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    Clinical Trial Results:
    A Multi-center Open-label Parallel Group Randomized Controlled Trial to Compare iGlarLixi Versus Premixed Insulin in Patients With Type 2 Diabetes Who Have Failed to Achieve Glycemic Control With Basal Insulin and Oral Antidiabetic Agents

    Summary
    EudraCT number
    		 2017-003370-13
    Trial protocol
    		 CZ   AT   ES   SE   BG   GR   RO  
    Global end of trial date
    19 Jul 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    28 Jul 2021
    First version publication date
    28 Jul 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    LPS15017
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Study Name: Global Premix
    Sponsors
    Sponsor organisation name
    Sanofi aventis recherche & développement
    Sponsor organisation address
    1 avenue Pierre Brossolette, Chilly-Mazarin, France, 91380
    Public contact
    Trial Transparency Team, Sanofi aventis recherche & développement, Contact-US@sanofi.com
    Scientific contact
    Trial Transparency Team, Sanofi aventis recherche & développement, Contact-US@sanofi.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
    15 Sep 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Jul 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate that in subjects with Type 2 diabetes mellitus (T2DM) failing to achieve control on their current basal insulin combined to 1 or 2 Oral Antidiabetic Drugs (OADs) regimen, iGlarLixi compared to premix insulin Biasp 30/70 twice daily (BID) showed non-inferiority of iGlarLixi in terms of Glycated hemoglobin (HbA1c) reduction or superiority in terms of body weight change at Week 26.
    Protection of trial subjects
    Subjects were fully informed of all pertinent aspects of the clinical trial as well as the possibility to discontinue at any time in language and terms appropriate for the subject and considering the local culture. During the course of the trial, subjects were provided with individual subject cards indicating the nature of the trial the subject is participating, contact details and any information needed in the event of a medical emergency. Collected personal data and human biological samples were processed in compliance with the Sanofi-Aventis Group Personal Data Protection Charter ensuring that the Group abides by the laws governing personal data protection in force in all countries in which it operates.
    Background therapy
    		 OAD treatment of Metformin alone or Metformin + Sodium-glucose co-transporter 2 inhibitor (SGLT-2i) was continued at stable doses.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    08 Nov 2018
    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
    North Macedonia: 40
    Country: Number of subjects enrolled
    Mexico: 90
    Country: Number of subjects enrolled
    Romania: 30
    Country: Number of subjects enrolled
    Saudi Arabia: 1
    Country: Number of subjects enrolled
    Serbia: 78
    Country: Number of subjects enrolled
    Taiwan: 30
    Country: Number of subjects enrolled
    Turkey: 18
    Country: Number of subjects enrolled
    Argentina: 70
    Country: Number of subjects enrolled
    India: 182
    Country: Number of subjects enrolled
    Korea, Republic of: 89
    Country: Number of subjects enrolled
    Kuwait: 25
    Country: Number of subjects enrolled
    Spain: 36
    Country: Number of subjects enrolled
    Sweden: 30
    Country: Number of subjects enrolled
    Austria: 5
    Country: Number of subjects enrolled
    Bulgaria: 51
    Country: Number of subjects enrolled
    Czechia: 90
    Country: Number of subjects enrolled
    Greece: 22
    Worldwide total number of subjects
    887
    EEA total number of subjects
    264
    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)
    573
    From 65 to 84 years
    313
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 1074 subjects were screened from 08 November 2018 to 02 December 2019 of which 187 were screen failures. Screen failure were mainly due to inclusion criteria not met.

    Pre-assignment
    Screening details
    		 A total of 887 subjects were randomised in 1:1 ratio to receive either iGlarLixi or Premixed insulin. Stratification was done at randomisation, based on HbA1c value (less than [<] 8 percentage [%], greater than or equal to [>=] 8%), use of SGLT-2i (Yes/No), and dose of basal insulin (<30 Units [U], >=30 U) at screening visit.

    Period 1
    Period 1 title
    Overall (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 iGlarLixi
    Arm description
    		 Subjects received iGlarLixi subcutaneously once a day for up to 26 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    iGlarLixi (insulin glargine/lixisenatide)
    Investigational medicinal product code
    HOE901/AVE0010
    Other name
    Suliqua
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    iGlarLixi (Fixed ratio combination of insulin glargine and lixisenatide) administered subcutaneously once a day within 1 hour prior to a meal with a prefilled disposable SoloStar® pen-injector. The dose was titrated according to the subject's need for insulin.

    Arm title
    		 Premixed insulin
    Arm description
    		 Subjects received Premix BiAsp 30 BID for up to 26 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Premix BiAsp 30
    Investigational medicinal product code
    Other name
    NovoMix® 30
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Premixed insulin 3 millilitre (mL) administered subcutaneously BID. The dose was titrated according to the subject's need for insulin and usual practice.

    Number of subjects in period 1
    		iGlarLixi Premixed insulin
    Started
    443
    444
    Treated
    442
    441
    Completed
    428
    416
    Not completed
    15
    28
         Adverse Events (AEs)
    4
    4
         Randomised and not treated
    1
    3
         Other
    1
    4
         Poor compliance to protocol
    1
    2
         Hypoglycemia
    -
    2
         Withdrawal by subject
    8
    12
         Lack of efficacy
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    iGlarLixi
    Reporting group description
    		 Subjects received iGlarLixi subcutaneously once a day for up to 26 weeks.

    Reporting group title
    Premixed insulin
    Reporting group description
    		 Subjects received Premix BiAsp 30 BID for up to 26 weeks.

    Reporting group values
    		 iGlarLixi Premixed insulin Total
    Number of subjects
    		 443 444 887
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 59.8 ± 10.3 59.8 ± 10.0 -
    Gender categorical
    Units: Subjects
        Female
    		 219 226 445
        Male
    		 224 218 442
    Body Mass Index (BMI)
    Data for BMI was collected and analysed for 886 subjects (442 subjects in iGlarLixi arm and 444 in Premixed insulin arm).
    Units: kilogram per metre square (kg/m^2)
        arithmetic mean (standard deviation)
    		 29.7 ± 4.7 30.0 ± 5.1 -
    Duration of T2DM
    Units: years
        arithmetic mean (standard deviation)
    		 13.0 ± 7.1 13.0 ± 7.4 -

    End points

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    End points reporting groups
    Reporting group title
    iGlarLixi
    Reporting group description
    		 Subjects received iGlarLixi subcutaneously once a day for up to 26 weeks.

    Reporting group title
    Premixed insulin
    Reporting group description
    		 Subjects received Premix BiAsp 30 BID for up to 26 weeks.

    Primary: Change From Baseline to Week 26 in HbA1c: Non Inferiority Analysis

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    End point title
    		 Change From Baseline to Week 26 in HbA1c: Non Inferiority Analysis
    End point description
    Combined estimate for Least square (LS) means and standard errors (SE) were obtained using an analysis of covariance (ANCOVA) (using multiple imputation) to account for missing data using values obtained during the 26-week randomised treatment period. Analysis was performed on intent-to-treat (ITT) population that included all randomised subjects.
    End point type
    Primary
    End point timeframe
    Baseline, Week 26
    End point values
    		 iGlarLixi Premixed insulin
    Number of subjects analysed
    443
    444
    Units: percentage of HbA1c
        least squares mean (standard error)
    -1.30 ± 0.06
    -1.05 ± 0.06
    Statistical analysis title
    		 iGlarLixi Versus Premixed insulin
    Statistical analysis description
    Analysis was performed using ANCOVA model including fixed categorical effects of randomisation strata (basal insulin dose at screening visit [<30 U, >=30 U] and SGLT-2i use [Yes, No] at screening visit), treatment group and country as well as fixed continuous covariates of Baseline values HbA1c.
    Comparison groups
    iGlarLixi v Premixed insulin
    Number of subjects included in analysis
    887
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    P-value
    		 < 0.001 [2]
    Method
    		 ANCOVA (using multiple imputation)
    Parameter type
    		 LS Mean difference
    Point estimate
    -0.24
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 -0.41
         upper limit
    		 -0.08
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.07
    Notes
    [1] - Non-inferiority of iGlarLixi versus premixed insulin on HbA1c change from Baseline to Week 26 was based on a non-inferiority margin of 0.3%.
    [2] - Threshold of significance at 0.025 level.

    Primary: Change From Baseline to Week 26 in Body Weight

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    End point title
    		 Change From Baseline to Week 26 in Body Weight
    End point description
    Combined estimate for LS means and SE were obtained using ANCOVA (using multiple imputation) to account for missing data using values obtained during the 26-week randomised treatment period. Analysis was performed on ITT population.
    End point type
    Primary
    End point timeframe
    Baseline, Week 26
    End point values
    		 iGlarLixi Premixed insulin
    Number of subjects analysed
    443
    444
    Units: kilograms (kg)
        least squares mean (standard error)
    -0.70 ± 0.20
    1.15 ± 0.20
    Statistical analysis title
    		 iGlarLixi Versus Premixed insulin
    Statistical analysis description
    Analysis was performed using ANCOVA model including fixed categorical effects of randomisation strata (screening HbA1c value [<8.0% versus >=8.0%], basal insulin dose at screening visit [<30 U, >=30 U] and SGLT-2i use [Yes, No] at screening visit), treatment group and country as well as fixed continuous covariates of Baseline weight values.
    Comparison groups
    iGlarLixi v Premixed insulin
    Number of subjects included in analysis
    887
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [3]
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean difference
    Point estimate
    -1.86
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.28
         upper limit
    		 -1.43
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.22
    Notes
    [3] - Threshold of significance at 0.05 level.

    Secondary: Percentage of Subjects With HbA1c <7.0 % Without Body Weight Gain at Week 26

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    End point title
    		 Percentage of Subjects With HbA1c <7.0 % Without Body Weight Gain at Week 26
    End point description
    Analysis was performed on ITT population.
    End point type
    Secondary
    End point timeframe
    Week 26
    End point values
    		 iGlarLixi Premixed insulin
    Number of subjects analysed
    443
    444
    Units: percentage of subjects
        number (not applicable)
    27.5
    12.4
    Statistical analysis title
    		 iGlarLixi Versus Premixed insulin
    Statistical analysis description
    Analysed using logistic regression model adjusted for fixed categorical effects of randomisation strata (basal insulin dose at screening visit [<30 U, >=30 U] and SGLT-2i use [Yes, No] at screening visit), treatment group as well as fixed continuous covariates of Baseline values for each of the primary endpoints (HbA1c and Weight).
    Comparison groups
    iGlarLixi v Premixed insulin
    Number of subjects included in analysis
    887
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [4]
    Method
    		 Logistic regression model
    Parameter type
    		 Adjusted Odds Ratio (OR)
    Point estimate
    2.83
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.98
         upper limit
    		 4.04
    Notes
    [4] - Threshold of significance at 0.05 level.

    Secondary: Percentage of Subjects with HbA1c <7 % Without Hypoglycemia and Without Body Weight Gain at Week 26

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    End point title
    		 Percentage of Subjects with HbA1c <7 % Without Hypoglycemia and Without Body Weight Gain at Week 26
    End point description
    Hypoglycemia was defined as plasma glucose <70 milligrams per decilitre (mg/dL) (<3.9 millimoles per litre [mmol/L]). Analysis was performed on ITT population.
    End point type
    Secondary
    End point timeframe
    Week 26
    End point values
    		 iGlarLixi Premixed insulin
    Number of subjects analysed
    443
    444
    Units: percentage of subjects
        number (not applicable)
    19.4
    7.0
    Statistical analysis title
    		 iGlarLixi Versus Premixed insulin
    Statistical analysis description
    Analysed using logistic regression model adjusting for fixed categorical effects of randomisation strata (basal insulin dose at screening visit [<30 U, >=30 U] and SGLT-2i use [Yes, No] at screening visit), treatment group as well as fixed continuous covariates of Baseline values for each of the primary endpoints (HbA1c and Weight).
    Comparison groups
    iGlarLixi v Premixed insulin
    Number of subjects included in analysis
    887
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [5]
    Method
    		 Logistic regression model
    Parameter type
    		 Adjusted OR
    Point estimate
    3.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.19
         upper limit
    		 5.28
    Notes
    [5] - Threshold of significance at 0.05 level.

    Secondary: Change From Baseline to Week 26 in HbA1c: Superiority Analysis

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    End point title
    		 Change From Baseline to Week 26 in HbA1c: Superiority Analysis
    End point description
    Analysis was performed on ITT population.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 26
    End point values
    		 iGlarLixi Premixed insulin
    Number of subjects analysed
    443
    444
    Units: percentage of HbA1c
        least squares mean (standard error)
    -1.30 ± 0.06
    -1.05 ± 0.06
    Statistical analysis title
    		 iGlarLixi Versus Premixed insulin
    Statistical analysis description
    Analysis was performed using ANCOVA model including fixed categorical effects of randomisation strata (basal insulin dose at screening visit [<30 U, >=30 U] and SGLT-2i use [Yes, No] at screening visit), treatment group and country as well as fixed continuous covariates of Baseline values HbA1c.
    Comparison groups
    iGlarLixi v Premixed insulin
    Number of subjects included in analysis
    887
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [6]
    Method
    		 ANCOVA (with multiple imputation)
    Parameter type
    		 LS mean difference
    Point estimate
    -0.24
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.39
         upper limit
    		 -0.1
    Notes
    [6] - Threshold of significance at 0.05 level.

    Secondary: Number of Subjects with Hypoglycemia Event

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    End point title
    		 Number of Subjects with Hypoglycemia Event
    End point description
    Any hypoglycemia event represents the number of subjects with any (severe or documented) hypoglycemia. Documented hypoglycemia was considered when measured plasma glucose concentration less than or equal to (<=) 70 mg/dL (<=3.9 mmol/L) (with or without symptoms). Hypoglycemia defined as plasma glucose level of <54 mg/dL (<3.0 mmol/L) was also considered. Severe hypoglycemia was an event defined as hypoglycemia with severe cognitive impairment (AE preferred term-hypoglycemic unconsciousness) requiring external assistance for recovery. Analysis was performed on the safety population that included randomised population who received at least 1 dose or part of a dose of the investigational medicinal product (IMP) analysed according to the treatment actually received.
    End point type
    Secondary
    End point timeframe
    Up to 26 weeks
    End point values
    		 iGlarLixi Premixed insulin
    Number of subjects analysed
    442
    441
    Units: subjects
    number (not applicable)
        Any Hypoglycemia Event
    138
    187
        Documented Hypoglycemia <=70 mg/dL (<=3.9 mmol/L)
    129
    179
        Hypoglycemia (<54 mg/dL [<3.0 mmol/L])
    28
    57
        Severe Hypoglycemia
    1
    2
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All AEs were collected from the first injection of the IMP up to 3 days after last injection regardless of seriousness or relationship to investigational product.
    Adverse event reporting additional description
    Reported AEs and deaths are TEAEs that developed, worsened, or became serious during the on-treatment period (time from the first injection of the IMP up to 3 days after the last injection of IMP). Analysis was performed on safety population.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.0
    Reporting groups
    Reporting group title
    iGlarLixi
    Reporting group description
    		 Subjects received iGlarLixi subcutaneously once a day for up to 26 weeks.

    Reporting group title
    Premixed Insulin
    Reporting group description
    		 Subjects received Premix BiAsp 30 BID for up to 26 weeks.

    Serious adverse events
    		 iGlarLixi Premixed Insulin
    Total subjects affected by serious adverse events
         subjects affected / exposed
    12 / 442 (2.71%)
    13 / 441 (2.95%)
         number of deaths (all causes)
    0
    2
         number of deaths resulting from adverse events
    0
    2
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Adenocarcinoma Gastric
         subjects affected / exposed
    1 / 442 (0.23%)
    0 / 441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Medullary Thyroid Cancer
         subjects affected / exposed
    1 / 442 (0.23%)
    0 / 441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Essential Hypertension
         subjects affected / exposed
    1 / 442 (0.23%)
    0 / 441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombophlebitis
         subjects affected / exposed
    1 / 442 (0.23%)
    0 / 441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombophlebitis Superficial
         subjects affected / exposed
    0 / 442 (0.00%)
    1 / 441 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Chronic Obstructive Pulmonary Disease
         subjects affected / exposed
    1 / 442 (0.23%)
    1 / 441 (0.23%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary Oedema
         subjects affected / exposed
    0 / 442 (0.00%)
    1 / 441 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Psychiatric disorders
    Schizophrenia
         subjects affected / exposed
    0 / 442 (0.00%)
    1 / 441 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicidal Behaviour
         subjects affected / exposed
    1 / 442 (0.23%)
    0 / 441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicide Attempt
         subjects affected / exposed
    1 / 442 (0.23%)
    0 / 441 (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
    Eye Contusion
         subjects affected / exposed
    0 / 442 (0.00%)
    1 / 441 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Humerus Fracture
         subjects affected / exposed
    0 / 442 (0.00%)
    1 / 441 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multiple Injuries
         subjects affected / exposed
    0 / 442 (0.00%)
    1 / 441 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nerve Injury
         subjects affected / exposed
    0 / 442 (0.00%)
    1 / 441 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rib Fracture
         subjects affected / exposed
    1 / 442 (0.23%)
    1 / 441 (0.23%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Road Traffic Accident
         subjects affected / exposed
    0 / 442 (0.00%)
    1 / 441 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Traumatic Haemothorax
         subjects affected / exposed
    0 / 442 (0.00%)
    1 / 441 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Hydrocele
         subjects affected / exposed
    0 / 442 (0.00%)
    1 / 441 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute Coronary Syndrome
         subjects affected / exposed
    0 / 442 (0.00%)
    1 / 441 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Acute Myocardial Infarction
         subjects affected / exposed
    1 / 442 (0.23%)
    0 / 441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac Failure
         subjects affected / exposed
    0 / 442 (0.00%)
    1 / 441 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Nervous system disorders
    Haemorrhage Intracranial
         subjects affected / exposed
    1 / 442 (0.23%)
    0 / 441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoglycaemic Unconsciousness
         subjects affected / exposed
    1 / 442 (0.23%)
    2 / 441 (0.45%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transient Ischaemic Attack
         subjects affected / exposed
    1 / 442 (0.23%)
    1 / 441 (0.23%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Diplopia
         subjects affected / exposed
    0 / 442 (0.00%)
    1 / 441 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    1 / 442 (0.23%)
    0 / 441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Hydronephrosis
         subjects affected / exposed
    0 / 442 (0.00%)
    1 / 441 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    1 / 442 (0.23%)
    1 / 441 (0.23%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary Tract Infection
         subjects affected / exposed
    0 / 442 (0.00%)
    1 / 441 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Diabetes Mellitus Inadequate Control
         subjects affected / exposed
    1 / 442 (0.23%)
    0 / 441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperkalaemia
         subjects affected / exposed
    1 / 442 (0.23%)
    0 / 441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 iGlarLixi Premixed Insulin
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    34 / 442 (7.69%)
    0 / 441 (0.00%)
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    34 / 442 (7.69%)
    0 / 441 (0.00%)
         occurrences all number
    39
    0

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    14 Jan 2019
    Following changes were made: clarified starting dose of Premix BiAsp 30 and distribution of it during the day; clarified that pre breakfast self-monitored plasma glucose (SMPG) value should be used for the adjustment of dinner dose of Premix BiAsp 30, and predinner SMPG for pre-breakfast dose; clarified the difference in SMPG schedule between intervention arms; added recommended hypoglycemia management guidelines following the request of India health authorities; allowed rescreening; clarified the statistical analysis procedure regarding multiplicity considerations.

    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
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