Efficacy and safety of liraglutide added to capped insulin treatment in subjects with type 1 diabetes: The adjunct two randomized trial

Diabetes Care

Volumn 39, Issue 10, 2016, Pages 1693-1701

  Ahren, Bo ^a   Hirsch, Irl B ^b   Pieber, Thomas R ^c   Mathieu, Chantal ^d   Gomez Peralta, Fernando ^e   Hansen, Troels Krarup ^f   Philotheou, Areti ^g   Birch, Sune ^h   Christiansen, Erik ^h   Jensen, Thomas Jon ^h   Buse, John B ⁱ  

^a LUND UNIVERSITY   (Sweden)

^b UNIVERSITY OF WASHINGTON   (United States)

^c MEDICAL UNIVERSITY OF GRAZ   (Austria)

^d UNIVERSITY OF LEUVEN   (Belgium)

^e HOSPITAL GENERAL DE SEGOVIA   (Spain)

^f AARHUS UNIVERSITY HOSPITAL   (Denmark)

^g UNIVERSITY OF CAPE TOWN   (South Africa)

^h NOVO NORDISK A S   (Denmark)

ⁱ UNIVERSITY OF NORTH CAROLINA SCHOOL OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

AMYLASE; C PEPTIDE; CALCITONIN; HEMOGLOBIN A1C; INSULIN; LIRAGLUTIDE; PLACEBO; TRIACYLGLYCEROL LIPASE; ANTIDIABETIC AGENT; GLYCOSYLATED HEMOGLOBIN;

ACUTE CORONARY SYNDROME; ADD ON THERAPY; ADULT; AGED; ARTICLE; ASYMPTOMATIC DISEASE; BENIGN TUMOR; CARDIOVASCULAR DISEASE; CEREBROVASCULAR DISEASE; COMBINATION DRUG THERAPY; CONTROLLED STUDY; DECREASED APPETITE; DEPRESSED BLOOD PRESSURE; DIABETIC KETOACIDOSIS; DIARRHEA; DIASTOLIC BLOOD PRESSURE; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG DOSE COMPARISON; DRUG DOSE ESCALATION; DRUG DOSE INCREASE; DRUG DOSE REDUCTION; DRUG DOSE TITRATION; DRUG EFFICACY; DRUG FATALITY; DRUG SAFETY; DRUG WITHDRAWAL; FEMALE; GLYCEMIC CONTROL; HUMAN; HYPERGLYCEMIA; HYPOGLYCEMIA; INSULIN DEPENDENT DIABETES MELLITUS; INSULIN TREATMENT; MAJOR CLINICAL STUDY; MALE; MALIGNANT NEOPLASTIC DISEASE; MEAN ARTERIAL PRESSURE; MULTICENTER STUDY; NAUSEA; NEOPLASM; NOCTURNAL HYPOGLYCEMIA; PANCREAS ISLET CELL HYPERPLASIA; PANCREATITIS; PARALLEL DESIGN; PHASE 3 CLINICAL TRIAL; PULSE PRESSURE; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; RECOMMENDED DRUG DOSE; SIDE EFFECT; SYSTOLIC BLOOD PRESSURE; THYROID DISEASE; TREATMENT DURATION; VOMITING; WEIGHT REDUCTION; ADOLESCENT; BLOOD; CLINICAL TRIAL; DIABETES MELLITUS, TYPE 1; MIDDLE AGED; SUBCUTANEOUS DRUG ADMINISTRATION; TREATMENT OUTCOME; VERY ELDERLY; YOUNG ADULT;

ADOLESCENT; ADULT; AGED; AGED, 80 AND OVER; DIABETES MELLITUS, TYPE 1; DOUBLE-BLIND METHOD; DRUG THERAPY, COMBINATION; FEMALE; HEMOGLOBIN A, GLYCOSYLATED; HUMANS; HYPOGLYCEMIC AGENTS; INJECTIONS, SUBCUTANEOUS; INSULIN; LIRAGLUTIDE; MALE; MIDDLE AGED; TREATMENT OUTCOME; YOUNG ADULT;

EID: 84988922530     PISSN: 01495992     EISSN: 19355548     Source Type: Journal    
DOI: 10.2337/dc16-0690     Document Type: Article

References (38)

1. Miller KM, Foster NC, Beck RW, et al.; T1D Exchange Clinic Network. Current state of type 1 diabetes treatment in the U.S.: Updated data from the T1D Exchange clinic registry. Diabetes Care 2015;38:971-978
2. Davies M. The reality of glycaemic control in insulin treated diabetes: Defining the clinical challenges. Int J Obes Relat Metab Disord 2004;28(Suppl. 2):S14-S22
3. Bae JP, Lage MJ, Mo D, Nelson DR, Hoogwerf BJ. Obesity and glycemic control in patients with diabetes mellitus: Analysis of physician electronic health records in the US from 2009-2011. J Diabetes Complications 2016;30:212-220
4. George P, McCrimmon RJ. Potential role of non-insulin adjunct therapy in type 1 diabetes. Diabet Med 2013;30:179-188
5. Bode BW, Garg SK. The emerging role of adjunctive noninsulin antihyperglycemic therapy in the management of type 1 diabetes. Endocr Pract 2016;22:220-230
6. Colburn WA, Gottlieb AB, Koda J, Kolterman OG. Pharmacokinetics and pharmacodynamics of AC137 (25,28,29 tripro-amylin, human) after intravenous bolus and infusion doses in patients with insulin-dependent diabetes. J Clin Pharmacol 1996;36:13-24
7. FDA. New diabetes drug. FDA Consum 2005; 39:3
8. Godoy-Matos AF. The role of glucagon on type 2 diabetes at a glance. Diabetol Metab Syndr 2014;6:91
9. van Can J, Sloth B, Jensen CB, Flint A, Blaak EE, Saris WH. Effects of the once-daily GLP-1 analog liraglutide on gastric emptying, glycemic parameters, appetite and energy metabolism in obese, non-diabetic adults. Int J Obes 2014;38: 784-793
10. NauckM, Frid A, Hermansen K, et al.; LEAD-2 Study Group. Efficacy and safety comparison of liraglutide, glimepiride, and placebo, all in combination with metformin, in type 2 diabetes: The LEAD (liraglutide effect and action in diabetes)-2 study. Diabetes Care 2009;32:84-90
11. Garber A, Henry R, Ratner R, et al.; LEAD-3 (Mono) Study Group. Liraglutide versus glimepiride monotherapy for type 2 diabetes (LEAD-3 Mono): A randomised, 52-week, phase III, doubleblind, parallel-treatment trial. Lancet 2009;373: 473-481
12. Zinman B, Gerich J, Buse JB, et al.; LEAD-4 Study Investigators. Efficacy and safety of the human glucagon-like peptide-1 analog liraglutide in combinationwithmetformin and thiazolidinedione in patients with type 2 diabetes (LEAD-4 Met+TZD). Diabetes Care 2009;32:1224-1230
13. Russell-Jones D, Vaag A, Schmitz O, et al.; Liraglutide Effect and Action in Diabetes 5 (LEAD-5) met+SU Study Group. 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 2009; 52:2046-2055
14. Buse JB, Rosenstock J, Sesti G, et al.; LEAD-6 Study Group. Liraglutide once a day versus exenatide twice a day for type 2 diabetes: A 26-week randomised, parallel-group, multinational, openlabel trial (LEAD-6). Lancet 2009;374:39-47
15. Harrison LB, Mora PF, Clark GO, Lingvay I. Type 1 diabetes treatment beyond insulin: Role of GLP-1 analogs. J Investig Med 2013;61:40-44
16. Kielgast U, Krarup T, Holst JJ, Madsbad S. Four weeks of treatment with liraglutide reduces insulin dose without loss of glycemic control in type 1 diabetic patients with and without residual β-cell function. Diabetes Care 2011; 34:1463-1468
17. Kielgast U, Holst JJ,Madsbad S. Antidiabetic actions of endogenous and exogenous GLP-1 in type 1 diabetic patientswith and without residual β-cell function. Diabetes 2011;60:1599-1607
18. 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;19:963-967
19. Traina AN, Lull ME, Hui AC, Zahorian TM, Lyons-Patterson J. Once-weekly exenatide as adjunct treatment of type 1 diabetes mellitus in patients receiving continuous subcutaneous insulin infusion therapy. Can J Diabetes 2014; 38:269-272
20. Varanasi A, Bellini N, Rawal D, et al. Liraglutide as additional treatment for type 1 diabetes. Eur J Endocrinol 2011;165:77-84
21. Pieber TR, Deller S, Korsatko S, et al. Counterregulatory hormone responses to hypoglycaemia in people with type 1 diabetes after 4 weeks of treatment with liraglutide adjunct to insulin: A randomized, placebo-controlled, double-blind, crossover trial. Diabetes Obes Metab 2015;17: 742-750
22. Dejgaard TF, Frandsen CS, Hansen TS, et al. Efficacy and safety of liraglutide for overweight adult patients with type 1 diabetes and insufficient glycaemic control (Lira-1): A randomised, double-blind, placebo-controlled trial. Lancet Diabetes Endocrinol 2016;4:221-232
23. Frandsen CS, Dejgaard TF, Holst JJ, Andersen HU, Thorsteinsson B, Madsbad S. Twelve-week treatment with liraglutide as add- on to insulin in normal-weight patients with poorly controlled type 1 diabetes: A randomized, placebo-controlled, double-blind parallel study. Diabetes Care 2015;38:2250-2257
24. Mathieu C, Zinman B, Uddén Hemmingsson J, et al. Efficacy and safety of liraglutide added to insulin treatment in type 1 diabetes, the ADJUNCT ONE treat-to-target randomized trial (Abstract). Endocr Pract 2016;22(Suppl. 2):A291
25. Kidney Disease: Improving Global Outcomes. Definition and classification of CKD. KDIGO 2012 Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease. Kidney Int Suppl 2013;3:19-62
26. Seaquist ER, Anderson J, Childs B, et al. Hypoglycemia and diabetes: A report of a workgroup of the American Diabetes Association and the Endocrine Society. Diabetes Care 2013;36:1384-1395
27. Edelman S,Garg S, Frias J, et al. A double-blind, placebo-controlled trial assessing pramlintide treatment in the setting of intensive insulin therapy in type 1 diabetes. Diabetes Care 2006;29:2189-2195
28. Kuhadiya ND, Dhindsa S, Ghanim H, et al. Addition of liraglutide to insulin in patients with type 1 diabetes: A randomized placebocontrolled clinical trial of 12 weeks. Diabetes Care 2016;39:1027-1035
29. Conway B, Miller RG, Costacou T, et al. Temporal patterns in overweight and obesity in Type 1 diabetes. Diabet Med 2010;27:398-404
30. The Diabetes Control And Complications Trial Research Group. Influence of intensive diabetes treatment on body weight and composition of adults with type 1 diabetes in the Diabetes Control and Complications Trial. Diabetes Care 2001;24:1711-1721
31. Purnell JQ, Zinman B, Brunzell JD; DCCT/ EDIC Research Group. The effect of excess weight gain with intensive diabetes mellitus treatment on cardiovascular disease risk factors and atherosclerosis in type 1 diabetes mellitus: Results from the Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications Study (DCCT/EDIC) study. Circulation 2013;127: 180-187
32. Hendrychova T, Vytrisalova M, Smahelova A, Vlcek J, Kubena AA. Adherence in adults with type 1 diabetes mellitus correlates with treatment satisfaction but not with adverse events. Patient Prefer Adherence 2013;7:867-876
33. Bradley C, Lewis KS. Measures of psychological well-being and treatment satisfaction developed from the responses of people with tablet-treated diabetes. Diabet Med 1990;7: 445-451
34. Redekop WK, KoopmanschapMA, Stolk RP, Rutten GE, Wolffenbuttel BH, Niessen LW. Health-related quality of life and treatment satisfaction in Dutch patients with type 2 diabetes. Diabetes Care 2002;25:458-463
35. Østergaard L, Dejgaard TF, Holst JJ, Andersen HU, Thorsteinsson B, Madsbad S. Effects of liraglutide as add-on to insulin on counter-regulatory hormone responses, gastric emptying and glycaemic recovery during hypoglycaemia (Abstract). Diabetologia 2015; 58(Suppl. 1):A963
36. Emoto M, Terauchi Y, Ozeki A, Oura T, Takeuchi M, Imaoka T. A 1-year safety study of dulaglutide in Japanese patients with type 2 diabetes on a single oral hypoglycemic agent: An open-label, nonrandomized, phase 3 trial. Endocr J 2015;62:1101-1114
37. Sun F, Wu S, Guo S, et al. Impact of GLP-1 receptor agonists on blood pressure, heart rate and hypertension among patients with type 2 diabetes: A systematic review and network meta-analysis. Diabetes Res Clin Pract 2015; 110:26-37
38. Kapitza C, Nosek L, Jensen L, Hartvig H, Jensen CB, Flint A. Semaglutide, a once-weekly human GLP-1 analog, does not reduce the bioavailability of the combined oral contraceptive, ethinylestradiol/levonorgestrel. J Clin Pharmacol 2015;55:497-504