Comparison of NN1250 Versus 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:
NCT00982644
First received: September 22, 2009
Last updated: November 20, 2015
Last verified: November 2015
Results First Received: October 14, 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 166 sites in 12 countries: Austria (6 sites), Belgium (5 sites), Canada (17 sites), Czech Republic (5 sites), Denmark (6 sites), Finland (6 sites), France (7 sites), Germany (16 sites), Norway (8 sites), Serbia (5 sites), Spain (9 sites) and United States (76 sites). Some subjects did not enrol in the extension period.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All subjects who completed the 52-week main trial (NN51250-3579, NCT00982644) and when found to be eligible for the extension trial, were offered to participate in the 52-week extension trial (NN1250-3643). The total duration of treatment was up to 104 weeks (52 weeks + 52 weeks).

Reporting Groups
  Description
IDeg OD Insulin degludec (IDeg) was given subcutaneously (s.c) once daily (OD) with the main evening meal in combination with metformin with or without DPP-IV inhibitors. IDeg was given for 52 weeks in the main period and for another 52 weeks in the extension period.
IGlar OD Insulin glargine (IGlar) was given subcutaneously (s.c) once daily (OD), according to the local labelling in combination with metformin with or without DPP-IV inhibitors. IGlar was given for 52 weeks in the main period and for another 52 weeks in the extension period.

Participant Flow for 2 periods

Period 1:   Main: Week 0 to 52 (NN1250-3579)
    IDeg OD     IGlar OD  
STARTED     773     257  
Full Analysis Set     773     257  
Exposed     766 [1]   257  
COMPLETED     607     197  
NOT COMPLETED     166     60  
Adverse Event                 20                 5  
Lack of Efficacy                 7                 2  
Protocol Violation                 46                 18  
Withdrawal criteria                 9                 5  
Unclassified                 84                 30  
[1] 7 subjects were withdrawn prior to exposure to trial products

Period 2:   Extension: Week 53 to 104 (NN1250-3643)
    IDeg OD     IGlar OD  
STARTED     551 [1]   174 [2]
COMPLETED     505     154  
NOT COMPLETED     46     20  
Adverse Event                 12                 5  
Lack of Efficacy                 3                 1  
Protocol Violation                 2                 4  
Withdrawal criteria                 6                 3  
Unclassified                 23                 7  
[1] Fifty-six subjects did not continue into extension trial
[2] Twenty-three 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 Insulin degludec (IDeg) was given subcutaneously (s.c) once daily (OD) with the main evening meal in combination with metformin with or without DPP-IV inhibitors. IDeg was given for 52 weeks in the main period and for another 52 weeks in the extension period.
IGlar OD Insulin glargine (IGlar) was given subcutaneously (s.c) once daily (OD), according to the local labelling in combination with metformin with or without DPP-IV inhibitors. IGlar was given for 52 weeks in the main period and for another 52 weeks in the extension period.
Total Total of all reporting groups

Baseline Measures
    IDeg OD     IGlar OD     Total  
Number of Participants  
[units: participants]
  773     257     1030  
Age  
[units: years]
Mean (Standard Deviation)
  59.3  (9.7)     58.7  (9.9)     59.1  (9.8)  
Gender  
[units: participants]
     
Female     302     90     392  
Male     471     167     638  
Glycosylated haemoglobin (HbA1c)  
[units: percentage of glycosylated haemoglobin]
Mean (Standard Deviation)
  8.2  (0.8)     8.2  (0.8)     8.2  (0.8)  
Fasting plasma glucose (FPG)  
[units: mmol/L]
Mean (Standard Deviation)
  9.6  (2.6)     9.7  (2.6)     9.7  (2.6)  



  Outcome Measures
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1.  Primary:   Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment   [ Time Frame: Week 0, Week 52 ]

2.  Primary:   Extension Trial (Primary Endpoint): Rate of Confirmed Hypoglycaemic Episodes   [ Time Frame: Week 0 to Week 104 + 7 days follow up ]

3.  Primary:   Extension Trial (Primary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes   [ Time Frame: Week 0 to Week 104 + 7 days follow up ]

4.  Primary:   Extension Trial (Primary Endpoint): Rate of Treatment Emergent Adverse Events (AEs)   [ Time Frame: Week 0 to Week 104 + 7 days of follow up ]

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

6.  Secondary:   Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 104 Weeks of Treatment   [ Time Frame: Week 0, Week 104 ]

7.  Secondary:   Main Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 52   [ Time Frame: Week 52 ]

8.  Secondary:   Extension Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 104   [ Time Frame: Week 104 ]

9.  Secondary:   Main Trial (Secondary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes   [ Time Frame: Week 0 to Week 52 + 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: NCT00982644     History of Changes
Obsolete Identifiers: NCT01193309
Other Study ID Numbers: NN1250-3579
2008-005776-27 ( EudraCT Number )
U1111-1111-8692 ( Other Identifier: WHO )
2009-015754-38 ( EudraCT Number )
U1111-1114-9426 ( Other Identifier: WHO )
Study First Received: September 22, 2009
Results First Received: October 14, 2015
Last Updated: November 20, 2015
Health Authority: Austria: Agency for Health and Food Safety
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Canada: Health Canada
Czech Republic: State Institute for Drug Control
Denmark: Danish Medicines Agency
Finland: Finnish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Norway: Norwegian Medicines Agency
Serbia: Agency for Drugs and Medicinal Devices
Spain: Spanish Agency of Medicines
United States: Food and Drug Administration