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Comparison of NN1250 Plus Insulin Aspart With Insulin Glargine 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 glargine
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%
  • BMI (Body Mass Index) below or equal to 35.0 kg/m^2
  • For the extension trial only: Completion of the 52 week treatment period in trial NN1250-3583 (NCT00982228)

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 according to local requirements
  • Cancer and medical history of cancer

Sites / Locations

  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

IDeg OD

IGlar OD

Arm Description

Outcomes

Primary Outcome Measures

Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment
Change from baseline in HbA1c after 52 weeks of treatment
Extension Trial (Primary Endpoint): Rate of Treatment Emergent Adverse Events (AEs)
Corresponds to rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild: no or 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.
Extension Trial (Primary 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 are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.
Extension Trial (Primary Endpoint): Cross-reacting Antibodies to Human Insulin
The unit for measuring antibody levels is amount of tracer bound to the antibodies in the precipitate (B) expressed in percentage of the total amount of tracer (T) added to the mixture (%B/T). Samples were taken before 1st dosing and after a 1-week wash-out period.

Secondary Outcome Measures

Extension Trial (Primary 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 are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occuring between 00:01 and 05:59 a.m.
Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 104 Weeks of Treatment
Change from baseline in HbA1c after 104 weeks of treatment
Extension Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 104 of Treatment
Mean of 9-point self-measured plasma glucose profile (SMPG) after 104 weeks of treatment. Plasma glucose measured: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, bedtime, at 4 am and before breakfast.
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 are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.
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 are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occuring between 00:01 and 05:59 a.m.
Main 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) after 52 weeks of treatment. Plasma glucose measured: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, bedtime, at 4 am and before breakfast.

Full Information

First Posted
September 22, 2009
Last Updated
March 8, 2017
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT00982228
Brief Title
Comparison of NN1250 Plus Insulin Aspart With Insulin Glargine Plus Insulin Aspart in Type 1 Diabetes
Acronym
BEGIN™
Official Title
NN1250-3583: A 52 Week Randomised, Controlled, Open Label, Multicentre, Multinational, Parallel, Treat-to-target Trial Comparing Efficacy and Safety of SIBA and Insulin Glargine Both Administered Once Daily in a Basal-bolus Regimen With Insulin Aspart as Mealtime Insulin in Subjects With Type 1 Diabetes (BEGIN™: BB T1 LONG) / NN1250-3644: An Extension Trial to Trial NN1250-3583 Comparing Safety and Efficacy of NN1250 With Insulin Glargine, Both With Insulin Aspart as Meal-time Insulin, in Type 1 Diabetes (BEGIN™: T1)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
September 1, 2009 (Actual)
Primary Completion Date
November 8, 2010 (Actual)
Study Completion Date
November 8, 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 Africa, Europe and the United States of America (USA). The aim of the trial is to compare NN1250 (insulin degludec, soluble insulin basal analogue (SIBA)) plus insulin aspart with insulin glargine (IGlar) plus insulin aspart in patients with type 1 diabetes. The main period is registered internally at Novo Nordisk as NN1250-3583 while the extension period is registered as NN1250-3644.

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
629 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IDeg OD
Arm Type
Experimental
Arm Title
IGlar OD
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
insulin degludec
Intervention Description
Injected subcutaneously once daily. Dose was individually adjusted.
Intervention Type
Drug
Intervention Name(s)
insulin glargine
Intervention Description
Injected subcutaneously once daily. Dose individually adjusted.
Intervention Type
Drug
Intervention Name(s)
insulin aspart
Intervention Description
Injected subcutaneously as mealtime insulin. Dose was individually adjusted.
Primary Outcome Measure Information:
Title
Main Trial (Primary 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
Extension Trial (Primary Endpoint): Rate of Treatment Emergent Adverse Events (AEs)
Description
Corresponds to rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild: no or 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.
Time Frame
Week 0 to Week 104 + 7 days follow up
Title
Extension Trial (Primary 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 are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.
Time Frame
Week 0 to Week 104 + 7 days follow up
Title
Extension Trial (Primary Endpoint): Cross-reacting Antibodies to Human Insulin
Description
The unit for measuring antibody levels is amount of tracer bound to the antibodies in the precipitate (B) expressed in percentage of the total amount of tracer (T) added to the mixture (%B/T). Samples were taken before 1st dosing and after a 1-week wash-out period.
Time Frame
Week 0, Week 106
Secondary Outcome Measure Information:
Title
Extension Trial (Primary 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 are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occuring between 00:01 and 05:59 a.m.
Time Frame
Week 0 to Week 104 + 7 days follow up
Title
Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 104 Weeks of Treatment
Description
Change from baseline in HbA1c after 104 weeks of treatment
Time Frame
Week 0, Week 104
Title
Extension Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 104 of Treatment
Description
Mean of 9-point self-measured plasma glucose profile (SMPG) after 104 weeks of treatment. Plasma glucose measured: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, bedtime, at 4 am and before breakfast.
Time Frame
Treatment week 104
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 are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.
Time Frame
Week 0 to Week 52 + 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 are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. 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
Title
Main 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) after 52 weeks of treatment. Plasma glucose measured: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, bedtime, at 4 am and before breakfast.
Time Frame
Week 52

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% BMI (Body Mass Index) below or equal to 35.0 kg/m^2 For the extension trial only: Completion of the 52 week treatment period in trial NN1250-3583 (NCT00982228) 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 according to local requirements 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
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Peoria
State/Province
Arizona
ZIP/Postal Code
85381
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Concord
State/Province
California
ZIP/Postal Code
94520
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Greenbrae
State/Province
California
ZIP/Postal Code
94904
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92648
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Los Gatos
State/Province
California
ZIP/Postal Code
95032
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93105
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Tustin
State/Province
California
ZIP/Postal Code
92780
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Ventura
State/Province
California
ZIP/Postal Code
93003
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598-3347
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045-7402
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Lake Mary
State/Province
Florida
ZIP/Postal Code
32746
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30318
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Lawrenceville
State/Province
Georgia
ZIP/Postal Code
30046
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96814
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611-2661
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Vincennes
State/Province
Indiana
ZIP/Postal Code
47591-1029
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536-0284
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Scarborough
State/Province
Maine
ZIP/Postal Code
04074-9302
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Hyattsville
State/Province
Maryland
ZIP/Postal Code
20782
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20852
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Brockton
State/Province
Massachusetts
ZIP/Postal Code
02301
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Flint
State/Province
Michigan
ZIP/Postal Code
48503-5904
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Livonia
State/Province
Michigan
ZIP/Postal Code
48154
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Eagan
State/Province
Minnesota
ZIP/Postal Code
55123
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Jefferson City
State/Province
Missouri
ZIP/Postal Code
65109
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
St. Charles
State/Province
Missouri
ZIP/Postal Code
63303
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68124
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Dover
State/Province
New Hampshire
ZIP/Postal Code
03820
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Lawrenceville
State/Province
New Jersey
ZIP/Postal Code
08648
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Flushing
State/Province
New York
ZIP/Postal Code
11365
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Rochester
State/Province
New York
ZIP/Postal Code
14607
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27517
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43203
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224-2215
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37411
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79423
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Round Rock
State/Province
Texas
ZIP/Postal Code
78681
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
St. George
State/Province
Utah
ZIP/Postal Code
84790
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Renton
State/Province
Washington
ZIP/Postal Code
98057
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53209
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Boisguillaume
ZIP/Postal Code
76233
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Brest
ZIP/Postal Code
29609
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
Novo Nordisk Investigational Site
City
LA ROCHELLE cedex
ZIP/Postal Code
17019
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Montpellier
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Nice
ZIP/Postal Code
06002
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Paris
ZIP/Postal Code
75877
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Aschaffenburg
ZIP/Postal Code
63739
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Bad Kreuznach
ZIP/Postal Code
55545
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Dormagen
ZIP/Postal Code
41539
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Hamburg
ZIP/Postal Code
21073
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Hamburg
ZIP/Postal Code
22607
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
St. Ingbert
ZIP/Postal Code
66386
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Moscow
ZIP/Postal Code
117036
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Moscow
ZIP/Postal Code
119034
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Moscow
ZIP/Postal Code
127486
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Novosibirsk
ZIP/Postal Code
630047
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Saint-Peterburg
ZIP/Postal Code
190068
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Saint-Petersburg
ZIP/Postal Code
194354
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Tumen
ZIP/Postal Code
625023
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Yaroslavl
ZIP/Postal Code
150062
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
1724
Country
South Africa
Facility Name
Novo Nordisk Investigational Site
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7130
Country
South Africa
Facility Name
Novo Nordisk Investigational Site
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7925
Country
South Africa
Facility Name
Novo Nordisk Investigational Site
City
Aberdeen
ZIP/Postal Code
AB25 1LD
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Birmingham
ZIP/Postal Code
B9 5SS
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Bradford
ZIP/Postal Code
BD9 6RJ
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Glasgow
ZIP/Postal Code
G21 3UW
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Guildford
ZIP/Postal Code
GU2 7XX
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Llantrisant
ZIP/Postal Code
CF72 8XR
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Sheffield
ZIP/Postal Code
S5 7AU
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
23130654
Citation
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Citation
Heller S, Mathieu C, Kapur R, Wolden ML, Zinman B. A meta-analysis of rate ratios for nocturnal confirmed hypoglycaemia with insulin degludec vs. insulin glargine using different definitions for hypoglycaemia. Diabet Med. 2016 Apr;33(4):478-87. doi: 10.1111/dme.13002. Epub 2015 Dec 13.
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Citation
Sorli C, Warren M, Oyer D, Mersebach H, Johansen T, Gough SC. Elderly patients with diabetes experience a lower rate of nocturnal hypoglycaemia with insulin degludec than with insulin glargine: a meta-analysis of phase IIIa trials. Drugs Aging. 2013 Dec;30(12):1009-18. doi: 10.1007/s40266-013-0128-2.
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Citation
Einhorn D, Handelsman Y, Bode BW, Endahl LA, Mersebach H, King AB. PATIENTS ACHIEVING GOOD GLYCEMIC CONTROL (HBA1c <7%) EXPERIENCE A LOWER RATE OF HYPOGLYCEMIA WITH INSULIN DEGLUDEC THAN WITH INSULIN GLARGINE: A META-ANALYSIS OF PHASE 3A TRIALS. Endocr Pract. 2015 Aug;21(8):917-26. doi: 10.4158/EP14523.OR. Epub 2015 Jun 29.
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PubMed Identifier
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Citation
Russell-Jones D, Gall MA, Niemeyer M, Diamant M, Del Prato S. Insulin degludec results in lower rates of nocturnal hypoglycaemia and fasting plasma glucose vs. insulin glargine: A meta-analysis of seven clinical trials. Nutr Metab Cardiovasc Dis. 2015 Oct;25(10):898-905. doi: 10.1016/j.numecd.2015.06.005. Epub 2015 Jun 18.
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PubMed Identifier
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Citation
Vora J, Christensen T, Rana A, Bain SC. Insulin degludec versus insulin glargine in type 1 and type 2 diabetes mellitus: a meta-analysis of endpoints in phase 3a trials. Diabetes Ther. 2014 Dec;5(2):435-46. doi: 10.1007/s13300-014-0076-9. Epub 2014 Aug 1.
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Citation
Aye MM, Atkin SL. Patient safety and minimizing risk with insulin administration - role of insulin degludec. Drug Healthc Patient Saf. 2014 Apr 30;6:55-67. doi: 10.2147/DHPS.S59566. eCollection 2014.
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Citation
Heller S, Buse J, Fisher M, Garg S, Marre M, Merker L, Renard E, Russell-Jones D, Philotheou A, Francisco AM, Pei H, Bode B; BEGIN Basal-Bolus Type 1 Trial Investigators. Insulin degludec, an ultra-longacting basal insulin, versus insulin glargine in basal-bolus treatment with mealtime insulin aspart in type 1 diabetes (BEGIN Basal-Bolus Type 1): a phase 3, randomised, open-label, treat-to-target non-inferiority trial. Lancet. 2012 Apr 21;379(9825):1489-97. doi: 10.1016/S0140-6736(12)60204-9.
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Evans M, Chubb B, Gundgaard J. Cost-effectiveness of Insulin Degludec Versus Insulin Glargine in Adults with Type 1 and Type 2 Diabetes Mellitus. Diabetes Ther. 2017 Apr;8(2):275-291. doi: 10.1007/s13300-017-0236-9. Epub 2017 Feb 16.
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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 Glargine Plus Insulin Aspart in Type 1 Diabetes

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