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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00982228
First received: September 22, 2009
Last updated: November 24, 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 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 trial was conducted at 79 sites in 6 countries: France (6), Germany (5), Russia (7), South Africa (3), United Kingdom (U.K.) (6) and United States (U.S.) (52).

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 (NN1250-3583, NCT00982228) and were found to be eligible for the extension trial were offered to participate in the 52-week extension trial (NN1250-3644).

Reporting Groups
  Description
IDeg OD Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal time insulin. IDeg was given for 52 weeks in the main period and for an additional 52 weeks in the extension period.
IGlar OD Insulin glargine (IGlar) was given s.c. once daily (OD) according to approved labelling in combination with insulin aspart (IAsp) as meal time insulin. IGlar was given for 52 weeks in the main period and for additional 52 weeks in the extension period.

Participant Flow for 2 periods

Period 1:   Main: Week 0 to 52 (NN1250-3583)
    IDeg OD     IGlar OD  
STARTED     472     157  
Full Analysis Set     472     157  
Exposed     472     154 [1]
COMPLETED     404     137  
NOT COMPLETED     68     20  
Adverse Event                 12                 2  
Lack of Efficacy                 2                 0  
Protocol Violation                 11                 2  
Withdrawal criteria                 15                 3  
Unclassified                 28                 13  
[1] Three subjects withdrew prior to exposure to trial drug

Period 2:   Extension: Week 53 to 104 (NN1250-3644)
    IDeg OD     IGlar OD  
STARTED     351 [1]   118 [2]
COMPLETED     330     113  
NOT COMPLETED     21     5  
Adverse Event                 3                 2  
Lack of Efficacy                 1                 0  
Protocol Violation                 1                 2  
Withdrawal criteria                 5                 0  
Unclassified                 11                 1  
[1] Fifty-three subjects from the main trial did not continue into the extension
[2] Nineteen subjects from the main trial did not continue into the extension



  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) in the evening in combination with insulin aspart (IAsp) as meal time insulin. IDeg was given for 52 weeks in the main period and for an additional 52 weeks in the extension period.
IGlar OD Insulin glargine (IGlar) was given s.c. once daily (OD) according to approved labelling in combination with insulin aspart (IAsp) as meal time insulin. IGlar was given for 52 weeks in the main period and for additional 52 weeks in the extension period.
Total Total of all reporting groups

Baseline Measures
    IDeg OD     IGlar OD     Total  
Number of Participants  
[units: participants]
  472     157     629  
Age  
[units: years]
Mean (Standard Deviation)
  42.8  (13.7)     43.7  (13.3)     43.0  (13.6)  
Gender  
[units: participants]
     
Female     194     67     261  
Male     278     90     368  
Glycosylated haemoglobin (HbA1c)  
[units: percentage of glycosylated haemoglobin]
Mean (Standard Deviation)
  7.7  (0.9)     7.7  (1.0)     7.7  (1.0)  
Fasting plasma glucose (FPG)  
[units: mmol/L]
Mean (Standard Deviation)
  9.1  (4.0)     9.7  (4.4)     9.3  (4.1)  



  Outcome Measures
  Show All Outcome Measures

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 Treatment Emergent Adverse Events (AEs)   [ Time Frame: Week 0 to Week 104 + 7 days follow up ]

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

4.  Primary:   Extension Trial (Primary Endpoint): Cross-reacting Antibodies to Human Insulin   [ Time Frame: Week 0, Week 106 ]

5.  Secondary:   Extension Trial (Primary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes   [ Time Frame: Week 0 to Week 104 + 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:   Extension Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 104 of Treatment   [ Time Frame: Treatment week 104 ]

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

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

10.  Secondary:   Main Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 52   [ Time Frame: 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: NCT00982228     History of Changes
Obsolete Identifiers: NCT01198041
Other Study ID Numbers: NN1250-3583
2008-005774-13 ( EudraCT Number )
U1111-1111-8789 ( Other Identifier: WHO )
2009-015755-24 ( EudraCT Number )
U1111-1116-1578 ( Other Identifier: WHO )
Study First Received: September 22, 2009
Results First Received: October 14, 2015
Last Updated: November 24, 2015
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
United Kingdom: Medicines and Healthcare Products Regulatory Agency
South Africa: Medicines Control Council
United States: Food and Drug Administration
Russia: Federal Service for Control of Health Care and Social Development