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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01006291
First received: October 30, 2009
Last updated: October 12, 2015
Last verified: October 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 69 sites in 14 countries: Hungary (3 sites), Macedonia (1 site), Serbia (3 sites), Finland (7 sites), Norway (6 sites), United Kingdom (6 sites), Argentina (4 sites), Mexico (2 sites), South Africa (3 sites), India (10 sites), Malaysia (5 sites), Taiwan (3 sites), Russian Federation (8 sites) and Israel (8 sites).

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 OD FF Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) with or without pre-trial OADs for 26 weeks with alternating morning and evening dosing according to a fixed flexible (FF) schedule (approximately 8-40 hours intervals between doses).
IDeg OD Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) at main evening meal with or without pre-trial OADs for 26 weeks.
IGlar OD Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) according to local labelling with or without pre-trial OADs for 26 weeks.

Participant Flow:   Overall Study
    IDeg OD FF     IDeg OD     IGlar OD  
STARTED     229     228     230  
Exposed     230 [1]   226 [2]   229 [3]
COMPLETED     203     204     203  
NOT COMPLETED     26     24     27  
Adverse Event                 2                 1                 2  
Lack of Efficacy                 2                 2                 1  
Protocol Violation                 3                 3                 3  
Withdrawal criteria                 5                 4                 4  
Other                 14                 14                 17  
[1] 1 subject withdrew before exposure to drug. 2 subjects randomised to IDeg OD received IDeg OD FF
[2] 2 subjects received IDeg OD FF
[3] 1 subject withdrew prior to exposure to trial drug



  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 or without pre-trial OADs for 26 weeks with alternating morning and evening dosing according to a fixed flexible (FF) schedule (approximately 8-40 hours intervals between doses).
IDeg OD Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) at main evening meal with or without pre-trial OADs for 26 weeks.
IGlar OD Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) according to local labelling with or without pre-trial OADs for 26 weeks.
Total Total of all reporting groups

Baseline Measures
    IDeg OD FF     IDeg OD     IGlar OD     Total  
Number of Participants  
[units: participants]
  229     228     230     687  
Age  
[units: years]
Mean (Standard Deviation)
  56.2  (10.3)     56.5  (9.6)     56.7  (8.8)     56.4  (9.6)  
Gender  
[units: participants]
       
Female     94     104     119     317  
Male     135     124     111     370  
Glycosylated haemoglobin (HbA1c)  
[units: percentage of glycosylated haemoglobin]
Mean (Standard Deviation)
  8.5  (1.0)     8.4  (0.9)     8.4  (0.9)     8.4  (0.9)  
Fasting plasma glucose (FPG)  
[units: mmol/L]
Mean (Standard Deviation)
  9.0  (2.6)     8.8  (2.8)     9.0  (2.8)     8.9  (2.7)  



  Outcome Measures
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1.  Primary:   Change in Glycosylated Haemoglobin (HbA1c)   [ Time Frame: Week 0, Week 26 ]

2.  Secondary:   Mean of 9-point Self Measured Plasma Glucose Profile (SMPG)   [ Time Frame: Week 26 ]

3.  Secondary:   Rate of Confirmed Hypoglycaemic Episodes   [ Time Frame: Week 0 to Week 26 + 7 days follow up ]

4.  Secondary:   Rate of Nocturnal Confirmed Hypoglycaemic Episodes   [ Time Frame: Week 0 to Week 26 + 7 days follow up ]


  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: NCT01006291     History of Changes
Other Study ID Numbers: NN1250-3668
U1111-1111-7084 ( Other Identifier: WHO )
2008-005771-10 ( EudraCT Number )
Study First Received: October 30, 2009
Results First Received: October 12, 2015
Last Updated: October 12, 2015
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia
Finland: Finnish Medicines Agency
Hungary: National Institute of Pharmacy
India: Ministry of Health
Israel: Israeli Health Ministry Pharmaceutical Administration
Macedonia, The Former Yugoslav Republic of: Drug Agency, Ministry of Health
Malaysia: Ministry of Health
Mexico: National Institute of Public Health, Health Secretariat
Norway: Norwegian Medicines Agency
Russia: Pharmacological Committee, Ministry of Health
Serbia: Agency for Drugs and Medicinal Devices
South Africa: Medicines Control Council
Taiwan: Department of Health, Executive Yuan, R.O.C.
United Kingdom: Medicines and Healthcare Products Regulatory Agency