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Comparison of NN1250 With Insulin Glargine in Type 1 Diabetes (BEGIN™)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01079234
First received: March 2, 2010
Last updated: November 27, 2015
Last verified: November 2015
Results First Received: October 12, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Diabetes
Diabetes Mellitus, Type 1
Interventions: Drug: insulin degludec
Drug: insulin glargine
Drug: insulin aspart

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations

The main/extension trial periods were conducted at 71/68 sites in 6 countries:

Belgium (5/5 sites), Germany (7/7 sites), Norway (5/5 sites), Poland (5/5 sites), United Kingdom (UK) (12/11 sites), and United States of America (U.S.) (37/35 sites). 57 patients did not participate in the extension trial.


Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All subjects who completed the 26-week main trial and were found to be eligible for the extension trial were offered to participate in the 26-week extension trial (NCT01079234). Total duration of trial was up to 52 weeks (26 weeks+ 26 weeks) with two times 7-12 day follow-up periods.

Reporting Groups
  Description
IDeg OD FF Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) with alternating morning and evening dosing according to a fixed flexible (FF) schedule (approximately 8-40 hours intervals) in combination with insulin aspart (IAsp) for 26 weeks in main period. Insulin doses were individually adjusted by the subjects.
IDeg OD Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) with the evening meal in combination with insulin aspart (IAsp) for 26 weeks in main period. Insulin doses were individually adjusted by the subjects.
IGlar OD Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) according to local labelling in combination with insulin aspart (IAsp) for 52 weeks (26 weeks in main period + 26 weeks in extension period). Insulin doses were individually adjusted by the subjects.
IDeg OD F The subjects randomised to the 2 insulin degludec (IDeg) treatment arms in the main period (IDeg OD FF and IDeg OD) were pooled into this IDeg OD Free Flex arm (IDeg OD F). IDeg was given once daily (OD) subcutaneously (s.c.) at any time of the day (approximately 8-40 hours intervals) in combination with insulin aspart (IAsp) for 26 weeks in the extension period (52 weeks in total). Insulin doses were individually adjusted by the subjects.

Participant Flow for 2 periods

Period 1:   Main: Week 0 to 26
    IDeg OD FF     IDeg OD     IGlar OD     IDeg OD F  
STARTED     164     165     164     0  
Exposed     164     165     161 [1]   0  
COMPLETED     138     139     152     0  
NOT COMPLETED     26     26     12     0  
Adverse Event                 5                 4                 1                 0  
Lack of Efficacy                 2                 1                 1                 0  
Protocol Violation                 6                 2                 4                 0  
Withdrawal criteria                 6                 6                 2                 0  
Unclassified                 7                 13                 4                 0  
[1] Three subjects withdrew prior to exposure to trial drug.

Period 2:   Extension: Week 27 to 52
    IDeg OD FF     IDeg OD     IGlar OD     IDeg OD F  
STARTED     0     0     133 [1]   239 [2]
COMPLETED     0     0     122     223  
NOT COMPLETED     0     0     11     16  
Adverse Event                 0                 0                 1                 0  
Lack of Efficacy                 0                 0                 0                 2  
Protocol Violation                 0                 0                 2                 5  
Withdrawal criteria                 0                 0                 4                 2  
Unclassified                 0                 0                 4                 7  
[1] Nineteen subjects from main trial did not continue into extension trial
[2] Thirty eight subjects did not continue into extension trial.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
IDeg OD FF Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) with alternating morning and evening dosing according to a fixed flexible (FF) schedule (approximately 8-40 hours intervals) in combination with insulin aspart (IAsp) for 26 weeks in main period. Insulin doses were individually adjusted by the subjects.
IDeg OD Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) with the evening meal in combination with insulin aspart (IAsp) for 26 weeks in main period. Insulin doses were individually adjusted by the subjects.
IGlar OD Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) according to local labelling in combination with insulin aspart (IAsp) for 52 weeks (26 weeks in main period + 26 weeks in extension period). Insulin doses were individually adjusted by the subjects.
Total Total of all reporting groups

Baseline Measures
    IDeg OD FF     IDeg OD     IGlar OD     Total  
Number of Participants  
[units: participants]
  164     165     164     493  
Age  
[units: years]
Mean (Standard Deviation)
  42.6  (13.4)     44.5  (13.1)     44.1  (12.6)     43.7  (13.1)  
Gender  
[units: participants]
       
Female     62     71     76     209  
Male     102     94     88     284  
HbA1c (glycosylated haemoglobin)  
[units: percentage of glycosylated haemoglobin]
Mean (Standard Deviation)
  7.7  (1.0)     7.7  (0.9)     7.7  (0.9)     7.7  (0.9)  
Fasting plasma glucose (FPG)  
[units: mmol/L]
Mean (Standard Deviation)
  9.6  (4.1)     10.0  (4.0)     9.7  (4.2)     9.8  (4.1)  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 26 Weeks of Treatment   [ Time Frame: Week 0, Week 26 ]

2.  Primary:   Extension Trial (Primary Endpoint): Rate of Confirmed Hypoglycaemic Episodes   [ Time Frame: Week 0 to Week 52 + 7 days follow up ]

3.  Primary:   Extension Trial (Primary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes   [ Time Frame: Week 0 to Week 52 + 7 days follow up ]

4.  Secondary:   Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment   [ Time Frame: Week 0, Week 52 ]

5.  Secondary:   Main Trial (Secondary Endpoint): Change in Fasting Plasma Glucose (FPG) After 26 Weeks of Treatment   [ Time Frame: Week 0, Week 26 ]

6.  Secondary:   Extension Trial (Secondary Endpoint): Change in Fasting Plasma Glucose (FPG) After 52 Weeks of Treatment   [ Time Frame: Week 0, Week 52 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Public Access to Clinical Trials
Organization: Novo Nordisk A/S
e-mail: clinicaltrials@novonordisk.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01079234     History of Changes
Other Study ID Numbers: NN1250-3770
U1111-1112-8813 ( Other Identifier: WHO )
2009-012923-27 ( EudraCT Number )
Study First Received: March 2, 2010
Results First Received: October 12, 2015
Last Updated: November 27, 2015
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
Germany: Federal Institute for Drugs and Medical Devices
Norway: Norwegian Medicines Agency
Poland: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration