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    Clinical Trial Results:
    A Phase 3, Randomized, Active Comparator, Double-Blind, Multi-Center Study to Compare the Efficacy, Safety and Tolerability of ITCA 650 to Sitagliptin as Add-on Therapy to Metformin in Patients with Type 2 Diabetes

    Summary
    EudraCT number
    		 2012-002117-19
    Trial protocol
    		 LV   DK   DE  
    Global end of trial date
    07 Jul 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    14 Aug 2016
    First version publication date
    14 Aug 2016
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    ITCA 650-CLP-105
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01455870
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Intarcia Therapeutics, Inc
    Sponsor organisation address
    24650 Industrial Blvd, Hayward, CA, United States, 94545
    Public contact
    Chief Medical Officer, Intarcia Therapeutics, Inc, +1 617.936.2500, medinfo@intarcia.com
    Scientific contact
    Chief Medical Officer, Intarcia Therapeutics, Inc, +1 617.936.2500, medinfo@intarcia.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
    07 Jul 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    07 Jul 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    07 Jul 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Demonstrate that ITCA 650 is non-inferior to sitagliptin in reducing HbA1c in patients with type 2 diabetes following 52 weeks of treatment. The non‑inferiority margin was 0.3%. If non-inferiority is demonstrated, then ITCA 650 will be tested for superiority in reducing HbA1c.
    Protection of trial subjects
    The study protocol, all study protocol amendments, written study patient information, informed consent form (ICF), and any other appropriate study-related information were reviewed and approved by an independent ethics committee (IEC) or institutional review board (IRB) at each study site. All subjects were free to withdraw from the clinical trial at any time for any reason given. Protocol pre-defined reasons for discontinuation were the following: (1) Patient withdraws consent or requests discontinuation from the study for any reason; (2) Sponsor discontinues the study; (3) Pregnancy; (4) Occurrence of a clinical or laboratory AE, either serious or non serious, at the discretion of the Investigator; (5) Need to initiate therapy with an excluded concomitant medication; (6) Permanent discontinuation of study medication; (7) Any medical condition or personal circumstance that, in the opinion of the Investigator, exposes the patient to risk by continuing in the study or precludes adherence to the protocol; (8) Loss of glucose control. Close medical monitoring of all subjects was adhered to throughout the trial duration. An independent safety monitor evaluated safety information on a continuous basis in a blinded fashion. Patients who experienced hyperglycemia were prescribed rescue therapy as described in the protocol.
    Background therapy
    		 Metformin, at least ≥1500 mg/day oral.
    Evidence for comparator
    		 The choice of a control group with an active comparator (sitagliptin) was justified because it allowed all participants to receive active treatment. Sitagliptin is an approved pharmacotherapy for the treatment of type 2 diabetes worldwide and has a well characterized safety and efficacy profile.
    Actual start date of recruitment
    13 May 2013
    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: 18
    Country: Number of subjects enrolled
    Germany: 18
    Country: Number of subjects enrolled
    Latvia: 19
    Country: Number of subjects enrolled
    United States: 321
    Country: Number of subjects enrolled
    Israel: 9
    Country: Number of subjects enrolled
    South Africa: 37
    Country: Number of subjects enrolled
    Croatia: 18
    Country: Number of subjects enrolled
    Mexico: 45
    Country: Number of subjects enrolled
    Canada: 34
    Country: Number of subjects enrolled
    Malaysia: 15
    Country: Number of subjects enrolled
    Saudi Arabia: 1
    Worldwide total number of subjects
    535
    EEA total number of subjects
    73
    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)
    448
    From 65 to 84 years
    87
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 One hundred and twenty four global investigational sites were involved in the recruitment and treatment of 535 and patients.

    Pre-assignment
    Screening details
    		 Eligible subjects were males and females age 18 to 80 years inclusive with a diagnosis of type 2 diabetes for ≥ 3 months. Subjects also had HbA1c ≥7.5% and ≤10.5% and a body mass index (BMI) ≥25 kg/m2 and ≤45 kg/m2.

    Period 1
    Period 1 title
    Overall study (D0 - Week 52) (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group 1: ITCA 650
    Arm description
    		 Group 1: ITCA 650 osmotic mini-pump placed sub-dermally. ITCA 650 was combined with an oral placebo to maintain the blind.
    Arm type
    		 Experimental

    Investigational medicinal product name
    ITCA 650 20 mcg/day
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Implant
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    From randomization to Week 13, subjects receive 20 mcg/day of ITCA 650. From week 13 to week 52, subjects receive 60 mcg/day of ITCA 650. Subjects also take oral placebo for treatment period duration to maintain the blind between treatment groups.

    Investigational medicinal product name
    ITCA 650 60 mcg/day
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Implant
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    From randomization to Week 13, subjects receive 20 mcg/day of ITCA 650. From week 13 to week 52, subjects receive 60 mcg/day of ITCA 650. Subjects also take oral placebo for treatment period duration to maintain the blind between treatment groups.

    Arm title
    		 Group 2: Sitagliptin
    Arm description
    		 Sitagliptin 100 mg/day, oral administration. Group 2 subjects received an ITCA placebo device to maintain the blind.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Sitagliptin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Sitagliptin 100 mg/day plus ITCA placebo.

    Number of subjects in period 1 [1]
    		Group 1: ITCA 650 Group 2: Sitagliptin
    Started
    265
    265
    Completed
    204
    217
    Not completed
    61
    48
         Patients who did not complete treatment
    61
    48
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Five of the enrolled subjects (all enrolled in the UNITED STATES) were never treated so although 535 subjects were randomized, only 530 actually received treatment and entered the treatment period.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Group 1: ITCA 650
    Reporting group description
    		 Group 1: ITCA 650 osmotic mini-pump placed sub-dermally. ITCA 650 was combined with an oral placebo to maintain the blind.

    Reporting group title
    Group 2: Sitagliptin
    Reporting group description
    		 Sitagliptin 100 mg/day, oral administration. Group 2 subjects received an ITCA placebo device to maintain the blind.

    Reporting group values
    		 Group 1: ITCA 650 Group 2: Sitagliptin Total
    Number of subjects
    		 265 265 530
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 220 223 443
        From 65-84 years
    		 45 42 87
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 55.4 ± 9.84 54.6 ± 10.32 -
    Gender categorical
    Units: Subjects
        Female
    		 120 107 227
        Male
    		 145 158 303

    End points

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    End points reporting groups
    Reporting group title
    Group 1: ITCA 650
    Reporting group description
    		 Group 1: ITCA 650 osmotic mini-pump placed sub-dermally. ITCA 650 was combined with an oral placebo to maintain the blind.

    Reporting group title
    Group 2: Sitagliptin
    Reporting group description
    		 Sitagliptin 100 mg/day, oral administration. Group 2 subjects received an ITCA placebo device to maintain the blind.

    Primary: Change in HbA1c (%) between Week 52 and Day 0

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    End point title
    		 Change in HbA1c (%) between Week 52 and Day 0
    End point description
    Calculated as: Value of HbA1c (%) at Week 52 - Hba1c at baseline (%) (mITT population).
    End point type
    Primary
    End point timeframe
    The primary efficacy variable is the change in HbA1c (%) between baseline and Week 52 from the mITT population.
    End point values
    		 Group 1: ITCA 650 Group 2: Sitagliptin
    Number of subjects analysed
    263
    257
    Units: Change from Baseline HbA1c (%)
        least squares mean (standard error)
    -1.47 ± 0.08
    -0.76 ± 0.08
    Statistical analysis title
    		 Change in HbA1c (%) between Week 52 and Day 0
    Statistical analysis description
    Mixed Model Repeated Measures (MMRM) was used to compare the ITCA 650 treatment group to the sitagliptin treatment group. In the model, change from baseline HbA1c through Week 52 was the outcome variable. Treatment group, visit, and the interaction between treatment and visit were fixed effects. Baseline HbA1c was the covariate.
    Comparison groups
    Group 1: ITCA 650 v Group 2: Sitagliptin
    Number of subjects included in analysis
    520
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    P-value
    		 < 0.001
    Method
    		 Mixed models analysis
    Parameter type
    		 LS Mean Difference (final values)
    Point estimate
    -0.71
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.93
         upper limit
    		 -0.49
    Notes
    [1] - 0.3 % inferiority margin.

    Secondary: Composite HbA1c/Weight Reduction

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    End point title
    		 Composite HbA1c/Weight Reduction
    End point description
    Proportion of patients with decrease in HbA1c >0.5% and weight loss ≥2 kg between Week 52 and Day 0.
    End point type
    Secondary
    End point timeframe
    Proportion of patients who achieved Composite HbA1c/Weight Reduction at Week 52.
    End point values
    		 Group 1: ITCA 650 Group 2: Sitagliptin
    Number of subjects analysed
    171 [2]
    126 [3]
    Units: Not Applicable
        Achieved
    104
    35
        Not Achieved
    67
    91
    Notes
    [2] - 171 evaluable subjects from ITCA 650 group, mITT population
    [3] - 126 evaluable subjects from sitagliptin group, mITT population
    Statistical analysis title
    		 Composite HbA1c/Weight Reduction
    Statistical analysis description
    The ITCA 650 treatment group was compared to the sitagliptin treatment group using a logistic regression model with proportion of patients with HbA1c reduction > 0.5% and weight loss >= 2kg from baseline at Week 52 as the outcome variable, and treatment as a factor and baseline HbA1c (%) and baseline body weight as covariates.
    Comparison groups
    Group 1: ITCA 650 v Group 2: Sitagliptin
    Number of subjects included in analysis
    297
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    3.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.3
         upper limit
    		 5.6

    Secondary: Change in body weight between Week 52 and Day 0

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    End point title
    		 Change in body weight between Week 52 and Day 0
    End point description
    Change in weight (kg) from baseline - 52 week time point.
    End point type
    Secondary
    End point timeframe
    Change in weight (kg) from baseline - 52 week time point.
    End point values
    		 Group 1: ITCA 650 Group 2: Sitagliptin
    Number of subjects analysed
    263
    257
    Units: kilogram(s)
        least squares mean (standard error)
    -3.97 ± 0.33
    -1.25 ± 0.35
    Statistical analysis title
    		 Change in body weight between Week 52 and Day 0
    Comparison groups
    Group 2: Sitagliptin v Group 1: ITCA 650
    Number of subjects included in analysis
    520
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 Mixed models analysis
    Parameter type
    		 LS Mean Difference (final values)
    Point estimate
    -2.71
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.66
         upper limit
    		 -1.77

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Treatment emergent adverse events (Day 0 - End of study).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17
    Reporting groups
    Reporting group title
    Group 1: ITCA 650
    Reporting group description
    		 Group 1: ITCA 650 osmotic mini-pump placed sub-dermally. ITCA 650 plus oral placebo (to maintain blind between treatment groups).

    Reporting group title
    Group 2: Sitagliptin
    Reporting group description
    		 Group 2: Sitagliptin 100 mg/day plus ITCA placebo.

    Serious adverse events
    		 Group 1: ITCA 650 Group 2: Sitagliptin
    Total subjects affected by serious adverse events
         subjects affected / exposed
    15 / 265 (5.66%)
    20 / 265 (7.55%)
         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)
    Malignant neoplasm of unknown primary site
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 265 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Uterine leiomyoma
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 265 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mucinous cystadenocarcinoma ovary
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 265 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Deep Vein Thrombosis
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 265 (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
    0 / 265 (0.00%)
    1 / 265 (0.38%)
         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
    Pneumothorax
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 265 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Depession
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 265 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicidal ideation
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 265 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mental status changes
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 265 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Incisional hernia
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 265 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Seroma
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 265 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rib fracture
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 265 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Head injury
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 265 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 265 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ankle fracture
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 265 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Congestive Heart Failure
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 265 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    2 / 265 (0.75%)
    1 / 265 (0.38%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    1 / 265 (0.38%)
    1 / 265 (0.38%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute myocardial infarction
         subjects affected / exposed
    0 / 265 (0.00%)
    2 / 265 (0.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute coronary syndrome
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 265 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Angina unstable
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 265 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Migraine
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 265 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic stroke
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 265 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 265 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Umbilical hernia
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 265 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal ulcer
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 265 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis acute
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 265 (0.38%)
         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
    Skin ulcer
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 265 (0.38%)
         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
    1 / 265 (0.38%)
    0 / 265 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephrolithiasis
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 265 (0.38%)
         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
    Rotator cuff syndrome
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 265 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral disc protrusion
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 265 (0.38%)
         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 / 265 (0.38%)
    0 / 265 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthritis infective
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 265 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 265 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Erysipelas
         subjects affected / exposed
    2 / 265 (0.75%)
    1 / 265 (0.38%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 265 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 265 (0.38%)
         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
    		 Group 1: ITCA 650 Group 2: Sitagliptin
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    146 / 265 (55.09%)
    112 / 265 (42.26%)
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    14 / 265 (5.28%)
    7 / 265 (2.64%)
         occurrences all number
    14
    7
    Headache
         subjects affected / exposed
    21 / 265 (7.92%)
    21 / 265 (7.92%)
         occurrences all number
    24
    26
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    30 / 265 (11.32%)
    19 / 265 (7.17%)
         occurrences all number
    36
    23
    Gastrooesophageal reflux disease
         subjects affected / exposed
    15 / 265 (5.66%)
    5 / 265 (1.89%)
         occurrences all number
    16
    6
    Nausea
         subjects affected / exposed
    83 / 265 (31.32%)
    36 / 265 (13.58%)
         occurrences all number
    119
    40
    Vomiting
         subjects affected / exposed
    51 / 265 (19.25%)
    14 / 265 (5.28%)
         occurrences all number
    76
    15
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    7 / 265 (2.64%)
    16 / 265 (6.04%)
         occurrences all number
    9
    20
    Upper respiratory tract infection
         subjects affected / exposed
    18 / 265 (6.79%)
    24 / 265 (9.06%)
         occurrences all number
    21
    30
    Urinary tract infection
         subjects affected / exposed
    25 / 265 (9.43%)
    17 / 265 (6.42%)
         occurrences all number
    32
    24
    Metabolism and nutrition disorders
    Hyperglycaemia
         subjects affected / exposed
    5 / 265 (1.89%)
    14 / 265 (5.28%)
         occurrences all number
    6
    15

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    14 Nov 2012
    Changes to study design, additional clarification to some study procedures.
    10 Sep 2013
    Updates to the I/E criteria and safety procedures.

    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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    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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