This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

A Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide and Insulin Degludec in Subjects With Type 2 Diabetes (DUAL™ II)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01392573
First received: July 7, 2011
Last updated: April 26, 2017
Last verified: April 2017
Results First Received: November 23, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions: Diabetes
Diabetes Mellitus, Type 2
Interventions: Drug: insulin degludec/liraglutide
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 75 sites in 7 countries: Bulgaria (6), Switzerland (2), Denmark (3), Hungary (3), India (6), Slovenia (3), and the United States (52).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
IDegLira Insulin degludec/liraglutide (IDegLira) was injected subcutaneously (under the skin) once daily for 26 weeks in combination with metformin treatment. Metformin dose was maintained at the stable, pre-randomisation dose and frequency level. Treatment with IDegLira was initiated at 16 dose steps containing 16 units insulin degludec and 0.6 mg liraglutide. Dose adjustment of IDegLira was to be performed twice weekly based on the mean of three pre-breakfast self-monitored plasma glucose (SMPG) values measured on the day of titration and the two days prior to titration aiming at a fasting glycaemic target of 4.0-5.0 mmol/L.
IDeg Insulin degludec (IDeg) was injected subcutaneously (under the skin) once daily for 26 weeks. Metformin dose was maintained at the stable, pre-randomisation dose and frequency level. Treatment with IDeg was initiated with 16 units. Dose adjustment of IDeg was to be performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0−5.0 mmol/L).

Participant Flow:   Overall Study
    IDegLira   IDeg
STARTED   207   206 
Exposed   207   206 
COMPLETED   175   171 
NOT COMPLETED   32   35 
Adverse Event                1                3 
Lack of Efficacy                1                2 
Protocol Violation                0                2 
Withdrawal Criteria                13                15 
Site closure                8                7 
Unclassified                9                6 



  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.
Full analysis set (FAS) included all randomised subjects except 15 subjects (8 in IDegLira arm and 7 in IDeg arm) that were excluded due to site closure.

Reporting Groups
  Description
IDegLira IDegLira was injected subcutaneously (under the skin) once daily for 26 weeks in combination with metformin treatment. Metformin dose was maintained at the stable, pre-randomisation dose and frequency level. Treatment with IDegLira was initiated at 16 dose steps containing 16 units insulin degludec and 0.6 mg liraglutide. Dose adjustment of IDegLira was to be performed twice weekly based on the mean of three pre-breakfast SMPG values measured on the day of titration and the two days prior to titration aiming at a fasting glycaemic target of 4.0-5.0 mmol/L.
IDeg Insulin degludec (IDeg) was injected subcutaneously (under the skin) once daily for 26 weeks. Metformin dose was maintained at the stable, pre-randomisation dose and frequency level. Treatment with IDeg was initiated with 16 units. Dose adjustment of IDeg was to be performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0−5.0 mmol/L).
Total Total of all reporting groups

Baseline Measures
   IDegLira   IDeg   Total 
Overall Participants Analyzed 
[Units: Participants]
 199   199   398 
Age 
[Units: Years]
Mean (Standard Deviation)
 56.8  (8.9)   57.5  (10.5)   57.2  (9.7) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      87  43.7%      93  46.7%      180  45.2% 
Male      112  56.3%      106  53.3%      218  54.8% 
HbA1c (glycosylated haemoglobin) 
[Units: Percentage of glycosylated haemoglobin]
Mean (Standard Deviation)
 8.7  (0.7)   8.8  (0.7)   8.8  (0.7) 
Body Weight 
[Units: Kg]
Mean (Standard Deviation)
 95.4  (19.4)   93.5  (20.0)   94.5  (19.7) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in HbA1c (Glycosylated Haemoglobin)   [ Time Frame: Week 0, week 26 ]

2.  Secondary:   Change in Body Weight   [ Time Frame: Week 0, week 26 ]


  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: Global Clinical Registry (GCR, 1452)
Organization: Novo Nordisk A/S
e-mail: clinicaltrials@novonordisk.com


Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01392573     History of Changes
Other Study ID Numbers: NN9068-3912
2011-002336-72 ( EudraCT Number )
U1111-1121-4897 ( Other Identifier: WHO )
Study First Received: July 7, 2011
Results First Received: November 23, 2016
Last Updated: April 26, 2017