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Efficacy and Safety of Liraglutide Versus Sulphonylurea Both in Combination With Metformin During Ramadan in Subjects With Type 2 Diabetes (LIRA-Ramadan™)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01917656
First received: July 29, 2013
Last updated: August 18, 2016
Last verified: August 2016
Results First Received: September 2, 2015  
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: metformin
Drug: sulfonylurea

  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 39 sites in 7 countries as follows: Algeria: 7 sites; Israel: 4 sites; India: 5 sites; Lebanon: 2 sites; Malaysia: 7 sites; South Africa: 8 sites; United Arab Emirates: 6 sites

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects were randomised in a 1:1 manner to either switch to liraglutide 1.8 mg/day added on to metformin or to continue their pre-trial SU and metformin treatment.

Reporting Groups
  Description
Liraglutide and Metformin Liraglutide 1.8 mg administered once daily subcutaneously, in combination with pre-trial tablet metformin of unchanged dose.
Sulfonylurea and Metformin Subjects continued on pre-trial sulfonylurea tablet treatment, in combination with pre-trial tablet metformin of unchanged dose.

Participant Flow:   Overall Study
    Liraglutide and Metformin     Sulfonylurea and Metformin  
STARTED     172     171  
Exposed     171 [1]   170 [2]
Exposed During Ramadan (Fasting)     152     163  
COMPLETED     146     147  
NOT COMPLETED     26     24  
Adverse Event                 11                 0  
Withdrawal criteria                 8                 14  
Unclassified                 0                 3  
Withdrawal by Subject                 4                 3  
Lost to Follow-up                 3                 4  
[1] 1 subject was withdrawn prior to exposure to trial products
[2] 1 subject was withdrawn prior to exposure to first SU dose after randomisation



  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.
Safety analysis set

Reporting Groups
  Description
Liraglutide and Metformin Liraglutide 1.8 mg administered once daily subcutaneously, in combination with pre-trial tablet metformin of unchanged dose.
Sulfonylurea and Metformin Subjects continued on pre-trial sulfonylurea tablet treatment, in combination with pre-trial tablet metformin of unchanged dose.
Total Total of all reporting groups

Baseline Measures
    Liraglutide and Metformin     Sulfonylurea and Metformin     Total  
Number of Participants  
[units: participants]
  171     170     341  
Age  
[units: years]
Mean (Standard Deviation)
  54.9  (9.27)     54.0  (9.33)     54.5  (9.30)  
Gender  
[units: participants]
     
Female     86     87     173  
Male     85     83     168  



  Outcome Measures
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1.  Primary:   Change in Fructosamine From Start of Ramadan to End of Ramadan   [ Time Frame: Day -1, day 29 ]

2.  Secondary:   Fructosamine at End of Ramadan   [ Time Frame: Day 29 ]

3.  Secondary:   Change From Start of Ramadan to End of Ramadan in Fasting Plasma Glucose (FPG)   [ Time Frame: Day -1, day 29 ]

4.  Secondary:   Change From Baseline to End of Ramadan in Fasting Plasma Glucose   [ Time Frame: Baseline, day 29 ]

5.  Secondary:   Change From Baseline to End of Ramadan in Glycosylated Haemoglobin (HbA1c)   [ Time Frame: Baseline, day 29 ]

6.  Secondary:   Change From Baseline to End of Ramadan in Body Weight   [ Time Frame: Baseline, day 29 ]

7.  Secondary:   Subjects Who at End of Treatment (4 Weeks Post Ramadan) Achieve (y/n): HbA1c Below 7.0% (53 mmol/Mol) (ADA Target)   [ Time Frame: Visit 14 (4 weeks post Ramadan) ]

8.  Secondary:   Subjects Who at End of Treatment (4 Weeks Post Ramadan) Achieve (y/n): HbA1c Below 7.0% (53 mmol/Mol), and no Confirmed Hypoglycaemic Episodes   [ Time Frame: Visit 14 (4 weeks post Ramadan) ]

9.  Secondary:   Number of Confirmed Hypoglycaemic Episodes During Ramadan (Fasting), Based on Each Subject's Individual Fasting Period.   [ Time Frame: Day -1 to day 29 ]

10.  Secondary:   Number of Treatment Emergent Adverse Events (TEAEs) During Ramadan (Fasting), Based on Each Subject's Individual Fasting Period.   [ Time Frame: Day -1 to day 29 ]


  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


Publications:

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01917656     History of Changes
Other Study ID Numbers: NN2211-3987
U1111-1132-9716 ( Other Identifier: WHO )
Study First Received: July 29, 2013
Results First Received: September 2, 2015
Last Updated: August 18, 2016
Health Authority: Algeria: Ministry of Health
India: Drugs Controller General of India
Israel: Ministry of Health
Lebanon: Ministry of Public Health
Malaysia: Ministry of Health
South Africa: Medicines Control Council
United Arab Emirates: Drug Control Department - Medicines and Pharmacy Control - Ministry of Health