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Comparison of NN1250 With Insulin Glargine 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 for 12 months or longer, hereof the last 3 months with injection based therapies
  • Current treatment with any basal insulin (e.g. insulin glargine, insulin detemir, NPH insulin) using one or two daily injections and with three or more daily meal-time insulin injections (e.g. insulin aspart, insulin lispro, insulin glulisine, human insulin) used as bolus insulin therapy
  • HbA1c maximum 10.0 % by central laboratory analysis
  • Body Mass Index (BMI) below or equal to 35.0 kg/m^2
  • Ability to self-manage insulin therapy as assessed by confirmation (verbal confirmation at screening visit) of a changed insulin dose in the preceding two months prior to screening
  • Ability and willingness to adhere to the protocol including performance of self measured plasma glucose (SMPG) profiles and self adjustment of insulin doses

Exclusion Criteria:

  • Use within the last 3 months prior to Visit 1 of any antidiabetic glucose lowering drug other than insulin
  • Cardiovascular disease, within the last 6 months prior to visit 1, defined as: stroke; decompensated heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty
  • Uncontrolled treated/ untreated severe hypertension (systolic blood pressure above or equal to 180 millimetre (mm) mercury (Hg) and/or diastolic blood pressure above or equal to 100 mmHg)
  • Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements
  • Cancer and medical history of cancer (except basal cell skin cancer or squamous cell skin 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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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Flex + insulin aspart

Fixed + insulin aspart

IGlar + insulin aspart

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 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): 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 occurring between 00:01 and 05:59 a.m.

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): 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.

Full Information

First Posted
March 2, 2010
Last Updated
December 16, 2016
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT01079234
Brief Title
Comparison of NN1250 With Insulin Glargine in Type 1 Diabetes
Acronym
BEGIN™
Official Title
A 26-week Trial Investigating the Dosing Flexibility, Efficacy and Safety of NN1250 in Subjects With Type 1 Diabetes With a 26-week Extension (Begin™: Flex T1)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
May 2011 (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 Europe and in the United States of America (USA). The aim of this trial is to investigate the efficacy and safety of NN1250 (insulin degludec) in subjects with type 1 diabetes.

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
493 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Flex + insulin aspart
Arm Type
Experimental
Arm Title
Fixed + insulin aspart
Arm Type
Experimental
Arm Title
IGlar + insulin aspart
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
insulin degludec
Intervention Description
Injected subcutaneously (under the skin) once daily
Intervention Type
Drug
Intervention Name(s)
insulin glargine
Intervention Description
Insulin glargine injected subcutaneously (under the skin) once daily
Intervention Type
Drug
Intervention Name(s)
insulin aspart
Intervention Description
At least three daily doses at meal-time
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 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
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 occurring between 00:01 and 05:59 a.m.
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): 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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Type 1 diabetes for 12 months or longer, hereof the last 3 months with injection based therapies Current treatment with any basal insulin (e.g. insulin glargine, insulin detemir, NPH insulin) using one or two daily injections and with three or more daily meal-time insulin injections (e.g. insulin aspart, insulin lispro, insulin glulisine, human insulin) used as bolus insulin therapy HbA1c maximum 10.0 % by central laboratory analysis Body Mass Index (BMI) below or equal to 35.0 kg/m^2 Ability to self-manage insulin therapy as assessed by confirmation (verbal confirmation at screening visit) of a changed insulin dose in the preceding two months prior to screening Ability and willingness to adhere to the protocol including performance of self measured plasma glucose (SMPG) profiles and self adjustment of insulin doses Exclusion Criteria: Use within the last 3 months prior to Visit 1 of any antidiabetic glucose lowering drug other than insulin Cardiovascular disease, within the last 6 months prior to visit 1, defined as: stroke; decompensated heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty Uncontrolled treated/ untreated severe hypertension (systolic blood pressure above or equal to 180 millimetre (mm) mercury (Hg) and/or diastolic blood pressure above or equal to 100 mmHg) Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements Cancer and medical history of cancer (except basal cell skin cancer or squamous cell skin 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
Encino
State/Province
California
ZIP/Postal Code
91436
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
Huntington Beach
State/Province
California
ZIP/Postal Code
92648
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Redondo Beach
State/Province
California
ZIP/Postal Code
90277
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
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
Denver
State/Province
Colorado
ZIP/Postal Code
80209
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
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
Miami
State/Province
Florida
ZIP/Postal Code
33136
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
Roswell
State/Province
Georgia
ZIP/Postal Code
30076
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Nampa
State/Province
Idaho
ZIP/Postal Code
83686-6011
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Crystal Lake
State/Province
Illinois
ZIP/Postal Code
60012
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50314-2610
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50314
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21204
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
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63141
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
Nashua
State/Province
New Hampshire
ZIP/Postal Code
03063
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Flemington
State/Province
New Jersey
ZIP/Postal Code
08822-5763
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Smithtown
State/Province
New York
ZIP/Postal Code
11787
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Staten Island
State/Province
New York
ZIP/Postal Code
10301
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28803
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
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Morehead City
State/Province
North Carolina
ZIP/Postal Code
28557
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29651
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
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Arlington
State/Province
Texas
ZIP/Postal Code
76014
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
Houston
State/Province
Texas
ZIP/Postal Code
77095
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
Spokane
State/Province
Washington
ZIP/Postal Code
99208
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Aalst
ZIP/Postal Code
9300
Country
Belgium
Facility Name
Novo Nordisk Investigational Site
City
Arlon
ZIP/Postal Code
6700
Country
Belgium
Facility Name
Novo Nordisk Investigational Site
City
Bonheiden
ZIP/Postal Code
2820
Country
Belgium
Facility Name
Novo Nordisk Investigational Site
City
Brussels
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Novo Nordisk Investigational Site
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Novo Nordisk Investigational Site
City
Bad Kreuznach
ZIP/Postal Code
55545
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Falkensee
ZIP/Postal Code
14612
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
22391
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Hamburg
ZIP/Postal Code
22607
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Hohenmölsen
ZIP/Postal Code
06679
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Rehburg-Loccum
ZIP/Postal Code
31547
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Rehlingen-Siersburg
ZIP/Postal Code
66780
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
St. Ingbert
ZIP/Postal Code
66386
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Völklingen
ZIP/Postal Code
66333
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Athens
ZIP/Postal Code
151 23
Country
Greece
Facility Name
Novo Nordisk Investigational Site
City
Athens
ZIP/Postal Code
GR-10552
Country
Greece
Facility Name
Novo Nordisk Investigational Site
City
Athens
ZIP/Postal Code
GR-11527
Country
Greece
Facility Name
Novo Nordisk Investigational Site
City
Thessaloniki
ZIP/Postal Code
54001
Country
Greece
Facility Name
Novo Nordisk Investigational Site
City
Thessaloniki
ZIP/Postal Code
GR-57001
Country
Greece
Facility Name
Novo Nordisk Investigational Site
City
Bergen
ZIP/Postal Code
5021
Country
Norway
Facility Name
Novo Nordisk Investigational Site
City
Elverum
ZIP/Postal Code
2408
Country
Norway
Facility Name
Novo Nordisk Investigational Site
City
Hamar
ZIP/Postal Code
2317
Country
Norway
Facility Name
Novo Nordisk Investigational Site
City
Kongsvinger
ZIP/Postal Code
2212
Country
Norway
Facility Name
Novo Nordisk Investigational Site
City
Stavanger
ZIP/Postal Code
4011
Country
Norway
Facility Name
Novo Nordisk Investigational Site
City
Ålesund
ZIP/Postal Code
6003
Country
Norway
Facility Name
Novo Nordisk Investigational Site
City
Bialystok
ZIP/Postal Code
15-435
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Lublin
ZIP/Postal Code
20-538
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Poznan
ZIP/Postal Code
60-834
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Warszawa
ZIP/Postal Code
02-507
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Belfast
ZIP/Postal Code
BT16 1RH
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Bristol
ZIP/Postal Code
BS10 5NB
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
Hull
ZIP/Postal Code
HU3 2JZ
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Inverness
ZIP/Postal Code
IV2 3JH
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Ipswich
ZIP/Postal Code
IP4 5PD
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Newcastle
ZIP/Postal Code
NE4 6BE
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Rugby
ZIP/Postal Code
CV22 5PX
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Southall
ZIP/Postal Code
UB1 3HW
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Stevenage
ZIP/Postal Code
SG1 4AB
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Swansea
ZIP/Postal Code
SA6 6NL
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Welwyn Garden City
ZIP/Postal Code
AL7 4HQ
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
23130654
Citation
Ratner RE, Gough SC, Mathieu C, Del Prato S, Bode B, Mersebach H, Endahl L, Zinman B. Hypoglycaemia risk with insulin degludec compared with insulin glargine in type 2 and type 1 diabetes: a pre-planned meta-analysis of phase 3 trials. Diabetes Obes Metab. 2013 Feb;15(2):175-84. doi: 10.1111/dom.12032. Epub 2012 Dec 3.
Results Reference
result
PubMed Identifier
26484727
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.
Results Reference
result
PubMed Identifier
24170235
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.
Results Reference
result
PubMed Identifier
26121451
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.
Results Reference
result
PubMed Identifier
26232910
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.
Results Reference
result
PubMed Identifier
26663320
Citation
Vora J, Seufert J, Solberg H, Kinduryte O, Johansen T, Hollander P. Insulin degludec does not increase antibody formation versus insulin glargine: an evaluation of phase IIIa trials. Diabetes Obes Metab. 2016 Jul;18(7):716-20. doi: 10.1111/dom.12621. Epub 2016 Feb 8.
Results Reference
result
PubMed Identifier
23393185
Citation
Mathieu C, Hollander P, Miranda-Palma B, Cooper J, Franek E, Russell-Jones D, Larsen J, Tamer SC, Bain SC; NN1250-3770 (BEGIN: Flex T1) Trial Investigators. Efficacy and safety of insulin degludec in a flexible dosing regimen vs insulin glargine in patients with type 1 diabetes (BEGIN: Flex T1): a 26-week randomized, treat-to-target trial with a 26-week extension. J Clin Endocrinol Metab. 2013 Mar;98(3):1154-62. doi: 10.1210/jc.2012-3249. Epub 2013 Feb 7.
Results Reference
derived
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk

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Comparison of NN1250 With Insulin Glargine in Type 1 Diabetes

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