ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03267576
Recruitment Status : Recruiting
First Posted : August 30, 2017
Last Update Posted : July 13, 2018
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: Canagliflozin 300 mg Drug: Sitagliptin 100 mg Drug: Metformin Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : October 27, 2017
Estimated Primary Completion Date : September 1, 2018
Estimated Study Completion Date : September 30, 2018


Arm Intervention/treatment
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
Participants will receive canagliflozin 300 mg oral tablet once-daily for 28 days.
Other Name: JNJ-28431754

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

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

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
Participants will receive canagliflozin 300 mg oral tablet once-daily for 28 days.
Other Name: JNJ-28431754

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

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




Primary Outcome Measures :
  1. Change From Baseline in Intrapatient Coefficient of Variation (CV) of Glucose Profiles [ Time Frame: Baseline and 4 weeks ]
    Intrapatient CV is expressed as a ratio percentage (%) of standard deviation (SD) to mean glucose levels. Intrapatient variability in glucose levels will be measured over a 6-day period at baseline and after 4 weeks of treatment.


Secondary Outcome Measures :
  1. Change From Baseline in Glycemic Standard Deviation (SD) for 24-hour Glucose Profile [ Time Frame: Baseline and 4 weeks ]
    To measure glycemic variability, the mean of standard deviation of 24-hour glucose profile, as measured by continuous glucose monitoring (CGM) will be determined over a 6-day period at baseline and at the end of each active treatment.

  2. Change From Baseline in Mean 24-hour Glucose Profile [ Time Frame: Baseline and 4 weeks ]
    Mean 24-hour glucose profiles as measured by CGM will be determined over a 6-day period at baseline and at the end of each active treatment. Change from baseline in mean 24-hour glucose profiles at the end of each active treatment will be determined.

  3. Change From Baseline in Mean Pre-prandial Glucose Levels [ Time Frame: Baseline and 4 weeks ]
    Mean pre-prandial glucose levels will be determined over a 6-day period at baseline and at the end of each active treatment. The change from baseline in mean pre-prandial glucose levels at the end of each active treatment will be determined.

  4. Change From Baseline in Mean 2-hour Post-prandial Glucose (PPG) Levels [ Time Frame: Baseline and 4 weeks ]
    Mean 2-hour post-prandial glucose levels will be determined over a 6-day period at baseline and at the end of each active treatment. The change from baseline in mean 2-hour post-prandial glucose levels at the end of each active treatment will be determined.

  5. Mean Time Spent Within Specified Glucose Levels [ Time Frame: Baseline and 4 weeks ]
    The mean time spent within the specified glucose levels: (equal to [=]70-139 milligram per deciliter [mg/dL], greater than [>]140 mg/dL, >180 mg/dL and less than [<]70 mg/dL) will be determined over a 6-day period at baseline and at the end of each active treatment.

  6. Mean Percentage of Time in 24-Hours Within Specified Glucose Levels [ Time Frame: Baseline and 4 weeks ]
    The mean percentage of time in 24 hours within the specified glucose levels (= 70-139 mg/dL, >140 mg/dL, >180 mg/dL and <70 mg/dL) will be determined over a 6-day period at baseline and at the end of each active treatment.

  7. Mean Area Under the Glucose Time Curve for 24 hours (AUC24h) Within Specified Glucose Levels [ Time Frame: Baseline and 4 weeks ]
    The mean AUC24h within specified glucose levels (=70-139 mg/dL, >140 mg/dL, >180 mg/dL and <70 mg/dL) will be determined over a 6-day period at baseline and at the end of each active treatment.

  8. Percentage of Participants With 2 Consecutive Glucose Readings <70 mg/dL [ Time Frame: Baseline and 4 weeks ]
    The percentage of participants with 2 consecutive glucose readings <70 mg/dL will be determined.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   19 Years to 54 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03267576


Contacts
Contact: Study Contact 844-434-4210 JNJ.CT@sylogent.com

Locations
Mexico
Consultorio Privado Recruiting
Guadalajara, Mexico, 44150
Investigación Clínica Especializada Recruiting
Guadalajara, Mexico, 44600
Consultorio Privado en Unidad de Patología Clínica Recruiting
Guadalajara, Mexico, 44650
Instituto Nacional de Ciencias Medicas y Nutrición Salvador Zubirán Recruiting
Mexico City, Mexico, 14080
Hospital Universitario 'Dr. Jose Eleuterio Gonzalez' Recruiting
Monterrey, Mexico, 64460
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC

Additional Information:
Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT03267576     History of Changes
Other Study ID Numbers: CR108346
28431754DIA4026 ( Other Identifier: Janssen Research & Development, LLC )
First Posted: August 30, 2017    Key Record Dates
Last Update Posted: July 13, 2018
Last Verified: July 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Sitagliptin Phosphate
Canagliflozin
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action