Fifty-two-week, randomized, multicenter trial to compare the safety and efficacy of the novel glucagon-like peptide-1 analog liraglutide vs glibenclamide in patients with type2 diabetes

Journal of Diabetes Investigation

Volumn 2, Issue 6, 2011, Pages 441-447

  Kaku, Kohei ^a   Rasmussen, Mads Frederik ^d   Nishida, Tomoyuki ^b   Seino, Yutaka ^c  

^a KAWASAKI MEDICAL SCHOOL   (Japan)

^b Novo Nordisk Pharma Ltd   (Japan)

^c KANSAI ELECTRIC POWER CO   (Japan)

^d NOVO NORDISK A S   (Denmark)

Author keywords

GLP 1 receptor agonist; Liraglutide; Type2 diabetes mellitus

Indexed keywords

GLIBENCLAMIDE; GLUCOSE; HEMOGLOBIN A1C; INSULIN; LIRAGLUTIDE;

ADULT; ARTHRALGIA; ARTICLE; BACKACHE; BRONCHITIS; COMPARATIVE EFFECTIVENESS; CONNECTIVE TISSUE DISEASE; CONSTIPATION; CONTROLLED STUDY; DIABETIC RETINOPATHY; DIARRHEA; DIET THERAPY; DOSE RESPONSE; DRUG DOSE ESCALATION; DRUG EFFICACY; DRUG SAFETY; DRUG WITHDRAWAL; EVENING DOSAGE; EYE DISEASE; FEMALE; GASTROINTESTINAL SYMPTOM; GLUCOSE BLOOD LEVEL; HEADACHE; HEART DISEASE; HEPATOBILIARY DISEASE; HUMAN; HYPERTENSION; HYPOGLYCEMIA; INJURY; INSULIN RELEASE; MAJOR CLINICAL STUDY; MALE; MENTAL DISEASE; METABOLIC DISORDER; METABOLIC REGULATION; MONOTHERAPY; MORNING DOSAGE; MULTICENTER STUDY; MUSCULOSKELETAL DISEASE; NAUSEA; NEUROLOGIC DISEASE; NON INSULIN DEPENDENT DIABETES MELLITUS; NUTRITIONAL DISORDER; POSTPRANDIAL STATE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RESPIRATORY TRACT DISEASE; RHINOPHARYNGITIS; SKIN DISEASE; SORE THROAT; STOMACH DISCOMFORT; THORAX DISEASE; UPPER RESPIRATORY TRACT INFECTION; VASCULAR DISEASE; WEIGHT GAIN; WEIGHT REDUCTION;

EID: 80053113861     PISSN: 20401116     EISSN: 20401124     Source Type: Journal    
DOI: 10.1111/j.2040-1124.2011.00128.x     Document Type: Article

References (24)

1. UK Progressive Diabetes Study Group. Intensive blood-glucose control with sulfonylureas or insulin compared with conventional treatment and risk of complications in subjects with non-insulin-dependent diabetes mellitus: a randomised prospective 6-year study. Diabetes Res Clin Pract 1995; 28: 103-117.
2. Ohkubo Y, Kishikawa H, Araki E, et al. Intensive insulin therapy prevents the progression of diabetic microvascular complications in Japanese patients with non-insulin-dependent diabetes mellitus: a randomized prospective 6-year study. Diabetes Res Clin Pract 1995; 28: 103-117.
3. Elbrønd B, Jakobsen G, Larsen S, et al. Pharmacokinetics, pharmacodynamics, safety, and tolerability of a single-dose of NN2211, a long-acting glucagon-like peptide 1 derivative, in healthy male subjects. Diabetes Care 2002; 25: 1398-1404.
4. Agersø H, Jensen LB, Elbrønd B, et al. The pharmacokinetics, pharmacodynamics, safety and tolerability of NN2211, a new long-acting GLP-1 derivative, in healthy men. Diabetologia 2002; 45: 195-202.
5. Juhl CB, Hollingdal M, Sturis J, et al. Bedtime administration of NN2211, a long-acting GLP-1 derivative, substantially reduces fasting and postprandial glycemia in type 2 diabetes. Diabetes 2002; 51: 424-429.
6. Nauck M, El-Ouaghlidi A, Hompesch M, et al. No impairment of hypoglycaemia counterregulation via glucagon with the long-acting GLP-1 derivative, NN2211, in subjects with type 2-diabetes. Diabetologia 2003; 46(Suppl 2): A285.
7. Chang AM, Jakobsen G, Sturis J, et al. The GLP-1 derivative NN2211 restores β-cell sensitivity to glucose in type 2 diabetic patients after a single dose. Diabetes 2003; 52: 1786-1791.
8. Irie S, Matsumura Y, Zdravkovic M, et al. Tolerability, pharmacokinetics and pharmacodynamics of the once-daily human GLP-1 analog liraglutide in Japanese healthy subjects: a randomized, double-blind, placebo-controlled dose-escalation study. Int J Clin Pharmacol Ther 2008; 46: 273-279.
9. Seino Y, Rasmussen MF, Zdravkovic M, et al. Dose-dependent improvement in glycemia with once-daily liraglutide without hypoglycemia or weight gain: a double-blind, randomized, controlled trial in Japanese patients with type 2 diabetes. Diabetes Res Clin Pract 2008; 81: 161-168.
10. Madsbad S, Schmitz O, Ranstam J, et al. Improved glycemic control with no weight increase in patients with type 2 diabetes after once-daily treatment with the long-acting glucagon-like peptide 1 analog liraglutide (NN2211): a 12-week, double-blind, randomized, controlled trial. Diabetes Care 2004; 27: 1335-1342.
11. Degn KB, Juhl CB, Sturis J, et al. One week's treatment with the long-acting glucagon-like peptide 1 derivative liraglutide (NN2211) markedly improves 24-h glycemia and α- and β-cell function and reduces endogenous glucose release in patients with type 2 diabetes. Diabetes 2004; 53: 1187-1194.
12. Harder H, Nielsen L, Thi TDT, et al. The effect of liraglutide, a long-acting glucagon-like peptide 1 derivative, on glycemic control, body composition, and 24-h energy expenditure in patients with type 2 diabetes. Diabetes Care 2004; 27: 1915-1921.
13. Saad MF, An B, Santiago O; on behalf of the 2072 Study Group The effect of NN2211, a long-acting GLP-1 derivative, on glycemic control and body weight in obese patients with type 2 diabetes. Diabetologia 2002; 45(Suppl 2): A44.
14. Nauck M, Hompesch M, Filipczak R, et al. Liraglutide significantly improves glycemic control and reduces body weight compared with glimepiride as add-on to metformin in type 2 diabetes. Diabetes 2004; 53(Suppl 2): A3.
15. Vilsbøll T, Zdravkovic M, Thi TDL, et al. Liraglutide significantly improves glycaemic control, and lowers body weight without risk of either major or minor hypoglycaemic episodes in subjects with type 2 diabetes. Diabetes 2006; 55(Suppl 1): A27.
16. Seino Y, Rasmussen MF, Nishida T, et al. Efficacy and safety of the once-daily human GLP-1 analogue, liraglutide, vs glibenclamide monotherapy in Japanese patients with type 2 diabetes. Curr Med Res Opin 2010; 26: 1013-1022.
17. Knudsen LB, Madsen LW, Andersen S, et al. Glucagon-like peptide-1 receptor agonists activate rodent thyroid C-cells causing calcitonin release and C-cell proliferation. Endocrinology 2010; 151: 1473-1486.
18. Cryer PE, Davis SN, Shamoon H. Hypoglycemia in diabetes. Diabetes Care 2003; 26: 1902-1912.
19. Kageyama S, Hirao K, Shimizu A, et al. Tolerability, pharmacokinetics, and pharmacodynamics of liraglutide, long acting human GLP-1 analogue. Endocrinol Diabetol 2007; 24: 95-104.
20. Garber A, Henry R, Ratner R, et al. Liraglutide versus glimepiride monotherapy for type 2 diabetes (LEAD-3 Mono): a randomised, 52-week, phase III, double-blind, parallel-treatment trial. Lancet 2009; 373: 473-481.
21. Parks M, Rosebraugh C. Weighing risks and benefits of liraglutide-the FDA's review of a new antidiabetic therapy. N Engl J Med 2010; 362: 774-777.
22. Flint A, Raben A, Astrup A, et al. Glucagon-like peptide 1 promotes satiety and suppresses energy intake in humans. J Clin Invest 1998; 101: 515-520.
23. Astrup A, Rössner S, Van Gaal L, et al. Effects of liraglutide in the treatment of obesity: a randomised, double-blind, placebo-controlled study. Lancet 2009; 374: 1606-1616.
24. Nauck M, Frid A, Hermansen K, et al. Efficacy and safety comparison of liraglutide, glimepiride, and placebo, all in combination with metformin, in type 2 diabetes. Diabetes Care 2009; 32: 84-90.