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The Efficacy of Insulin Degludec/Liraglutide as add-on Therapy in Controlling Glycaemia in Adults With Type 2 Diabetes Inadequately Controlled on Sulphonylurea With or Without Metformin Therapy (DUAL™IV)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01618162
First received: June 11, 2012
Last updated: March 24, 2017
Last verified: March 2017
Results First Received: December 20, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Participant, Investigator;   Primary Purpose: Treatment
Conditions: Diabetes
Diabetes Mellitus, Type 2
Interventions: Drug: insulin degludec/liraglutide
Drug: placebo

  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 77 sites in 7 countries: Bulgaria (7), Canada (9), Germany (6), India (6), Israel (7), Turkey (3), United States (39).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The trial included a 2 week screening period to assess subject eligibility.

Reporting Groups
  Description
IDegLira In this arm, subjects suboptimally controlled on sulfonyl urea (SU) +/- metformin, were given subcutenaous (s.c.) injection of insulin degludec/liraglutide (IDegLira). SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. IDegLira was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Treatment with IDegLira was initiated at 10 dose steps containing 10 units insulin degludec and 0.36 mg liraglutide. Adjustment of the IDegLira dose was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0−6.0 mmol/L).
Placebo In this arm, subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of placebo solution (matched to IDegLira) and was initiated and titrated as described for IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. Placebo solution was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Adjustment of placebo was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-6.0 mmol/L).

Participant Flow:   Overall Study
    IDegLira   Placebo
STARTED   289   146 
Exposed   288   146 
COMPLETED   251   111 
NOT COMPLETED   38   35 
Protocol Violation                13                10 
Adverse Event                9                2 
Withdrawal Criteria                2                10 
Unclassified                14                13 



  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) included all randomized subjects.

Reporting Groups
  Description
IDegLira In this arm, Subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. IDegLira was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Treatment with IDegLira was initiated at 10 dose steps containing 10 units insulin degludec and 0.36 mg liraglutide. Adjustment of the IDegLira dose was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0−6.0 mmol/L).
Placebo In this arm, subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of placebo solution (matched to IDegLira) and was initiated and titrated as described for IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. Placebo solution was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Adjustment of placebo was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-6.0 mmol/L).
Total Total of all reporting groups

Baseline Measures
   IDegLira   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 289   146   435 
Age 
[Units: Years]
Mean (Standard Deviation)
 60  (9.6)   59.4  (10.8)   59.8  (10.0) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      135  46.7%      73  50.0%      208  47.8% 
Male      154  53.3%      73  50.0%      227  52.2% 
Glycosylated haemoglobin 
[Units: Percentage of glycosylated haemoglobin]
Mean (Standard Deviation)
 7.9  (0.6)   7.9  (0.6)   7.9  (0.6) 
Fasting plasma glucose 
[Units: mmol/L]
Mean (Standard Deviation)
 9.1  (2.2)   9.1  (2.1)   9.1  (2.1) 
Body weight 
[Units: Kilograms]
Mean (Standard Deviation)
 87.2  (18.6)   89.3  (17.5)   87.9  (18.2) 


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

2.  Secondary:   Responders Achieving Pre-defined Target: HbA1c Below 7.0% (53 mmol/Mol)   [ Time Frame: Week 26 ]

3.  Secondary:   Responders Achieving Pre-defined Target: HbA1c Below or Equal to 6.5% (48 mmol/Mol)   [ Time Frame: Week 26 ]

4.  Secondary:   Change From Baseline in Fasting Plasma Glucose (FPG)   [ Time Frame: Week 0, week 26 ]

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

6.  Secondary:   Number of Treatment Emergent (Confirmed) Hypoglycaemic Episodes   [ Time Frame: After 26 weeks of treatment ]

7.  Secondary:   Number of Adverse Events (AEs)   [ Time Frame: After 26 weeks of treatment ]


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


Publications of Results:

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01618162     History of Changes
Other Study ID Numbers: NN9068-3951
2012-000140-97 ( EudraCT Number )
U1111-1126-9776 ( Other Identifier: WHO )
Study First Received: June 11, 2012
Results First Received: December 20, 2016
Last Updated: March 24, 2017