Efficacy and safety of the glucagon-like peptide-1 receptor agonist liraglutide added to insulin therapy in poorly regulated patients with type 1 diabetes - A protocol for a randomised, double-blind, placebo-controlled study: The Lira-1 study

BMJ Open

Volumn 5, Issue 4, 2015, Pages

  Dejgaard, Thomas Fremming ^a,b   Knop, Filip Krag ^b   Tarnow, Lise ^b   Frandsen, Christian Seerup ^b   Hansen, Tanja Stenbæk ^a   Almdal, Thomas ^b   Holst, Jens Juul ^b   Madsbad, Sten ^b   Andersen, Henrik Ullits ^a  

^a STENO DIABETES CENTER   (Denmark)

^b UNIVERSITY OF COPENHAGEN   (Denmark)

Author keywords

[No Author keywords available]

Indexed keywords

HEMOGLOBIN A1C; INSULIN; LIRAGLUTIDE; PLACEBO; ANTIDIABETIC AGENT;

ADD ON THERAPY; ADULT; ARTICLE; BODY MASS; CLINICAL PROTOCOL; CONSTIPATION; CONTROLLED STUDY; DIARRHEA; DOUBLE BLIND PROCEDURE; DRUG DOSE ESCALATION; DRUG EFFICACY; DRUG INDUCED HEADACHE; DRUG SAFETY; FAT MASS; FEMALE; FOOD PREFERENCE; GLUCAGON BLOOD LEVEL; HUMAN; HYPOGLYCEMIA; INSULIN DEPENDENT DIABETES MELLITUS; INSULIN TREATMENT; LEAN BODY WEIGHT; MAJOR CLINICAL STUDY; METABOLIC REGULATION; OBESITY; RANDOMIZED CONTROLLED TRIAL; STOMACH EMPTYING; TEST MEAL; ADOLESCENT; AGED; COMBINATION DRUG THERAPY; COMPLICATION; DIABETES MELLITUS, TYPE 1; DRUG ADMINISTRATION; MALE; MIDDLE AGED; TREATMENT OUTCOME; VERY ELDERLY; YOUNG ADULT;

ADOLESCENT; ADULT; AGED; AGED, 80 AND OVER; CLINICAL PROTOCOLS; DIABETES MELLITUS, TYPE 1; DOUBLE-BLIND METHOD; DRUG ADMINISTRATION SCHEDULE; DRUG THERAPY, COMBINATION; FEMALE; HUMANS; HYPOGLYCEMIC AGENTS; INSULIN; LIRAGLUTIDE; MALE; MIDDLE AGED; OVERWEIGHT; TREATMENT OUTCOME; YOUNG ADULT;

EID: 84926507089     PISSN: None     EISSN: 20446055     Source Type: Journal    
DOI: 10.1136/bmjopen-2015-007791     Document Type: Article

References (30)

1. Banting FG, Best CH. The internal secretion of the pancreas 1922. Indian J Med Res 2007;125:251-66.
2. [No authors listed]. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. The Diabetes Control and Complications Trial Research Group. N Engl J Med 1993;329:977-86.
3. Nathan DM, Cleary PA, Backlund JY, et al. Intensive diabetes treatment and cardiovascular disease in patients with type 1 diabetes. N Engl J Med 2005;353:2643-53.
4. American Diabetes Association. Standards of medical care in diabetes - 2014. Diabetes Care 2014;37(Suppl 1):S14-80.
5. Cryer PE. Hypoglycemia: still the limiting factor in the glycemic management of diabetes. Endocr Pract 2008;14:750-6.
6. Cryer PE, Davis SN, Shamoon H. Hypoglycemia in diabetes. Diabetes Care 2003;26:1902-12.
7. Must A, Spadano J, Coakley EH, et al. The disease burden associated with overweight and obesity. JAMA 1999;282:1523-9.
8. Wajchenberg BL, Feitosa AC, Rassi N, et al. Glycemia and cardiovascular disease in type 1 diabetes mellitus. Endocr Pract 2008;14:912-23.
9. Chillaron JJ, Flores Le-Roux JA, Benaiges D, et al. Type 1 diabetes, metabolic syndrome and cardiovascular risk. Metabolism 2014;63:181-7.
10. Inzucchi SE, Bergenstal RM, Buse JB, et al. Management of hyperglycemia in type 2 diabetes: a patient-centered approach: position statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care 2012;35:1364-79.
11. Russell-Jones D, Khan R. Insulin-associated weight gain in diabetes-causes, effects and coping strategies. Diabetes Obes Metab 2007;9:799-812.
12. Eng C, Kramer CK, Zinman B, et al. Glucagon-like peptide-1 receptor agonist and basal insulin combination treatment for the management of type 2 diabetes: a systematic review and meta-analysis. Lancet 2014;384:2228-34.
13. Madsbad S, Krarup T, Deacon CF, et al. Glucagon-like peptide receptor agonists and dipeptidyl peptidase-4 inhibitors in the treatment of diabetes: a review of clinical trials. Curr Opin Clin Nutr Metab Care 2008;11:491-9.
14. Kielgast U, Holst JJ, Madsbad S. Antidiabetic actions of endogenous and exogenous GLP-1 in type 1 diabetic patients with and without residual beta-cell function. Diabetes 2011;60:1599-607.
15. Ghazi T, Rink L, Sherr JL, et al. Acute metabolic effects of exenatide in patients with type 1 diabetes with and without residual insulin to oral and intravenous glucose challenges. Diabetes Care 2014;37:210-16.
16. Gutniak M, Orskov C, Holst JJ, et al. Antidiabetogenic effect of glucagon-like peptide-1 (7-36)amide in normal subjects and patients with diabetes mellitus. N Engl J Med 1992;326:1316-22.
17. Dupre J, Behme MT, Hramiak IM, et al. Glucagon-like peptide I reduces postprandial glycemic excursions in IDDM. Diabetes 1995;44:626-30.
18. Hari Kumar KV, Shaikh A, Prusty P. Addition of exenatide or sitagliptin to insulin in new onset type 1 diabetes: a randomized, open label study. Diabetes Res Clin Pract 2013;100:e55-8.
19. Kielgast U, Krarup T, Holst JJ, et al. Four weeks of treatment with liraglutide reduces insulin dose without loss of glycemic control in type 1 diabetic patients with and without residual beta-cell function. Diabetes Care 2011;34:1463-8.
20. Kuhadiya ND, Malik R, Bellini NJ, et al. Liraglutide as additional treatment to insulin in obese patients with type 1 diabetes mellitus. Endocr Pract 2013;19:963-7.
21. Rother KI, Spain LM, Wesley RA, et al. Effects of exenatide alone and in combination with daclizumab on beta-cell function in long-standing type 1 diabetes. Diabetes Care 2009;32:2251-7.
22. Sarkar G, Alattar M, Brown RJ, et al. Exenatide treatment for 6 months improves insulin sensitivity in adults with type 1 diabetes. Diabetes Care 2014;37:666-70.
23. Varanasi A, Bellini N, Rawal D, et al. Liraglutide as additional treatment for type 1 diabetes. Eur J Endocrinol 2011;165:77-84.
24. Kuhadiya N, Dhindsa S, Mehta A, et al. Liraglutide as additional treatment to insulin in patients with type 1 diabetes mellitus: a randomized clinical trial, 23rd Annual Meeting and Clinical Congress of the American Association of Clinical Endocrinologists (AACE), abstract 295, 2014.
25. TK H. NBV: Type 1 Diabetes Mellitus. Secondary NBV: Type 1 Diabetes Mellitus 2014, 2014. http://www.endocrinology.dk/index.php/1-diabetes-mellitus/3-type-1-diabetes-mellitus
26. Bergenstal RM, Tamborlane WV, Ahmann A, et al. Effectiveness of sensor-augmented insulin-pump therapy in type 1 diabetes. N Engl J Med 2010;363:311-20.
27. Li L, Shen J, Bala MM, et al. Incretin treatment and risk of pancreatitis in patients with type 2 diabetes mellitus: systematic review and meta-analysis of randomised and non-randomised studies. BMJ 2014;348:g2366.
28. Madsbad S. Prevalence of residual B cell function and its metabolic consequences in Type 1 (insulin-dependent) diabetes. Diabetologia 1983;24:141-7.
29. Unger RH, Aguilar-Parada E, Muller WA, et al. Studies of pancreatic alpha cell function in normal and diabetic subjects. J Clin Invest 1970;49:837-48.
30. Nauck MA, Kemmeries G, Holst JJ, et al. Rapid tachyphylaxis of the glucagon-like peptide 1-induced deceleration of gastric emptying in humans. Diabetes 2011;60:1561-5.