- 1.
- 2.
- 3.
Diabetes Canada Clinical Practice Guidelines Expert Committee. Diabetes Canada 2018 clinical practice guidelines for the prevention and management of diabetes in Canada.
Can J Diabetes. 2018;42(Suppl 1):S1–S325. [
PubMed: 29650079]
- 4.
Wexler
DJ. Management of persistent hyperglycemia in T2DM. In: Post
TW, ed.
UpToDate. Watham (MA): UpToDate; 2018:
www.uptodate.com. Accessed 2018 Dec 12.
- 5.
Lexicomp. Semaglutide: drug information. In: Post
TW, ed.
UpToDate. Waltham (MA): UpToDate; 2018:
www.uptodate.com. Accessed 2018 Dec 12.
- 6.
PrOzempic® (semaglutide injection): 2 mg/pen (1.34 mg/mL), 4 mg/pen (1.34 mg/mL). Pre-filled pen delivering doses of 0.25 mg or 0.5 mg and pre-filled pen delivering doses of 1 mg [product monograph]. Mississauga (ON): Norvo Nordisk Canada Inc.; 2018.
- 7.
Clinical Study Report: NN9535-3623. SUSTAIN 1 - monotherapy. Efficacy and safety of semaglutide once-weekly versus placebo in drug-naive subjects with type 2 diabetes. Trial phase: 3a [CONFIDENTIAL internal manufacturer’s report]. Bagsvaerd (DK): Novo Nordisk; 2016.
- 8.
Clinical Study Report: NN9535-3627. SUSTAIN™ 5 – add on to basal insulin. Efficacy and safety of semaglutide once-weekly versus placebo as add-on to basal insulin alone or basal insulin in combination with metformin in subjects with type 2 diabetes. Trial phase: 3a. [CONFIDENTIAL internal manufacturer’s report]. Bagsvaerd (DK): Novo Nordisk; 2016.
- 9.
Clinical Study Report: NN9535-3744. SUSTAIN 6 – long-term outcomes. A long-term, randomised, double-blind, placebo-controlled, multinational, multi-centre trial to evaluate cardiovascular and other long-term outcomes with semaglutide in subjects with type 2 diabetes. Trial phase: 3a. [CONFIDENTIAL internal manufacturer’s report]. Bagsvaerd (DK): Novo Nordisk; 2016.
- 10.
Clinical Study Report: NN9535-3626. SUSTAIN 2 – vs. DPP-4 inhibitor. Efficacy and safety of semaglutide once-weekly versus sitagliptin once-daily as add-on to metformin and/or TZD in subjects with type 2 diabetes. Trial phase: 3a [CONFIDENTIAL internal manufacturer’s report]. Bagsvaerd (DK): Novo Nordisk; 2016.
- 11.
Clinical Study Report: NN9535-3624. SUSTAIN 3. Efficacy and safety of semaglutide once-weekly versus exenatide ER 2.0 mg once-weekly as add-on to 1–2 oral antidiabetic drugs (OADs) in subjects with type 2 diabetes. Trial phase: 3a. [CONFIDENTIAL internal manufacturer’s report]. Bagsvaerd (DK): Novo Nordisk; 2016.
- 12.
Clinical Study Report: NN9535-3625. SUSTAIN™ 4 – vs. basal insulin. Efficacy and safety of semaglutide once weekly versus insulin glargine once daily as add on to metformin with or without sulphonylurea in insulin-naive subjects with type 2 diabetes. Trial phase: 3a. [CONFIDENTIAL internal manufacturer’s report]. Bagsvaerd (DK): Novo Nordisk; 2016.
- 13.
Clinical Study Report: NN9535-4216. Efficacy and safety of semaglutide versus dulaglutide as addon to metformin in subjects with type 2 diabetes. Trial phase: 3a. [CONFIDENTIAL internal manufacturer’s report]. Bagsvaerd (DK): Novo Nordisk; 2016.
- 14.
Seino
Y, Terauchi
Y, Osonoi
T, et al. Safety and efficacy of semaglutide once weekly vs sitagliptin once daily, both as monotherapy in Japanese people with type 2 diabetes.
Diabetes Obes Metab. 2018;20(2):378–388. [
PMC free article: PMC5813234] [
PubMed: 28786547]
- 15.
Leiter
LA, Berard
L, Bowering
CK, et al. Type 2 diabetes mellitus management in Canada: is it improving?
Can J Diabetes. 2013;37(2):82–89. [
PubMed: 24070797]
- 16.
Clinical Study Report: NN9535-EXPLORATORY. Subgroup Analyses of SUSTAIN-2, SUSTAIN-3 and SUSTAIN-4 (draft). [CONFIDENTIAL internal manufacturer’s report]. Bagsvaerd (DNK): Novo Nordisk; 2018.
- 17.
- 18.
- 19.
- 20.
- 21.
Palanisamy
S, Yien
ELH, Shi
LW, et al. Systematic review of efficacy and safety of newer antidiabetic drugs approved from 2013 to 2017 in controlling A1C in diabetes patients.
Pharmacy (Basel). 2018;6(3):57. [
PMC free article: PMC6164486] [
PubMed: 29954090]
- 22.
Sharma
R, Wilkinson
L, Vrazic
H, et al. Comparative efficacy of once-weekly semaglutide and SGLT2 inhibitors in type 2 diabetic patients inadequately controlled with metformin monotherapy: a systematic literature review and network meta-analysis.
Curr Med Res Opin. 2018;34(9):1595–1603. [
PubMed: 29764222]
- 23.
- 24.
- 25.
- 26.
PrAdlyxine™ (lixisenatide injection): 0.05 mg per mL (10 μg/dose), 0.1 mg per mL (20 μg/dose), solution for injection in a pre-filled pen. Laval (QC): Sanofi-Aventis Canada Inc; 2017:
https://pdf.hres.ca/dpd_pm/00039567.PDF. Accessed 2019 Feb 12.
- 27.
Sorli
C, Harashima
SI, Tsoukas
GM, et al. Efficacy and safety of once-weekly semaglutide monotherapy versus placebo in patients with type 2 diabetes (SUSTAIN 1): a double-blind, randomised, placebo-controlled, parallel-group, multinational, multicentre phase 3a trial.
Lancet Diabetes Endocrinol. 2017;5(4):251–260. [
PubMed: 28110911]
- 28.
Rodbard
HW, Lingvay
I, Reed
J, et al. Semaglutide added to basal insulin in type 2 diabetes (SUSTAIN 5): a randomized, controlled trial.
J Clin Endocrinol Metab. 2018;103(6):2291–2301. [
PMC free article: PMC5991220] [
PubMed: 29688502]
- 29.
Marso
SP, Bain
SC, Consoli
A, et al. Semaglutide and cardiovascular outcomes in patients with type 2 diabetes.
New Engl J Med. 2016;375(19):1834–1844. [
PubMed: 27633186]
- 30.
CDR submission: Ozempic (semaglutide), 1.34 mh/mL, solution for injection in a pre-filled pen, 0.5 mg once weekly and 1.0 mg once weekly [CONFIDENTIAL manufacturer’s submission]. Mississauga (ON): Norvo Nordisk Canada Inc.; 2018.
- 31.
Health Canada reviewer’s report: Ozempic (semaglutide) [CONFIDENTIAL internal report]. Ottawa (ON): Therapeutics Products Directorate, Health Canada; 2018.
- 32.
- 33.
Ahren
B, Masmiquel
L, Kumar
H, et al. Efficacy and safety of once-weekly semaglutide versus once-daily sitagliptin as an add-on to metformin, thiazolidinediones, or both, in patients with type 2 diabetes (SUSTAIN 2): a 56-week, double-blind, phase 3a, randomised trial.
Lancet Diabetes Endocrinol. 2017;5(5):341–354. [
PubMed: 28385659]
- 34.
Ahmann
AJ, Capehorn
M, Charpentier
G, et al. Efficacy and safety of once-weekly semaglutide versus exenatide ER in subjects with type 2 diabetes (SUSTAIN 3): a 56-week, open-label, randomized clinical trial.
Diabetes Care. 2018;41(2):258–266. [
PubMed: 29246950]
- 35.
Aroda
VR, Bain
SC, Cariou
B, et al. Efficacy and safety of once-weekly semaglutide versus once-daily insulin glargine as add-on to metformin (with or without sulfonylureas) in insulin-naive patients with type 2 diabetes (SUSTAIN 4): a randomised, open-label, parallel-group, multicentre, multinational, phase 3a trial.
Lancet Diabetes Endocrinol. 2017;5(5):355–366. [
PubMed: 28344112]
- 36.
Pratley
RE, Aroda
VR, Lingvay
I, et al. Semaglutide versus dulaglutide once weekly in patients with type 2 diabetes (SUSTAIN 7): a randomised, open-label, phase 3b trial.
Lancet Diabetes Endocrinol. 2018;6(4):275–286. [
PubMed: 29397376]
- 37.
Bradley
C, Plowright
R, Stewart
J, Valentine
J, Witthaus
E. The Diabetes Treatment Satisfaction Questionnaire change version (DTSQc) evaluated in insulin glargine trials shows greater responsiveness to improvements than the original DTSQ.
Health Qual Life Outcomes. 2007;5:57. [
PMC free article: PMC2170436] [
PubMed: 17927832]
- 38.
- 39.
Hays
RD, Morales
LS. The RAND-36 measure of health-related quality of life.
Ann Med. 2001;33(5):350–357. [
PubMed: 11491194]
- 40.
Hill-Briggs
F, Gary
TL, Baptiste-Roberts
K, Brancati
FL. Thirty-six–item short-form outcomes following a randomized controlled trial in type 2 diabetes.
Diabetes Care. 2005;28(2):443–444. [
PubMed: 15677813]
- 41.
American Diabetes Association. Standards of medical care in diabetes - 2016.
Diabetes Care. 2016;39(Suppl 1):S1–S112. [
PubMed: 26696671]
- 42.
- 43.
Stratton
IM, Adler
AI, Neil
HA, et al. Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35): prospective observational study.
BMJ. 2000;321(7258):405–412. [
PMC free article: PMC27454] [
PubMed: 10938048]
- 44.
Systematic literature review and network meta-analysis to assess the relative efficacy and safety of once-weekly semaglutide compared with GLP-1 receptor agonists in patients inadequately controlled with one oral anti-diabetic drugs: technical report. CDR submission: Ozempic (semaglutide), 1.34 mh/mL, solution for injection in a pre-filled pen, 0.5 mg once weekly and 1.0 mg once weekly [CONFIDENTIAL manufacturer’s submission]. Missassauga (ON): Norvo Nordisk Canada Inc.; 2018.
- 45.
Systematic literature review and network meta-analysis of comparative efficacy and safety of once-weekly semaglutide relative to SGLT2 inhibitors in patients inadequately controlled with metformin monotherapy: technical report. CDR submission: Ozempic (semaglutide), 1.34 mh/mL, solution for injection in a pre-filled pen, 0.5 mg once weekly and 1.0 mg once weekly [CONFIDENTIAL manufacturer’s submission]. Missassauga (ON): Norvo Nordisk Canada Inc.; 2018.
- 46.
Systematic literature review and network meta-analysis to assess the relative efficacy and safety of oncw-weekly semaglutide compared with SUs in patients inadequately controlled with metformin: technical report. CDR submission: Ozempic (semaglutide), 1.34 mh/mL, solution for injection in a pre-filled pen, 0.5 mg once weekly and 1.0 mg once weekly [CONFIDENTIAL manufacturer’s submission]. Missassauga (ON): Norvo Nordisk Canada Inc.; 2018.
- 47.
Systematic literature review and network meta-analysis to assess the relative efficacy and safety of once-weekly semaglutide compared with GLP-1 receptor agonists in patients inadequately controlled with 1–2 oral anti-diabetic drugs: analysis at 24 ±4 weeks: technical report. CDR submission: Ozempic (semaglutide), 1.34 mh/mL, solution for injection in a pre-filled pen, 0.5 mg once weekly and 1.0 mg once weekly [CONFIDENTIAL manufacturer’s submission]. Missassauga (ON): Norvo Nordisk Canada Inc.; 2018.
- 48.
Systematic literature review and network meta-analysis of comparative efficacy and safety of once-weekly semaglutide relative to SGLT2 inhibitors in patients inadequately controlled with 1–2 OADs: technical report. CDR submission: Ozempic (semaglutide), 1.34 mh/mL, solution for injection in a pre-filled pen, 0.5 mg once weekly and 1.0 mg once weekly [CONFIDENTIAL manufacturer’s submission]. Missassauga (ON): Norvo Nordisk Canada Inc.; 2018.
- 49.
Systematic literature review and feasibility assessment to explore the relative efficacy and safety of once-weekly semaglutide compared with SGLT2is in patients with T2D inadequately controlled with 2 OADs: technical report. CDR submission: Ozempic (semaglutide), 1.34 mh/mL, solution for injection in a pre-filled pen, 0.5 mg once weekly and 1.0 mg once weekly [CONFIDENTIAL manufacturer’s submission]. Missassauga (ON): Norvo Nordisk Canada Inc; 2018.
- 50.
Systematic literature review and network meta-analysis of comparative efficacy and safety of once-weekly semaglutide relative to SGLT2 inhibitors in patients inadequately controlled with metformin monotherapy: appendices for technical report version 9.0. CDR submission: Ozempic (semaglutide), 1.34 mh/mL, solution for injection in a pre-filled pen, 0.5 mg once weekly and 1.0 mg once weekly [CONFIDENTIAL manufacturer’s submission]. Missassauga (ON): Novo Nordisk Canada Inc.; 2018.
- 51.
Sharma
R, Wilkinson
L, Vrazic
H, et al. Comparative efficacy of once-weekly semaglutide and SGLT2 inhibitors in type 2 diabetic patients inadequately controlled with metformin monotherapy: a systematic literature review and network meta-analysis.
Curr Med Res Opin. 2018;34(9):1595–1603. [
PubMed: 29764222]
- 52.
Zheng
SL, Roddick
AJ, Aghar-Jaffar
R, et al. Association between use of sodium-glucose cotransporter 2 inhibitors, glucagon-like peptide 1 agonists, and dipeptidyl peptidase-4 inhibitors with all-cause mortality in patients with type 2 diabetes: a systematic review and meta-analysis.
JAMA. 2018;319(15):1580–1591. [
PMC free article: PMC5933330] [
PubMed: 29677303]
- 53.
Systematic literature review and network meta-analysis of comparative efficacy and safety of once-weekly semaglutide relative to SGLT2 inhibitors in patients inadequately controlled with 1–2 OADs: appendices for technical report version 9.0. CDR submission: Ozempic (semaglutide), 1.34 mh/mL, solution for injection in a pre-filled pen, 0.5 mg once weekly and 1.0 mg once weekly [CONFIDENTIAL manufacturer’s submission]. Missassauga (ON): Norvo Nordisk Canada Inc; 2018.
- 54.
Witkowski
M, Wilkinson
L, Webb
N, Weids
A, Glah
D, Vrazic
H. A systematic literature review and network meta-analysis comparing once-weekly semaglutide with other GLP-1 receptor agonists in patients with type 2 diabetes previously receiving 1–2 oral anti-diabetic drugs.
Diabetes Ther. 2018;9(3):1149–1167. [
PMC free article: PMC5984927] [
PubMed: 29675798]
- 55.
Webb
N, Orme
M, Witkowski
M, Nakanishi
R, Langer
J. A network meta-analysis comparing semaglutide once-weekly with other GLP-1 receptor agonists in Japanese patients with type 2 diabetes.
Diabetes Ther. 2018;9(3):973–986. [
PMC free article: PMC5984907] [
PubMed: 29574633]
- 56.
Witkowski
M, Wilkinson
L, Webb
N, Weids
A, Glah
D, Vrazic
H. A systematic literature review and network meta-analysis comparing once-weekly semaglutide with other GLP-1 receptor agonists in patients with type 2 diabetes previously receiving basal insulin.
Diabetes Ther. 2018;9(3):1233–1251. [
PMC free article: PMC5984931] [
PubMed: 29713961]
- 57.
Fei
Y, Tsoi
MF, Kumana
CR, Cheung
TT, Cheung
BMY. Network meta-analysis of cardiovascular outcomes in randomized controlled trials of new antidiabetic drugs.
Int J Cardiol. 2018;254:291–296. [
PubMed: 29277321]
- 58.
Kramer
CK, Ye
C, Campbell
S, Retnakaran
R. Comparison of new glucose-lowering drugs on risk of heart failure in type 2 diabetes: a network meta-analysis.
JACC Heart Fail. 2018;6(10):823–830. [
PubMed: 30196071]
- 59.
Palmer
SC, Mavridis
D, Nicolucci
A, et al. Comparison of clinical outcomes and adverse events associated with glucose-lowering drugs in patients with type 2 diabetes: a meta-analysis.
JAMA. 2016;316(3):313–324. [
PubMed: 27434443]
- 60.
Yoon
JH, Min
SH, Ahn
CH, Cho
YM, Hahn
S. Comparison of non-insulin antidiabetic agents as an add-on drug to insulin therapy in type 2 diabetes: a network meta-analysis.
Sci Rep. 2018;8(1):4095. [
PMC free article: PMC5840350] [
PubMed: 29511288]
- 61.
Zaccardi
F, Dhalwani
NN, Dales
J, et al. Comparison of glucose-lowering agents after dual therapy failure in type 2 diabetes: a systematic review and network meta-analysis of randomized controlled trials.
Diabetes Obes Metab. 2018;20(4):985–997. [
PubMed: 29205774]
- 62.
Zhuang
XD, He
X, Yang
DY, et al. Comparative cardiovascular outcomes in the era of novel anti-diabetic agents: a comprehensive network meta-analysis of 166,371 participants from 170 randomized controlled trials.
Cardiovasc Diabetol. 2018;17(1):79. [
PMC free article: PMC5989345] [
PubMed: 29871636]
- 63.
Zhang
YS, Weng
WY, Xie
BC, et al. Glucagon-like peptide-1 receptor agonists and fracture risk: a network meta-analysis of randomized clinical trials.
Osteoporosis Int. 2018;29(12):2639–2644. [
PubMed: 30083774]
- 64.
Norvo Nordisk response to January 25 2019 CDR request for additional information regarding Ozempic CDR review [CONFIDENTIAL additional manufacturer’s information]. Bagsvaerd (DNK): Norvo Nordisk; 2019.
- 65.
- 66.
Jansen
JP, Trikalinos
T, Cappelleri
JC, et al. Indirect treatment comparison/network meta-analysis study questionnaire to assess relevance and credibility to inform health care decision making: an ISPOR-AMCP-NPC Good Practice Task Force report.
Value Health. 2014;17(2):157–173. [
PubMed: 24636374]
- 67.
- 68.