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Comparison of NN1250 Plus Insulin Aspart With Insulin Detemir Plus Insulin Aspart in Type 1 Diabetes (BEGIN™)

Primary Purpose

Diabetes, Diabetes Mellitus, Type 1

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
insulin degludec
insulin detemir
insulin aspart
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
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  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

IDeg OD

IDet

Arm Description

Outcomes

Primary Outcome Measures

Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 26 Weeks of Treatment
Change from baseline in HbA1c after 26 weeks of treatment
Extension Trial (Primary Endpoint): Rate of Treatment Emergent Adverse Events (AEs)
Rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild: no/transient symptoms, no interference with subject's daily activities. Moderate: marked symptoms, moderate interference with subject's daily activities. Severe: considerable interference with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect or important medical issues

Secondary Outcome Measures

Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment
Change from baseline in HbA1c after 52 weeks of treatment
Main Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 26
Mean of 9-point self-measured plasma glucose profile (SMPG) after week 26. Plasma glucose was measured before breakfast, 90 minutes after the start of breakfast, before lunch, 90 minutes after the start of lunch, before main evening meal, 90 minutes after the start of main evening meal, before bedtime, at 04:00 AM and before breakfast on the following day.
Extension Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 52
Mean of 9-point self-measured plasma glucose profile (SMPG) at week 52. Plasma glucose was measured before breakfast, 90 minutes after the start of breakfast, before lunch, 90 minutes after the start of lunch, before main evening meal, 90 minutes after the start of main evening meal, before bedtime, at 04:00 AM and before breakfast on the following day.
Main Trial (Secondary Endpoint): Change in Fasting Plasma Glucose (FPG) After 26 Weeks of Treatment
Change from baseline in FPG after 26 weeks of treatment
Extension Trial (Secondary Endpoint): Change in Fasting Plasma Glucose (FPG) After 52 Weeks of Treatment
Change from baseline in FPG after 52 weeks of treatment
Main Trial (Secondary Endpoint): Rate of Confirmed Hypoglycaemic Episodes
Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes: episodes requiring active assistance of another person to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes: episodes where the subject was able to treat her/himself and plasma glucose below 3.1 mmol/L, with or without symptoms.
Main Trial (Secondary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes
Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes: episodes requiring active assistance of another person to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes: episodes where subject was able to treat her/himself and plasma glucose below 3.1 mmol/L, with or without symptoms. Nocturnal hypoglycaemic episodes are defined as occuring between 00:01 and 05:59 a.m.
Extension Trial (Secondary Endpoint): Rate of Confirmed Hypoglycaemic Episodes
Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes: episodes requiring active assistance of another person to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes: episodes where the subject was able to treat her/himself and plasma glucose below 3.1 mmol/L with or without symptoms
Extension Trial (Secondary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes
Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes: episodes requiring active assistance of another person to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes: episodes where subject was able to treat her/himself and plasma glucose below 3.1 mmol/L, with or without symptoms. Nocturnal hypoglycaemic episodes are defined as occuring between 00:01 and 05:59 a.m.

Full Information

First Posted
February 22, 2010
Last Updated
January 20, 2017
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT01074268
Brief Title
Comparison of NN1250 Plus Insulin Aspart With Insulin Detemir Plus Insulin Aspart in Type 1 Diabetes
Acronym
BEGIN™
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

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Diabetes Mellitus, Type 1

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
456 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IDeg OD
Arm Type
Experimental
Arm Title
IDet
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
insulin degludec
Intervention Description
Injected s.c. (under the skin) once daily. Dose was individually adjusted.
Intervention Type
Drug
Intervention Name(s)
insulin detemir
Intervention Description
Injected s.c. (under the skin) once daily or twice daily (BID). Dose was individually adjusted.
Intervention Type
Drug
Intervention Name(s)
insulin aspart
Intervention Description
Injected s.c. (under the skin) as mealtime insulin. Dose was individually adjusted.
Primary Outcome Measure Information:
Title
Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 26 Weeks of Treatment
Description
Change from baseline in HbA1c after 26 weeks of treatment
Time Frame
Week 0, Week 26
Title
Extension Trial (Primary Endpoint): Rate of Treatment Emergent Adverse Events (AEs)
Description
Rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild: no/transient symptoms, no interference with subject's daily activities. Moderate: marked symptoms, moderate interference with subject's daily activities. Severe: considerable interference with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect or important medical issues
Time Frame
Week 0 to Week 52 + 7 days follow up
Secondary Outcome Measure Information:
Title
Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment
Description
Change from baseline in HbA1c after 52 weeks of treatment
Time Frame
Week 0, Week 52
Title
Main Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 26
Description
Mean of 9-point self-measured plasma glucose profile (SMPG) after week 26. Plasma glucose was measured before breakfast, 90 minutes after the start of breakfast, before lunch, 90 minutes after the start of lunch, before main evening meal, 90 minutes after the start of main evening meal, before bedtime, at 04:00 AM and before breakfast on the following day.
Time Frame
Week 26
Title
Extension Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 52
Description
Mean of 9-point self-measured plasma glucose profile (SMPG) at week 52. Plasma glucose was measured before breakfast, 90 minutes after the start of breakfast, before lunch, 90 minutes after the start of lunch, before main evening meal, 90 minutes after the start of main evening meal, before bedtime, at 04:00 AM and before breakfast on the following day.
Time Frame
Week 52
Title
Main Trial (Secondary Endpoint): Change in Fasting Plasma Glucose (FPG) After 26 Weeks of Treatment
Description
Change from baseline in FPG after 26 weeks of treatment
Time Frame
Week 0, Week 26
Title
Extension Trial (Secondary Endpoint): Change in Fasting Plasma Glucose (FPG) After 52 Weeks of Treatment
Description
Change from baseline in FPG after 52 weeks of treatment
Time Frame
Week 0, Week 52
Title
Main Trial (Secondary Endpoint): Rate of Confirmed Hypoglycaemic Episodes
Description
Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes: episodes requiring active assistance of another person to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes: episodes where the subject was able to treat her/himself and plasma glucose below 3.1 mmol/L, with or without symptoms.
Time Frame
Week 0 to Week 26 + 7 days follow up
Title
Main Trial (Secondary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes
Description
Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes: episodes requiring active assistance of another person to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes: episodes where subject was able to treat her/himself and plasma glucose below 3.1 mmol/L, with or without symptoms. Nocturnal hypoglycaemic episodes are defined as occuring between 00:01 and 05:59 a.m.
Time Frame
Week 0 to Week 26 + 7 days follow up
Title
Extension Trial (Secondary Endpoint): Rate of Confirmed Hypoglycaemic Episodes
Description
Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes: episodes requiring active assistance of another person to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes: episodes where the subject was able to treat her/himself and plasma glucose below 3.1 mmol/L with or without symptoms
Time Frame
Week 0 to Week 52 + 7 days follow up
Title
Extension Trial (Secondary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes
Description
Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes: episodes requiring active assistance of another person to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes: episodes where subject was able to treat her/himself and plasma glucose below 3.1 mmol/L, with or without symptoms. Nocturnal hypoglycaemic episodes are defined as occuring between 00:01 and 05:59 a.m.
Time Frame
Week 0 to Week 52 + 7 days follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Caba
ZIP/Postal Code
C1440AAD
Country
Argentina
Facility Name
Novo Nordisk Investigational Site
City
Ciudad Autónoma de Bs As
ZIP/Postal Code
C1426ABP
Country
Argentina
Facility Name
Novo Nordisk Investigational Site
City
Mar del Plata
ZIP/Postal Code
B7600FZN
Country
Argentina
Facility Name
Novo Nordisk Investigational Site
City
Rosario
ZIP/Postal Code
2000
Country
Argentina
Facility Name
Novo Nordisk Investigational Site
City
Porto Alegre
State/Province
Rio Grande do Sul
ZIP/Postal Code
91350-250
Country
Brazil
Facility Name
Novo Nordisk Investigational Site
City
São Paulo
State/Province
Sao Paulo
ZIP/Postal Code
01244-030
Country
Brazil
Facility Name
Novo Nordisk Investigational Site
City
Marília
ZIP/Postal Code
17519-000
Country
Brazil
Facility Name
Novo Nordisk Investigational Site
City
Porto Alegre
ZIP/Postal Code
90035-170
Country
Brazil
Facility Name
Novo Nordisk Investigational Site
City
Sao Paulo
ZIP/Postal Code
04022-001
Country
Brazil
Facility Name
Novo Nordisk Investigational Site
City
Helsinki
ZIP/Postal Code
00250
Country
Finland
Facility Name
Novo Nordisk Investigational Site
City
Helsinki
ZIP/Postal Code
00260
Country
Finland
Facility Name
Novo Nordisk Investigational Site
City
Hämeenlinna
ZIP/Postal Code
13530
Country
Finland
Facility Name
Novo Nordisk Investigational Site
City
Kuopio
ZIP/Postal Code
70210
Country
Finland
Facility Name
Novo Nordisk Investigational Site
City
Lahti
ZIP/Postal Code
15110
Country
Finland
Facility Name
Novo Nordisk Investigational Site
City
Seinäjoki
ZIP/Postal Code
60220
Country
Finland
Facility Name
Novo Nordisk Investigational Site
City
Tampere
ZIP/Postal Code
33520
Country
Finland
Facility Name
Novo Nordisk Investigational Site
City
Turku
ZIP/Postal Code
FI-20520
Country
Finland
Facility Name
Novo Nordisk Investigational Site
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560034
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Chennai
State/Province
Tamil Nadu
ZIP/Postal Code
600029
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Chennai
State/Province
Tamil Nadu
ZIP/Postal Code
600086
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Ahmedabad
ZIP/Postal Code
380015
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Bilaspur
ZIP/Postal Code
495001
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Dhantoli, Nagpur
ZIP/Postal Code
440012
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Hyderabad
ZIP/Postal Code
500034
Country
India
Facility Name
Novo Nordisk Investigational Site
City
New Dehli
ZIP/Postal Code
110029
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Ramdaspeth / Nagpur
ZIP/Postal Code
440010
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Thriruvananthapuram
ZIP/Postal Code
695 032
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Bari
ZIP/Postal Code
70124
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Forlì
ZIP/Postal Code
47100
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Gazi
ZIP/Postal Code
98124
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Milano
ZIP/Postal Code
200122
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Milano
ZIP/Postal Code
20162
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Olbia
ZIP/Postal Code
07026
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Palermo
ZIP/Postal Code
90127
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Partinico
ZIP/Postal Code
90047
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Treviglio
ZIP/Postal Code
24047
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Treviso
ZIP/Postal Code
31100
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Chuo-ku, Tokyo
ZIP/Postal Code
103 0002
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Ebina-shi
ZIP/Postal Code
243 0432
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Imizu-shi
ZIP/Postal Code
939 0363
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Izumisano-shi
ZIP/Postal Code
598 0048
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Koriyama-shi, Fukushima
ZIP/Postal Code
963 8851
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Kumamoto-shi,Kumamoto
ZIP/Postal Code
862 0976
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Miyazaki-shi
ZIP/Postal Code
880 0034
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Naka-shi, Ibaraki
ZIP/Postal Code
311 0113
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Nishinomiya-shi, Hygo
ZIP/Postal Code
662 0971
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Oita-shi
ZIP/Postal Code
870 0039
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Ota-ku, Tokyo
ZIP/Postal Code
144 0035
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Sapporo-shi, Hokkaido
ZIP/Postal Code
060 0062
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Sapporo-shi, Hokkaido
ZIP/Postal Code
060-0001
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Sapporo-shi, Hokkaido
ZIP/Postal Code
062 0007
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Yokohama-shi
ZIP/Postal Code
235 0045
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Skopje
ZIP/Postal Code
1000
Country
Macedonia, The Former Yugoslav Republic of
Facility Name
Novo Nordisk Investigational Site
City
Bath
ZIP/Postal Code
BA1 3NG
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Blackburn
ZIP/Postal Code
BB2 3HH
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Carmarthen
ZIP/Postal Code
SA31 2AF
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Edinburgh
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Leicester
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Manchester
ZIP/Postal Code
M8 5RB
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Middlesbrough
ZIP/Postal Code
TS4 3BW
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Northampton
ZIP/Postal Code
NN1 5BD
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Nottingham
ZIP/Postal Code
NG7 2UH
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Penarth
ZIP/Postal Code
CF64 2XX
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Plymouth
ZIP/Postal Code
PL6 8BQ
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Sheffield
ZIP/Postal Code
S5 7AU
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Torquay
ZIP/Postal Code
TQ2 7AA
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Wirral, Merseyside
ZIP/Postal Code
CH63 4JY
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
24702700
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.
Results Reference
result
PubMed Identifier
26435472
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.
Results Reference
result
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk

Learn more about this trial

Comparison of NN1250 Plus Insulin Aspart With Insulin Detemir Plus Insulin Aspart in Type 1 Diabetes

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