Randomized Cross-Over Trial of Insulin Glargine Plus Lispro or NPH Insulin Plus Regular Human Insulin in Adolescents With Type 1 Diabetes on Intensive Insulin Regimens
Randomized Cross-Over Trial of Insulin Glargine Plus Lispro or NPH Insulin Plus Regular Human Insulin in Adolescents With Type 1 Diabetes on Intensive Insulin Regimens Nuala P. Murphy , MRCPI 1 , Suzanne M. Keane , MRCPCH 2 , Ken K. Ong , MRCPCH 1 , Martha Ford-Adams , MRCPCH 1 , Julie A. Edge , MD...
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| Published in: | Diabetes care Vol. 26; no. 3; pp. 799 - 804 |
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| Main Authors: | , , , , , , |
| Format: | Journal Article |
| Language: | English |
| Published: |
Alexandria, VA
American Diabetes Association
01-03-2003
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| Subjects: | |
| Online Access: | Get full text |
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| Summary: | Randomized Cross-Over Trial of Insulin Glargine Plus Lispro or NPH Insulin Plus Regular Human Insulin in Adolescents With
Type 1 Diabetes on Intensive Insulin Regimens
Nuala P. Murphy , MRCPI 1 ,
Suzanne M. Keane , MRCPCH 2 ,
Ken K. Ong , MRCPCH 1 ,
Martha Ford-Adams , MRCPCH 1 ,
Julie A. Edge , MD 2 ,
Carlo L. Acerini , MD 1 and
David B. Dunger , MD 1
1 Department of Paediatrics, Addenbrooke’s Hospital, University of Cambridge, Cambridge, U.K.
2 Department of Paediatrics, John Radcliffe Hospital, University of Oxford, Oxford, U.K.
Abstract
OBJECTIVE —To compare blood glucose control and incidence of nocturnal hypoglycemia in adolescents with type 1 diabetes on multiple
injection regimens managed with either an insulin analog combination or NPH insulin plus regular human insulin.
RESEARCH DESIGN AND METHODS —In a randomized cross-over study, 28 adolescents with type 1 diabetes on multiple injection therapy received either insulin
glargine prebedtime plus lispro preprandially (LIS/GLAR) or NPH insulin prebedtime plus regular human insulin preprandially
(R/NPH). During each 16-week treatment arm, subjects completed home blood glucose profiles, and at the end of each treatment
arm, they were admitted for an overnight metabolic profile. A total of 25 subjects completed the study.
RESULTS —Compared with R/NPH therapy, LIS/GLAR was associated with lower mean blood glucose levels (LIS/GLAR versus R/NPH): fasting
(8.0 vs. 9.2 mmol/l, P < 0.0001), 2 h postbreakfast (8.1 vs. 10.7 mmol/l, P < 0.0005), prelunch (8.9 vs. 10.1 mmol/l, P < 0.01), and 2 h postlunch (8.0 vs. 9.5 mmol/l, P < 0.002). However, there was no difference in mean blood glucose levels before or after the evening meal. Incidence of nocturnal
hypoglycemia on overnight profiles was 43% lower on LIS/GLAR compared with R/NPH therapy; however, there was no difference
in rates of self-reported symptomatic hypoglycemia. Total insulin dose required to achieve target blood glucose control was
lower on LIS/GLAR (1.16 IU/kg) compared with R/NPH therapy (1.26 IU/kg, P < 0.005), but there was no significant difference in HbA 1c levels (LIS/GLAR versus R/NPH: 8.7 vs. 9.1%, P = 0.13).
CONCLUSIONS —Combination therapy with insulin glargine plus lispro reduced the incidence of nocturnal hypoglycemia and was at least as
effective as R/NPH insulin therapy in maintaining glycemic control in adolescents on multiple injection regimens.
CV, coefficient of variation
FBG, fasting blood glucose
LIS/GLAR, prebedtime insulin glargine plus preprandial lispro
MIR, multiple injection regimens
R/NPH, prebedtime NPH insulin plus preprandial regular human insulin
Footnotes
Address correspondence and reprint requests to Professor David B. Dunger, Department of Paediatrics, University of Cambridge,
Level 8, Addenbrooke’s Hospital, Box 116, Cambridge CB2 2QQ U.K. E-mail: dbd25{at}cam.ac.uk .
Received for publication 25 July 2002 and accepted in revised form 17 November 2002.
D.B.D. has received grant/research support from Aventis.
A table elsewhere in this issue shows conventional and Système International (SI) units and conversion factors for many substances.
DIABETES CARE |
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| ISSN: | 0149-5992 1935-5548 |
| DOI: | 10.2337/diacare.26.3.799 |