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Switching From Insulin Glargine to Insulin Degludec in Subjects With Type 2 Diabetes Mellitus (BEGIN™) (BEGIN™)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01135992
First received: May 31, 2010
Last updated: December 14, 2015
Last verified: December 2015
Results First Received: October 16, 2015  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group 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 27 sites in the United States of America (U.S.)

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The trial was conducted on subjects with type 2 diabetes mellitus currently treated with IGlar once daily (OD) and oral antidiabetic drug (OAD) therapy.

Reporting Groups
  Description
IGlar/IDeg Subjects received 4 weeks of unchanged pre-trial insulin glargine (IGlar) once daily (OD) followed by 12 weeks of insulin degludec (IDeg) 200 U/mL 3 times weekly (3TW) subcutaneously, both in combination with unchanged pre-trial oral antidiabetic drug [OAD] treatment.

Participant Flow:   Overall Study
    IGlar/IDeg  
STARTED     143  
Exposed     142 [1]
Full Analysis Set     129  
COMPLETED     122  
NOT COMPLETED     21  
Adverse Event                 1  
Lack of Efficacy                 1  
Protocol Violation                 2  
Withdrawal criteria                 10  
Unclassified                 7  
[1] One subject was withdrawn before being exposed.



  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)-Includes 129 subjects only as 13 subjects did not receive IDeg.

Reporting Groups
  Description
IGlar/IDeg Subjects received 4 weeks of unchanged pre-trial insulin glargine (IGlar) once daily (OD) followed by 12 weeks of insulin degludec (IDeg) 200 U/mL 3 times weekly (3TW) subcutaneously, both in combination with unchanged pre-trial oral antidiabetic drug [OAD] treatment.

Baseline Measures
    IGlar/IDeg  
Number of Participants  
[units: participants]
  129  
Age  
[units: years]
Mean (Standard Deviation)
  58.7  (10.2)  
Gender  
[units: participants]
 
Female     43  
Male     86  
HbA1c (glycosylated haemoglobin) at baseline  
[units: percentage of glycosylated haemoglobin]
Mean (Standard Deviation)
  7.5  (1.1)  
Fasting plasma glucose (FPG) at baseline  
[units: mmol/L]
Mean (Standard Deviation)
  7.0  (2.2)  
Body weight at baseline  
[units: kg]
Mean (Standard Deviation)
  99.3  (20.4)  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   HbA1c (Glycosylated Haemoglobin)   [ Time Frame: Week 4 and Week 16 ]

2.  Secondary:   Fasting Plasma Glucose (FPG)   [ Time Frame: Week 4 and Week 16 ]

3.  Secondary:   Change in Body Weight   [ Time Frame: Week 0, Week 4, Week 16 ]

4.  Secondary:   Rate of Treatment Emergent Adverse Events (AEs)   [ Time Frame: Weeks 0-4 (IGlar), Weeks 4-16 (IDeg 3TW) ]

5.  Secondary:   Rate of Confirmed Hypoglycaemic Episodes   [ Time Frame: Weeks 0-4 (IGlar), Weeks 4-16 (IDeg 3TW) ]

6.  Secondary:   Rate of Nocturnal Confirmed Hypoglycaemic Episodes   [ Time Frame: Weeks 0-4 (IGlar), Weeks 4-16 (IDeg 3TW) ]


  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



Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01135992     History of Changes
Other Study ID Numbers: NN1250-3839
U1111-1114-8802 ( Other Identifier: WHO )
Study First Received: May 31, 2010
Results First Received: October 16, 2015
Last Updated: December 14, 2015
Health Authority: United States: Food and Drug Administration