Safety and Efficacy of Liraglutide in Combination With an OAD in Subjects With Type 2 Diabetes Insufficiently Controlled on OAD Alone

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01512108
First received: January 10, 2012
Last updated: April 25, 2014
Last verified: April 2014
Results First Received: April 25, 2014  
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
Interventions: Drug: liraglutide
Drug: oral anti-diabetic drug

  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 36 sites in Japan.

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
Liraglutide 0.9 mg/Day Liraglutide 0.9 mg/day was injected subcutaneously, once daily in morning or evening in addition to unchanged pre-trial oral anti-diabetic drug (OAD) (either glinide, metformin, α-glucosidase inhibitor or thiazolidinedione) for 52 weeks. Liraglutide was started at 0.3 mg/day and dose was escalated to maximum dose level of 0.9 mg/day by weekly increment of 0.3 mg.
Additional OAD Subject's received additional OAD to pre-trial OAD. The type and dosage of additional OAD was chosen based on each individual’s glycaemic control by the investigator as per Japanese labelling.

Participant Flow:   Overall Study
    Liraglutide 0.9 mg/Day     Additional OAD  
STARTED     243     120  
Exposed     240 [1]   120  
COMPLETED     221     111  
NOT COMPLETED     22     9  
Adverse Event                 9                 4  
Protocol Violation                 1                 2  
Withdrawal Criteria                 1                 0  
Unclassified                 11                 3  
[1] 3 subjects withdrew prior to exposure to trial drug



  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.
No text entered.

Reporting Groups
  Description
Liraglutide 0.9 mg/Day Liraglutide 0.9 mg/day was injected subcutaneously, once daily in morning or evening in addition to unchanged pre-trial oral anti-diabetic drug (OAD) (either glinide, metformin, α-glucosidase inhibitor or thiazolidinedione) for 52 weeks. Liraglutide was started at 0.3 mg/day and dose was escalated to maximum dose level of 0.9 mg/day by weekly increment of 0.3 mg.
Additional OAD Subject's received additional OAD to pre-trial OAD. The type and dosage of additional OAD was chosen based on each individual’s glycaemic control by the investigator as per Japanese labelling.
Total Total of all reporting groups

Baseline Measures
    Liraglutide 0.9 mg/Day     Additional OAD     Total  
Number of Participants  
[units: participants]
  240     120     360  
Age  
[units: years]
Mean ± Standard Deviation
  59.6  ± 11.6     59.2  ± 10.2     59.5  ± 11.1  
Gender  
[units: participants]
     
Female     58     40     98  
Male     182     80     262  
Glycosylated haemoglobin (HbA1c)  
[units: percentage¬†of¬†glycosylated¬†haemoglobin]
Mean ± Standard Deviation
  8.1  ± 0.8     8.1  ± 0.8     8.1  ± 0.8  
Fasting plasma glucose (FPG)  
[units: mmol/L]
Mean ± Standard Deviation
  8.68  ± 1.61     8.96  ± 1.82     8.77  ± 1.69  



  Outcome Measures
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1.  Primary:   Incidence of Treatment Emergent Adverse Events (AEs)   [ Time Frame: Week 0 to Week 52 + 7 days ]

2.  Secondary:   Number of Confirmed Hypoglycaemic Episodes   [ Time Frame: Week 0 to Week 52 ]

3.  Secondary:   Change in HbA1c From Baseline to Week 52   [ Time Frame: Week 0, week 52 ]

4.  Secondary:   Change in FPG From Baseline to Week 52   [ Time Frame: Week 0, week 52 ]


  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: Public Access to Clinical Trials
Organization: Novo Nordisk A/S
e-mail: clinicaltrials@novonordisk.com


No publications provided


Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01512108     History of Changes
Other Study ID Numbers: NN2211-3924, U1111-1121-3457, JapicCTI-121744
Study First Received: January 10, 2012
Results First Received: April 25, 2014
Last Updated: April 25, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare