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    Clinical Trial Results:
    Does the GLP-1 receptor agonist (Victoza®) improve the metabolic response to physical training in patients with type 2 diabetes?

    Summary
    EudraCT number
    		 2011-002739-24
    Trial protocol
    		 DK  
    Global end of trial date
    31 Dec 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    02 Jun 2022
    First version publication date
    02 Jun 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    60
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 U1111-1122-0819
    Sponsors
    Sponsor organisation name
    Gentofte Hospital
    Sponsor organisation address
    Gentofte Hospitalsvej 1, 2900 Hellerup, Denmark,
    Public contact
    Department of Internal Medicine F, Dr. med. Tina Vilsbøll, +45 3977 2297, t.vilsboll@dadlnet.dk
    Scientific contact
    Department of Internal Medicine F, Dr. med. Tina Vilsbøll, +45 3977 2297, t.vilsboll@dadlnet.dk
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    04 Sep 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Dec 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The objective of this study is to investigate the effects of physical training in patients with type 2 diabetes during treatment with the GLP-1 receptor agonist liraglutide (Victoza®) in a 16-weeks double-blinded, randomized placebo-controlled clinical trial
    Protection of trial subjects
    Treated in rutine care
    Background therapy
    		 Medical treatment was similar in the groups and remained unchanged during the study. Besides metformin, patients received no medication known to interfere with glucose metabolism
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Oct 2011
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Denmark: 36
    Worldwide total number of subjects
    36
    EEA total number of subjects
    36
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    23
    From 65 to 84 years
    13
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients were recruited from the Diabetes Outpatient Clinic at Gentofte Hospital, Denmark, and through advertisement. Oral and written informed consent were obtained before inclusion.

    Pre-assignment
    Screening details
    		 Inclusion criteria were: age >18 years; type 2 diabetes treated with diet and/or metformin; HbA1c between 7% and 11% (53-97 mmol/mol), body mass index (BMI) > 25 kg/m2 ; and sedentary lifestyle (self-reported physical activity <150 min/wk). Exclusion criteria were clinically relevant cardiovascular disease, impaired liver function, anaemia a

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor
    Blinding implementation details
    An employee otherwise not involved in the study carried out the randomization at a 1:1 ratio from a prespecified randomization list.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Treated
    Arm description
    		 Exercise+Liraglutide
    Arm type
    		 Experimental

    Investigational medicinal product name
    liraglutide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Injection , Subcutaneous use
    Dosage and administration details
    Liraglutide was injected subcutaneous (s.c.) once-daily of 0.1 mL (0.6 mg ) in the evening for 1 week, 0.2 mL (1.2 mg) the following week and thereafter 0.3 mL (1.8 mg ) for the remaining study period.

    Arm title
    		 Placebo
    Arm description
    		 Exercise+placebo
    Arm type
    		 Placebo

    Investigational medicinal product name
    Saline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Injection
    Dosage and administration details
    Saline (placebo) was injected subcutaneous (s.c.) once-daily of 0.1 mL (0.6 mg ) in the evening for 1 week, 0.2 mL (1.2 mg) the following week and thereafter 0.3 mL (1.8 mg ) for the remaining study period.

    Number of subjects in period 1
    		Treated Placebo
    Started
    19
    17
    Completed
    17
    16
    Not completed
    2
    1
         Withdrawn consent, patient decision
    2
    -
         Protocol deviation
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Treated
    Reporting group description
    		 Exercise+Liraglutide

    Reporting group title
    Placebo
    Reporting group description
    		 Exercise+placebo

    Reporting group values
    		 Treated Placebo Total
    Number of subjects
    		 19 17 36
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 12 11 23
        From 65-84 years
    		 7 6 13
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 56.5 ( 9 ) 55.6 ( 12 ) -
    Gender categorical
    Units: Subjects
        Female
    		 4 6 10
        Male
    		 15 11 26
    Subject analysis sets

    Subject analysis set title
    HbA1c
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Per-protocol analyses were performed. Data are reported as +/-mean standard deviation; in case of non-normal distribution, data were log-transformed and back-transformed. Estimates are reported as geometric means with 95% confidence interval (CI). Differences between mean values in the two groups were analysed using Student’s t-test. Analyses of between-group differences were performed by analysis of covariance (ANCOVA) with the end-of-study value as the dependent variable

    Subject analysis sets values
    		 HbA1c
    Number of subjects
    33
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
    23
        From 65-84 years
    13
        85 years and over
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    ( )
    Gender categorical
    Units: Subjects
        Female
    10
        Male
    23

    End points

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    End points reporting groups
    Reporting group title
    Treated
    Reporting group description
    		 Exercise+Liraglutide

    Reporting group title
    Placebo
    Reporting group description
    		 Exercise+placebo

    Subject analysis set title
    HbA1c
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Per-protocol analyses were performed. Data are reported as +/-mean standard deviation; in case of non-normal distribution, data were log-transformed and back-transformed. Estimates are reported as geometric means with 95% confidence interval (CI). Differences between mean values in the two groups were analysed using Student’s t-test. Analyses of between-group differences were performed by analysis of covariance (ANCOVA) with the end-of-study value as the dependent variable

    Primary: HbA1c

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    End point title
    		 HbA1c
    End point description
    End point type
    Primary
    End point timeframe
    16 weeks
    End point values
    		 Treated Placebo
    Number of subjects analysed
    17
    16
    Units: mmol/mol
        arithmetic mean (standard deviation)
    44.0 ( 8.0 )
    61.0 ( 17.0 )
    Statistical analysis title
    		 HbA1c
    Comparison groups
    Treated v Placebo
    Number of subjects included in analysis
    33
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Fasting plasma glucose

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    End point title
    		 Fasting plasma glucose
    End point description
    End point type
    Secondary
    End point timeframe
    16 weeks
    End point values
    		 Treated Placebo
    Number of subjects analysed
    17
    16
    Units: mmol
        arithmetic mean (standard deviation)
    7.0 ( 1.6 )
    9.8 ( 3.7 )
    No statistical analyses for this end point

    Secondary: Glucagon

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    End point title
    		 Glucagon
    End point description
    End point type
    Secondary
    End point timeframe
    Changes between baseline and end of study
    End point values
    		 Treated Placebo
    Number of subjects analysed
    17
    16
    Units: pmol
        arithmetic mean (standard deviation)
    9.4 ( 3.2 )
    8.2 ( 2.1 )
    No statistical analyses for this end point

    Secondary: GLP-1

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    End point title
    		 GLP-1
    End point description
    End point type
    Secondary
    End point timeframe
    Changes between baseline and end of study
    End point values
    		 Treated Placebo
    Number of subjects analysed
    17
    16
    Units: pmol
        arithmetic mean (standard deviation)
    19.3 ( 5.6 )
    18.1 ( 5.7 )
    No statistical analyses for this end point

    Secondary: GIP

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    End point title
    		 GIP
    End point description
    End point type
    Secondary
    End point timeframe
    Changes between baseline and end of study
    End point values
    		 Treated Placebo
    Number of subjects analysed
    17
    16
    Units: pmol
        arithmetic mean (standard deviation)
    16.3 ( 5.2 )
    17.0 ( 8.5 )
    No statistical analyses for this end point

    Secondary: Body weight

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    End point title
    		 Body weight
    End point description
    End point type
    Secondary
    End point timeframe
    Changes between baseline and end of study
    End point values
    		 Treated Placebo
    Number of subjects analysed
    17
    16
    Units: kg
        arithmetic mean (standard deviation)
    97.6 ( 14.9 )
    95.2 ( 17.7 )
    No statistical analyses for this end point

    Secondary: Body mass index

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    End point title
    		 Body mass index
    End point description
    End point type
    Secondary
    End point timeframe
    Changes between baseline and end of study
    End point values
    		 Treated Placebo
    Number of subjects analysed
    17
    16
    Units: kg/m2
        arithmetic mean (standard deviation)
    31.3 ( 3.4 )
    31.8 ( 5.1 )
    No statistical analyses for this end point

    Secondary: Fat percent

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    End point title
    		 Fat percent
    End point description
    End point type
    Secondary
    End point timeframe
    Changes between baseline and end of study
    End point values
    		 Treated Placebo
    Number of subjects analysed
    17
    16
    Units: percent
        arithmetic mean (standard deviation)
    31.8 ( 6.8 )
    34.8 ( 7.0 )
    No statistical analyses for this end point

    Secondary: Gynoid fat

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    End point title
    		 Gynoid fat
    End point description
    End point type
    Secondary
    End point timeframe
    Changes between baseline and end of study
    End point values
    		 Treated Placebo
    Number of subjects analysed
    17
    16
    Units: percent
        arithmetic mean (standard deviation)
    32.5 ( 9.6 )
    36.3 ( 8.6 )
    No statistical analyses for this end point

    Secondary: Android fat

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    End point title
    		 Android fat
    End point description
    End point type
    Secondary
    End point timeframe
    Changes between baseline and end of study
    End point values
    		 Treated Placebo
    Number of subjects analysed
    17
    16
    Units: percent
        arithmetic mean (standard deviation)
    41.4 ( 5.2 )
    42.8 ( 7.8 )
    No statistical analyses for this end point

    Secondary: Lean body mass

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    End point title
    		 Lean body mass
    End point description
    End point type
    Secondary
    End point timeframe
    Changes between baseline and end of study
    End point values
    		 Treated Placebo
    Number of subjects analysed
    17
    16
    Units: kg
        arithmetic mean (standard deviation)
    63.4 ( 12.8 )
    58.7 ( 12.1 )
    No statistical analyses for this end point

    Secondary: Systolic blood pressure

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    End point title
    		 Systolic blood pressure
    End point description
    End point type
    Secondary
    End point timeframe
    Changes between baseline and end of study
    End point values
    		 Treated Placebo
    Number of subjects analysed
    17
    16
    Units: mmHg
        arithmetic mean (standard deviation)
    130.8 ( 8.8 )
    135.8 ( 11.1 )
    No statistical analyses for this end point

    Secondary: Diastolic blood pressure

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    End point title
    		 Diastolic blood pressure
    End point description
    End point type
    Secondary
    End point timeframe
    Changes between baseline and end of study
    End point values
    		 Treated Placebo
    Number of subjects analysed
    17
    16
    Units: mmHg
        arithmetic mean (standard deviation)
    81.5 ( 7.2 )
    81.8 ( 8.0 )
    No statistical analyses for this end point

    Secondary: Resting heart rate

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    End point title
    		 Resting heart rate
    End point description
    End point type
    Secondary
    End point timeframe
    Changes between baseline and end of study
    End point values
    		 Treated Placebo
    Number of subjects analysed
    17
    16
    Units: beats per minutes
        arithmetic mean (standard deviation)
    71.3 ( 9.4 )
    68.1 ( 12.7 )
    No statistical analyses for this end point

    Secondary: VO2max

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    End point title
    		 VO2max
    End point description
    End point type
    Secondary
    End point timeframe
    Changes between baseline and end of study
    End point values
    		 Treated Placebo
    Number of subjects analysed
    17
    16
    Units: L/O2/min
        arithmetic mean (standard deviation)
    3.4 ( 1.1 )
    2.9 ( 0.8 )
    No statistical analyses for this end point

    Secondary: Total cholesterol

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    End point title
    		 Total cholesterol
    End point description
    End point type
    Secondary
    End point timeframe
    Changes between baseline and end of study
    End point values
    		 Treated Placebo
    Number of subjects analysed
    17
    6
    Units: mmol
        arithmetic mean (standard deviation)
    4.4 ( 1.3 )
    4.3 ( 0.9 )
    No statistical analyses for this end point

    Secondary: HDL cholesterol

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    End point title
    		 HDL cholesterol
    End point description
    End point type
    Secondary
    End point timeframe
    Changes between baseline and end of study
    End point values
    		 Treated Placebo
    Number of subjects analysed
    17
    16
    Units: mmol
        arithmetic mean (standard deviation)
    1.2 ( 0.4 )
    1.3 ( 0.4 )
    No statistical analyses for this end point

    Secondary: LDL cholesterol

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    End point title
    		 LDL cholesterol
    End point description
    End point type
    Secondary
    End point timeframe
    Changes between baseline and end of study
    End point values
    		 Treated Placebo
    Number of subjects analysed
    17
    16
    Units: mmol
        arithmetic mean (standard deviation)
    2.4 ( 1.2 )
    2.3 ( 0.8 )
    No statistical analyses for this end point

    Secondary: VLDL cholesterol

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    End point title
    		 VLDL cholesterol
    End point description
    End point type
    Secondary
    End point timeframe
    Changes between baseline and end of study
    End point values
    		 Treated Placebo
    Number of subjects analysed
    17
    16
    Units: mmol
        arithmetic mean (standard deviation)
    0.7 ( 0.4 )
    0.7 ( 0.3 )
    No statistical analyses for this end point

    Secondary: Insulin

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    End point title
    		 Insulin
    End point description
    End point type
    Secondary
    End point timeframe
    Changes between baseline and end of study
    End point values
    		 Treated Placebo
    Number of subjects analysed
    17
    16
    Units: pM
        geometric mean (confidence interval 95%)
    111 (91 to 135)
    93 (63 to 138)
    No statistical analyses for this end point

    Secondary: C-peptide

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    End point title
    		 C-peptide
    End point description
    End point type
    Secondary
    End point timeframe
    Changes between baseline and end of study
    End point values
    		 Treated Placebo
    Number of subjects analysed
    17
    16
    Units: pM
        geometric mean (confidence interval 95%)
    913 (814 to 1023)
    799 (634 to 1008)
    No statistical analyses for this end point

    Secondary: HOMA2-IR, insulin

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    End point title
    		 HOMA2-IR, insulin
    End point description
    End point type
    Secondary
    End point timeframe
    Changes between baseline and end of study
    End point values
    		 Treated Placebo
    Number of subjects analysed
    17
    16
    Units: AU
        geometric mean (confidence interval 95%)
    2.2 (1.8 to 2.7)
    2.0 (1.4 to 3.1)
    No statistical analyses for this end point

    Secondary: HOMA2-IR c-peptide

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    End point title
    		 HOMA2-IR c-peptide
    End point description
    End point type
    Secondary
    End point timeframe
    Changes between baseline and end of study
    End point values
    		 Treated Placebo
    Number of subjects analysed
    17
    16
    Units: AU
        geometric mean (confidence interval 95%)
    2.2 (2.0 to 2.5)
    2.4 (1.9 to 3.1)
    No statistical analyses for this end point

    Secondary: HOMA2-beta, insulin

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    End point title
    		 HOMA2-beta, insulin
    End point description
    End point type
    Secondary
    End point timeframe
    Changes between baseline and end of study
    End point values
    		 Treated Placebo
    Number of subjects analysed
    17
    16
    Units: AU
        geometric mean (confidence interval 95%)
    86.5 (70.1 to 106.7)
    45.7 (30.3 to 69.1)
    No statistical analyses for this end point

    Secondary: HOMA2-beta, c-peptide

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    End point title
    		 HOMA2-beta, c-peptide
    End point description
    End point type
    Secondary
    End point timeframe
    Changes between baseline and end of study
    End point values
    		 Treated Placebo
    Number of subjects analysed
    17
    16
    Units: AU
        geometric mean (confidence interval 95%)
    86.7 (70.7 to 106.3)
    51.6 (36.8 to 72.3)
    No statistical analyses for this end point

    Secondary: Triglycerides

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    End point title
    		 Triglycerides
    End point description
    End point type
    Secondary
    End point timeframe
    Changes between baseline and end of study
    End point values
    		 Treated Placebo
    Number of subjects analysed
    17
    16
    Units: mM
        geometric mean (confidence interval 95%)
    1.5 (1.0 to 2.1)
    1.4 (1.1 to 1.8)
    No statistical analyses for this end point

    Secondary: Alanine aminotransferase

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    End point title
    		 Alanine aminotransferase
    End point description
    End point type
    Secondary
    End point timeframe
    Changes between baseline and end of study
    End point values
    		 Treated Placebo
    Number of subjects analysed
    17
    16
    Units: U/L
        geometric mean (confidence interval 95%)
    32.9 (23.2 to 46.5)
    28.4 (22.7 to 35.4)
    No statistical analyses for this end point

    Secondary: Aspartate aminotransferase

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    End point title
    		 Aspartate aminotransferase
    End point description
    End point type
    Secondary
    End point timeframe
    Changes between baseline and end of study
    End point values
    		 Treated Placebo
    Number of subjects analysed
    17
    16
    Units: U/L
        geometric mean (confidence interval 95%)
    33.2 (27.5 to 40.1)
    27.6 (23.7 to 32.1)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Adverse events and serious adverse events were recorded throughout the study in the time period December 2011 to March 2013
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    1
    Reporting groups
    Reporting group title
    Liraglutide
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 Liraglutide Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 16 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Liraglutide Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: No non-serious adverse events were reported

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/28188972
    http://www.ncbi.nlm.nih.gov/pubmed/27717126
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