Clinical trial NCT01074268: Comparison of NN1250 Plus Insulin Aspart With Insulin Detemir Plus Insulin Aspart in Type 1 Diabetes
Official title: NN1250-3585: A Trial Investigating the Efficacy and Safety of NN1250 Compared to Insulin Detemir in Subjects With Type 1 Diabetes Mellitus in a Basal/Bolus Treatment Regimen / NN1250-3725: An Extension Trial to NN1250-3585 Investigating Safety and Efficacy of NN1250 Compared to Insulin Detemir in Subjects With Type 1 Diabetes Mellitus in a Basal/Bolus Treatment Regimen (BEGIN™: BB T1)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes
Diabetes Mellitus, Type 1
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2010-02-24
Enrollment: 456
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 is conducted in Asia, Europe, Japan and South America. The aim of the trial is to compare the efficacy, safety and tolerability of NN1250 (insulin degludec (\[Deg\]) with insulin detemir (IDet), both combined with insulin aspart.

The main period is registered internally at Novo Nordisk as NN1250-3585 while the extension period is registered as NN1250-3725.


Eligibility criteria: Inclusion Criteria:

* Type 1 diabetes mellitus for at least 12 months
* Current treatment with any basal bolus insulin for at least 12 months
* HbA1c below or equal to 10.0%
* Body Mass Index (BMI) below or equal to 35.0 kg/m\^2
* For Japan only: Minimum age is 20 years
* For the extension trial only: Completed the six-month treatment period in trial NN1250-3585 (NCT01074268)

Exclusion Criteria:

* Use of any other antidiabetic drug than insulin within the last 3 months
* Cardiovascular disease within the last 6 months
* Uncontrolled treated/untreated severe hypertension
* Recurrent severe hypoglycemia or hypoglycemic unawareness or hospitalisation for diabetic ketoacidosis during the previous 6 months
* Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures
* Cancer and medical history of cancer

Primary outcomes:
measure: Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 26 Weeks of Treatment
timeFrame: Week 0, Week 26
measure: Extension Trial (Primary Endpoint): Rate of Treatment Emergent Adverse Events (AEs)
timeFrame: Week 0 to Week 52 + 7 days follow up
Secondary outcomes:
measure: Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment
timeFrame: Week 0, Week 52
measure: Main Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 26
timeFrame: Week 26
measure: Extension Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 52
timeFrame: Week 52
measure: Main Trial (Secondary Endpoint): Change in Fasting Plasma Glucose (FPG) After 26 Weeks of Treatment
timeFrame: Week 0, Week 26
measure: Extension Trial (Secondary Endpoint): Change in Fasting Plasma Glucose (FPG) After 52 Weeks of Treatment
timeFrame: Week 0, Week 52
measure: Main Trial (Secondary Endpoint): Rate of Confirmed Hypoglycaemic Episodes
timeFrame: Week 0 to Week 26 + 7 days follow up
measure: Main Trial (Secondary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes
timeFrame: Week 0 to Week 26 + 7 days follow up
measure: Extension Trial (Secondary Endpoint): Rate of Confirmed Hypoglycaemic Episodes
timeFrame: Week 0 to Week 52 + 7 days follow up
measure: Extension Trial (Secondary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes
timeFrame: Week 0 to Week 52 + 7 days follow up
Other outcomes:
Locations:
city: Caba
country: Argentina
facility: Novo Nordisk Investigational Site
city: Ciudad Autónoma de Bs As
country: Argentina
facility: Novo Nordisk Investigational Site
city: Mar del Plata
country: Argentina
facility: Novo Nordisk Investigational Site
city: Rosario
country: Argentina
facility: Novo Nordisk Investigational Site
city: Porto Alegre
country: Brazil
facility: Novo Nordisk Investigational Site
state: Rio Grande do Sul
city: São Paulo
country: Brazil
facility: Novo Nordisk Investigational Site
state: Sao Paulo
city: Marília
country: Brazil
facility: Novo Nordisk Investigational Site
city: Porto Alegre
country: Brazil
facility: Novo Nordisk Investigational Site
city: Sao Paulo
country: Brazil
facility: Novo Nordisk Investigational Site
city: Helsinki
country: Finland
facility: Novo Nordisk Investigational Site
city: Helsinki
country: Finland
facility: Novo Nordisk Investigational Site
city: Hämeenlinna
country: Finland
facility: Novo Nordisk Investigational Site
city: Kuopio
country: Finland
facility: Novo Nordisk Investigational Site
city: Lahti
country: Finland
facility: Novo Nordisk Investigational Site
city: Seinäjoki
country: Finland
facility: Novo Nordisk Investigational Site
city: Tampere
country: Finland
facility: Novo Nordisk Investigational Site
city: Turku
country: Finland
facility: Novo Nordisk Investigational Site
city: Bangalore
country: India
facility: Novo Nordisk Investigational Site
state: Karnataka
city: Chennai
country: India
facility: Novo Nordisk Investigational Site
state: Tamil Nadu
city: Chennai
country: India
facility: Novo Nordisk Investigational Site
state: Tamil Nadu
city: Ahmedabad
country: India
facility: Novo Nordisk Investigational Site
city: Bilaspur
country: India
facility: Novo Nordisk Investigational Site
city: Dhantoli, Nagpur
country: India
facility: Novo Nordisk Investigational Site
city: Hyderabad
country: India
facility: Novo Nordisk Investigational Site
city: New Dehli
country: India
facility: Novo Nordisk Investigational Site
city: Ramdaspeth / Nagpur
country: India
facility: Novo Nordisk Investigational Site
city: Thriruvananthapuram
country: India
facility: Novo Nordisk Investigational Site
city: Bari
country: Italy
facility: Novo Nordisk Investigational Site
city: Forlì
country: Italy
facility: Novo Nordisk Investigational Site
city: Gazi
country: Italy
facility: Novo Nordisk Investigational Site
city: Milano
country: Italy
facility: Novo Nordisk Investigational Site
city: Milano
country: Italy
facility: Novo Nordisk Investigational Site
city: Olbia
country: Italy
facility: Novo Nordisk Investigational Site
city: Palermo
country: Italy
facility: Novo Nordisk Investigational Site
city: Partinico
country: Italy
facility: Novo Nordisk Investigational Site
city: Roma
country: Italy
facility: Novo Nordisk Investigational Site
city: Torino
country: Italy
facility: Novo Nordisk Investigational Site
city: Treviglio
country: Italy
facility: Novo Nordisk Investigational Site
city: Treviso
country: Italy
facility: Novo Nordisk Investigational Site
city: Chuo-ku, Tokyo
country: Japan
facility: Novo Nordisk Investigational Site
city: Ebina-shi
country: Japan
facility: Novo Nordisk Investigational Site
city: Imizu-shi
country: Japan
facility: Novo Nordisk Investigational Site
city: Izumisano-shi
country: Japan
facility: Novo Nordisk Investigational Site
city: Koriyama-shi, Fukushima
country: Japan
facility: Novo Nordisk Investigational Site
city: Kumamoto-shi,Kumamoto
country: Japan
facility: Novo Nordisk Investigational Site
city: Miyazaki-shi
country: Japan
facility: Novo Nordisk Investigational Site
city: Naka-shi, Ibaraki
country: Japan
facility: Novo Nordisk Investigational Site
city: Nishinomiya-shi, Hygo
country: Japan
facility: Novo Nordisk Investigational Site
city: Oita-shi
country: Japan
facility: Novo Nordisk Investigational Site
city: Ota-ku, Tokyo
country: Japan
facility: Novo Nordisk Investigational Site
city: Sapporo-shi, Hokkaido
country: Japan
facility: Novo Nordisk Investigational Site
city: Sapporo-shi, Hokkaido
country: Japan
facility: Novo Nordisk Investigational Site
city: Sapporo-shi, Hokkaido
country: Japan
facility: Novo Nordisk Investigational Site
city: Yokohama-shi
country: Japan
facility: Novo Nordisk Investigational Site
city: Skopje
country: Macedonia, The Former Yugoslav Republic of
facility: Novo Nordisk Investigational Site
city: Bath
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Blackburn
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Carmarthen
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Edinburgh
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Leicester
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Manchester
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Middlesbrough
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Northampton
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Nottingham
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Penarth
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Plymouth
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Sheffield
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Torquay
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Wirral, Merseyside
country: United Kingdom
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Davies MJ, Gross JL, Ono Y, Sasaki T, Bantwal G, Gall MA, Niemeyer M, Seino H; BEGIN BB T1 Study Group. Efficacy and safety of insulin degludec given as part of basal-bolus treatment with mealtime insulin aspart in type 1 diabetes: a 26-week randomized, open-label, treat-to-target non-inferiority trial. Diabetes Obes Metab. 2014 Oct;16(10):922-30. doi: 10.1111/dom.12298. Epub 2014 May 8.
citation: Davies M, Sasaki T, Gross JL, Bantwal G, Ono Y, Nishida T, Tojjar D, Seino H. Comparison of insulin degludec with insulin detemir in type 1 diabetes: a 1-year treat-to-target trial. Diabetes Obes Metab. 2016 Jan;18(1):96-9. doi: 10.1111/dom.12573. Epub 2015 Oct 19.