Randomized controlled clinical trial of glargine versus ultralente insulin in the treatment of type 1 diabetes

Yogish C Kudva, Ananda Basu, Gregory D. Jenkins, Guillermo M. Pons, Lori L. Quandt, Julie A. Gebel, Debra A. Vogelsang, Steven A. Smith, Robert A. Rizza, William L. Isley

Research output: Contribution to journalArticle

28 Citations (Scopus)

Abstract

OBJECTIVE - Multiple daily insulin injection programs are commonly accompanied by considerable glycemic variation and hypoglycemia. We conducted a randomized crossover design clinical trial to compare glargine with ultralente insulin as a basal insulin in type 1 diabetes. RESEARCH DESIGN AND METHODS - To determine whether the use of glargine insulin as a basal insulin would result in a comparable HbA1c and less glycemic variation and hypoglycemia than ultralente insulin, 22 individuals (aged 44 ± 14 years [±SD], 55% men) with type 1 diabetes who were experienced with multiple daily insulin injections and had an HbA1c of <7.8% were randomized in a crossover design to receive either glargine or ultralente as the basal insulin for 4 months. Aspart insulin was used as the prandial insulin. Physicians providing insulin dose adjustment advice were masked to the type of basal insulin. RESULTS - Treatment with glargine resulted in lower mean HbA 1c (6.82 ± 0.13 vs. 7.02 ± 0.13, difference: 0.2 ± 0.08, P = 0.026), less nocturnal variability (plasma glucose 49.06 ± 4.74 vs. 62.36 ± 5.21 mg/dl, P = 0.04), and less hypoglycemia (24.5 ± 2.99 vs. 31.3 ± 4.04 events, P = 0.05), primarily due to less daytime hypoglycemia (P = 0.002). On the other hand, serious hypoglycemia and average glucose concentration measured with continuous subcutaneous glucose monitoring did not differ. CONCLUSIONS - We conclude that while use of either ultralente or glargine as a basal insulin can result in excellent glycemic control, treatment with glargine is associated with slightly but significantly lower HbA1c and less nocturnal glycemic variability and hypoglycemia.

Original languageEnglish (US)
Pages (from-to)10-14
Number of pages5
JournalDiabetes Care
Volume28
Issue number1
DOIs
StatePublished - Jan 2005

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Ultralente Insulin
Type 1 Diabetes Mellitus
Randomized Controlled Trials
Insulin
Hypoglycemia
Therapeutics
Glucose
Cross-Over Studies
Insulin Aspart
Insulin Glargine
Injections
Meals
Research Design

ASJC Scopus subject areas

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism

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Randomized controlled clinical trial of glargine versus ultralente insulin in the treatment of type 1 diabetes. / Kudva, Yogish C; Basu, Ananda; Jenkins, Gregory D.; Pons, Guillermo M.; Quandt, Lori L.; Gebel, Julie A.; Vogelsang, Debra A.; Smith, Steven A.; Rizza, Robert A.; Isley, William L.

In: Diabetes Care, Vol. 28, No. 1, 01.2005, p. 10-14.

Research output: Contribution to journalArticle

Kudva, YC, Basu, A, Jenkins, GD, Pons, GM, Quandt, LL, Gebel, JA, Vogelsang, DA, Smith, SA, Rizza, RA & Isley, WL 2005, 'Randomized controlled clinical trial of glargine versus ultralente insulin in the treatment of type 1 diabetes', Diabetes Care, vol. 28, no. 1, pp. 10-14. https://doi.org/10.2337/diacare.28.1.10
Kudva, Yogish C ; Basu, Ananda ; Jenkins, Gregory D. ; Pons, Guillermo M. ; Quandt, Lori L. ; Gebel, Julie A. ; Vogelsang, Debra A. ; Smith, Steven A. ; Rizza, Robert A. ; Isley, William L. / Randomized controlled clinical trial of glargine versus ultralente insulin in the treatment of type 1 diabetes. In: Diabetes Care. 2005 ; Vol. 28, No. 1. pp. 10-14.
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AU - Quandt, Lori L.

AU - Gebel, Julie A.

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AU - Smith, Steven A.

AU - Rizza, Robert A.

AU - Isley, William L.

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N2 - OBJECTIVE - Multiple daily insulin injection programs are commonly accompanied by considerable glycemic variation and hypoglycemia. We conducted a randomized crossover design clinical trial to compare glargine with ultralente insulin as a basal insulin in type 1 diabetes. RESEARCH DESIGN AND METHODS - To determine whether the use of glargine insulin as a basal insulin would result in a comparable HbA1c and less glycemic variation and hypoglycemia than ultralente insulin, 22 individuals (aged 44 ± 14 years [±SD], 55% men) with type 1 diabetes who were experienced with multiple daily insulin injections and had an HbA1c of <7.8% were randomized in a crossover design to receive either glargine or ultralente as the basal insulin for 4 months. Aspart insulin was used as the prandial insulin. Physicians providing insulin dose adjustment advice were masked to the type of basal insulin. RESULTS - Treatment with glargine resulted in lower mean HbA 1c (6.82 ± 0.13 vs. 7.02 ± 0.13, difference: 0.2 ± 0.08, P = 0.026), less nocturnal variability (plasma glucose 49.06 ± 4.74 vs. 62.36 ± 5.21 mg/dl, P = 0.04), and less hypoglycemia (24.5 ± 2.99 vs. 31.3 ± 4.04 events, P = 0.05), primarily due to less daytime hypoglycemia (P = 0.002). On the other hand, serious hypoglycemia and average glucose concentration measured with continuous subcutaneous glucose monitoring did not differ. CONCLUSIONS - We conclude that while use of either ultralente or glargine as a basal insulin can result in excellent glycemic control, treatment with glargine is associated with slightly but significantly lower HbA1c and less nocturnal glycemic variability and hypoglycemia.

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