Analysis of efficacy and safety of dulaglutide 0.75 mg stratified by sex in patients with type 2 diabetes in 2 randomized, controlled phase 3 studies in Japan

Endocrine Journal

Volumn 64, Issue 5, 2017, Pages 553-560

  Onishi, Yukiko ^a   Oura, Tomonori ^b   Matsui, Akiko ^b   Matsuura, Jun ^b   Iwamoto, Noriyuki ^b  

^a INSTITUTE FOR ADULT DISEASES   (Japan)

^b ELI LILLY AND COMPANY   (United States)

Author keywords

Dulaglutide; GLP 1 receptor agonist; Sex; Subgroup analysis; Type 2 diabetes

Indexed keywords

BIGUANIDE DERIVATIVE; DULAGLUTIDE; HEMOGLOBIN A1C; INSULIN GLARGINE; LIRAGLUTIDE; ORAL ANTIDIABETIC AGENT; PLACEBO; SULFONYLUREA DERIVATIVE; TRIACYLGLYCEROL LIPASE; ANTIDIABETIC AGENT; GLUCAGON LIKE PEPTIDE; HYBRID PROTEIN; IMMUNOGLOBULIN FC FRAGMENT;

ABDOMINAL DISTENSION; ADULT; ARTICLE; BODY MASS; COMBINATION CHEMOTHERAPY; CONSTIPATION; CONTROLLED STUDY; DECREASED APPETITE; DIARRHEA; DRUG EFFICACY; DRUG SAFETY; FEMALE; GASTROINTESTINAL SYMPTOM; HUMAN; HYPOGLYCEMIA; INCIDENCE; JAPAN; JAPANESE (PEOPLE); MAJOR CLINICAL STUDY; MALE; MONOTHERAPY; NAUSEA; NOCTURNAL HYPOGLYCEMIA; NON INSULIN DEPENDENT DIABETES MELLITUS; PHASE 3 CLINICAL TRIAL; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS; SEX DIFFERENCE; SIDE EFFECT; TREATMENT DURATION; VOMITING; WEIGHT GAIN; WEIGHT REDUCTION; ANALOGS AND DERIVATIVES; CLINICAL TRIAL; COMBINATION DRUG THERAPY; MIDDLE AGED; SEX FACTOR; TREATMENT OUTCOME;

DIABETES MELLITUS, TYPE 2; DRUG THERAPY, COMBINATION; FEMALE; GLUCAGON-LIKE PEPTIDES; HUMANS; HYPOGLYCEMIC AGENTS; IMMUNOGLOBULIN FC FRAGMENTS; INSULIN GLARGINE; JAPAN; LIRAGLUTIDE; MALE; MIDDLE AGED; RECOMBINANT FUSION PROTEINS; SEX FACTORS; TREATMENT OUTCOME;

EID: 85020089476     PISSN: 09188959     EISSN: 13484540     Source Type: Journal    
DOI: 10.1507/endocrj.EJ16-0552     Document Type: Article

References (17)

1. Kautzky-Willer A, Kosi L, Lin J, Mihaljevic R (2015) Gender-based differences in glycaemic control and hypoglycaemia prevalence in patients with type 2 diabetes: results from patient-level pooled data of six randomized controlled trials. Diabetes Obes Metab 17: 533-540.
2. Arnetz L, Ekberg NR, Alvarsson M (2014) Sex differences in type 2 diabetes: focus on disease course and outcomes. Diabetes Metab Syndr Obes 7: 409-420.
3. Pencek R, Blickensderfer A, Li Y, Brunell SC, Anderson PW (2012) Exenatide twice daily: analysis of effectiveness and safety data stratified by age, sex, race, duration of diabetes, and body mass index. Postgrad Med 124: 21-32.
4. Pencek R, Blickensderfer A, Li Y, Brunell SC, Chen S (2012) Exenatide once weekly for the treatment of type 2 diabetes: effectiveness and tolerability in patient sub-populations. Int J Clin Pract 66: 1021-1032.
5. Quan H, Zhang H, Wei W, Fang T (2016) Gender-related different effects of a combined therapy of exenatide and metformin on overweight or obesity patients with type 2 diabetes mellitus. J Diabetes Complications 30: 686-692.
6. Heymann A, Maor Y, Goldstein I, Todorova L, Schertz-Sternberg P, et al. (2014) Efficacy of liraglutide in a real-life cohort. Diabetes Ther 5: 193-206.
7. Tanzeum (albiglutide). [USPI] Wilmington, DE: GlaxoSmithKline LLC; 2015. Available at: https://www.gsksource.com/pharma/content/dam/GlaxoSmithKline/US/en/Prescribing_Information/Tanzeum/pdf/TANZEUM-PI-MG-IFU-COMBINED.PDF. Accessed 13 January 2017.
8. Miyagawa J, Odawara M, Takamura T, Iwamoto N, Takita Y, et al. (2015) Once-weekly glucagon-like peptide-1 receptor agonist dulaglutide is non-infe-rior to once-daily liraglutide and superior to placebo in Japanese patients with type 2 diabetes: a 26-week randomized phase III study. Diabetes Obes Metab 17: 974-983.
9. Araki E, Inagaki N, Tanizawa Y, Oura T, Takeuchi M, et al. (2015) Efficacy and safety of once-weekly dulaglutide in combination with sulphonylurea and/or big-uanide compared with once-daily insulin glargine in Japanese patients with type 2 diabetes: a randomized, open-label, phase III, non-inferiority study. Diabetes Obes Metab 17: 994-1002.
10. Emoto M, Terauchi Y, Ozeki A, Oura T, Takeuchi M, et al. (2015) 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 62: 1101-1114.
11. Onishi Y, Oura T, Nishiyama H, Ohyama S, Takeuchi M, et al. (2016) Subgroup analysis of phase 3 studies of dulaglutide in Japanese patients with type 2 diabetes. Endocr J 63: 263-273.
12. Odawara M, Miyagawa J, Iwamoto N, Takita Y, Imaoka T, et al. (2016) Once-weekly glucagon-like peptide-1 receptor agonist dulaglutide significantly decreases glycated haemoglobin compared with once-daily liraglutide in Japanese patients with type 2 diabetes: 52 weeks of treatment in a randomized phase III study. Diabetes Obes Metab 18: 249-257.
13. Inagaki N, Araki E, Oura T, Matsui A, Takeuchi M, et al. (2016) The combination of dulaglutide and bigua-nide reduced bodyweight in Japanese patients with type 2 diabetes. Diabetes Obes Metab 18: 1279-1282.
14. Tuthill A, McKenna MJ, O’Shea D, McKenna TJ (2008) Weight changes in type 2 diabetes and the impact of gender. Diabetes Obes Metab 10: 726-732.
15. Yu Y, Chen J, Li D, Wang L, Wang W, et al. (2016) Systematic analysis of adverse event reports for sex differences in adverse drug events. Sci Rep 6: 24955.
16. Geiser JS, Heathman MA, Cui X, Martin J, Loghin C, et al. (2016) Clinical pharmacokinetics of dulaglutide in patients with type 2 diabetes: analyses of data from clinical trials. Clin Pharmacokinet 55: 625-634.
17. Jacobsen LV, Flint A, Olsen AK, Ingwersen SH (2016) Liraglutide in type 2 diabetes mellitus: clinical pharmacokinetics and pharmacodynamics. Clin Pharmacokinet 55: 657-672.