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    Clinical Trial Results:
    A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Study the Safety and Efficacy of the Addition of Sitagliptin During Metformin Up-titration Compared with Metformin Up-titration Alone in Subjects with Type 2 Diabetes Mellitus

    Summary
    EudraCT number
    		 2015-004224-59
    Trial protocol
    		 CZ  
    Global end of trial date
    01 Feb 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    14 Feb 2019
    First version publication date
    14 Feb 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    0431-848
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02791490
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Merck Protocol Number: MK-0431-848
    Sponsors
    Sponsor organisation name
    Merck Sharp & Dohme Corp.
    Sponsor organisation address
    2000 Galloping Hill Road, Kenilworth, NJ, United States, 07033
    Public contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
    Scientific contact
    Senior Vice President, Global Clinical Development, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.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
    01 Feb 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Feb 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This trial is designed to evaluate, in adult participants with Type 2 diabetes mellitus and inadequate glycemic control on sub-maximal metformin mono-therapy (1000 mg/day), the effect of up-titration of metformin plus the addition of sitagliptin compared to up-titration of metformin alone on glycemic control. The primary hypothesis of this study is that up-titration of metformin to 2000 mg/day (1000 mg, twice daily [b.i.d]) plus the addition of sitagliptin 100 mg/day provides greater reduction in hemoglobin A1C (A1C) compared to metformin up-titration alone. Another primary objective of this study is to evaluate the safety and tolerability of this treatment.
    Protection of trial subjects
    This study was conducted in conformance with Good Clinical Practice standards and applicable country and/or local statutes and regulations regarding ethical committee review, informed consent, and the protection of human subjects participating in biomedical research.
    Background therapy
    		 Metformin is a well-established treatment for individuals with Type 2 diabetes mellitus which has been used in Europe for ~40 years and in the United States since 1995. Sitagliptin is an orally active and highly-selective dipeptidyl peptidase intravenous (IV) (DPP- 4) inhibitor indicated for the treatment of individuals with Type 2 diabetes mellitus.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    16 Jun 2016
    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
    Argentina: 53
    Country: Number of subjects enrolled
    Brazil: 59
    Country: Number of subjects enrolled
    Canada: 18
    Country: Number of subjects enrolled
    Czech Republic: 11
    Country: Number of subjects enrolled
    Guatemala: 73
    Country: Number of subjects enrolled
    Mexico: 85
    Country: Number of subjects enrolled
    Russian Federation: 80
    Country: Number of subjects enrolled
    United States: 79
    Worldwide total number of subjects
    458
    EEA total number of subjects
    11
    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)
    365
    From 65 to 84 years
    91
    85 years and over
    2

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 This trial included male and female adult participants with Type 2 diabetes mellitus and inadequate glycemic control on sub-maximal metformin mono-therapy. Additional criteria applied.

    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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Sitagliptin
    Arm description
    		 Participants received sitagliptin 100 mg once daily for 20 weeks. They also received immediate-release metformin (Met-IR), which was titrated from a baseline dose of 1000 mg/day (500 mg/twice a day [b.i.d]) up to 2000 mg/day (1000 mg/b.i.d.) by Day 15. Participants also received glycemic rescue therapy as needed.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sitagliptin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Sitagliptin 100 mg once a day for 20 weeks.

    Investigational medicinal product name
    Metformin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Immediate-release metformin (Met-IR) titrated from a baseline dose of 1000 mg/day (500 mg/b.i.d.) up to 2000 mg/day (1000 mg/b.i.d.) by Day 15 and continued at that dose for remainder of treatment period.

    Arm title
    		 Placebo
    Arm description
    		 Participants received placebo matching sitagliptin once daily for 20 weeks. They also received Met-IR, which was titrated from baseline dose of 1000 mg/day (500 mg/b.i.d.) up to 2000 mg/day (1000 mg/b.i.d.) by Day 15. Participants also received glycemic rescue therapy as needed.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Metformin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Immediate-release metformin (Met-IR) titrated from a baseline dose of 1000 mg/day (500 mg/b.i.d.) up to 2000 mg/day (1000 mg/b.i.d.) by Day 15 and continued at that dose for remainder of treatment period.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Matching placebo to sitagliptin 100 mg once a day for 20 weeks.

    Number of subjects in period 1
    		Sitagliptin Placebo
    Started
    229
    229
    Completed
    226
    221
    Not completed
    3
    8
         Consent withdrawn by subject
    2
    6
         Lost to follow-up
    1
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Sitagliptin
    Reporting group description
    		 Participants received sitagliptin 100 mg once daily for 20 weeks. They also received immediate-release metformin (Met-IR), which was titrated from a baseline dose of 1000 mg/day (500 mg/twice a day [b.i.d]) up to 2000 mg/day (1000 mg/b.i.d.) by Day 15. Participants also received glycemic rescue therapy as needed.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received placebo matching sitagliptin once daily for 20 weeks. They also received Met-IR, which was titrated from baseline dose of 1000 mg/day (500 mg/b.i.d.) up to 2000 mg/day (1000 mg/b.i.d.) by Day 15. Participants also received glycemic rescue therapy as needed.

    Reporting group values
    		 Sitagliptin Placebo Total
    Number of subjects
    		 229 229 458
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 176 189 365
        From 65-84 years
    		 53 38 91
        85 years and over
    		 0 2 2
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 55.6 ± 10.5 55.3 ± 10.4 -
    Sex: Female, Male
    Units: Subjects
        Female
    		 139 136 275
        Male
    		 90 93 183
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 23 27 50
        Asian
    		 0 1 1
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        Black or African American
    		 8 7 15
        White
    		 167 155 322
        More than one race
    		 31 39 70
        Unknown or Not Reported
    		 0 0 0
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 147 151 298
        Not Hispanic or Latino
    		 78 70 148
        Unknown or Not Reported
    		 4 8 12
    Hemoglobin A1C (%)
    Units: Percentage of glycosylated hemoglobin
        arithmetic mean (standard deviation)
    		 8.6 ± 0.9 8.7 ± 1.0 -
    Fasting Plasma Glucose
    Units: mg/dL
        arithmetic mean (standard deviation)
    		 181.7 ± 41.6 184.4 ± 44.7 -

    End points

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    End points reporting groups
    Reporting group title
    Sitagliptin
    Reporting group description
    		 Participants received sitagliptin 100 mg once daily for 20 weeks. They also received immediate-release metformin (Met-IR), which was titrated from a baseline dose of 1000 mg/day (500 mg/twice a day [b.i.d]) up to 2000 mg/day (1000 mg/b.i.d.) by Day 15. Participants also received glycemic rescue therapy as needed.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received placebo matching sitagliptin once daily for 20 weeks. They also received Met-IR, which was titrated from baseline dose of 1000 mg/day (500 mg/b.i.d.) up to 2000 mg/day (1000 mg/b.i.d.) by Day 15. Participants also received glycemic rescue therapy as needed.

    Subject analysis set title
    Sitagliptin
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants received sitagliptin 100 mg once daily for 20 weeks. They also received Met-IR, which was titrated from a baseline dose of 1000 mg/day (500 mg/b.i.d.) up to 2000 mg/day (1000 mg/b.i.d.) by Day 15. Participants also received glycemic rescue therapy as needed.

    Subject analysis set title
    Placebo
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants received placebo matching sitagliptin once daily for 20 weeks. They also received Met-IR, which was titrated from baseline dose of 1000 mg/day (500 mg/b.i.d.) up to 2000 mg/day (1000 mg/b.i.d.) by Day 15. Participants also received glycemic rescue therapy as needed.

    Primary: Change From Baseline in Hemoglobin A1C at Week 20

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    End point title
    		 Change From Baseline in Hemoglobin A1C at Week 20
    End point description
    Hemoglobin A1C is a blood marker used to report average blood glucose levels over prolonged periods of time. Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. The change from baseline represents the Week 20 A1C value minus the Week 0 (baseline) A1C value. The population analyzed included all randomized participants who received at least 1 dose of study medication and had at least 1 observation for the analysis end point.
    End point type
    Primary
    End point timeframe
    Baseline and Week 20
    End point values
    		 Sitagliptin Placebo
    Number of subjects analysed
    229
    229
    Units: A1C (%)
        least squares mean (confidence interval 95%)
    -1.10 (-1.28 to -0.93)
    -0.69 (-0.88 to -0.51)
    Statistical analysis title
    		 Change from Baseline in Hemoglobin A1C at Week 20
    Comparison groups
    Placebo v Sitagliptin
    Number of subjects included in analysis
    458
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.001
    Method
    		 Longitudinal Data Analysis
    Parameter type
    		 Difference in Least Squares Means
    Point estimate
    -0.41
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.59
         upper limit
    		 -0.23

    Primary: Percentage of Participants Who Experienced at Least One Adverse Event (AE)

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    End point title
    		 Percentage of Participants Who Experienced at Least One Adverse Event (AE)
    End point description
    An adverse event (AE) is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. The population analyzed for this end point included all randomized participants who received at least 1 dose of study medication.
    End point type
    Primary
    End point timeframe
    Up to 22 weeks
    End point values
    		 Sitagliptin Placebo
    Number of subjects analysed
    229
    229
    Units: Percentage of participants
        number (not applicable)
    44.1
    45.9
    Statistical analysis title
    		 Pct of part. who experienced at least one AE
    Comparison groups
    Sitagliptin v Placebo
    Number of subjects included in analysis
    458
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen method
    Parameter type
    		 Difference in % vs Placebo
    Point estimate
    -1.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.8
         upper limit
    		 7.4

    Primary: Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event

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    End point title
    		 Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event [1]
    End point description
    An adverse event (AE) is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. The population analyzed for this end point included all randomized participants who received at least 1 dose of study medication.
    End point type
    Primary
    End point timeframe
    Up to 20 weeks
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No between-group statistical comparison was provided for this primary end point because the statistical analysis plan called for between-group comparisons for only those safety endpoints reported by at least 4 participants in one or both treatment groups.
    End point values
    		 Sitagliptin Placebo
    Number of subjects analysed
    229
    229
    Units: Percentage of participants
        number (not applicable)
    0.9
    0.0
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Hemoglobin A1C <7% at Week 20

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    End point title
    		 Percentage of Participants With Hemoglobin A1C <7% at Week 20
    End point description
    Hemoglobin A1C is a blood marker used to report average blood glucose levels over prolonged periods of time. Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. The population analyzed included all randomized participants who received at least 1 dose of study medication and had at least 1 observation for the analysis end point.
    End point type
    Secondary
    End point timeframe
    Week 20
    End point values
    		 Sitagliptin Placebo
    Number of subjects analysed
    229
    229
    Units: Percentage of participants
        number (not applicable)
    28.8
    16.6
    Statistical analysis title
    		 Pct of Participants with A1C<7% at Wk 20
    Comparison groups
    Sitagliptin v Placebo
    Number of subjects included in analysis
    458
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.002
    Method
    		 Miettinen and Nurminen method
    Parameter type
    		 Relative Risk
    Point estimate
    1.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.2
         upper limit
    		 2.5

    Secondary: Change from Baseline in Fasting Plasma Glucose (FPG) at Week 20

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    End point title
    		 Change from Baseline in Fasting Plasma Glucose (FPG) at Week 20
    End point description
    Plasma glucose was measured on a fasting basis and is expressed as mg/dL. Blood was drawn predose on Day 1 and after 20 weeks of treatment to determine change in FPG levels. The change from baseline represents the Week 20 FPG value minus the Week 0 (baseline) FPG value. The population analyzed included all randomized participants who received at least 1 dose of study medication and had at least 1 observation for the analysis end point.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 20
    End point values
    		 Sitagliptin Placebo
    Number of subjects analysed
    229
    229
    Units: mg/dL
        least squares mean (confidence interval 95%)
    -29.3 (-37.5 to -21.1)
    -16.9 (-25.2 to -8.6)
    Statistical analysis title
    		 Chg from Baseline in FPG at Week 20
    Comparison groups
    Sitagliptin v Placebo
    Number of subjects included in analysis
    458
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.002
    Method
    		 Longitudinal Data Analysis
    Parameter type
    		 Difference in Least Squares Means
    Point estimate
    -12.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -20.2
         upper limit
    		 -4.6

    Secondary: Percentage of Participants With Hemoglobin A1C ≥8.5% at Baseline That Attained A1C Goal of <7% at Week 20

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    End point title
    		 Percentage of Participants With Hemoglobin A1C ≥8.5% at Baseline That Attained A1C Goal of <7% at Week 20
    End point description
    Hemoglobin A1C is a blood marker used to report average blood glucose levels over prolonged periods of time. Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. The population analyzed included the subgroup of randomized participants who had a baseline hemoglobin A1C ≥8.5%, received at least 1 dose of study medication, and had at least 1 observation for the analysis endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 20
    End point values
    		 Sitagliptin Placebo
    Number of subjects analysed
    122
    122
    Units: Percentage of participants
        number (not applicable)
    15.6
    5.7
    No statistical analyses for this end point

    Secondary: Percentage of Participants Receiving Glycemic Rescue Therapy

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    End point title
    		 Percentage of Participants Receiving Glycemic Rescue Therapy
    End point description
    Participants who met pre-specified criteria for glycemic rescue received appropriate rescue therapy. The choice of anti-hyperglycemic rescue agent, dose, and regimen was directed by the investigator, as clinically appropriate. The population analyzed included all randomized participants who received at least 1 dose of study medication.
    End point type
    Secondary
    End point timeframe
    Up to 20 weeks
    End point values
    		 Sitagliptin Placebo
    Number of subjects analysed
    229
    229
    Units: Percentage of participants
        number (not applicable)
    1.3
    3.1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 22 weeks
    Adverse event reporting additional description
    All randomized participants who received at least 1 dose of study medication
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received placebo matching sitagliptin once daily for 20 weeks. They also received Met-IR, which was titrated from baseline dose of 1000 mg/day (500 mg/b.i.d.) up to 2000 mg/day (1000 mg/b.i.d.) by Day 15. Participants also received glycemic rescue therapy as needed.

    Reporting group title
    Sitagliptin
    Reporting group description
    		 Participants received sitagliptin 100 mg once daily for 20 weeks. They also received Met-IR, which was titrated from a baseline dose of 1000 mg/day (500 mg/b.i.d.) up to 2000 mg/day (1000 mg/b.i.d.) by Day 15. Participants also received glycemic rescue therapy as needed.

    Serious adverse events
    		 Placebo Sitagliptin
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 229 (1.75%)
    3 / 229 (1.31%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Stab wound
         subjects affected / exposed
    1 / 229 (0.44%)
    0 / 229 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    0 / 229 (0.00%)
    1 / 229 (0.44%)
         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 / 229 (0.44%)
    0 / 229 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Metrorrhagia
         subjects affected / exposed
    1 / 229 (0.44%)
    0 / 229 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostatitis
         subjects affected / exposed
    0 / 229 (0.00%)
    1 / 229 (0.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Fatty liver alcoholic
         subjects affected / exposed
    0 / 229 (0.00%)
    1 / 229 (0.44%)
         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 / 229 (0.00%)
    1 / 229 (0.44%)
         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
    Intervertebral disc protrusion
         subjects affected / exposed
    1 / 229 (0.44%)
    0 / 229 (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
    		 Placebo Sitagliptin
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    11 / 229 (4.80%)
    18 / 229 (7.86%)
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    11 / 229 (4.80%)
    18 / 229 (7.86%)
         occurrences all number
    11
    18

    More information

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

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

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