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

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 4

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Metformin; Drug: Sitagliptin 100 mg; Drug: Canagliflozin 300 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT03267576

CR108346

28431754DIA4026 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 64 patients

Sex: All

Ages: 19 to 54 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

64 participants in 2 patient groups

Treatment Sequence AB

Experimental group

Description:

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.

Treatment:

Drug: Canagliflozin 300 mg

Drug: Sitagliptin 100 mg

Drug: Metformin

Treatment Sequence BA

Experimental group

Description:

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.

Treatment:

Drug: Canagliflozin 300 mg

Drug: Sitagliptin 100 mg

Drug: Metformin