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Dual Action of Liraglutide and Insulin Degludec in Type 2 Diabetes: A Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide, Insulin Degludec and Liraglutide in Subjects With Type 2 Diabetes (DUAL™ I)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01336023
First received: April 13, 2011
Last updated: April 26, 2017
Last verified: April 2017
Results First Received: December 12, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Diabetes
Diabetes Mellitus, Type 2
Interventions: Drug: insulin degludec/liraglutide
Drug: insulin degludec
Drug: liraglutide

  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
Countries: 19; Sites: 271; Number of sites as in parenthesis. Australia (7), Canada (14 ), Finland (5 ), Germany (12 ), Hungary (6), India (23), Ireland (2), Italy (6), Malaysia (5), Mexico (2 ), Russian Federation (11), Singapore (3), Slovakia (5), South Africa (13), Spain (8), Taiwan (3), Thailand (4), United Kingdom (16) and United States (126).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects on metformin and/or pioglitazone treatment underwent a 26-week main trial and continued to enter an additional 26-week extension trial. Total duration of the trial was up to 55 weeks (2 weeks screening + 26 week main period + 26 week extension period + 1 week follow-up after last dose).

Reporting Groups
  Description
IDeg Insulin degludec (IDeg: 100 U/mL) was injected once daily (OD) subcutaneously (s.c.) for 26 weeks (main trial) + 26 weeks (extension trial). IDeg treatment was initiated at a dose of 10 units and titrated twice weekly to the fasting glycaemic target of 4.0-5.0 mmol/L (72-90 mg/dL) based on the mean fasting self-measured plasma glucose (SMPG) from 3 preceeding measurements. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial.
IDegLira Insulin Degludec/Liraglutide (IDegLira: 100 U/3.6 mg per mL) was injected subcutaneously OD for 26 weeks(main trial) + 26 weeks (extension trial). IDegLira treatment was initiated at 10 dose steps (containing 10 units IDeg and 0.36 mg liraglutide) and titrated twice weekly to a fasting glycaemic target of 4.0-5.0 mmol/L (72-90 mg/dL) based on the mean SMPG (fasting) from 3 preceeding measurements. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial.
Liraglutide Liraglutide (6 mg/mL) was injected subcutaneously OD for 26 weeks (main trial). Liraglutide treatment was initiated at a dose of 0.6 mg/day, and subsequently increased by 0.6 mg in weekly dose escalation steps to reach maximum dose of 1.8 mg/day. Subjects continued with liraglutide 1.8 mg once daily in the 26 week extension period. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial.

Participant Flow for 2 periods

Period 1:   Week 0 to Week 26
    IDeg   IDegLira   Liraglutide
STARTED   414   834   415 
Exposed   413 [1]   826 [2]   413 [3] 
COMPLETED   366   736   342 
NOT COMPLETED   48   98   73 
Adverse Event                8                10                24 
Lack of Efficacy                0                1                0 
Protocol Violation                1                2                0 
Withdrawal Criteria                34                69                40 
Unclassified                5                16                9 
[1] 1 subject withdrew before exposure to trial drug and was not included in the analysis
[2] 8 subjects withdrew before exposure to trial drug and were not included in the analysis
[3] 2 subjects withdrew before exposure to trial drug and were not included in the analysis

Period 2:   Week 27 to 52
    IDeg   IDegLira   Liraglutide
STARTED   333 [1]   665 [2]   313 [3] 
COMPLETED   305   621   285 
NOT COMPLETED   28   44   28 
Adverse Event                1                5                2 
Protocol Violation                0                2                1 
Withdrawal Criteria                14                19                16 
Unclassified                13                18                9 
[1] From the main trial, 33 subjects were not enrolled in the extension (week 27-52).
[2] From the main trial, 71 subjects were not enrolled in the extension (week 27-52).
[3] From the main trial, 29 subjects were not enrolled in the extension (week 27-52).



  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.
The full analysis set (FAS) included all randomised subjects and missing data was imputed using last observation carried forward (LOCF). Three subjects did not have their case book signed off due to discontinuation of an investigator’s participation in the trial, hence 1 subject from each arm was excluded from the FAS.

Reporting Groups
  Description
IDeg Insulin degludec (IDeg: 100 U/mL) was injected once daily (OD) subcutaneously (s.c.) for 26 weeks (main trial) + 26 weeks (extension trial). IDeg treatment was initiated at a dose of 10 units and titrated twice weekly to the fasting glycaemic target of 4.0-5.0 mmol/L (72-90 mg/dL) based on the mean fasting self-measured plasma glucose (SMPG) from 3 preceeding measurements. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial.
IDegLira Insulin Degludec/Liraglutide (IDegLira: 100 U/3.6 mg per mL) was injected subcutaneously OD for 26 weeks(main trial) + 26 weeks (extension trial). IDegLira treatment was initiated at 10 dose steps (containing 10 units IDeg and 0.36 mg liraglutide) and titrated twice weekly to a fasting glycaemic target of 4.0-5.0 mmol/L (72-90 mg/dL) based on the mean SMPG (fasting) from 3 preceeding measurements. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial.
Liraglutide Liraglutide (6 mg/mL) was injected subcutaneously OD for 26 weeks (main trial). Liraglutide treatment was initiated at a dose of 0.6 mg/day, and subsequently increased by 0.6 mg in weekly dose escalation steps to reach maximum dose of 1.8 mg/day. Subjects continued with liraglutide 1.8 mg once daily in the 26 week extension period. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial.
Total Total of all reporting groups

Baseline Measures
   IDeg   IDegLira   Liraglutide   Total 
Overall Participants Analyzed 
[Units: Participants]
 413   833   414   1660 
Age 
[Units: Years]
Mean (Standard Deviation)
       
Participants Analyzed 
[Units: Participants]
 413   833   414   1660 
   54.9  (9.7)   55.1  (9.9)   55.0  (10.2)   55.0  (9.9) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Participants Analyzed 
[Units: Participants]
 413   833   414   1660 
Female      213  51.6%      398  47.8%      206  49.8%      817  49.2% 
Male      200  48.4%      435  52.2%      208  50.2%      843  50.8% 
Body Weight 
[Units: Kg]
Mean (Standard Deviation)
       
Participants Analyzed 
[Units: Participants]
 413   833   414   1660 
   87.4  (19.2)   87.2  (19.0)   87.4  (18.0)   87.3  (18.8) 
Prandial Increment [1] [2] 
[Units: mmol/L]
Mean (Standard Deviation)
       
Participants Analyzed 
[Units: Participants]
 63   128   61   252 
   4.12  (1.80)   4.11  (2.05)   4.12  (1.82)   4.11  (1.93) 
[1] The area under the glucose concentration (AUC) curve during 0-4 hours after the start of a standardised meal. The incremental AUC was calculated using the trapezoidal method and the resulting area was divided length of the observation period to yield the (normalised) prandial increment in mmol/L.
[2] The data was derived from the subjects who underwent a standard meal test conducted at selected sites.
Glycosylated haemoglobin (HbA1c) 
[Units: Percentage of glycosylated haemoglobin]
Mean (Standard Deviation)
       
Participants Analyzed 
[Units: Participants]
 413   833   414   1660 
   8.3  (1.0)   8.3  (0.9)   8.3  (0.9)   8.3  (0.9) 


  Outcome Measures
  Show All Outcome Measures

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

2.  Secondary:   Mean Change From Baseline in Body Weight at Week 26   [ Time Frame: Week 0, Week 26 ]

3.  Secondary:   Number of Hypoglycaemic Episodes   [ Time Frame: Weeks 0-26 ]

4.  Secondary:   Change From Baseline in Incremental Area Under the Curve 0-4h (iAUC0-4h) Derived From the Glucose Concentration Profile During Meal Test   [ Time Frame: Week 0, Week 26 ]

5.  Secondary:   Mean Actual Daily Insulin Dose   [ Time Frame: 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
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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: 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: NCT01336023     History of Changes
Other Study ID Numbers: NN9068-3697
U1111-1119-1174 ( Other Identifier: WHO )
2010-021560-15 ( EudraCT Number )
Study First Received: April 13, 2011
Results First Received: December 12, 2016
Last Updated: April 26, 2017