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

Diabetes Care - Tập 26 Số 3 - Trang 799-804 - 2003
Nuala Murphy1, S Keane2, Ken K. Ong1, Martha Ford‐Adams1, Julie Edge2, Carlo L. Acerini1, David B. Dunger1
1Department of Paediatrics, Addenbrooke's Hospital, University of Cambridge, Cambridge, U.K.
2Department of Paediatrics, John Radcliffe Hospital, University of Oxford, Oxford, U.K.

Tóm tắt

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 HbA1c 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.

Từ khóa


Tài liệu tham khảo

DCCT Research Group: Effect of intensive diabetes treatment on the development and progression of long-term complications in adolescents with insulin dependent diabetes: the Diabetes Control and Complications Trial. J Pediatr 125: 177–188, 1994

Dunger DB: Diabetes and puberty. Arch Dis Child 67:569–570, 1992

DCCT Research Group: Hypoglycaemia in the Diabetes Control and Complications Trial. Diabetes 46:271–286, 1997

Thompson CJ, Cummings JFR, Chalmers J, Gould C, Newton RW: How have patients reacted to the implications of the DCCT? Diabetes Care 19:876–879, 1996

Bolli GB, Fanelli CG, Porter PA, Cryer P, Gerich J: Nocturnal blood glucose control in type 1 diabetes mellitus. Diabetes Care 17:78–80, 1993

Eaton RP, Allen RC, Schade DS, Standefer JC: “Normal” insulin secretion: the goal of artificial delivery systems? Diabetes Care 6:374–377, 1980

American Diabetes Association: Report of the Expert Committee on the Diagnosis and Classification of Diabetes Mellitus. Diabetes Care 20:1183–1197, 1997

Barnett AH, Owens DR: Insulin analogues. Lancet 349:47–51, 1997

Galloway JA, Chance RB: Improving insulin therapy: achievements and challenges. Horm Metab Res 26:591–598, 1994

Beregszazzi M, Tubiana-Rufi N, Benali K, Noel M, Bloch J, Czemichow P: Nocturnal hypoglycaemia in children and adolescents with insulin-dependent diabetes: prevalence and risk factors. J Pediatr 131:27–33, 1997

Porter PA, Byrne G, Stick S, Jones TW: Nocturnal hypoglycaemia and sleep disturbances in young teenagers with insulin dependent diabetes. Arch Dis Child 75:120–123, 1996

Hilgenfeld R, Dorschug M, Geisen K, Neubauer H, Obermeier R, Seipke G, Berchtold H: Controlling insulin bioavailability by crystal contact engineering (Abstract). Diabetologia 35(Suppl. 1):A193, 1992

Seipke G, Geisen K, Neubauer H-P, Pittius C, Rosskamp R, Schwabe D: New insulin preparations with prolonged action profiles: A21-modified arginine insulins (Abstract). Diabetologia 35(Suppl. 1):A4, 1992

Seipke G, Berchthold H, Geisen K, Hilgenfeld R, Rosskamp R: HOE 901: a new insulin with prolonged action (Abstract). Eur J Endocrinol 132(Suppl. 1):25, 1995

Lepore M, Kurzhals R, Pamjpanelli S, Fanelli CG, Bolli GB: Pharmacokinetics and dynamics of s.c. injection of the long-acting insulin glargine (HOE 901) in IDDM (Abstract). Diabetes 48(Suppl. 1):A97, 1999

Heinemann L, Linkeschova R, Rave K, Hompesch B, Sedlak M, Heise T: Time-action profile of the long-acting insulin analog insulin glargine (HOE 901) in comparison with those of NPH insulin and placebo. Diabetes Care 23:644–649, 2000

Ratner RE, Hirsch IB, Neifing JL, Garg SK, Mecca TE, Wilson CA: Less hypoglycaemia with insulin glargine in intensive insulin therapy for type 1 diabetes. Diabetes Care 23:639–643, 2000

Raskin P, Klaff L, Bergenstal R, Halle JP, Donley D, Mecca T: A 16 week comparison of the novel insulin analog insulin glargine (HOE 901) and NPH human insulin used with insulin lispro in patients with type 1 diabetes. Diabetes Care 23:1666–1671, 2000

DCCT Group: The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin dependent diabetes mellitus. N Engl J Med 3:615–622, 1993

Gale EA, Tattersall RB: Unrecognized nocturnal hypoglycaemia in insulin-treated diabetics. Lancet 1:1049–1052, 1979

Matyka K, Wigg L, Pramming S, Dunger DB: Cognitive function and mood after profound nocturnal hypoglycaemia in prepubertal children with R/NPH insulin treatment for diabetes. Arch Dis Child 81:138–142, 1999

Veneman T, Mitrakou A, Mokan M, Cryer P, Gerich J: Induction of hypoglycaemia unawareness at asymptomatic nocturnal hypoglycaemia. Diabetes 42:1233–1237, 1993

Tattersall RB, Gill GV: Unexplained deaths of type 1 diabetic patients. Diabet Med 8:49–58, 1991

Thông tin
Thông tin xuất bản

Diabetes Care

Tập 26 Số 3

799-804

Thông tin tác giả