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Safety, Tolerability and Pharmacokinetics of Liraglutide-depot in Healthy Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01473953
First received: November 2, 2011
Last updated: October 11, 2013
Last verified: October 2013
Results First Received: June 20, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Diabetes
Diabetes Mellitus, Type 2
Healthy
Interventions: Drug: liraglutide-depot
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 one site in Evansville, Indiana, USA.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
It was a Novo Nordisk business decision, and not a decision due to safety concerns, not to continue the development of liraglutide depot. Therefore cohorts with liraglutide pre-treatment were not initiated based on review of pharmacokinetic data, and hence no analysis was done. So no subjects were enrolled for the outcome measure 6.

Reporting Groups
  Description
Cohort 1a: Lira-depot 2.25 mg In cohort 1a a single subcutaneous dose of 2.25 mg liraglutide-depot was administered.
Cohort 2a: Lira-depot 6.75 mg In cohort 2a a single subcutaneous dose of 6.75 mg liraglutide-depot was administered.
Cohort 3a: Lira-depot 15 mg In cohort 3a a single subcutaneous dose of 15 mg liraglutide-depot was administered.
Cohort 4a: Lira-depot 30 mg In cohort 4a a single subcutaneous dose of 30 mg liraglutide-depot was administered.
Placebo In the placebo group a corresponding volume of liraglutide-depot placebo was administered subcutaneous (s.c.).

Participant Flow:   Overall Study
    Cohort 1a: Lira-depot 2.25 mg     Cohort 2a: Lira-depot 6.75 mg     Cohort 3a: Lira-depot 15 mg     Cohort 4a: Lira-depot 30 mg     Placebo  
STARTED     6     6     6     5     8  
COMPLETED     5     6     6     5     8  
NOT COMPLETED     1     0     0     0     0  
Unspecified                 1                 0                 0                 0                 0  



  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
Cohort 1a: Lira-depot 2.25 mg In cohort 1a a single subcutaneous dose of 2.25 mg liraglutide-depot was administered.
Cohort 2a: Lira-depot 6.75 mg In cohort 2a a single subcutaneous dose of 6.75 mg liraglutide-depot was administered.
Cohort 3a: Lira-depot 15 mg In cohort 3a a single subcutaneous dose of 15 mg liraglutide-depot was administered.
Cohort 4a: Lira-depot 30 mg In cohort 4a a single subcutaneous dose of 30 mg liraglutide-depot was administered.
Placebo In the placebo group a corresponding volume of liraglutide-depot placebo was administered subcutaneous (s.c.).
Total Total of all reporting groups

Baseline Measures
    Cohort 1a: Lira-depot 2.25 mg     Cohort 2a: Lira-depot 6.75 mg     Cohort 3a: Lira-depot 15 mg     Cohort 4a: Lira-depot 30 mg     Placebo     Total  
Number of Participants  
[units: participants]
  6     6     6     5     8     31  
Age  
[units: years]
Mean ± Standard Deviation
  39.8  ± 11.4     30.0  ± 12.6     29.8  ± 7.7     39.0  ± 8.4     28.5  ± 7.9     32.9  ± 10.3  
Gender  
[units: participants]
           
Female     0     0     0     0     0     0  
Male     6     6     6     5     8     31  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Treatment Emergent Adverse Events (TEAEs)   [ Time Frame: Day 0 and up to 21 days after treatment ]

2.  Secondary:   Maximum Plasma Concentration of Liraglutide After a Single Dose of Liraglutide-depot   [ Time Frame: Day 0 through day 21 at 1,3,6,12,18, 24, 36, 48, 72, 96, 120, 168, 336, 504 hours post dose ]

3.  Secondary:   Time to Maximum Plasma Concentration of Liraglutide After a Single Dose of Liraglutide-depot   [ Time Frame: Day 0 through day 21 at 1,3,6,12,18, 24, 36, 48, 72, 96, 120, 168, 336, 504 hours post dose ]

4.  Secondary:   Area Under the Plasma Concentration Curve in the Period From the Time of Liraglutide-depot Administration to Infinity   [ Time Frame: Day 0 through day 21 at 1,3,6,12,18, 24, 36, 48, 72, 96, 120, 168, 336, 504 hours post dose ]

5.  Secondary:   Area Under the Liraglutide Plasma Concentration Curve in the First Week Following Liraglutide-depot Administration for Subjects Without Liraglutide 6 mg/ml Pre-treatment   [ Time Frame: 1,3,6,12,18, 24, 36, 48, 72, 96, 120, 168 hours post dose ]

6.  Secondary:   Area Under the Plasma Concentration Curve in the First Week Following Liraglutide-depot Administration for Subjects With Liraglutide 6 mg/ml Pre-treatment   [ Time Frame: 0 to 168 hours after dosing ]

7.  Secondary:   Number of Subjects With Antibodies (Positive) or Without Antibodies (Negative) Against Liraglutide Observed at Pre-dose and at Last Follow-up   [ Time Frame: Day 0 and Day 21 ]


  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
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: 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: NCT01473953     History of Changes
Other Study ID Numbers: NN9223-3928, U1111-1123-0547
Study First Received: November 2, 2011
Results First Received: June 20, 2013
Last Updated: October 11, 2013
Health Authority: United States: Food and Drug Administration