Efficacy and Safety of Switching From Sitagliptin to Liraglutide in Subjects With Type 2 Diabetes Not Achieving Adequate Glycaemic Control on Sitagliptin and Metformin (LIRA-SWITCH™)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01907854
First received: July 22, 2013
Last updated: May 23, 2016
Last verified: May 2016
Results First Received: May 23, 2016  
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: sitagliptin
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 86 sites in 6 countries: Canada (14); Hungary (8); India (7); Israel (8); Spain (6); and United States (43).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Screening details: Subjects were adult males or females with type 2 diabetes mellitus (T2DM) who had inadequate glycaemic control with stable doses of sitagliptin and metformin for 90 days prior to screening.

Reporting Groups
  Description
Liraglutide

Subjects in this arm received treatments for a duration of 26 weeks; once-daily (OD) liraglutide (s.c., [under the skin] injection 0.6 mg/day, with weekly dose escalations of 0.6 mg/day up to a maintenance dose of 1.8 mg/day) + metformin tablets (≥1500 mg/day [or documented maximum tolerated dose

≥1000 mg/day]) + OD sitagliptin placebo tablets.

Sitagliptin Subjects in this arm received treatments for a duration of 26 weeks; OD sitagliptin tablets (100 mg) + metformin tablets (≥1500 mg/day [or documented maximum tolerated dose ≥1000 mg/day]) + OD s.c., injection of liraglutide placebo.

Participant Flow:   Overall Study
    Liraglutide     Sitagliptin  
STARTED     203     204  
Exposed     202 [1]   204  
COMPLETED     187     191  
NOT COMPLETED     16     13  
Protocol Violation                 1                 1  
Withdrawal by Subject                 9                 7  
Lost to Follow-up                 2                 2  
Unclassified                 4                 3  
[1] One subject in lira arm was not exposed (Reason: withdrawal by subject)



  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.
Demographics and baseline characteristics of all exposed subjects are summarised in continuous variables. There were missing baseline values for fasting plasma glucose in 2 subjects in the liraglutide arm and 1 subject in the sitagliptin arm.

Reporting Groups
  Description
Liraglutide

Subjects in this arm received treatments for a duration of 26 weeks; once-daily (OD) liraglutide (s.c., [under the skin] injection 0.6 mg/day, with weekly dose escalations of 0.6 mg/day up to a maintenance dose of 1.8 mg/day) + metformin tablets (≥1500 mg/day [or documented maximum tolerated dose

≥1000 mg/day]) + OD sitagliptin placebo tablets.

Sitagliptin Subjects in this arm received treatments for a duration of 26 weeks; OD sitagliptin tablets (100 mg) + metformin tablets (≥1500 mg/day [or documented maximum tolerated dose ≥1000 mg/day]) + OD s.c., injection of liraglutide placebo.
Total Total of all reporting groups

Baseline Measures
    Liraglutide     Sitagliptin     Total  
Number of Participants  
[units: participants]
  202     204     406  
Age  
[units: years]
Mean (Standard Deviation)
  56.3  (10.6)     56.5  (9.7)     56.4  (10.2)  
Gender  
[units: participants]
     
Female     85     79     164  
Male     117     125     242  
HbA1c  
[units: percentage of glycosylated haemoglobin]
Mean (Standard Deviation)
  8.3  (0.6)     8.2  (0.6)     8.3  (0.6)  
Body Weight  
[units: kg]
Mean (Standard Deviation)
  88.9  (19.8)     91.2  (19.6)     90.1  (19.7)  
Fasting Plasma Glucose  
[units: mmol/L]
Mean (Standard Deviation)
  10.0  (2.7)     9.7  (2.5)     9.9  (2.6)  



  Outcome Measures
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1.  Primary:   Change in HbA1c (Glycosylated Haemoglobin)   [ Time Frame: From baseline to week 26 ]

2.  Secondary:   Change in Body Weight   [ Time Frame: From baseline to week 26 ]

3.  Secondary:   Change in Fasting Plasma Glucose   [ Time Frame: From baseline to week 26 ]

4.  Secondary:   Change in Fasting Blood Lipids   [ Time Frame: From baseline to week 26 ]

5.  Secondary:   Change in Systolic Blood Pressure and Diastolic Blood Pressure   [ Time Frame: From baseline to week 26 ]

6.  Secondary:   Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol) (American Diabetes Association Target) (y/n)   [ Time Frame: After 26 weeks of treatment ]

7.  Secondary:   Number of Treatment Emergent Adverse Events (TEAEs)   [ Time Frame: During 26 weeks of treatment plus one week follow-up period. ]


  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



Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01907854     History of Changes
Other Study ID Numbers: NN2211-4059
2012-004931-22 ( EudraCT Number )
U1111-1136-2073 ( Other Identifier: WHO )
CTRI/2014/05/004623 ( Registry Identifier: Clinical Trial Registry India (CTRI) )
Study First Received: July 22, 2013
Results First Received: May 23, 2016
Last Updated: May 23, 2016
Health Authority: Canada: Health Canada
Hungary: Ministry of Health, Social and Family Affairs
India: Drugs Controller General of India
Israel: Ministry of Health
Spain: Spanish Agency of Medicines
United States: Food and Drug Administration