Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Comparison of Two Insulin Degludec Formulations in 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:
NCT01364428
First received: May 31, 2011
Last updated: November 18, 2015
Last verified: November 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
  Hide Participant Flow

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 44 sites within United States of America.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects who were treated with basal insulin in combination with unchanged dosing of oral antidiabetic drug treatment (e.g. metformin, pioglitazone or DPP-IV inhibitor) in any approved dose or combination at unchanged dosing for at least 12 weeks prior to randomisation in a 1:1 manner to IDeg 200 U/mL or IDeg.

Reporting Groups
  Description
IDeg 200 U/mL Insulin degludec 200 U/mL (IDeg 200 U/mL) in a 3 mL prefilled pen PDS290 was given subcutaneously once daily in combination with pre-trial oral antidiabetic drug treatment(metformin, insulin secretagogue [sulfonylurea or glinide], alpha-glucosidase inhibitor, pioglitazone or DPP-IV inhibitor). IDeg 200 U/mL was administered at any time of the day but preferably at the same time each day.
IDeg Insulin degludec 100 U/mL (IDeg) in a 3 mL prefilled pen PDS290 was given subcutaneously once daily in combination with pre-trial oral antidiabetic drug treatment (metformin, insulin secretagogue [sulfonylurea or glinide], alpha-glucosidase inhibitor, pioglitazone or DPP-IV inhibitor). IDeg was administered at any time of the day but preferably at the same time each day.

Participant Flow:   Overall Study
    IDeg 200 U/mL     IDeg  
STARTED     186     187  
Exposed     184 [1]   187  
COMPLETED     166     172  
NOT COMPLETED     20     15  
Adverse Event                 1                 2  
Protocol Violation                 2                 0  
Withdrawal Criteria                 14                 10  
Other                 3                 3  
[1] Two subjects were randomised in error and withdrew prior to exposure to drug



  Baseline Characteristics
  Hide Baseline Characteristics

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 200 U/mL Insulin degludec 200 U/mL (IDeg 200 U/mL) in a 3 mL prefilled pen PDS290 was given subcutaneously once daily in combination with pre-trial oral antidiabetic drug treatment(metformin, insulin secretagogue [sulfonylurea or glinide], alpha-glucosidase inhibitor, pioglitazone or DPP-IV inhibitor). IDeg 200 U/mL was administered at any time of the day but preferably at the same time each day.
IDeg Insulin degludec 100 U/mL (IDeg) in a 3 mL prefilled pen PDS290 was given subcutaneously once daily in combination with pre-trial oral antidiabetic drug treatment (metformin, insulin secretagogue [sulfonylurea or glinide], alpha-glucosidase inhibitor, pioglitazone or DPP-IV inhibitor). IDeg was administered at any time of the day but preferably at the same time each day.
Total Total of all reporting groups

Baseline Measures
    IDeg 200 U/mL     IDeg     Total  
Number of Participants  
[units: participants]
  186     187     373  
Age  
[units: years]
Mean (Standard Deviation)
  59.3  (10.0)     60.3  (10.2)     59.8  (10.1)  
Gender  
[units: participants]
     
Female     98     70     168  
Male     88     117     205  
Glycosylated haemoglobin (HbA1c)  
[units: percentage of glycosylated haemoglobin]
Mean (Standard Deviation)
  8.1  (0.9)     8.2  (0.9)     8.2  (0.9)  
Fasting plasma glucose (FPG)  
[units: mmol/L]
Mean (Standard Deviation)
  8.3  (3.0)     8.3  (3.4)     8.3  (3.2)  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in Glycosylated Haemoglobin (HbA1c)   [ Time Frame: Week 0, Week 22 ]

2.  Secondary:   Change in Fasting Plasma Glucose (FPG)   [ Time Frame: Week 0, Week 22 ]

3.  Secondary:   Rate of Treatment Emergent Adverse Events (AEs)   [ Time Frame: Week 0 to Week 22 + 7 days follow up ]

4.  Secondary:   Rate of Confirmed Hypoglycaemic Episodes   [ Time Frame: Week 0 to Week 22 + 7 days follow up ]

5.  Secondary:   Rate of Nocturnal Confirmed Hypoglycaemic Episodes   [ Time Frame: Week 0 to Week 22 + 7 days follow up ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
No text entered.


  More Information
  Hide More Information

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: NCT01364428     History of Changes
Other Study ID Numbers: NN1250-3923
U1111-1119-2518 ( Registry Identifier: WHO )
Study First Received: May 31, 2011
Results First Received: October 16, 2015
Last Updated: November 18, 2015
Health Authority: United States: Food and Drug Administration