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Comparison of insulin detemir and insulin glargine using a basal-bolus regimen in a randomized, controlled clinical study in patients with type 2 diabetes

  1. Philip Raskin1,*,
  2. Titus Gylvin2,
  3. Wayne Weng3,
  4. Louis Chaykin4

Article first published online: 29 JUN 2009

DOI: 10.1002/dmrr.989

Issue

Diabetes/Metabolism Research and Reviews

Diabetes/Metabolism Research and Reviews

Volume 25, Issue 6, pages 542–548, September 2009

Additional Information

How to Cite

Raskin, P., Gylvin, T., Weng, W. and Chaykin, L. (2009), Comparison of insulin detemir and insulin glargine using a basal-bolus regimen in a randomized, controlled clinical study in patients with type 2 diabetes. Diabetes/Metabolism Research and Reviews, 25: 542–548. doi: 10.1002/dmrr.989

Author Information

  1. 1

    University of Texas Southwestern Medical Center at Dallas, Dallas, Texas, USA

  2. 2

    Medical Affairs, Novo Nordisk Inc., Princeton, New Jersey, USA

  3. 3

    Clinical Development, Medical and Regulatory Affairs, Novo Nordisk Inc., Princeton, New Jersey, USA

  4. 4

    Medical Research Unlimited, Aventura, Florida, USA

*Professor of Medicine Clifton and Betsy Robinson Chair in Biomedical Research, University of Texas Southwestern Medical Center at Dallas, 5323 Harry Hines Boulevard, Dallas, Texas 75390-8858 USA.

Publication History

  1. Issue published online: 27 AUG 2009
  2. Article first published online: 29 JUN 2009
  3. Manuscript Accepted: 13 MAY 2009
  4. Manuscript Revised: 2 APR 2009
  5. Manuscript Received: 11 JUL 2008

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Keywords:

  • insulin detemir;
  • insulin glargine;
  • type 2 diabetes;
  • glycemic control;
  • weight gain;
  • hypoglycemia

Abstract

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 HbA1c 95% CI upper limit <0.4.

Results

IDet and IGla showed similar efficacy in HbA1c 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 HbA1c, 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). HbA1c 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 HbA1c 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 HbA1c were achieved in both groups, but with significantly less weight gain in the IDet group at comparable basal insulin dosage. Copyright © 2009 John Wiley & Sons, Ltd.

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