) and 7.0% (LOCF) in IGla. Final FPG were 130 mg/dL (26 weeks) and 135 mg/dL (LOCF) in IDet, and 134 mg/dL (26 weeks) and 137 mg/dL (LOCF) in IGla. There was significantly less weight gain in IDet-treated patients (1.2 +/- 3.96 kg versus 2.7 +/- 3.94 kg, p = 0.001). Hypoglycemia risk was comparable between groups. The majority of IDet-treated patients (87.4%) remained on a once-daily basal insulin regimen throughout the study.


CONCLUSIONS
IDet and IGla were both effective and safe treatments for glycemic control in a basal-bolus regimen for type 2 diabetes. Clinically significant reductions in HbA(1c) were achieved in both groups, but with significantly less weight gain in the IDet group at comparable basal insulin dosage.
Raskin
Philip
P
University of Texas Southwestern Medical Center at Dallas, Dallas, Texas 75390-8858, USA. Philip.Raskin@UTSouthwestern.edu
Gylvin
Titus
T
Weng
Wayne
W
Chaykin
Louis
L
D000328:Adult; D001786:Blood Glucose / Q000032:analysis; D015992:Body Mass Index; D016001:Confidence Intervals; D003924:Diabetes Mellitus, Type 2 / Q000150:complications / Q000188:drug therapy*; D004487:Edema / Q000150:complications; D005215:Fasting / Q000097:blood; D005260:Female; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D007003:Hypoglycemia / Q000150:complications; D007004:Hypoglycemic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D007328:Insulin / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D061267:Insulin Aspart; D000069057:Insulin Detemir; D000069036:Insulin Glargine; D049528:Insulin, Long-Acting; D008297:Male; D008875:Middle Aged; D016012:Poisson Distribution; D012141:Respiratory Tract Infections / Q000150:complications; D013997:Time Factors; D016896:Treatment Outcome; D015430:Weight Gain / Q000187:drug effects
D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D007328:Insulin; D061267:Insulin Aspart; D000069057:Insulin Detemir; D000069036:Insulin Glargine; D049528:Insulin, Long-Acting; C517652:hemoglobin A1c protein, human