Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Efficacy and Safety of Liraglutide Versus Placebo as add-on to Existing Diabetes Medication in Subjects With Type 2 Diabetes and Moderate Renal Impairment

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01620489
First received: June 13, 2012
Last updated: October 23, 2014
Last verified: October 2014
Results First Received: August 20, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Diabetes
Diabetes Mellitus, Type 2
Interventions: Drug: liraglutide
Drug: placebo

  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
This trial was conducted in France, Poland, Russian Federation, Ukraine, United Kingdom, and the United States of America.

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
Lira 1.8 mg Subjects received subcutaneous (s.c) liraglutide 1.8 mg once daily, applying a 3−4 week dose escalation regimen with weekly increments of 0.6 mg until the maintenance dose of 1.8 mg was reached, as an add-on to the subject’s stable pre-trial oral antidiabetic drug (OAD) and/or insulin regimen (monotherapy or any duo-combinations of metformin and/or sulphonylureas and/or pioglitazone; or monotherapy of basal or premix insulin or combination with metformin and/or pioglitazone).
Placebo Subjects received s.c placebo 1.8 mg once daily, applying a 3−4 week dose escalation regimen with weekly increments of 0.6 mg until the maintenance dose of 1.8 mg was reached, as an add-on to the subject’s stable pre-trial OAD and/or insulin regimen (monotherapy or any duo-combinations of metformin and/or sulphonylureas and/or pioglitazone; or monotherapy of basal or premix insulin or combination with metformin and/or pioglitazone).

Participant Flow:   Overall Study
    Lira 1.8 mg     Placebo  
STARTED     140     139  
Exposed     140     137 [1]
COMPLETED     105     105 [1]
NOT COMPLETED     35     34  
Adverse Event                 17                 4  
Protocol Violation                 0                 3  
Withdrawal Criteria                 17                 25  
Unclassified                 1                 2  
[1] 2 subjects did not take trial product



  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.
No text entered.

Reporting Groups
  Description
Lira 1.8 mg Subjects received subcutaneous (s.c) liraglutide 1.8 mg once daily, applying a 3−4 week dose escalation regimen with weekly increments of 0.6 mg until the maintenance dose of 1.8 mg was reached, as an add-on to the subject’s stable pre-trial oral antidiabetic drug (OAD) and/or insulin regimen (monotherapy or any duo-combinations of metformin and/or sulphonylureas and/or pioglitazone; or monotherapy of basal or premix insulin or combination with metformin and/or pioglitazone).
Placebo Subjects received s.c placebo 1.8 mg once daily, applying a 3−4 week dose escalation regimen with weekly increments of 0.6 mg until the maintenance dose of 1.8 mg was reached, as an add-on to the subject’s stable pre-trial OAD and/or insulin regimen (monotherapy or any duo-combinations of metformin and/or sulphonylureas and/or pioglitazone; or monotherapy of basal or premix insulin or combination with metformin and/or pioglitazone).
Total Total of all reporting groups

Baseline Measures
    Lira 1.8 mg     Placebo     Total  
Number of Participants  
[units: participants]
  140     137     277  
Age  
[units: years]
Mean ± Standard Deviation
  68.0  ± 8.3     66.3  ± 8.0     67.2  ± 8.2  
Gender  
[units: participants]
     
Female     65     72     137  
Male     75     65     140  
Fasting plasma glucose (FPG)  
[units: mmol/L]
Mean ± Standard Deviation
  9.48  ± 3.270     9.27  ± 2.842     9.38  ± 3.061  
Glycosylated haemoglobin (%)(HbA1c)  
[units: Percent¬†(%)¬†glycosylated¬†haemoglobin]
Mean ± Standard Deviation
  8.08  ± 0.792     8.00  ± 0.853     8.04  ± 0.823  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Estimated Mean From the Statistical Model and Standard Deviation From Observed Data For Change From Baseline to Week 26 in HbA1c (%) (Glycosylated Haemoglobin)   [ Time Frame: Week 0, Week 26 ]

2.  Secondary:   Estimated Proportion of Responders Achieving HbA1c <7.0% and no Weight Gain After 26 Weeks of Treatment   [ Time Frame: At week 26 ]

3.  Secondary:   Estimated Proportion of Responders Achieving HbA1c <7.0% and no Minor or Severe Hypoglycaemic Episodes After 26 Weeks of Treatment   [ Time Frame: At week 26 ]

4.  Secondary:   Estimated Mean From the Statistical Model and Standard Deviation From Observed Data For Change From Baseline to Week 26 in Self-measured Plasma Glucose (SMPG) 7-point Profiles   [ Time Frame: Week 0, week 26 ]

5.  Secondary:   Estimated Mean From the Statistical Model and Standard Deviation From Observed Data For Change From Baseline to Week 26 in Body Mass Index (BMI)   [ Time Frame: Week 0, week 26 ]

6.  Secondary:   Estimated Mean Ratio to Baseline and Observed Coefficient of Variation in Renal Function-estimated Glomerular Filtration Rate (eGFR) (to Check How Well the Kidneys Are Functioning Using Modification of Diet in Renal Disease (MDRD) Formula)   [ Time Frame: Week 0, 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
  Hide 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


No publications provided


Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01620489     History of Changes
Other Study ID Numbers: NN2211-3916, 2011-002968-24, U1111-1122-3303
Study First Received: June 13, 2012
Results First Received: August 20, 2014
Last Updated: October 23, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Poland: Ministry of Health and Social Security
Russia: Federal Service for Control of Health Care and Social Development
Ukraine: Ministry of Health Ukraine
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration