Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43861   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    Efficacy and safety of switching from sitagliptin to liraglutide in subjects with type 2 diabetes not achieving adequate glycaemic control on sitagliptin and metformin

    Summary
    EudraCT number
    		 2012-004931-22
    Trial protocol
    		 ES   HU  
    Global end of trial date
    15 Jun 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    08 Jun 2016
    First version publication date
    08 Jun 2016
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    NN2211-4059
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01907854
    WHO universal trial number (UTN)
    		 U1111-1136-2073
    Sponsors
    Sponsor organisation name
    Novo Nordisk A/S
    Sponsor organisation address
    Novo Allé, Bagsværd, Denmark, 2880
    Public contact
    Global Clinical Registry (GCR, 1452), Novo Nordisk A/S, clinicaltrials@novonordisk.com
    Scientific contact
    Global Clinical Registry (GCR, 1452), Novo Nordisk A/S, clinicaltrials@novonordisk.com
    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
    14 Dec 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    15 Jun 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Jun 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To confirm superiority of switch from sitagliptin 100 mg/day to liraglutide 1.8 mg/day, both + metformin vs. continued sitagliptin 100 mg/day + metformin on glycaemic control after 26 weeks of treatment in subjects with type 2 diabetes.
    Protection of trial subjects
    The trial was conducted in accordance with the Declaration of Helsinki (Seoul, Oct 2008) and ICH Good Clinical Practice (01-May-1996) and 21 CFR 312.120.
    Background therapy
    		 Metformin was considered as background medication (NIMP) and was open-label throughout the trial. Subjects were to continue their pre-trial metformin treatment. Pre-trial dose level, dosing frequency and formulation had to remain the same throughout the trial, at the discretion of the investigator. An oral anti-diabetic, Metformin is administered as a tablet. The total daily dose was to be greater than equal to 1000 mg/day, divided into 1-3 doses.
    Evidence for comparator
    		 Not applicable
    Actual start date of recruitment
    02 Dec 2013
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 59
    Country: Number of subjects enrolled
    Hungary: 66
    Country: Number of subjects enrolled
    Canada: 60
    Country: Number of subjects enrolled
    India: 70
    Country: Number of subjects enrolled
    Israel: 39
    Country: Number of subjects enrolled
    United States: 113
    Worldwide total number of subjects
    407
    EEA total number of subjects
    125
    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)
    321
    From 65 to 84 years
    85
    85 years and over
    1

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 The trial was conducted at 86 sites in 6 countries as follows: Canada: 14 sites; Hungary: 8 sites; India: 7 sites; Israel: 8 sites; Spain: 6 sites; United States: 43 sites.

    Pre-assignment
    Screening details
    		 Subjects were adult males or females with Type 2 diabetes mellitus (T2DM) who had inadequate glycemic control with stable doses of sitagliptin and metformin for 90 days prior to screening.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator
    Blinding implementation details
    A randomised double-blind, double-dummy, active-controlled design was chosen in accordance with the trial objectives. The double-dummy design was applied to eliminate potential bias of efficacy and safety results to the widest possible extent. Stratification was implemented in order to avoid bias arising from differences in glycosylated hemoglobin (HbA1c) and metformin dose at screening between the two arms.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Liraglutide
    Arm description
    		 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.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Liraglutide
    Investigational medicinal product code
    Other name
    Victoza
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Liraglutide was initiated with a starting dose of 0.6 mg/day, with subsequent weekly dose escalations of 0.6 mg/day in accordance with the approved dose escalation for liraglutide until the maintenance dose of 1.8 mg/day in this trial was reached. Escalation from 0.6 to 1.2 then 1.8 mg/day could be extended by 7 days in total if subjects did not tolerate an increase in dose during dose escalation, at the discretion of the investigator. The liraglutide maintenance dose of 1.8 mg/day had to remain unchanged throughout the remainder of the trial. Liraglutide was to be injected subcutaneously (sc., under the skin) in the thigh, upper arm (deltoid region) or abdomen. The injection site did not have to be consistent throughout the trial. Injections could be done at any time of the day irrespective of meals.

    Investigational medicinal product name
    Sitagliptin placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Matching sitagliptin placebo is an oral anti-diabetic administered as a tablet. Sitagliptin 100 mg was administered once daily irrespective of meals. The dose and daily time of tablet administration was to remain the same throughout the treatment period.

    Arm title
    		 Sitagliptin
    Arm description
    		 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.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Sitagliptin
    Investigational medicinal product code
    Other name
    Januvia
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Sitagliptin is an oral anti-diabetic administered as a tablet. Sitagliptin 100 mg was administered once daily irrespective of meals. The dose and daily time of tablet administration was to remain the same throughout the treatment period.

    Investigational medicinal product name
    Liraglutide placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Matching liraglutide placebo was initiated with a starting dose of 0.6 mg/day, with subsequent weekly dose escalations of 0.6 mg/day in accordance with the approved dose escalation for liraglutide until the maintenance dose of 1.8 mg/day in this trial was reached. Escalation from 0.6 to 1.2 then 1.8 mg/day could be extended by 7 days in total if subjects did not tolerate an increase in dose during dose escalation, at the discretion of the investigator. The liraglutide maintenance dose of 1.8 mg/day had to remain unchanged throughout the remainder of the trial. Liraglutide was to be injected subcutaneously in the thigh, upper arm (deltoid region) or abdomen. The injection site did not have to be consistent throughout the trial. Injections could be done at any time of the day irrespective of meals.

    Number of subjects in period 1
    		Liraglutide Sitagliptin
    Started
    203
    204
    Exposed
    202
    204
    Completed
    187
    191
    Not completed
    16
    13
         Consent withdrawn by subject
    9
    7
         Unclassified
    4
    3
         Lost to follow-up
    2
    2
         Protocol deviation
    1
    1

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Liraglutide
    Reporting group description
    		 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.

    Reporting group title
    Sitagliptin
    Reporting group description
    		 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.

    Reporting group values
    		 Liraglutide Sitagliptin Total
    Number of subjects
    		 203 204 407
    Age categorical
    Units: Subjects
    Age continuous
    Demographics and baseline age characteristics of exposed subjects were summarised in continuous variables. The number of exposed subjects in liraglutide arm was 202 subjects and sitagliptin arm was 204 subjects. Only the exposed subjects have contributed to the baseline age values reported here.
    Units: years
        arithmetic mean (standard deviation)
    		 56.3 ± 10.6 56.5 ± 9.7 -
    Gender categorical
    Demographics and baseline gender characteristics of randomised subjects were summarised in categorical variables. Although, the number of exposed subjects in liraglutide arm was 202 subjects and sitagliptin arm was 204 subjects; randomised subjects (203 and 204) have contributed to the baseline gender values reported here.
    Units: Subjects
        Female
    		 85 79 164
        Male
    		 118 125 243
    HbA1c
    Demographics and baseline HbA1c characteristics of exposed subjects were summarised in continuous variables. The number of exposed subjects in liraglutide arm was 202 subjects and sitagliptin arm was 204 subjects. Only the exposed subjects have contributed to the baseline age values reported here.
    Units: percentage of glycosylated haemoglobin
        arithmetic mean (standard deviation)
    		 8.3 ± 0.6 8.2 ± 0.6 -
    Body Weight
    Demographics and baseline body weight characteristics of exposed subjects were summarised in continuous variables. The number of exposed subjects in liraglutide arm was 202 subjects and sitagliptin arm was 204 subjects. Only the exposed subjects have contributed to the baseline body weight reported here.
    Units: kilograms
        arithmetic mean (standard deviation)
    		 88.9 ± 19.8 91.2 ± 19.6 -
    Fasting plasma glucose
    Demographics and baseline fasting plasma glucose characteristics of exposed subjects were summarised in continuous variables. The number of exposed subjects in liraglutide arm was 200 subjects and sitagliptin arm was 203 subjects. Only the exposed subjects have contributed to the baseline fasting plasma glucose values reported here.
    Units: mmol/L
        arithmetic mean (standard deviation)
    		 10 ± 2.7 9.7 ± 2.5 -

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Liraglutide
    Reporting group description
    		 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.

    Reporting group title
    Sitagliptin
    Reporting group description
    		 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.

    Primary: Change in HbA1c

    		 Close Top of page
    End point title
    		 Change in HbA1c
    End point description
    Change from baseline in HbA1c was analysed after 26 weeks of treatment. Analysis population set: full analysis set (FAS); all randomised subjects receiving at least one dose of any of the trial products. Missing values were imputed using mixed model for repeated measurements (MMRM).
    End point type
    Primary
    End point timeframe
    From baseline to Week 26
    End point values
    		 Liraglutide Sitagliptin
    Number of subjects analysed
    176
    182
    Units: percentage of glycosylated haemoglobin
        arithmetic mean (standard deviation)
    -1.146 ± 0.9748
    -0.529 ± 1.0148
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Changes in HbA1c from baseline to the 26 weeks’ measurements were analysed using MMRM, with treatment, baseline HbA1c level (≤8.5% and >8.5%), metformin dose (<1500 mg/day and ≥1500 mg/day), the interaction between baseline HbA1c level and metformin dose, and country as factors and the HbA1c value at baseline as a covariate, all variables nested within week as a factor.
    Comparison groups
    Liraglutide v Sitagliptin
    Number of subjects included in analysis
    358
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [1]
    Method
    		 Mixed models analysis
    Parameter type
    		 Treatment difference
    Point estimate
    -0.61
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.82
         upper limit
    		 -0.4
    Notes
    [1] - Superiority of liraglutide over sitagliptin would be concluded if the 95% CI for the treatment difference was entirely below 0%.

    Secondary: Change in body weight

    		 Close Top of page
    End point title
    		 Change in body weight
    End point description
    Change from baseline in body weight was analysed after 26 weeks of treatment. Analysis population set: full analysis set (FAS); all randomised subjects receiving at least one dose of any of the trial products. Missing values were imputed using MMRM.
    End point type
    Secondary
    End point timeframe
    From baseline to Week 26
    End point values
    		 Liraglutide Sitagliptin
    Number of subjects analysed
    192
    200
    Units: kilogram(s)
        arithmetic mean (standard deviation)
    -3.32 ± 3.135
    -1.8 ± 2.974
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    Change in body weight from baseline to week 26 was analysed using MMRM, with treatment, baseline HbA1c level (≤ 8.5% and > 8.5%), metformin dose (<1500 mg/day and ≥1500 mg/day), the interaction between baseline HbA1c level and metformin dose, and country as factors and the body weight at baseline as a covariate and all variables nested within week as a factor.
    Comparison groups
    Liraglutide v Sitagliptin
    Number of subjects included in analysis
    392
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [2]
    Method
    		 Mixed models analysis
    Parameter type
    		 Treatment difference
    Point estimate
    -1.67
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.34
         upper limit
    		 -0.99
    Notes
    [2] - Superiority of liraglutide was concluded when 95% CI for the treatment difference for change from baseline in body weight after 26 weeks was entirely below 0%, implying that the 2-sided p-value for the hypothesis of no treatment difference was < 5% .

    Secondary: Change in fasting plasma glucose

    		 Close Top of page
    End point title
    		 Change in fasting plasma glucose
    End point description
    Change from baseline in fasting blood glucose was analysed after 26 weeks of treatment. Analysis population set: full analysis set (FAS); all randomised subjects receiving at least one dose of any of the trial products. Missing values were imputed using MMRM.
    End point type
    Secondary
    End point timeframe
    From baseline to Week 26
    End point values
    		 Liraglutide Sitagliptin
    Number of subjects analysed
    190
    199
    Units: nmol/L
        arithmetic mean (standard deviation)
    -1.967 ± 2.3585
    -0.588 ± 2.1363
    No statistical analyses for this end point

    Secondary: Change in fasting blood lipids

    		 Close Top of page
    End point title
    		 Change in fasting blood lipids
    End point description
    Ratio to baseline in fasting blood lipids (total cholesterol, low density lipoprotein [LDL], very low density lipoprotein [VLDL], high density lipoprotein [HDL], triglycerides, and free fatty acids) were analysed after 26 weeks of treatment. Analysis population set: full analysis set; all randomised subjects receiving at least one dose of any of the trial products. Missing values were imputed using MMRM. Here we are presenting ratio to baseline data.
    End point type
    Secondary
    End point timeframe
    From baseline to Week 26
    End point values
    		 Liraglutide Sitagliptin
    Number of subjects analysed
    155 [3]
    156 [4]
    Units: ratio
    arithmetic mean (standard deviation)
        Total Cholesterol
    1.011 ± 0.1906
    1.045 ± 0.2323
        LDL Cholesterol
    1.049 ± 0.3899
    1.121 ± 0.4661
        VLDL Cholesterol
    1.062 ± 0.4236
    1.075 ± 0.4625
        HDL Cholesterol
    1.004 ± 0.1528
    0.997 ± 0.1548
        Triglycerides
    1.089 ± 0.4975
    1.099 ± 0.4889
        Free Fatty Acids
    1.086 ± 0.774
    1.104 ± 0.5839
    Notes
    [3] - For Free Fatty Acids 154 subjects were analysed.
    [4] - For Free Fatty Acids 150 subjects were analysed.
    No statistical analyses for this end point

    Secondary: Change in systolic blood pressure and diastolic blood pressure

    		 Close Top of page
    End point title
    		 Change in systolic blood pressure and diastolic blood pressure
    End point description
    Change from baseline in systolic blood pressure and diastolic blood pressure were analysed after 26 weeks of treatment. Analysis population set: full analysis set; all randomised subjects receiving at least one dose of any of the trial products. Missing values were imputed using MMRM.
    End point type
    Secondary
    End point timeframe
    From baseline to Week 26
    End point values
    		 Liraglutide Sitagliptin
    Number of subjects analysed
    192
    200
    Units: mmHg
    arithmetic mean (standard deviation)
        systolic blood pressure
    -3.6 ± 11.596
    -2.57 ± 11.593
        diastolic blood pressure
    -0.23 ± 7.085
    -0.81 ± 7.193
    No statistical analyses for this end point

    Secondary: Subjects who achieve HbA1c <7.0% (53 mmol/mol) (American Diabetes Association target)

    		 Close Top of page
    End point title
    		 Subjects who achieve HbA1c <7.0% (53 mmol/mol) (American Diabetes Association target)
    End point description
    Number of subjects who achieve HbA1c <7.0% were analysed after 26 weeks of treatment. Analysis population set: full analysis set; all randomised subjects receiving at least one dose of any of the trial products. Missing values were imputed using MMRM.
    End point type
    Secondary
    End point timeframe
    After 26 weeks of treatment
    End point values
    		 Liraglutide Sitagliptin
    Number of subjects analysed
    176
    182
    Units: Percentage of subjects
    number (not applicable)
        Yes
    50.6
    26.9
        No
    49.4
    73.1
    No statistical analyses for this end point

    Secondary: Number of treatment emergent adverse events

    		 Close Top of page
    End point title
    		 Number of treatment emergent adverse events
    End point description
    A treatment emergent adverse event (TEAE) was defined as an event that had an onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. The number of TEAEs was recorded during 26 weeks of treatment plus a one -week of follow-up. Number of Analysis population set: safety analysis set; all randomised subjects receiving at least one dose of any of the trial products.
    End point type
    Secondary
    End point timeframe
    During 26 weeks of treatment plus one week of follow-up period.
    End point values
    		 Liraglutide Sitagliptin
    Number of subjects analysed
    202
    204
    Units: Events
    455
    318
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    27 weeks (26 weeks of treatment period + 1 week follow-up)
    Adverse event reporting additional description
    Adverse events were collected for safety analysis set that included all subjects who received at least one dose of any of the trial products.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18
    Reporting groups
    Reporting group title
    Sitagliptin
    Reporting group description
    		 Subjects in this arm received sitagliptin + metformin + liraglutide placebo for a duration of 26 weeks of treatment (a 3−4 week dose escalation period followed by a maintenance period).

    Reporting group title
    Liraglutide
    Reporting group description
    		 Subjects in this arm received liraglutide + metformin + sitagliptin placebo for a duration of 26 weeks and more (a 3−4 week dose escalation period followed by a maintenance period).

    Serious adverse events
    		 Sitagliptin Liraglutide
    Total subjects affected by serious adverse events
         subjects affected / exposed
    7 / 204 (3.43%)
    6 / 202 (2.97%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Bladder cancer
         subjects affected / exposed
    1 / 204 (0.49%)
    0 / 202 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    0 / 204 (0.00%)
    2 / 202 (0.99%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute coronary syndrome
         subjects affected / exposed
    0 / 204 (0.00%)
    1 / 202 (0.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure congestive
         subjects affected / exposed
    0 / 204 (0.00%)
    1 / 202 (0.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial ischaemia
         subjects affected / exposed
    1 / 204 (0.49%)
    0 / 202 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prinzmetal angina
         subjects affected / exposed
    0 / 204 (0.00%)
    1 / 202 (0.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Joint arthroplasty
         subjects affected / exposed
    0 / 204 (0.00%)
    1 / 202 (0.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    1 / 204 (0.49%)
    0 / 202 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multiple sclerosis
         subjects affected / exposed
    1 / 204 (0.49%)
    0 / 202 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Non-cardiac chest pain
         subjects affected / exposed
    1 / 204 (0.49%)
    0 / 202 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Acute febrile neutrophilic dermatosis
         subjects affected / exposed
    1 / 204 (0.49%)
    0 / 202 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    0 / 204 (0.00%)
    1 / 202 (0.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Pneumococcal sepsis
         subjects affected / exposed
    1 / 204 (0.49%)
    0 / 202 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 204 (0.49%)
    1 / 202 (0.50%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Sitagliptin Liraglutide
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    61 / 204 (29.90%)
    96 / 202 (47.52%)
    Investigations
    Lipase increased
         subjects affected / exposed
    9 / 204 (4.41%)
    11 / 202 (5.45%)
         occurrences all number
    9
    12
    Nervous system disorders
    Headache
         subjects affected / exposed
    12 / 204 (5.88%)
    13 / 202 (6.44%)
         occurrences all number
    16
    16
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    19 / 204 (9.31%)
    33 / 202 (16.34%)
         occurrences all number
    21
    45
    Nausea
         subjects affected / exposed
    16 / 204 (7.84%)
    44 / 202 (21.78%)
         occurrences all number
    21
    59
    Vomiting
         subjects affected / exposed
    10 / 204 (4.90%)
    15 / 202 (7.43%)
         occurrences all number
    15
    18
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    7 / 204 (3.43%)
    12 / 202 (5.94%)
         occurrences all number
    7
    14
    Upper respiratory tract infection
         subjects affected / exposed
    13 / 204 (6.37%)
    12 / 202 (5.94%)
         occurrences all number
    15
    12
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    7 / 204 (3.43%)
    18 / 202 (8.91%)
         occurrences all number
    7
    18

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    30 Sep 2013
    Global Amendment: Storage condition description for sitagliptin and placebo has been updated to reflect the current storage conditions. Minor changes in several sections have been made in to order to ensure clarity and alignment across trials.

    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
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Fri Apr 26 02:37:27 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA