Clinical trial NCT01849289: A Trial Comparing Efficacy and Safety of Insulin Degludec and Insulin Glargine in Insulin naïve Subjects With Type 2 Diabetes
Official title: A Trial Comparing Efficacy and Safety of Insulin Degludec and Insulin Glargine in Insulin naïve Subjects With Type 2 Diabetes (BEGIN™: ONCE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2013-05-08
Enrollment: 833
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial was conducted in Africa, Asia, Europe, North and South America. The aim of the trial was to compare efficacy and safety of insulin degludec and insulin glargine in insulin naïve subjects with type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes mellitus (diagnosed clinically) for at least 6 months
* Insulin naïve subjects (Allowed are: previous short term insulin treatment up to 14 days; treatment during hospitalisation or during gestational diabetes is allowed for periods longer than 14 days)
* Current treatment: metformin monotherapy or metformin in any combination with an insulin secretagogue (sulfonylurea or glinide), dipeptidyl peptidase IV (DPP-IV) inhibitor, alfa-glucosidase-inhibitors (acarbose) with unchanged dosing for at least 3 months prior to randomisation (Visit 2) with the minimum doses stated: metformin: alone or in combination (including fixed combination) 1500 mg daily, or maximum tolerated dose (at least 1000 mg daily), insulin secretagogue (sulfonylurea or glinide): minimum half of the daily maximal dose according to local labelling, DPP-IV inhibitor: minimum 100 mg daily or according to local labelling, alfa-glucosidase-inhibitors (acarbose): minimum half of the daily maximal dose or maximum tolerated dose
* HbA1c (glycosylated haemoglobin) 7.0-10.0% (both inclusive) by central laboratory analysis
* BMI (Body Mass Index) below or equal to 40.0 kg/m\^2

Exclusion Criteria:

* Treatment with TZDs (thiazoledinedione), or GLP-1 (glucagon-like peptide 1) receptor agonists within the last 3 months prior to Visit 1 (screening)
* Anticipated change in concomitant medication known to interfere significantly with glucose metabolism, such as systemic corticosteroids, beta-blockers, MAO (monoamine oxidase) inhibitors
* Cardiovascular disease within the last 6 months prior to Visit 1 (screening) defined as stroke; decompensated heart failure NYHA (New York Heart Association) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty
* Any clinically significant disease or disorder, except for conditions associated with type 2 diabetes mellitus, which in the Investigator's opinion could interfere with the results of the trial
* Previous participation in this trial. Participation is defined as randomised. Re-screening of screening failures is allowed only once within the limits of the recruitment period
* Known or suspected hypersensitivity to trial product(s) or related products

Primary outcomes:
measure: Change From Baseline in HbA1c (%) (Analysed by Central Laboratory)
timeFrame: Week 0, week 26
Secondary outcomes:
measure: Number of Severe and Minor Treatment Emergent Hypoglycaemic Episodes
timeFrame: On or after the first day of exposure to randomised trial drug (week 0) and no later than 7 days after last exposure to randomised trial drug (week 27)
measure: Change From Baseline in FPG (Fasting Plasma Glucose) (Analysed by Central Laboratory)
timeFrame: Week 0, week 26
measure: Within-subject Variability as Measured by Coefficient of Variation (CV%) in Pre-breakfast SMPG (Self-measured Plasma Glucose)
timeFrame: Week 26
measure: Responder for HbA1c (Below 7.0%) at End of Trial Without Severe and Minor Hypoglycaemic Episodes
timeFrame: Week 26
measure: Number of Treatment Emergent AEs (Adverse Events)
timeFrame: On or after the first day of exposure to randomised trial drug (week 0) and no later than seven days after last exposure to randomised trial drug (week 27)
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Lomita
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Los Angeles
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Golden
country: United States
facility: Novo Nordisk Investigational Site
state: Colorado
city: Clearwater
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Chicago
country: United States
facility: Novo Nordisk Investigational Site
state: Illinois
city: Crestview Hills
country: United States
facility: Novo Nordisk Investigational Site
state: Kentucky
city: Metairie
country: United States
facility: Novo Nordisk Investigational Site
state: Louisiana
city: Troy
country: United States
facility: Novo Nordisk Investigational Site
state: Michigan
city: Chesterfield
country: United States
facility: Novo Nordisk Investigational Site
state: Missouri
city: Nashua
country: United States
facility: Novo Nordisk Investigational Site
state: New Hampshire
city: Toms River
country: United States
facility: Novo Nordisk Investigational Site
state: New Jersey
city: Smithtown
country: United States
facility: Novo Nordisk Investigational Site
state: New York
city: Simpsonville
country: United States
facility: Novo Nordisk Investigational Site
state: South Carolina
city: Jackson
country: United States
facility: Novo Nordisk Investigational Site
state: Tennessee
city: Dallas
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Newport News
country: United States
facility: Novo Nordisk Investigational Site
state: Virginia
city: Kenosha
country: United States
facility: Novo Nordisk Investigational Site
state: Wisconsin
city: São Paulo
country: Brazil
facility: Novo Nordisk Investigational Site
state: Sao Paulo
city: Porto Alegre
country: Brazil
facility: Novo Nordisk Investigational Site
city: São Paulo
country: Brazil
facility: Novo Nordisk Investigational Site
city: Calgary
country: Canada
facility: Novo Nordisk Investigational Site
state: Alberta
city: Burnaby
country: Canada
facility: Novo Nordisk Investigational Site
state: British Columbia
city: Surrey
country: Canada
facility: Novo Nordisk Investigational Site
state: British Columbia
city: Victoria
country: Canada
facility: Novo Nordisk Investigational Site
state: British Columbia
city: Burlington
country: Canada
facility: Novo Nordisk Investigational Site
state: Ontario
city: London
country: Canada
facility: Novo Nordisk Investigational Site
state: Ontario
city: London
country: Canada
facility: Novo Nordisk Investigational Site
state: Ontario
city: Newmarket
country: Canada
facility: Novo Nordisk Investigational Site
state: Ontario
city: Sarnia
country: Canada
facility: Novo Nordisk Investigational Site
state: Ontario
city: Strathroy
country: Canada
facility: Novo Nordisk Investigational Site
state: Ontario
city: Trois Rivieres
country: Canada
facility: Novo Nordisk Investigational Site
state: Quebec
city: Quebec
country: Canada
facility: Novo Nordisk Investigational Site
city: Hefei
country: China
facility: Novo Nordisk Investigational Site
state: Anhui
city: Beijing
country: China
facility: Novo Nordisk Investigational Site
state: Beijing
city: Beijing
country: China
facility: Novo Nordisk Investigational Site
state: Beijing
city: Beijing
country: China
facility: Novo Nordisk Investigational Site
state: Beijing
city: Beijing
country: China
facility: Novo Nordisk Investigational Site
state: Beijing
city: Beijing
country: China
facility: Novo Nordisk Investigational Site
state: Beijing
city: Beijing
country: China
facility: Novo Nordisk Investigational Site
state: Beijing
city: Chongqing
country: China
facility: Novo Nordisk Investigational Site
state: Chongqing
city: Chongqing
country: China
facility: Novo Nordisk Investigational Site
state: Chongqing
city: ChongQing
country: China
facility: Novo Nordisk Investigational Site
state: Chongqing
city: Fuzhou
country: China
facility: Novo Nordisk Investigational Site
state: Fujian
city: Guangzhou
country: China
facility: Novo Nordisk Investigational Site
state: Guangdong
city: Nanning
country: China
facility: Novo Nordisk Investigational Site
state: Guangxi
city: Guiyang
country: China
facility: Novo Nordisk Investigational Site
state: Guizhou
city: Shijiazhuang
country: China
facility: Novo Nordisk Investigational Site
state: Hebei
city: Shijiazhuang
country: China
facility: Novo Nordisk Investigational Site
state: Hebei
city: Harbin
country: China
facility: Novo Nordisk Investigational Site
state: Heilongjiang
city: Wuhan
country: China
facility: Novo Nordisk Investigational Site
state: Hubei
city: Wuhan
country: China
facility: Novo Nordisk Investigational Site
state: Hubei
city: Yueyang
country: China
facility: Novo Nordisk Investigational Site
state: Hunan
city: Yangzhou
country: China
facility: Novo Nordisk Investigational Site
state: Jiangsu
city: Zhenjiang
country: China
facility: Novo Nordisk Investigational Site
state: Jiangsu
city: Nanchang
country: China
facility: Novo Nordisk Investigational Site
state: Jiangxi
city: Changchun
country: China
facility: Novo Nordisk Investigational Site
state: Jilin
city: Siping
country: China
facility: Novo Nordisk Investigational Site
state: Jilin
city: Shenyang
country: China
facility: Novo Nordisk Investigational Site
state: Liaoning
city: Shenyang
country: China
facility: Novo Nordisk Investigational Site
state: Liaoning
city: Xi'an
country: China
facility: Novo Nordisk Investigational Site
state: Shaanxi
city: Shanghai
country: China
facility: Novo Nordisk Investigational Site
state: Shanghai
city: Shanghai
country: China
facility: Novo Nordisk Investigational Site
state: Shanghai
city: Kunming
country: China
facility: Novo Nordisk Investigational Site
state: Yunnan
city: Hangzhou
country: China
facility: Novo Nordisk Investigational Site
state: Zhejiang
city: Wenzhou
country: China
facility: Novo Nordisk Investigational Site
state: Zhejiang
city: Oradea
country: Romania
facility: Novo Nordisk Investigational Site
state: Bihor
city: Bucharest
country: Romania
facility: Novo Nordisk Investigational Site
city: Buzau
country: Romania
facility: Novo Nordisk Investigational Site
city: Galati
country: Romania
facility: Novo Nordisk Investigational Site
city: Sibiu
country: Romania
facility: Novo Nordisk Investigational Site
city: George
country: South Africa
facility: Novo Nordisk Investigational Site
state: Eastern Cape
city: Johannesburg
country: South Africa
facility: Novo Nordisk Investigational Site
state: Gauteng
city: Johannesburg
country: South Africa
facility: Novo Nordisk Investigational Site
state: Gauteng
city: Durban
country: South Africa
facility: Novo Nordisk Investigational Site
state: KwaZulu-Natal
city: Durban
country: South Africa
facility: Novo Nordisk Investigational Site
state: KwaZulu-Natal
city: Dnepropetrovsk
country: Ukraine
facility: Novo Nordisk Investigational Site
city: Dnepropetrovsk
country: Ukraine
facility: Novo Nordisk Investigational Site
city: Kiev
country: Ukraine
facility: Novo Nordisk Investigational Site
city: Mykolaiv
country: Ukraine
facility: Novo Nordisk Investigational Site
city: Vinnitsa
country: Ukraine
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Pan C, Gross JL, Yang W, Lv X, Sun L, Hansen CT, Xu H, Wagner R. A Multinational, Randomized, Open-label, Treat-to-Target Trial Comparing Insulin Degludec and Insulin Glargine in Insulin-Naive Patients with Type 2 Diabetes Mellitus. Drugs R D. 2016 Jun;16(2):239-49. doi: 10.1007/s40268-016-0134-z.
citation: Mu YM, Guo LX, Li L, Li YM, Xu XJ, Li QM, Xu MT, Zhu LY, Yuan GY, Liu Y, Xu C, Wang ZJ, Shen FX, Luo Y, Liu JY, Li QF, Wang WH, Lai XY, Xu HF, Pan CY. [The efficacy and safety of insulin degludec versus insulin glargine in insulin-naive subjects with type 2 diabetes: results of a Chinese cohort from a multinational randomized controlled trial]. Zhonghua Nei Ke Za Zhi. 2017 Sep 1;56(9):660-666. doi: 10.3760/cma.j.issn.0578-1426.2017.09.008. Chinese.