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CompletedNCT03267576COMETAUpdated Nov 29, 2019Results posted

An Efficacy Study of Canagliflozin or Sitagliptin to Determine Glucose Variability in Mexican Participants With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin

A Phase 4 interventional study of Canagliflozin 300 mg and Sitagliptin 100 mg in Diabetes Mellitus, Type 2, sponsored by Janssen Research & Development, LLC. Completed at 5 sites in Mexico. Open to participants aged 19 Years to 54 Years. Per ClinicalTrials.gov, last updated 2019-11-29.

Sponsored by Janssen Research & Development, LLC · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
64
Allocation
Randomized
Ages
19 Years to 54 Years
Sex
All
01

Study summary

The main purpose of this study is to assess the effects of 4 weeks each of daily treatment with canagliflozin 300 milligram (mg) versus sitagliptin 100 mg as treatment adjuncts to metformin (at stable dosages) on intrapatient glycemic coefficient of variation (CV), expressed as a ratio percentage of standard deviation (SD) to mean glucose levels.

02

Conditions studied

  • Diabetes Mellitus, Type 2
03

Who can participate

Ages eligible
19 Years to 54 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Type 2 diabetes mellitus

  • Inadequate glucose control while using metformin monotherapy (MET) for at least 8 weeks at stable daily doses of at least 1500 milligram (mg) before screening visit (Visit 1)

    a. Hemoglobin A1c (HbA1c) equal to (=) 7.5 percent (%) to 10.5% at Visit 1

  • Adequate qualifying continuous glucose monitoring (CGM) reading during the pre-randomization (selection) phase
  • Estimated glomerular filtration rate (eGFR) of at least 60 milliliter/minute (mL/min)/1.73 meter square (m\^2) at Visit 1
  • Body mass index of 22 through 45 kilogram per meter square (kg/m\^2) at Visit 1

Exclusion criteria

Exclusion Criteria:

  • History of any of the following (at Visit 1):

    1. Diabetic ketoacidosis (DKA)
    2. Type 1 diabetes mellitus (T1DM)
    3. Pancreatic (for example, Beta-islet cell) transplantation
    4. Diabetes secondary to pancreatitis or pancreatectomy
    5. Personal history of, or ongoing, pancreatitis
    6. One or more episodes of severe hypoglycemia (requiring assistance from others), as documented in the history obtained at Visit 1
    7. Hereditary glucose-galactose malabsorption or primary renal glucosuria
  • Repeated fasting plasma glucose (FPG) or fasting self-monitored blood glucose (SMBG) greater than (>) 270 milligram per deciliter (mg/dL) during the pre-treatment phase
  • Treatment with any other oral or parenteral antidiabetic medications different from metformin monotherapy, including but not limited to Dipeptidyl peptidase-4 (DPP-4) inhibitors, Sulphonylureas, thiazolidinediones, insulins and Glucagon-like peptide-1 receptor agonist (GLP-1RAs); Sodium-glucose co-transporter 2 (SGLT-2) inhibitors and investigational agents
  • Received an investigational drug or vaccine or used an invasive investigational medical device within 30 days before the planned first dose of study drug
  • Current use of "natural medicines" or natural medicinal products for diabetes (for example, cactus-derived nutrients, celery)
04

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
64 participants (actual)

Study arms

  • Experimental
    Treatment Sequence AB

    Participants will receive metformin monotherapy at stable doses (greater than or equal to \[\>=\] 1500 milligram per day \[mg/day\]) orally once daily with canagliflozin 300 milligram (mg) tablet orally once daily (Treatment A) from Day 0 to 27 (treatment period 1), followed by sitagliptin 100 mg tablet orally once daily with metformin \>=1500 mg/day (Treatment B) from Day 44 to 71 (treatment period 2), under fasted condition. A washout period of at least 16 days (from Days 28 to 43) of metformin monotherapy will be maintained between each treatment period.

    Drug: Canagliflozin 300 mg · Drug: Sitagliptin 100 mg · Drug: Metformin

  • Experimental
    Treatment Sequence BA

    Participants will receive treatment B from Day 0 to 27 (treatment Period 1), followed by treatment A from Day 44 to 71 (treatment period 2), under fasted condition. A washout period of at least 16 days (from days 28 to 43) of metformin monotherapy will be maintained between each treatment period.

    Drug: Canagliflozin 300 mg · Drug: Sitagliptin 100 mg · Drug: Metformin

Interventions

  • DrugCanagliflozin 300 mg

    Participants will receive canagliflozin 300 mg oral tablet once-daily for 28 days.

    Also known as: JNJ-28431754

  • DrugSitagliptin 100 mg

    Participants will receive sitagliptin 100 mg oral tablet once-daily for 28 days.

  • DrugMetformin

    Participants will receive metformin at a stable dose of \>= 1500 mg/day throughout the study including the washout period between each intervention.

05

What researchers measure

Primary outcomes

  1. Change From Baseline in Glycemic Coefficient of Variation (CV) in Treatment Period 1

    Continuous blood glucose monitoring was done in participants using continuous glucose monitoring (CGM) determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and after each active treatment. Glucose coefficient of variation (CV) was calculated based on CGM data dividing the standard deviation of blood glucose values by the mean of the corresponding glucose readings. The participants were analyzed according to treatment received in treatment period 2 as per the sequence reported in this outcome measure.

    Time frame: Baseline up to End of Treatment Period 1 (Days 22 to 27)

  2. Change From Baseline in Glycemic Coefficient of Variation (CV) in Treatment Period 2

    Continuous blood glucose monitoring was done in participants using CGM determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and after each active treatment. Glucose coefficient of variation was calculated based on CGM data dividing the standard deviation of blood glucose values by the mean of the corresponding glucose readings. The participants were analyzed according to treatment received in treatment period 2 as per the sequence reported in this outcome measure.

    Time frame: Baseline up to End of Treatment Period 2 (Days 66 to 71)

Secondary outcomes

  1. Change From Baseline in Glycemic Standard Deviation (SD) for 24-hour Glucose Profile

    Glycemic standard deviation for 24-hour glucose profile (glycemic variability), as measured by CGM was determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants who received the study drug in the treatment period 1 and 2 as per the sequence were reported in this outcome measure.

    Time frame: Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)

  2. Change From Baseline in Mean 24-hour Glucose Profile

    Mean 24-hour glucose profiles as measured by CGM was determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 and treatment period 2 as per the sequence reported in this outcome measure.

    Time frame: Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)

  3. Change From Baseline in Fasting Plasma Glucose Levels

    Fasting plasma glucose levels were determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 and treatment period 2 as per the sequence reported in this outcome measure.

    Time frame: Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)

  4. Change From Baseline in 2-hour Post-prandial Glucose (PPG) Levels

    2-hour post-prandial glucose levels were determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 and treatment period 2 as per the sequence reported in this outcome measure.

    Time frame: Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)

  5. Percent Change From Baseline in Time During 24 Hours With Glucose 70 to 139 mg/dL

    Percent change from baseline in time during 24 hours with glucose levels 70 to 139 mg/dL was determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 and treatment period 2 as per the sequence reported in this outcome measure.

    Time frame: Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)

  6. Percent Change From Baseline in Time During 24 Hours With Glucose Greater Than (>) 140 mg/dL

    Percent change from baseline in time during 24 hours within the glucose levels \>140 mg/dL was determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 and treatment period 2 as per the sequence reported in this outcome measure.

    Time frame: Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)

  7. Percent Change From Baseline in Time During 24 Hours With Glucose Level > 180 mg/dL

    Percent change from baseline in time during 24 hours within the glucose levels \>180 mg/dL was determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 as per the sequence reported in this outcome measure.

    Time frame: Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)

  8. Percent Change From Baseline in Time During 24 Hours With Glucose Level Less Than (<) 70 mg/dL

    Percent change from baseline in time during 24 hours within the glucose levels \< 70 mg/dL was determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 and treatment period 2 as per the sequence reported in this outcome measure.

    Time frame: Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)

  9. Change From Baseline in Time Spent With Glucose Level 70 to 139 mg/dL

    Time spent with the glucose level 70 to 139 mg/dL was determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 and treatment period 2 as per the sequence reported in this outcome measure.

    Time frame: Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)

  10. Change From Baseline in Time Spent With Glucose Level > 140 mg/dL

    Time spent with the glucose level \> 140 mg/dL was determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 and treatment period 2 as per the sequence reported in this outcome measure.

    Time frame: Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)

  11. Change From Baseline in Time Spent With Glucose Level > 180 mg/dL

    Time spent with the glucose level \> 180 mg/dL was determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 as per the sequence reported in this outcome measure.

    Time frame: Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)

  12. Change From Baseline in Time Spent With Glucose Level < 70 mg/dL

    Time spent with the glucose level \< 70 mg/dL was determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 and treatment period 2 as per the sequence reported in this outcome measure.

    Time frame: Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)

  13. Change From Baseline in Percentage of 2 Consecutive Glucose Readings With < 70 mg/dL

    The percentage of 2 consecutive glucose readings with \< 70 mg/dL were reported. The participants were analyzed according to treatment received in treatment period 1 and treatment period 2 as per the sequence reported in this outcome measure.

    Time frame: Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)

06

Results

Posted Nov 29, 2019
Limitations and caveats
The main limitation of the study was the sample size limited to demonstrate any significant difference.

Participant flow

Period 1: Day 0 to 27
Participant flow — Period 1: Day 0 to 27
MilestoneTreatment Sequence ABTreatment Sequence BA
Started3132
Completed3132
Not completed00
Washout Period: 16 Days
Participant flow — Washout Period: 16 Days
MilestoneTreatment Sequence ABTreatment Sequence BA
Started3132
Completed3132
Not completed00
Period 2: Day 44 to 71
Participant flow — Period 2: Day 44 to 71
MilestoneTreatment Sequence ABTreatment Sequence BA
Started3132
Completed3030
Not completed12
Withdrew: Lost to follow-up01
Withdrew: Withdrawal by subject11

Outcome measures

PrimaryChange From Baseline in Glycemic Coefficient of Variation (CV) in Treatment Period 1

Continuous blood glucose monitoring was done in participants using continuous glucose monitoring (CGM) determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and after each active treatment. Glucose coefficient of variation (CV) was calculated based on CGM data dividing the standard deviation of blood glucose values by the mean of the corresponding glucose readings. The participants were analyzed according to treatment received in treatment period 2 as per the sequence reported in this outcome measure.

Time frame:
Baseline up to End of Treatment Period 1 (Days 22 to 27)
Reported as:
Mean · Percentage of CV
Change From Baseline in Glycemic Coefficient of Variation (CV) in Treatment Period 1
Percentage of CVTreatment Sequence ABTreatment Sequence BA
Change From Baseline in Glycemic Coefficient of Variation (CV) in Treatment Period 1-0.69 ± 5.170.24 ± 10.23
PrimaryChange From Baseline in Glycemic Coefficient of Variation (CV) in Treatment Period 2

Continuous blood glucose monitoring was done in participants using CGM determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and after each active treatment. Glucose coefficient of variation was calculated based on CGM data dividing the standard deviation of blood glucose values by the mean of the corresponding glucose readings. The participants were analyzed according to treatment received in treatment period 2 as per the sequence reported in this outcome measure.

Time frame:
Baseline up to End of Treatment Period 2 (Days 66 to 71)
Reported as:
Mean · Percentage of CV
Change From Baseline in Glycemic Coefficient of Variation (CV) in Treatment Period 2
Percentage of CVTreatment Sequence ABTreatment Sequence BA
Change From Baseline in Glycemic Coefficient of Variation (CV) in Treatment Period 2-1.26 ± 7.410.77 ± 6.16
SecondaryChange From Baseline in Glycemic Standard Deviation (SD) for 24-hour Glucose Profile

Glycemic standard deviation for 24-hour glucose profile (glycemic variability), as measured by CGM was determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants who received the study drug in the treatment period 1 and 2 as per the sequence were reported in this outcome measure.

Time frame:
Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)
Reported as:
Mean · mg/dL
Change From Baseline in Glycemic Standard Deviation (SD) for 24-hour Glucose Profile
mg/dLTreatment Sequence ABTreatment Sequence BA
Treatment Period 1-7.64 ± 6.56-8.40 ± 11.07
Treatment Period 2-8.53 ± 10.35-7.13 ± 12.00
SecondaryChange From Baseline in Mean 24-hour Glucose Profile

Mean 24-hour glucose profiles as measured by CGM was determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 and treatment period 2 as per the sequence reported in this outcome measure.

Time frame:
Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)
Reported as:
Mean · mg/dL
Change From Baseline in Mean 24-hour Glucose Profile
mg/dLTreatment Sequence ABTreatment Sequence BA
Treatment Period 1-34.81 ± 34.87-39.56 ± 39.79
Treatment Period 2-31.27 ± 33.27-41.74 ± 34.14
SecondaryChange From Baseline in Fasting Plasma Glucose Levels

Fasting plasma glucose levels were determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 and treatment period 2 as per the sequence reported in this outcome measure.

Time frame:
Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)
Reported as:
Mean · mg/dL
Change From Baseline in Fasting Plasma Glucose Levels
mg/dLTreatment Sequence ABTreatment Sequence BA
Treatment Period 1-32.04 ± 33.95-34.48 ± 32.94
Treatment Period 2-27.69 ± 32.19-45.51 ± 35.26
SecondaryChange From Baseline in 2-hour Post-prandial Glucose (PPG) Levels

2-hour post-prandial glucose levels were determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 and treatment period 2 as per the sequence reported in this outcome measure.

Time frame:
Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)
Reported as:
Mean · mg/dL
Change From Baseline in 2-hour Post-prandial Glucose (PPG) Levels
mg/dLTreatment Sequence ABTreatment Sequence BA
Treatment Period 1-47.03 ± 45.85-43.36 ± 48.00
Treatment Period 2-41.12 ± 44.77-44.03 ± 43.80
SecondaryPercent Change From Baseline in Time During 24 Hours With Glucose 70 to 139 mg/dL

Percent change from baseline in time during 24 hours with glucose levels 70 to 139 mg/dL was determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 and treatment period 2 as per the sequence reported in this outcome measure.

Time frame:
Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)
Reported as:
Mean · Percent Change
Percent Change From Baseline in Time During 24 Hours With Glucose 70 to 139 mg/dL
Percent ChangeTreatment Sequence ABTreatment Sequence BA
Treatment Period 10.157 ± 0.1340.191 ± 0.224
Treatment Period 20.192 ± 0.2140.182 ± 0.209
SecondaryPercent Change From Baseline in Time During 24 Hours With Glucose Greater Than (>) 140 mg/dL

Percent change from baseline in time during 24 hours within the glucose levels \>140 mg/dL was determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 and treatment period 2 as per the sequence reported in this outcome measure.

Time frame:
Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)
Reported as:
Mean · Percent Change
Percent Change From Baseline in Time During 24 Hours With Glucose Greater Than (>) 140 mg/dL
Percent ChangeTreatment Sequence ABTreatment Sequence BA
Treatment Period 1-0.161 ± 0.145-0.216 ± 0.257
Treatment Period 2-214 ± 0.237-0.221 ± 0.210
SecondaryPercent Change From Baseline in Time During 24 Hours With Glucose Level > 180 mg/dL

Percent change from baseline in time during 24 hours within the glucose levels \>180 mg/dL was determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 as per the sequence reported in this outcome measure.

Time frame:
Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)
Reported as:
Mean · Percent Change
Percent Change From Baseline in Time During 24 Hours With Glucose Level > 180 mg/dL
Percent ChangeTreatment Sequence ABTreatment Sequence BA
Treatment Period 1-0.235 ± 0.204-0.212 ± 0.286
Treatment Period 2-0.246 ± 0.232-0.251 ± 0.249
SecondaryPercent Change From Baseline in Time During 24 Hours With Glucose Level Less Than (<) 70 mg/dL

Percent change from baseline in time during 24 hours within the glucose levels \< 70 mg/dL was determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 and treatment period 2 as per the sequence reported in this outcome measure.

Time frame:
Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)
Reported as:
Mean · Percent Change
Percent Change From Baseline in Time During 24 Hours With Glucose Level Less Than (<) 70 mg/dL
Percent ChangeTreatment Sequence ABTreatment Sequence BA
Treatment Period 1NA ± NANA ± NA
Treatment Period 2NA ± NANA ± NA
SecondaryChange From Baseline in Time Spent With Glucose Level 70 to 139 mg/dL

Time spent with the glucose level 70 to 139 mg/dL was determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 and treatment period 2 as per the sequence reported in this outcome measure.

Time frame:
Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)
Reported as:
Mean · Minutes
Change From Baseline in Time Spent With Glucose Level 70 to 139 mg/dL
MinutesTreatment Sequence ABTreatment Sequence BA
Treatment Period 1226.64 ± 193.01275.64 ± 323.39
Treatment Period 2277.00 ± 309.46261.57 ± 301.75
SecondaryChange From Baseline in Time Spent With Glucose Level > 140 mg/dL

Time spent with the glucose level \> 140 mg/dL was determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 and treatment period 2 as per the sequence reported in this outcome measure.

Time frame:
Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)
Reported as:
Mean · Minutes
Change From Baseline in Time Spent With Glucose Level > 140 mg/dL
MinutesTreatment Sequence ABTreatment Sequence BA
Treatment Period 1-231.98 ± 208.27-310.41 ± 370.20
Treatment Period 2-308.68 ± 341.00318.23 ± 303.02
SecondaryChange From Baseline in Time Spent With Glucose Level > 180 mg/dL

Time spent with the glucose level \> 180 mg/dL was determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 as per the sequence reported in this outcome measure.

Time frame:
Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)
Reported as:
Mean · Minutes
Change From Baseline in Time Spent With Glucose Level > 180 mg/dL
MinutesTreatment Sequence ABTreatment Sequence BA
Treatment Period 1-338.36 ± 293.40-305.69 ± 412.30
Treatment Period 2-354.63 ± 333.52-361.65 ± 358.27
SecondaryChange From Baseline in Time Spent With Glucose Level < 70 mg/dL

Time spent with the glucose level \< 70 mg/dL was determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 and treatment period 2 as per the sequence reported in this outcome measure.

Time frame:
Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)
Reported as:
Mean · Minutes
Change From Baseline in Time Spent With Glucose Level < 70 mg/dL
MinutesTreatment Sequence ABTreatment Sequence BA
Treatment Period 1NA ± NANA ± NA
Treatment Period 2NA ± NANA ± NA
SecondaryChange From Baseline in Percentage of 2 Consecutive Glucose Readings With < 70 mg/dL

The percentage of 2 consecutive glucose readings with \< 70 mg/dL were reported. The participants were analyzed according to treatment received in treatment period 1 and treatment period 2 as per the sequence reported in this outcome measure.

Time frame:
Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)
Reported as:
Mean · Percentage of readings
Change From Baseline in Percentage of 2 Consecutive Glucose Readings With < 70 mg/dL
Percentage of readingsTreatment Sequence ABTreatment Sequence BA
Treatment Period 1NA ± NANA ± NA
Treatment Period 2NA ± NANA ± NA

Adverse events

Collected over Up to 96 Days. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Canagliflozin 300 mg0/63 (0%)0/63 (0%)7/63 (11.1%)
Sitagliptin 100 mg0/63 (0%)0/63 (0%)2/63 (3.2%)
Most frequent other events
Most frequent other events
EventCanagliflozin 300 mgSitagliptin 100 mg
FatigueGeneral disorders2/630/63
TachycardiaCardiac disorders1/630/63
DiarrhoeaGastrointestinal disorders1/630/63
VomitingGastrointestinal disorders1/630/63
DiscomfortGeneral disorders1/630/63
InfluenzaInfections and infestations1/630/63
Neck painMusculoskeletal and connective tissue disorders1/630/63
HeadacheNervous system disorders0/631/63
HypertensionVascular disorders0/631/63

Baseline characteristics

Intent-to-treat (ITT) analysis set included all participants who received at least one dose of medication and in whom CGM recordings at baseline and after each active treatment were successful (greater than \[\>\] 70 percent (%) of tracings available).

Age, Continuous
Age, Continuous(Years)Treatment Sequence ABTreatment Sequence BATotal
Mean46.03 ± 6.23744.84 ± 9.08845.3 ± 7.8
Sex: Female, Male
Sex: Female, Male(Participants)Treatment Sequence ABTreatment Sequence BATotal
Female141428
Male171835
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Treatment Sequence ABTreatment Sequence BATotal
Hispanic Mexican mestizo313263
Caucasian000
Asian000
Afro-American000
Height
Height(Meter)Treatment Sequence ABTreatment Sequence BATotal
Mean1.63 ± 0.101.64 ± 0.101.63 ± 0.10
Weight
Weight(Kilogram)Treatment Sequence ABTreatment Sequence BATotal
Mean84.01 ± 15.8688.96 ± 14.1786.52 ± 15.11
07

Study locations

5 sites
  • Consultorio Privado
    Guadalajara, 44150, Mexico
  • Investigación Clínica Especializada
    Guadalajara, 44600, Mexico
  • Consultorio Privado en Unidad de Patología Clínica
    Guadalajara, 44650, Mexico
  • Instituto Nacional de Ciencias Medicas y Nutrición Salvador Zubirán
    Mexico City, 14080, Mexico
  • Hospital Universitario 'Dr. Jose Eleuterio Gonzalez'
    Monterrey, 64460, Mexico
08

References and documents

Study documents

  • Study protocol · Jul 31, 2017
  • Statistical analysis plan · Aug 13, 2018

Documents are hosted by the registry — open the source record to download them.

09

Registry details

Key details

Study ID
NCT03267576
Lead sponsor
Janssen Research & Development, LLC
Responsible party
Sponsor
First posted
Aug 30, 2017
Start date
Oct 27, 2017
Primary completion
Oct 1, 2018
Completion
Oct 1, 2018
Results posted
Nov 29, 2019
Last update
Nov 29, 2019

Study contacts

Janssen Research & Development, LLC Clinical Trial
study director · Janssen Research & Development, LLC

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
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