Liraglutide vs insulin glargine and placebo in combination with metformin and sulfonylurea therapy in type 2 diabetes mellitus (LEAD-5 met+SU): A randomised controlled trial

Diabetologia

Volumn 52, Issue 10, 2009, Pages 2046-2055

  Russell Jones, D ^a   Vaag, A ^b   Schmitz, O ^c   Sethi, B K ^d   Lalic, N ^e   Antic, S ^f   Zdravkovic, M ^g   Ravn, G M ^g   Simo R ^h,i  

^a Royal Guildford Hospital   (United Kingdom)

^b STENO DIABETES CENTER   (Denmark)

^c AARHUS UNIVERSITY HOSPITAL   (Denmark)

^d CARE HOSPITAL   (India)

^e UNIVERSITY OF BELGRADE   (Serbia)

^f Diabetes and Metabolic Diseases Clinic   (Serbia)

^g NOVO NORDISK A S   (Denmark)

^h INSTITUTO DE SALUD CARLOS III   (Spain)

ⁱ HOSPITAL UNIVERSITARI VALL D HEBRON   (Spain)

Author keywords

DPP 4; Exenatide; Incretin; Insulin glargine; LEAD 5

Indexed keywords

GLIMEPIRIDE; GLUCOSE; HEMOGLOBIN A1C; INSULIN GLARGINE; LIRAGLUTIDE; METFORMIN; PLACEBO; SULFONYLUREA;

ADULT; AGED; ARTICLE; BODY WEIGHT; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG DOSE ESCALATION; DRUG DOSE REDUCTION; DRUG DOSE TITRATION; DRUG EFFICACY; DRUG SAFETY; DRUG WITHDRAWAL; FEMALE; GASTROINTESTINAL SYMPTOM; GLUCOSE BLOOD LEVEL; HUMAN; HYPOGLYCEMIA; MAJOR CLINICAL STUDY; MALE; MONOTHERAPY; MULTICENTER STUDY; NAUSEA; NON INSULIN DEPENDENT DIABETES MELLITUS; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SYSTOLIC BLOOD PRESSURE; WEIGHT REDUCTION;

ADOLESCENT; ADULT; AGED; AGED, 80 AND OVER; BLOOD GLUCOSE; BODY WEIGHT; DIABETES MELLITUS, TYPE 2; DRUG THERAPY, COMBINATION; FEMALE; GLUCAGON-LIKE PEPTIDE 1; HUMANS; HYPOGLYCEMIC AGENTS; INSULIN; MALE; METFORMIN; MIDDLE AGED; PLACEBOS; SULFONYLUREA COMPOUNDS; YOUNG ADULT;

EID: 69949117621     PISSN: 0012186X     EISSN: 14320428     Source Type: Journal    
DOI: 10.1007/s00125-009-1472-y     Document Type: Article

References (30)

1. RC Turner CA Cull V Frighi RR Holman 1999 Glycemic control with diet, sulphonylurea, metformin, or insulin in patients with type 2 diabetes mellitus: progressive requirement for multiple therapies (UKPDS 49). UK Prospective UK Prospective Diabetes Study (UKPDS) Group JAMA 281 2005 2012
2. JJ Holst 2002 Therapy of type 2 diabetes mellitus based on the actions of glucagon-like peptide-1 Diabetes Metab Res Rev 18 430 441
3. JJ Holst 2007 The physiology of glucagon-like peptide 1 Physiol Rev 87 1409 1439
4. MA Nauck JJ Meier W Creutzfeldt 2003 Incretins and their analogues as new antidiabetic agents Drug News Perspect 16 413 422
5. LB Knudsen PF Nielsen PO Huusfeldt, et al. 2000 Potent derivatives of glucagon-like peptide-1 with pharmacokinetic properties suitable for once daily administration J Med Chem 43 1664 1669
6. B Elbrønd G Jakobsen S Larsen, et al. 2002 Pharmacokinetics, pharmacodynamics, safety and tolerability of a single dose of NN2211, a long-acting glucagon-like peptide 1 derivative, in healthy male patients Diabetes Care 25 1398 1404 (Pubitemid 41071152)
7. H Agersø LB Jensen B Elbrønd P Rolan M Zdravkovic 2002 The pharmacokinetics, pharmacodynamics, safety and tolerability of NN2211, a new long-acting GLP-1 derivative, in healthy men Diabetologia 45 195 202
8. KB Degn CB Juhl J Sturis, et al. 2004 One week's treatment with the long-acting GLP-1 derivative, liraglutide (NN2211), markedly improves 24-h glycemia, alpha- and beta-cell function and reduces endogenous glucose release in patients with type 2 diabetes Diabetes 53 1187 1194
9. T Vilsbøll M Zdravkovic T Le-Thi, et al. 2007 Liraglutide, a long-acting human glucagon-like peptide-1 analog, given as monotherapy significantly improves glycemic control and lowers body weight without risk of hypoglycemia in patients with type 2 diabetes Diabetes Care 30 1608 1610
10. RJ Heine L Van Gaal D Johns MJ Mihm MH Widel RG Brodows for the GWAA Study Group 2005 Exenatide versus insulin glargine in patients with suboptimally controlled type 2 diabetes: a randomized trial Ann Intern Med 143 559 569
11. M Davies F Storms S Shutler M Bianchi-Biscay R Gomis for the ATLANTUS study group 2005 Improvement of glycemic control in participants with poorly controlled type 2 diabetes: comparison of two algorithms using insulin glargine Diabetes Care 28 1282 1288
12. American Diabetes Association 2008 Standards of medical care in diabetes-2008 Diabetes Care 31 Suppl 1 S12 S54
13. AACE Diabetes Mellitus Clinical Practice Guidelines Task Force 2007 American Association of Clinical Endocrinologists medical guidelines for clinical practice for the management of diabetes mellitus Endocr Pract 13 Suppl 1 1 66
14. J Rosenstock SL Schwartz CM Clark Jr GD Park DW Donley MB Edwards 2001 Basal insulin therapy in type 2 diabetes: 28-week comparison of insulin glargine (HOE 901) and NPH insulin Diabetes Care 24 631 636
15. H Yki-Jarvinen A Dressler M Ziemen 2000 Less nocturnal hypoglycemia and better post-dinner glucose control with bedtime insulin glargine compared with bedtime NPH insulin during insulin combination therapy in type 2 diabetes. HOE 901/3002 Study Group Diabetes Care 23 1130 1136
16. M Massi Benedetti E Humburg A Dressler M Ziemen 2003 A one-year, randomised, multicentre trial comparing insulin glargine with NPH insulin in combination with oral agents in patients with type 2 diabetes Horm Metab Res 35 189 196
17. A Fritsche MA Schweitzer HU Haring 2003 Glimepiride combined with morning insulin glargine, bedtime neutral protamine Hagedorn insulin, or bedtime insulin glargine in patients with type 2 diabetes. A randomized, controlled trial Ann Intern Med 138 952 959
18. L Kennedy WH Herman GOAL A1C Study Team 2005 Glycated hemoglobin assessment in clinical practice: comparison of the A1cNow point-of-care device with central laboratory testing (GOAL A1C Study) Diabetes Technol Ther 7 907 912
19. HU Janka G Plewe MC Riddle C Kliebe-Frisch MA Schweitzer H Yki-Jarvinen 2005 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
20. P Raskin E Allen P Hollander, et al. 2005 Initiating insulin therapy in type 2 diabetes: a comparison of biphasic and basal insulin analogs Diabetes Care 28 260 265
21. MC Riddle J Rosenstock J Gerich 2003 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
22. A Flint C Kapitza C Hindsberger M Zdravkovic 2008 The once-daily human GLP-1 analogue liraglutide improves both absolute and baseline corrected postprandial glucose levels Diabetes 57 Suppl 1 A165
23. JP Courreges T Vilsboll M Zdravkovic, et al. 2006 Beneficial effects of once-daily liraglutide, a human glucagon-like peptide-1 analogue, on cardiovascular risk biomarkers in patients with type 2 diabetes Diabet Med 25 1129 1131
24. JP Gutzwiller S Tschopp A Bock, et al. 2004 Glucagon-like peptide 1 induces natriuresis in healthy participants and in insulin-resistant obese men J Clin Endocrinol Metab 89 3055 3061
25. M Horowitz T Vilsbøll M Zdravkovic M Hammer S Madsbad 2008 Patient-reported rating of gastrointestinal adverse effects during treatment of type 2 diabetes with the once-daily human GLP-1 analogue, liraglutide Diab Obes Metab 10 593 596
26. B Bode P Hale M Hammer MA Testa A Garber 2008 Patient reported outcomes in participants with type 2 diabetes treated with monotherapy regimens of once-daily human GLP-1 analogue liraglutide or glimepiride Diabetologia 51 1 S357 (Abstract 894)
27. JB Buse RR Henry J Han DD Kim MS Fineman AD Baron Exenatide-113 Clinical Study Group 2004 Effects of exenatide (exendin-4) on glycemic control over 30 weeks in sulfonylurea-treated patients with type 2 diabetes Diabetes Care 27 2628 2635
28. DM Kendall MC Riddle J Rosenstock, et al. 2005 Effects of exenatide (exendin-4) on glycemic control over 30 weeks in patients with type 2 diabetes treated with metformin and a sulfonylurea Diabetes Care 28 1083 1091
29. M Marre J Shaw M Brandle, et al. 2009 Liraglutide, a once-daily human GLP-1 analogue, added to a sulphonylurea over 26 produces greater improvements in glycaemic and weight control compared with adding rosiglitazone or placebo in participants with type 2 diabetes (LEAD-1 SU) Diabet Med 26 268 278
30. J de Heer JJ Holst 2007 Sulfonylurea compounds uncouple the glucose dependence of the insulinotropic effect of glucagon-like peptide 1 Diabetes 56 438 443