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Completed

NCT Number: NCT03267576

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

19 year–54 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Consultorio Privado, Guadalajara, Mexico

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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):
  • Diabetic ketoacidosis (DKA)
  • Type 1 diabetes mellitus (T1DM)
  • Pancreatic (for example, Beta-islet cell) transplantation
  • Diabetes secondary to pancreatitis or pancreatectomy
  • Personal history of, or ongoing, pancreatitis
  • One or more episodes of severe hypoglycemia (requiring assistance from others), as documented in the history obtained at Visit 1
  • 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)

Treatment and study plan

Canagliflozin 300 mg

Drug

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

Other names: JNJ-28431754

Sitagliptin 100 mg

Drug

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

metformin

Drug

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

Primary outcomes

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

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

    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.

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

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

    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.

Secondary outcomes

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

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

    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.

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

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

    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.

  3. Change From Baseline in Fasting Plasma Glucose Levels

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

    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.

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

    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-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.

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

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

    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.

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

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

    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.

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

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

    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.

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

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

    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.

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

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

    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.

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

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

    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.

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

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

    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.

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

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

    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.

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

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

    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.

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Registry information

Official study 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

Acronym: COMETA

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 30, 2017
Registry last updated
Nov 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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