A Trial Comparing Efficacy and Safety of Insulin Degludec and Insulin Glargine in Insulin naïve Subjects With Type 2 Diabetes (BEGIN™)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01849289
First received: May 6, 2013
Last updated: December 10, 2015
Last verified: December 2015
Results First Received: October 16, 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 2
Interventions: Drug: insulin degludec
Drug: insulin glargine

  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 trial was conducted at 68 sites in six countries as follows:

Brazil: 3 sites; Canada: 7 sites; China: 37 sites; South Africa: 4 sites; Ukraine: 6 sites; United States: 11 sites.


Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The subjects discontinued their current Oral Antidiabetic drug (OAD) treatment at Visit 2 (randomisation visit) except for metformin, before starting the treatment with trial drugs.

Reporting Groups
  Description
IDeg OD Insulin degludec (IDeg) 10U was injected subcutaneously (under the skin) once daily (OD) in the evening (start of main evening meal to bedtime) either in the thigh, upper arm (deltoid area) or abdomen along with metformin given orally for 26 weeks. At last treatment visit (Visit 28) subjects were instructed to switch basal insulin treatment to the intermediate acting insulin NPH until the follow-up visit (Visit 29).
IGlar OD Insulin glargine (IGlar) 10U was injected subcutaneously (under the skin) once daily (OD) in the evening (start of main evening meal to bedtime) either in the thigh, upper arm (deltoid area) or abdomen along with metformin given orally for 26 weeks. At last treatment visit (Visit 28) subjects were instructed to switch basal insulin treatment to the intermediate acting insulin NPH until the follow-up visit (Visit 29).

Participant Flow:   Overall Study
    IDeg OD     IGlar OD  
STARTED     555     278  
Exposed     553 [1]   278  
COMPLETED     523     254  
NOT COMPLETED     32     24  
Adverse Event                 3                 3  
Protocol Violation                 3                 3  
Withdrawal criteria                 1                 0  
Unclassified                 25                 18  
[1] 2 subjects withdrew prior to exposure of trial products



  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.
The full analysis set (FAS) included all randomised subjects.

Reporting Groups
  Description
IDeg OD Insulin degludec (IDeg) 10U was injected subcutaneously (under the skin) once daily (OD) in the evening (start of main evening meal to bedtime) either in the thigh, upper arm (deltoid area) or abdomen along with metformin given orally for 26 weeks. At last treatment visit (Visit 28) subjects were instructed to switch basal insulin treatment to the intermediate acting insulin NPH until the follow-up visit (Visit 29).
IGlar OD Insulin glargine (IGlar) 10U was injected subcutaneously (under the skin) once daily (OD) in the evening (start of main evening meal to bedtime) either in the thigh, upper arm (deltoid area) or abdomen along with metformin given orally for 26 weeks. At last treatment visit (Visit 28) subjects were instructed to switch basal insulin treatment to the intermediate acting insulin NPH until the follow-up visit (Visit 29).
Total Total of all reporting groups

Baseline Measures
    IDeg OD     IGlar OD     Total  
Number of Participants  
[units: participants]
  555     278     833  
Age  
[units: years]
Mean (Standard Deviation)
  55.9  (9.7)     56.6  (9.2)     56.2  (9.6)  
Gender  
[units: Subjects]
     
Female     256     146     402  
Male     299     132     431  
HbA1c  
[units: percentage¬†of¬†glycosylated¬†haemoglobin]
Mean (Standard Deviation)
  8.3  (0.9)     8.3  (0.8)     8.3  (0.8)  
Fasting Plasma Glucose (FPG)  
[units: mmol/L]
Mean (Standard Deviation)
  9.4  (2.4)     9.4  (2.5)     9.4  (2.5)  



  Outcome Measures
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1.  Primary:   Change From Baseline in HbA1c (%) (Analysed by Central Laboratory)   [ Time Frame: Week 0, week 26 ]

2.  Secondary:   Number of Severe and Minor Treatment Emergent Hypoglycaemic Episodes   [ Time Frame: On or after the first day of exposure to randomised trial drug (week 0) and no later than 7 days after last exposure to randomised trial drug (week 27) ]

3.  Secondary:   Change From Baseline in FPG (Fasting Plasma Glucose) (Analysed by Central Laboratory)   [ Time Frame: Week 0, week 26 ]

4.  Secondary:   Within-subject Variability as Measured by Coefficient of Variation (CV%) in Pre-breakfast SMPG (Self-measured Plasma Glucose)   [ Time Frame: Week 26 ]

5.  Secondary:   Responder for HbA1c (Below 7.0%) at End of Trial Without Severe and Minor Hypoglycaemic Episodes   [ Time Frame: Week 26 ]

6.  Secondary:   Number of Treatment Emergent AEs (Adverse Events)   [ Time Frame: On or after the first day of exposure to randomised trial drug (week 0) and no later than seven days after last exposure to randomised trial drug (week 27) ]


  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


No publications provided


Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01849289     History of Changes
Other Study ID Numbers: NN1250-3587
U1111-1121-5325 ( Other Identifier: WHO )
Study First Received: May 6, 2013
Results First Received: October 16, 2015
Last Updated: December 10, 2015
Health Authority: Brazil: National Health Surveillance Agency
Canada: Public Health Agency of Canada
China: Ministry of Health
Ukraine: Ministry of Health Ukraine
United States: Food and Drug Administration
South Africa: Medicines Control Council