An Efficacy Study of Canagliflozin or Sitagliptin to Determine Glucose Variability in Mexican Participants With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Canagliflozin 300 mg; Sitagliptin 100 mg; Metformin
Intervention description: Participants will receive canagliflozin 300 mg oral tablet once-daily for 28 days.; Participants will receive sitagliptin 100 mg oral tablet once-daily for 28 days.; Participants will receive metformin at a stable dose of >= 1500 mg/day throughout the study including the washout period between each intervention.
Intervention MeSH terms: Metformin; Sitagliptin Phosphate; Canagliflozin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 64.0
Sex: All
Minimum age: 19 Years
Maximum age: 54 Years
Healthy volunteers: No

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)