Clinical trial NCT03267576: An Efficacy Study of Canagliflozin or Sitagliptin to Determine Glucose Variability in Mexican Participants With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin
Official title: Canagliflozin Continuous Glucose Monitoring (CANA CGM) Trial: A Pilot Randomized, Double-Blind, Controlled, Crossover Study on the Effects of the SGLT-2 Inhibitor Canagliflozin (vs. the DPP-4 Inhibitor Sitagliptin) on Glucose Variability in Mexican Patients With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2017-08-30
Enrollment: 64
Sex: ALL
Minimum age (years): 19
Maximum age (years): 54
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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:

* 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)

Primary outcomes:
measure: Change From Baseline in Glycemic Coefficient of Variation (CV) in Treatment Period 1
timeFrame: Baseline up to End of Treatment Period 1 (Days 22 to 27)
measure: Change From Baseline in Glycemic Coefficient of Variation (CV) in Treatment Period 2
timeFrame: Baseline up to End of Treatment Period 2 (Days 66 to 71)
Secondary outcomes:
measure: Change From Baseline in Glycemic Standard Deviation (SD) for 24-hour Glucose Profile
timeFrame: Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)
measure: Change From Baseline in Mean 24-hour Glucose Profile
timeFrame: Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)
measure: Change From Baseline in Fasting Plasma Glucose Levels
timeFrame: Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)
measure: Change From Baseline in 2-hour Post-prandial Glucose (PPG) Levels
timeFrame: Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)
measure: Percent Change From Baseline in Time During 24 Hours With Glucose 70 to 139 mg/dL
timeFrame: Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)
measure: Percent Change From Baseline in Time During 24 Hours With Glucose Greater Than (>) 140 mg/dL
timeFrame: Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)
measure: Percent Change From Baseline in Time During 24 Hours With Glucose Level > 180 mg/dL
timeFrame: Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)
measure: Percent Change From Baseline in Time During 24 Hours With Glucose Level Less Than (<) 70 mg/dL
timeFrame: Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)
measure: Change From Baseline in Time Spent With Glucose Level 70 to 139 mg/dL
timeFrame: Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)
measure: Change From Baseline in Time Spent With Glucose Level > 140 mg/dL
timeFrame: Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)
measure: Change From Baseline in Time Spent With Glucose Level > 180 mg/dL
timeFrame: Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)
measure: Change From Baseline in Time Spent With Glucose Level < 70 mg/dL
timeFrame: Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)
measure: Change From Baseline in Percentage of 2 Consecutive Glucose Readings With < 70 mg/dL
timeFrame: Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: Consultorio Privado
city: Guadalajara
country: Mexico
facility: Investigación Clínica Especializada
city: Guadalajara
country: Mexico
facility: Consultorio Privado en Unidad de Patología Clínica
city: Mexico City
country: Mexico
facility: Instituto Nacional de Ciencias Medicas y Nutrición Salvador Zubirán
city: Monterrey
country: Mexico
facility: Hospital Universitario 'Dr. Jose Eleuterio Gonzalez'
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: