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Comparing the Efficacy and Safety of NN1250 Once Daily When Titrated Using 2 Different Algorithms in Insulin naïve Subjects With Type 2 Diabetes Mellitus (BEGIN™)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01326026
First received: March 29, 2011
Last updated: October 16, 2015
Last verified: October 2015
Results First Received: October 16, 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
Intervention: Drug: insulin degludec

  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 43 sites in 4 countries: Finland (5), Germany (6), Spain (6) and United States of America (26).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects continued on metformin treatment at the pre-randomisation dose level and dosing frequency.

Reporting Groups
  Description
IDeg Simple Insulin degludec (IDeg) was given once daily (OD) subcutaneously (approximately 8-40 hours intervals between doses) with pre-trial metformin according to simple titration algorithm: self-titration was performed once weekly based upon a single pre-breakfast self measured plasma glucose (SMPG) value measured on the day of insulin titration.
IDeg Step Wise Insulin degludec (IDeg) was given once daily (OD) subcutaneously (approximately 8-40 hours intervals between doses) with pre-trial metformin according to step wise titration algorithm: self-titration was performed once weekly based on the lowest value of three pre-breakfast SMPG values measured on three consecutive days, the two days prior to and on the day of insulin titration.

Participant Flow:   Overall Study
    IDeg Simple     IDeg Step Wise  
STARTED     111     111  
Exposed     110 [1]   111  
COMPLETED     99     98  
NOT COMPLETED     12     13  
Adverse Event                 4                 3  
Withdrawal Criteria                 5                 7  
Other                 3                 3  
[1] One subject withdrew before 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 Simple Insulin degludec (IDeg) was given once daily (OD) subcutaneously (approximately 8-40 hours intervals between doses) with pre-trial metformin according to simple titration algorithm: self-titration was performed once weekly based upon a single pre-breakfast self measured plasma glucose (SMPG) value measured on the day of insulin titration.
IDeg Step Wise Insulin degludec (IDeg) was given once daily (OD) subcutaneously (approximately 8-40 hours intervals between doses) with pre-trial metformin according to step wise titration algorithm: self-titration was performed once weekly based on the lowest value of three pre-breakfast SMPG values measured on three consecutive days, the two days prior to and on the day of insulin titration.
Total Total of all reporting groups

Baseline Measures
    IDeg Simple     IDeg Step Wise     Total  
Number of Participants  
[units: participants]
  111     111     222  
Age  
[units: years]
Mean (Standard Deviation)
  59.4  (9.5)     58.5  (11.1)     58.9  (10.3)  
Gender  
[units: participants]
     
Female     43     36     79  
Male     68     75     143  
Glycosylated haemoglobin (HbA1c)  
[units: percentage of glycosylated haemoglobin]
Mean (Standard Deviation)
  8.1  (0.9)     8.2  (0.9)     8.1  (0.9)  
Fasting plasma glucose (FPG)  
[units: mmol/L]
Mean (Standard Deviation)
  9.3  (2.6)     9.4  (2.8)     9.4  (2.7)  



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

2.  Secondary:   Change in Fasting Plasma Glucose (FPG)   [ Time Frame: Week 0, Week 26 ]

3.  Secondary:   Rate of Treatment Emergent Adverse Events (AEs)   [ Time Frame: Week 0 to Week 26 + 7 days follow up ]

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

5.  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: NCT01326026     History of Changes
Other Study ID Numbers: NN1250-3846
U1111-1117-0616 ( Other Identifier: WHO )
2010-022337-29 ( EudraCT Number )
Study First Received: March 29, 2011
Results First Received: October 16, 2015
Last Updated: October 16, 2015
Health Authority: Finland: Finnish Medicines Agency Fimea
Germany: Federal Institute for Drugs and Medical Devices
Spain: Spanish Agency of Medicines
United States: Food and Drug Administration