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    Clinical Trial Results:
    An Open-label, Randomized, Multicenter, Phase III Study to Compare the Immunogenicity, Efficacy, and Safety of Gan & Lee Pharmaceuticals Insulin Glargine Injection to Lantus® (Insulin Glargine Injection) in Adult Subjects with Type 1 Diabetes Mellitus

    Summary
    EudraCT number
    		 2017-001450-34
    Trial protocol
    		 HU   CZ   ES  
    Global end of trial date
    19 Aug 2019

    Results information
    Results version number
    		 v2(current)
    This version publication date
    17 Jun 2022
    First version publication date
    14 Jul 2021
    Other versions
    		 v1
    Version creation reason
    • New data added to full data set
    The study result analysis and the study report were delayed because of both technical challenges with data collection which needed verification at the study sites, and Covid-19 over the past year. The results are now available and are ready to be uploaded.
    Summary report(s)
    		 Response to EudraCT May 2021

    Trial information

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    Trial identification
    Sponsor protocol code
    GL-GLAT1-3001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Gan & Lee Pharmaceuticals, USA
    Sponsor organisation address
    520 US Highway 22 Ste 302, Bridgewater, United States, 08807
    Public contact
    Mike Hu, CEO, Gan & Lee Pharmaceuticals, USA, 1 8882885395, mike.hu@ganlee.us
    Scientific contact
    Mike Hu, CEO, Gan & Lee Pharmaceuticals, USA, 1 8882885395, mike.hu@ganlee.us
    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
    11 Oct 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    19 Aug 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Aug 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate equivalence of Gan & Lee Pharmaceuticals insulin glargine and Lantus® in terms of immunogenicity and efficacy
    Protection of trial subjects
    In this study, safety was assessed by evaluating the following: • AEs, AEs of hypoglycemia, serious AEs (SAEs), fatal SAEs, AEs leading to discontinuation of the study treatment and/or withdrawal from the study, IP-related AEs, and injection site reactions • Treatment-emergent AEs (TEAEs) • Clinical laboratory parameters • Vital signs (blood pressure, pulse, and body weight) • 12-lead electrocardiogram (ECG) AEs were collected at every in-person visit and telephone visit.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    31 Oct 2017
    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
    Poland: 74
    Country: Number of subjects enrolled
    Spain: 54
    Country: Number of subjects enrolled
    Czechia: 49
    Country: Number of subjects enrolled
    Germany: 57
    Country: Number of subjects enrolled
    Hungary: 41
    Country: Number of subjects enrolled
    United States: 301
    Worldwide total number of subjects
    576
    EEA total number of subjects
    275
    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)
    508
    From 65 to 84 years
    68
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 A Total of 576 subjects (80.2%) met the entry criteria and were randomly assigned to treatment. Of these 576 subjects, a total of 513 subjects (89.1%) completed the study (89.9% in the GL Glargine Injection treatment group and 88.2% in the EU Lantus treatment group).

    Pre-assignment
    Screening details
    		 A total of 718 subjects with T1DM were screened for enrollment into this study.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Gan & Lee Insulin Glargine Injection
    Arm description
    		 Gan & Lee Insulin Glargine Injection for subcutaneous injection, 100 U/mL, in the integrated, disposable 3.0-mL pre-filled Gan & Lee injector pen
    Arm type
    		 Experimental

    Investigational medicinal product name
    Gan & Lee Insulin Glargine Injection
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion in pre-filled syringe
    Routes of administration
    Injection
    Dosage and administration details
    Gan & Lee Insulin Glargine Injection will be contained in Gan & Lee injector pens (3.0-mL pre-filled glass cartridge) for multiple dose administration. Gan & Lee Insulin Glargine should be administered once daily at any time but at the same time each day.

    Arm title
    		 Lantus®
    Arm description
    		 Lantus® (insulin glargine injection) solution for subcutaneous injection, 100 U/mL, in the SoloStar® 3-mL pre-filled insulin pen
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Lantus®
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled injector
    Routes of administration
    Injection
    Dosage and administration details
    Lantus® should be administered once daily at any time but at the same time each day.

    Number of subjects in period 1
    		Gan & Lee Insulin Glargine Injection Lantus®
    Started
    287
    289
    Completed
    287
    289

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall Trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall Trial Total
    Number of subjects
    		 576 576
    Age categorical
    Male or nonpregnant, nonlactating female subjects between the ages of 18 and 75 years, inclusive.
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 508 508
        From 65-84 years
    		 68 68
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 215 215
        Male
    		 361 361
    Subject analysis sets

    Subject analysis set title
    GL Glargine Injection
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects in this set received GL Glargine Injection, 100 U/mL, in the integrated, disposable 3.0-mL prefilled Gan & Lee UnoPen injection pen

    Subject analysis set title
    Lantus
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Lantus® Injection for subcutaneous injection.

    Subject analysis sets values
    		 GL Glargine Injection Lantus
    Number of subjects
    287
    289
    Age categorical
    Male or nonpregnant, nonlactating female subjects between the ages of 18 and 75 years, inclusive.
    Units: Subjects
        In utero
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
        Newborns (0-27 days)
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
        Children (2-11 years)
    0
    0
        Adolescents (12-17 years)
    0
    0
        Adults (18-64 years)
    256
    252
        From 65-84 years
    31
    37
        85 years and over
    0
    0
    Age continuous
    Units: years
        median (standard deviation)
    ( )
    ( )
    Gender categorical
    Units: Subjects
        Female
    101
    112
        Male
    184
    177

    End points

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    End points reporting groups
    Reporting group title
    Gan & Lee Insulin Glargine Injection
    Reporting group description
    		 Gan & Lee Insulin Glargine Injection for subcutaneous injection, 100 U/mL, in the integrated, disposable 3.0-mL pre-filled Gan & Lee injector pen

    Reporting group title
    Lantus®
    Reporting group description
    		 Lantus® (insulin glargine injection) solution for subcutaneous injection, 100 U/mL, in the SoloStar® 3-mL pre-filled insulin pen

    Subject analysis set title
    GL Glargine Injection
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects in this set received GL Glargine Injection, 100 U/mL, in the integrated, disposable 3.0-mL prefilled Gan & Lee UnoPen injection pen

    Subject analysis set title
    Lantus
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Lantus® Injection for subcutaneous injection.

    Primary: Immunogenicity

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    End point title
    		 Immunogenicity
    End point description
    End point type
    Primary
    End point timeframe
    The percentage of subjects in each treatment group who develop treatment induced AIA, defined as treatment-emergent AIA development or important (at least 4-fold) increase in titers and up to visit Week 26
    End point values
    		 Gan & Lee Insulin Glargine Injection Lantus® GL Glargine Injection Lantus
    Number of subjects analysed
    287
    289
    287
    289
    Units: percentage protection
        number (confidence interval 90%)
    287 (258 to 287)
    289 (260 to 289)
    287 (258 to 287)
    289 (260 to 289)
    Statistical analysis title
    		 Statistical Analysis
    Statistical analysis description
    The primary endpoint was met. The percentages of subjects positive for treatment-induced AIA (composite of newly developed or important increase in AIA) up to Week 26 were similar between the GL Glargine Injection (25.8%) and EU Lantus (25.3%) treatment groups, with a 90% CI (-5.4, 6.5) of the difference in proportions (0.6 percentage points) that fell completely between the similarity margins (-11.3, 11.3) for equivalence.
    Comparison groups
    GL Glargine Injection v Lantus
    Number of subjects included in analysis
    576
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.4
    Method
    		 Regression Logic
    Parameter type
    		 Risk difference (RD)
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events will be recorded beginning at the screening visit. Nonserious adverse events will be recorded from the time informed consent is signed through the subject’s last study visit.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    4.03
    Reporting groups
    Reporting group title
    GL Glargine Injection
    Reporting group description
    		 Subjects who met the eligibility criteria to receive GL Glargine Injection or EU Lantus treatment for 26 weeks.

    Reporting group title
    Lantus
    Reporting group description
    		 Subjects who met the eligibility criteria and received Lantus treatment for 26 weeks.

    Serious adverse events
    		 GL Glargine Injection Lantus
    Total subjects affected by serious adverse events
         subjects affected / exposed
    10 / 287 (3.48%)
    14 / 289 (4.84%)
         number of deaths (all causes)
    0
    1
         number of deaths resulting from adverse events
    0
    1
    Cardiac disorders
    Carotid artery occlusion
         subjects affected / exposed
    1 / 287 (0.35%)
    0 / 289 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocarditis
         subjects affected / exposed
    0 / 287 (0.00%)
    1 / 289 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Benign neoplasm of spinal cord
         subjects affected / exposed
    1 / 287 (0.35%)
    0 / 289 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebrovascular accident
         subjects affected / exposed
    0 / 287 (0.00%)
    1 / 289 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Craniocerebral injury
         subjects affected / exposed
    0 / 287 (0.00%)
    1 / 289 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Peripheral ischaemia
         subjects affected / exposed
    0 / 287 (0.00%)
    1 / 289 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Appendicitis
         subjects affected / exposed
    0 / 287 (0.00%)
    1 / 289 (0.35%)
         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
    Cough
         subjects affected / exposed
    0 / 287 (0.00%)
    1 / 289 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 287 (0.00%)
    1 / 289 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Diabetic foot
         subjects affected / exposed
    1 / 287 (0.35%)
    0 / 289 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prurigo
         subjects affected / exposed
    0 / 287 (0.00%)
    1 / 289 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 287 (0.00%)
    2 / 289 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    0 / 287 (0.00%)
    2 / 289 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicidal ideation
         subjects affected / exposed
    0 / 287 (0.00%)
    1 / 289 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Cellulitis
         subjects affected / exposed
    1 / 287 (0.35%)
    0 / 289 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gangrene
         subjects affected / exposed
    1 / 287 (0.35%)
    0 / 289 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    0 / 287 (0.00%)
    1 / 289 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower limb fracture
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 287 (0.35%)
    0 / 289 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar vertebral fracture
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 287 (0.00%)
    1 / 289 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteomyelitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 287 (0.00%)
    1 / 289 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rib fracture
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 287 (0.00%)
    1 / 289 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Localised infection
         subjects affected / exposed
    0 / 287 (0.00%)
    1 / 289 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritonitis
         subjects affected / exposed
    0 / 287 (0.00%)
    1 / 289 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural infection
         subjects affected / exposed
    1 / 287 (0.35%)
    0 / 289 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 287 (0.00%)
    1 / 289 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Septic shock
         subjects affected / exposed
    0 / 287 (0.00%)
    1 / 289 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hypoglycaemia
         subjects affected / exposed
    3 / 287 (1.05%)
    1 / 289 (0.35%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperglycinaemia
         subjects affected / exposed
    1 / 287 (0.35%)
    1 / 289 (0.35%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic ketoacidosis
         subjects affected / exposed
    0 / 287 (0.00%)
    1 / 289 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolic acidosis
         subjects affected / exposed
    0 / 287 (0.00%)
    1 / 289 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    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
    		 GL Glargine Injection Lantus
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    172 / 287 (59.93%)
    165 / 289 (57.09%)
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    3 / 287 (1.05%)
    0 / 289 (0.00%)
         occurrences all number
    3
    0
    Dizziness
         subjects affected / exposed
    1 / 287 (0.35%)
    0 / 289 (0.00%)
         occurrences all number
    1
    0
    Herpes zoster
         subjects affected / exposed
    1 / 287 (0.35%)
    0 / 289 (0.00%)
         occurrences all number
    1
    0
    Blood and lymphatic system disorders
    Blood creatine phosphokinase increased
         subjects affected / exposed
    1 / 287 (0.35%)
    0 / 289 (0.00%)
         occurrences all number
    1
    0
    Endocrine disorders
    Diabetes mellitus
         subjects affected / exposed
    1 / 287 (0.35%)
    0 / 289 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Contusion
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 287 (0.00%)
    1 / 289 (0.35%)
         occurrences all number
    0
    1
    Facial edema
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 287 (0.35%)
    0 / 289 (0.00%)
         occurrences all number
    1
    0
    Foot fracture
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 287 (0.35%)
    0 / 289 (0.00%)
         occurrences all number
    1
    0
    Metabolism and nutrition disorders
    Hypoglycaemia
         subjects affected / exposed
    158 / 287 (55.05%)
    161 / 289 (55.71%)
         occurrences all number
    158
    161
    Weight increased
         subjects affected / exposed
    3 / 287 (1.05%)
    1 / 289 (0.35%)
         occurrences all number
    0
    0
    Hyperglycaemia
         subjects affected / exposed
    2 / 287 (0.70%)
    1 / 289 (0.35%)
         occurrences all number
    2
    1
    Blood glucose increased
         subjects affected / exposed
    0 / 287 (0.00%)
    1 / 289 (0.35%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    18 Apr 2018
    Amendment 1.0
    01 Nov 2018
    Amendment 2

    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.

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