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The Efficacy of Insulin Degludec/Liraglutide in Controlling Glycaemia in Adults With Type 2 Diabetes Inadequately Controlled on GLP-1 Receptor Agonist and OAD Therapy (DUAL™ III)

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ClinicalTrials.gov Identifier: NCT01676116
Recruitment Status : Completed
First Posted : August 30, 2012
Results First Posted : July 9, 2018
Last Update Posted : July 9, 2018
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

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: liraglutide
Drug: exenatide

  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 81 sites in 5 countries as follows: Australia: 5 sites; France: 7 sites; Hungary: 4 sites; Slovakia 6 sites; United States: 59 sites.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The duration of the screening period was 2 weeks. All subjects continued GLP-1 receptor agonist and metformin±pioglitazone±SU treatments in their pre-trial doses during the screening period.

Reporting Groups
  Description
Insulin Degludec/Liraglutide + Oral Anti Diabetic Drugs (OADs) Subjects were treated with subcutaneous (under the skin) once daily (OD) insulin degludec/liraglutide. Treatment with insulin degludec/liraglutide was initiated at 16 dose steps containing 16 units of insulin degludec and 0.6 mg liraglutide. Adjustment of the insulin degludec/liraglutide dose was performed twice weekly based on the mean of 3 preceding daily fasting self measured plasma glucose (SMPG) values on 3 consecutive days. The aim was to achieve a fasting plasma glucose (FPG) target of 4.0–5.0 mmol/L (72−90 mg/dL) and the maximum allowed dose was 50 dose steps (50 units insulin degludec/1.8 mg liraglutide). Subjects also continued their pre-trial OADs (metformin±pioglitazone±SU) treatment without changing the frequency or dose throughout the trial, unless there was a safety concern.
Liraglutide or Exenatide + OADs Subjects continued on their pre-trial GLP-1 receptor agonist treatment with subcutaneous (under the skin) liraglutide (Victoza®) or exenatide (Byetta®) in stable pre-trial dose without changing the frequency or dose throughout the trial. Subjects also continued their pre-trial OADs (metformin±pioglitazone±SU) without changing the frequency or dose throughout the trial, unless there was a safety concern.

Participant Flow:   Overall Study
    Insulin Degludec/Liraglutide + Oral Anti Diabetic Drugs (OADs)   Liraglutide or Exenatide + OADs
STARTED   292   146 
COMPLETED   276   117 
NOT COMPLETED   16   29 
Withdrawal criteria                2                14 
Adverse Event                1                2 
Unclassified                4                10 
Protocol Violation                9                3 



  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
Insulin Degludec/Liraglutide + Oral Anti Diabetic Drugs (OADs) Subjects were treated with subcutaneous (under the skin) once daily (OD) insulin degludec/liraglutide. Treatment with insulin degludec/liraglutide was initiated at 16 dose steps containing 16 units of insulin degludec and 0.6 mg liraglutide. Adjustment of the insulin degludec/liraglutide dose was performed twice weekly based on the mean of 3 preceding daily fasting self measured plasma glucose (SMPG) values on 3 consecutive days. The aim was to achieve a fasting plasma glucose (FPG) target of 4.0–5.0 mmol/L (72−90 mg/dL) and the maximum allowed dose was 50 dose steps (50 units insulin degludec/1.8 mg liraglutide). Subjects also continued their pre-trial OADs (metformin±pioglitazone±SU) treatment without changing the frequency or dose throughout the trial, unless there was a safety concern.
Liraglutide or Exenatide + OADs Subjects continued on their pre-trial GLP-1 receptor agonist treatment with subcutaneous (under the skin) liraglutide (Victoza®) or exenatide (Byetta®) in stable pre-trial dose without changing the frequency or dose throughout the trial. Subjects also continued their pre-trial OADs (metformin±pioglitazone±SU) without changing the frequency or dose throughout the trial, unless there was a safety concern.
Total Total of all reporting groups

Baseline Measures
   Insulin Degludec/Liraglutide + Oral Anti Diabetic Drugs (OADs)   Liraglutide or Exenatide + OADs   Total 
Overall Participants Analyzed 
[Units: Participants]
 292   146   438 
Age 
[Units: Years]
Mean (Standard Deviation)
 58.3  (9.9)   58.4  (8.8)   58.3  (9.5) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      139  47.6%      75  51.4%      214  48.9% 
Male      153  52.4%      71  48.6%      224  51.1% 
HbA1c 
[Units: Percentage of glycosylated haemoglobin]
Mean (Standard Deviation)
 7.8  (0.6)   7.7  (0.6)   7.8  (0.6) 
Body weight 
[Units: Kg]
Mean (Standard Deviation)
 95.6  (16.6)   95.5  (17.3)   95.5  (16.8) 
Fasting plasma glucose 
[Units: mmol/L]
Mean (Standard Deviation)
 9  (2.1)   9.4  (2.3)   9.1  (2.2) 


  Outcome Measures

1.  Primary:   Change in Glycosylated Haemoglobin (HbA1c) From Baseline (Randomisation, Visit 2)   [ 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 Body Weight   [ Time Frame: Week 0, week 26 ]

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

6.  Secondary:   Number of Severe or Minor Hypoglycaemic Episodes   [ Time Frame: After 26 weeks of treatment ]

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

8.  Secondary:   Change From Baseline in Patient Reported Outcomes (PROs) Based on the Treatment Related Impact Measure – Diabetes (TRIM-D)   [ Time Frame: Week 0, week 26 ]

9.  Secondary:   Change From Baseline in Patient Reported Outcomes (PROs) Based on Diabetes Treatment Satisfaction Questionnaire (DTSQ).   [ Time Frame: Week 0, week 26 ]


  Serious Adverse Events


  Other Adverse Events


  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

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 of Results:

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01676116     History of Changes
Other Study ID Numbers: NN9068-3851
2012-000209-63 ( EudraCT Number )
U1111-1127-1321 ( Other Identifier: WHO )
First Submitted: August 28, 2012
First Posted: August 30, 2012
Results First Submitted: March 22, 2018
Results First Posted: July 9, 2018
Last Update Posted: July 9, 2018