Oral glucose lowering with linagliptin and metformin compared with linagliptin alone as initial treatment in Asian patients with newly diagnosed type 2 diabetes and marked hyperglycemia: Subgroup analysis of a randomized clinical trial

Journal of Diabetes Investigation

Volumn 9, Issue 3, 2018, Pages 579-586

  Ma, Ronald CW ^a   Del Prato, Stefano ^b   Gallwitz, Baptist ^c   Shivane, Vyankatesh K ^d   Lewis D'Agostino, Diane ^e,i   Bailes, Zelie ^f,j   Patel, Sanjay ^f,k   Lee, Jisoo ^g   von Eynatten, Maximilian ^g   Di Domenico, Maximiliano ^g   Ross, Stuart A ^h  

^a CHINESE UNIVERSITY OF HONG KONG   (Hong Kong)

^b UNIVERSITY OF PISA   (Italy)

^c UNIVERSITY HOSPITAL TÜBINGEN   (Germany)

^d KEM HOSPITAL   (India)

^e BOEHRINGER INGELHEIM PHARMACEUTICALS INC   (United States)

^f BOEHRINGER INGELHEIM LTD   (United Kingdom)

^g BOEHRINGER INGELHEIM PHARMA GMBH AND CO KG   (Germany)

^h UNIVERSITY OF CALGARY   (Canada)

ⁱ PURDUE PHARMA L P   (United States)

^j GLAXOSMITHKLINE   (United Kingdom)

^k ProMetic BioSciences Ltd   (United Kingdom)

more..

Author keywords

Asia; Diabetes mellitus type 2; Dipeptidyl peptidase 4 inhibitors

Indexed keywords

HEMOGLOBIN A1C; LINAGLIPTIN; METFORMIN;

ADULT; AGED; ALLERGIC REACTION; ARTICLE; ASIAN; BACKACHE; BODY WEIGHT CHANGE; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG DOSE INCREASE; DRUG DOSE TITRATION; DRUG EFFICACY; DRUG HYPERSENSITIVITY; DYSLIPIDEMIA; FEMALE; GASTROINTESTINAL SYMPTOM; HEADACHE; HUMAN; HYPERGLYCEMIA; HYPERTENSION; HYPOGLYCEMIA; MAJOR CLINICAL STUDY; MALE; MONOTHERAPY; MULTICENTER STUDY; NON INSULIN DEPENDENT DIABETES MELLITUS; PARALLEL DESIGN; POST HOC ANALYSIS; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; TOXIC HEPATITIS; UPPER RESPIRATORY TRACT INFECTION; URINARY TRACT INFECTION;

EID: 85036576902     PISSN: 20401116     EISSN: 20401124     Source Type: Journal    
DOI: 10.1111/jdi.12746     Document Type: Article

References (41)

1. Nanditha A, Ma RC, Ramachandran A, et al. Diabetes in Asia and the Pacific: implications for the Global Epidemic. Diabetes Care 2016; 39: 472–485.
2. Lu J, Bi Y, Ning G. Curbing the obesity epidemic in China. Lancet Diabetes Endocrinol 2016; 4: 470–471.
3. Chan JC, Malik V, Jia W, et al. Diabetes in Asia: epidemiology, risk factors, and pathophysiology. JAMA 2009; 301: 2129–2140.
4. Ma RC, Chan JC. Type 2 diabetes in East Asians: similarities and differences with populations in Europe and the United States. Ann N Y Acad Sci 2013; 1281: 64–91.
5. Ramachandran A, Snehalatha C, Ma RC. Diabetes in South-East Asia: an update. Diabetes Res Clin Pract 2014; 103: 231–237.
6. International Diabetes Federation. IDF Diabetes Atlas, 7th edn. Brussels: International Diabetes Federation, 2015.
7. Gujral UP, Pradeepa R, Weber MB, et al. Type 2 diabetes in South Asians: similarities and differences with white Caucasian and other populations. Ann N Y Acad Sci 2013; 1281: 51–63.
8. Cho YM. Incretin physiology and pathophysiology from an Asian perspective. J Diabetes Investig 2015; 6: 495–507.
9. Thiers FA, Sinskey AJ, Berndt ER. Trends in the globalization of clinical trials. Nat Rev Drug Discovery 2008; 7: 13–14.
10. Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). UK Prospective Diabetes Study (UKPDS) Group. Lancet 1998; 352: 837–853.
11. Holman RR, Paul SK, Bethel MA, et al. 10-year follow-up of intensive glucose control in type 2 diabetes. N Engl J Med 2008; 359: 1577–1589.
12. 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.
13. Inzucchi SE, Bergenstal RM, Buse JB, et al. Management of hyperglycemia in type 2 diabetes, 2015: a patient-centered approach: update to a position statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care 2015; 38: 140–149.
14. 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: 1364–1379.
15. International Diabetes Federation Guideline Development Group. Global guideline for type 2 diabetes. Diabetes Res Clin Pract 2014; 104: 1–52.
16. Seino Y, Kuwata H, Yabe D. Incretin-based drugs for type 2 diabetes: focus on East Asian perspectives. J Diabetes Investig 2016; 7(Suppl 1): 102–109.
17. Karagiannis T, Paschos P, Paletas K, et al. Dipeptidyl peptidase-4 inhibitors for treatment of type 2 diabetes mellitus in the clinical setting: systematic review and meta-analysis. BMJ 2012; 344: e1369.
18. Tradjenta (linagliptin) prescribing information. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals Inc., 2015.
19. Trajenta (linagliptin). Summary of Product Characteristics. Ingelheim: Boehringer Ingelheim International GmbH & Co. KG, 2013.
20. Graefe-Mody U, Retlich S, Friedrich C. Clinical pharmacokinetics and pharmacodynamics of linagliptin. Clin Pharmacokinet 2012; 51: 411–427.
21. Ross SA, Caballero AE, Del Prato S, et al. Initial combination of linagliptin and metformin compared with linagliptin monotherapy in patients with newly diagnosed type 2 diabetes and marked hyperglycaemia: a randomized, double-blind, active-controlled, parallel group, multinational clinical trial. Diabetes Obes Metab 2015; 17: 136–144.
22. Ross SA, Caballero AE, Del Prato S, et al. Linagliptin plus metformin in patients with newly diagnosed type 2 diabetes and marked hyperglycemia. Postgrad Med 2016; 128: 747–754.
23. Cc Chow F, Chan SP, Hwu CM, et al. Challenges in achieving optimal glycemic control in type 2 diabetes patients with declining renal function: The Southeast Asia perspective. J Diabetes Investig 2012; 3: 481–489.
24. Yang W, Weng J. Early therapy for type 2 diabetes in China. Lancet Diabetes Endocrinol 2014; 2: 992–1002.
25. Indian Council of Medical Research. Guidelines for Management of Type 2 Diabetes: Pharmacological Treatment of Diabetes. Available from: http://icmr.nic.in/guidelines_diabetes/section7.pdf Accessed August 30, 2016.
26. Japanese Diabetes Society. Treatment guide for diabetes: 2014-2015. Available from: http://www.fa.kyorin.co.jp/jds/uploads/Treatment_Guide_for_Diabetes_2014-2015.pdf Accessed August 30, 2016.
27. Wang W, Yang J, Yang G, et al. Efficacy and safety of linagliptin in Asian patients with type 2 diabetes mellitus inadequately controlled by metformin: a multinational 24-week, randomized clinical trial. J Diabetes 2016; 8: 229–237.
28. Chen Y, Ning G, Wang C, et al. Efficacy and safety of linagliptin monotherapy in Asian patients with inadequately controlled type 2 diabetes mellitus: a multinational, 24-week, randomized, clinical trial. J Diabetes Investig 2015; 6: 692–698.
29. Zeng Z, Choi DS, Mohan V, et al. Efficacy and safety of linagliptin as monotherapy or add-on treatment in Asian patients with suboptimal glycemic control: a pooled analysis. Curr Med Res Opin 2015; 31: 99–106.
30. Araki E, Kawamori R, Inagaki N, et al. Long-term safety of linagliptin monotherapy in Japanese patients with type 2 diabetes. Diabetes Obes Metab 2013; 15: 364–371.
31. Inagaki N, Watada H, Murai M, et al. Linagliptin provides effective, well-tolerated add-on therapy to pre-existing oral antidiabetic therapy over 1 year in Japanese patients with type 2 diabetes. Diabetes Obes Metab 2013; 15: 833–843.
32. Kawamori R, Inagaki N, Araki E, et al. Linagliptin monotherapy provides superior glycaemic control versus placebo or voglibose with comparable safety in Japanese patients with type 2 diabetes: a randomized, placebo and active comparator-controlled, double-blind study. Diabetes Obes Metab 2012; 14: 348–357.
33. Zeng Z, Yang JK, Tong N, et al. Efficacy and safety of linagliptin added to metformin and sulphonylurea in Chinese patients with type 2 diabetes: a sub-analysis of data from a randomised clinical trial. Curr Med Res Opin 2013; 29: 921–929.
34. Wu W, Li Y, Chen X, et al. Effect of linagliptin on glycemic control in Chinese patients with newly-diagnosed, drug-naive type 2 diabetes mellitus: a randomized controlled trial. Med Sci Monit 2015; 21: 2678–2684.
35. Sherifali D, Nerenberg K, Pullenayegum E, et al. The effect of oral antidiabetic agents on A1C levels: a systematic review and meta-analysis. Diabetes Care 2010; 33: 1859–1864.
36. Bloomgarden ZT, Dodis R, Viscoli CM, et al. Lower baseline glycemia reduces apparent oral agent glucose-lowering efficacy: a meta-regression analysis. Diabetes Care 2006; 29: 2137–2139.
37. DeFronzo RA, Stonehouse AH, Han J, et al. Relationship of baseline HbA1c and efficacy of current glucose-lowering therapies: a meta-analysis of randomized clinical trials. Diabet Med 2010; 27: 309–317.
38. Nauck M. Incretin therapies: highlighting common features and differences in the modes of action of glucagon-like peptide-1 receptor agonists and dipeptidyl peptidase-4 inhibitors. Diabetes Obes Metab 2016; 18: 203–216.
39. Wang JS, Tu ST, Lee IT, et al. Contribution of postprandial glucose to excess hyperglycaemia in Asian type 2 diabetic patients using continuous glucose monitoring. Diabetes Metab Res Rev 2011; 27: 79–84.
40. Kim YG, Hahn S, Oh TJ, et al. Differences in the glucose-lowering efficacy of dipeptidyl peptidase-4 inhibitors between Asians and non-Asians: a systematic review and meta-analysis. Diabetologia 2013; 56: 696–708.
41. Ceriello A, Inagaki N. Pharmacokinetic and pharmacodynamic evaluation of linagliptin for the treatment of type 2 diabetes mellitus, with consideration of Asian patient populations. J Diabetes Investig 2017; 8: 19–28.