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Letters: Comments and Responses

Initiation of Insulin in Patients With Type 2 Diabetes Failing Oral Therapy

Response to Raskin et al. and Janka et al.

  1. Nasser E. Mikhail, MD, MSC and
  2. Dennis Cope, MD
  1. Department of Medicine, UCLA Medical Center, Sylmar, California
  1. Address correspondence to Nasser E. Mikhail, MD, MSc, UCLA Medical Center, Department of Medicine, 14445 Olive View Dr., Sylmar, CA 91342. E-mail: nasser.mikhail{at}gte.net
Diabetes Care 2005 Jun; 28(6): 1537-1538. https://doi.org/10.2337/diacare.28.6.1537
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Response to Raskin et al. and Janka et al.

We read with interest the two studies conducted by Janka et al. (1) and Raskin et al. (2) and the accompanying editorial (3) regarding the initiation of insulin in patients with type 2 diabetes failing oral agents and noted the apparent discrepancy between the study results. We believe that the data of the two previous trials (1,2) may not be necessarily conflicting. One important factor that contributed to the more favorable HbA1c levels with insulin aspart 70/30 compared with insulin glargine in the study of Raskin et al. was the difference in insulin dosage between the two insulin regimens. Thus, at the end of the study, the mean daily insulin doses were ∼50% greater for the insulin aspart 70/30 group than for the glargine group (78.5 and 51.3 units, respectively). The magnitude of difference between the insulin doses remained essentially unchanged when expressed as units by weight (0.82 vs. 0.55 units/kg, respectively). The reasons for this substantial difference in insulin dose were not totally clear, particularly that patient characteristics were well balanced at the study entry, with nearly identical mean body weight, baseline HbA1c, and proportions of patients on metformin and pioglitazone in the two study groups (2). Failure of the investigators in the trial of Raskin et al. to increase the doses of glargine was unlikely attributed to the fear of hypoglycemia, since previous data have consistently shown that the peakless insulin glargine was associated with lower risk of hypoglycemia compared with traditional insulins (4). Moreover, there was enough room to increase glargine doses because the achieved mean fasting plasma glucose was 116 mg/dl, well above the study target of 80–110 mg/dl. The study of Raskin et al. was inevitably unblinded and financially supported by the manufacturer of insulin aspart 70/30. Therefore, the possibility that the investigators in the previous study were more aggressive in increasing the doses of insulin aspart compared with glargine to achieve better glycemic control with aspart could not be excluded. It would have been of interest if Raskin et al. had reported HbA1c values after adjusting for differences in insulin doses between the two insulin regimens.

Another factor that could have contributed to the variable results between the two trials (1,2) was the timing of injecting insulin glargine, which was administered in the morning in the study of Janka et al. (1) and at bedtime in the study of Raskin et al. (2). In one large trial, patients with type 2 diabetes who injected glargine in the morning had lower HbA1c values and lesser frequency of hypoglycemia than subjects who injected similar doses of glargine at bedtime (5).

Footnotes

  • DIABETES CARE

References

  1. ↵
    Janka HU, Plewe G, Riddle MC, Kliebe-Frisch C, Schweitzer MA, Yki-Järvinen H: Comparison of basal insulin added to oral agents versus twice-daily premixed insulin as initial insulin therapy for type 2 diabetes. Diabetes Care 28:254–259, 2005
    OpenUrlAbstract/FREE Full Text
  2. ↵
    Raskin P, Allen E, Hollander P, Lewin A, Gabby RA, Hu P, Bode B, Garber A, the INITIATE Study Group: Initiating insulin therapy in type 2 diabetes: a comparison of biphasic and basal insulin analogs. Diabetes Care 28:260–265, 2005
    OpenUrlAbstract/FREE Full Text
  3. ↵
    Davidson MB: Starting insulin therapy in type 2 diabetic patients: does it really matter how? (Editorial). Diabetes Care 28:494–495, 2005
    OpenUrlFREE Full Text
  4. ↵
    Riddle MC, Rosentock J, Gerich J, the Insulin Glargine 4002 Study Investigators: The treat-to-target trial: randomized addition of glargine or human NPH insulin to oral therapy of type 2 diabetic patients. Diabetes Care 26:3080–3086, 2003
    OpenUrlAbstract/FREE Full Text
  5. ↵
    Fritsche A, Schweitzer M, Haring HU, the 4001 Study Group: Glimepiride combined with morning insulin glargine, bedtime neutral protamine Hagedorn insulin, or bedtime insulin glargine in patients with type 2 diabetes. Ann Intern Med 138:952–959, 2003
    OpenUrlCrossRefPubMedWeb of Science
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Diabetes Care: 28 (6)

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June 2005, 28(6)
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Initiation of Insulin in Patients With Type 2 Diabetes Failing Oral Therapy
Nasser E. Mikhail, Dennis Cope
Diabetes Care Jun 2005, 28 (6) 1537-1538; DOI: 10.2337/diacare.28.6.1537

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Initiation of Insulin in Patients With Type 2 Diabetes Failing Oral Therapy
Nasser E. Mikhail, Dennis Cope
Diabetes Care Jun 2005, 28 (6) 1537-1538; DOI: 10.2337/diacare.28.6.1537
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