Comparison of NN1250 With Insulin Glargine in Subjects With Type 2 Diabetes (BEGIN™)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01068678
First received: February 12, 2010
Last updated: November 19, 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 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 94 sites in 7 countries: Canada (14 sites), Czech Republic (5 sites), Israel (5 sites), Slovakia (5 sites), South Africa (3 sites), United Kingdom (8 sites) and United States (54 sites). In addition, 9 sites (United Kingdom (1 site) and United States (8 sites)) were approved, but did not enroll any subjects.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
IDeg 3TW Insulin degludec (IDeg) 200U/mL given 3 times weekly (Mondays, Wednesdays, Fridays) in the morning with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
IGlar OD Insulin glargine (IGlar) 100U/mL given once a day (OD), according to the labelling instructions with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.

Participant Flow:   Overall Study
    IDeg 3TW     IGlar OD  
STARTED     230     230  
Exposed     227 [1]   229 [2]
COMPLETED     192     206  
NOT COMPLETED     38     24  
Lack of Efficacy                 3                 2  
Protocol Violation                 5                 1  
Withdrawal criteria                 12                 6  
Unclassified                 18                 15  
[1] Three subjects withdrew prior to exposure to trial product.
[2] one subject withdrew prior to exposure to trial product



  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.
Full Analysis Set (FAS)- included all randomised subjects. 1 subject was randomised despite being a screening failure

Reporting Groups
  Description
IDeg 3TW Insulin degludec (IDeg) 200U/mL given 3 times weekly (Mondays, Wednesdays, Fridays) in the morning with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
IGlar OD Insulin glargine (IGlar) 100U/mL given once a day (OD), according to the labelling instructions with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
Total Total of all reporting groups

Baseline Measures
    IDeg 3TW     IGlar OD     Total  
Number of Participants  
[units: participants]
  229     230     459  
Age  
[units: years]
Mean (Standard Deviation)
  58.4  (9.9)     57.9  (9.7)     58.1  (9.8)  
Gender  
[units: participants]
     
Female     105     93     198  
Male     124     137     261  
Glycosylated haemoglobin (HbA1c)  
[units: percentage¬†of¬†glycosylated¬†haemoglobin]
Mean (Standard Deviation)
  8.2  (0.8)     8.3  (0.9)     8.2  (0.8)  
Body weight  
[units: kg]
Mean (Standard Deviation)
  90.8  (18.6)     95.7  (19.0)     93.3  (18.9)  
Fasting Plasma Glucose  
[units: mmol/L]
Mean (Standard Deviation)
  9.3  (2.4)     9.6  (2.4)     9.5  (2.4)  



  Outcome Measures
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1.  Primary:   Change in Glycosylated Haemoglobin (HbA1c)   [ Time Frame: Week 26 ]

2.  Secondary:   Change in Body Weight   [ Time Frame: Week 26 ]


  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: NCT01068678     History of Changes
Other Study ID Numbers: NN1250-3724
2009-011398-33 ( EudraCT Number )
U1111-1113-2412 ( Other Identifier: WHO )
Study First Received: February 12, 2010
Results First Received: October 12, 2015
Last Updated: November 19, 2015
Health Authority: Canada: Health Canada
Czech Republic: State Institute for Drug Control
Israel: Ministry of Health
Slovakia: State Institute for Drug Control
South Africa: Medicines Control Council
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration