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

Primary Purpose

Diabetes Mellitus, Type 2

Status

Completed

Phase

Phase 4

Locations

Mexico

Study Type

Interventional

Intervention

Canagliflozin 300 mg

Sitagliptin 100 mg

Metformin

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

19 Years - 54 Years (Adult)All SexesDoes not accept 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)

Sites / Locations

Consultorio Privado
Investigación Clínica Especializada
Consultorio Privado en Unidad de Patología Clínica
Instituto Nacional de Ciencias Medicas y Nutrición Salvador Zubirán
Hospital Universitario 'Dr. Jose Eleuterio Gonzalez'

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Treatment Sequence AB

Treatment Sequence BA

Arm 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.

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.

Outcomes

Primary Outcome Measures

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

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.

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

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 Outcome Measures

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

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.

Change From Baseline in Mean 24-hour Glucose Profile

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.

Change From Baseline in Fasting Plasma Glucose Levels

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.

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

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.

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

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.

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

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.

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

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.

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

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.

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

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.

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

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.

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

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.

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

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.

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

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.

Full Information

NCT ID

NCT03267576

First Posted

August 29, 2017

Last Updated

November 11, 2019

Sponsor

Janssen Research & Development, LLC

1. Study Identification

Unique Protocol Identification Number

NCT03267576

Brief Title

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

Acronym

COMETA

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

2. Study Status

Record Verification Date

November 2019

Overall Recruitment Status

Completed

Study Start Date

October 27, 2017 (Actual)

Primary Completion Date

October 1, 2018 (Actual)

Study Completion Date

October 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Janssen Research & Development, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

64 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment Sequence AB

Arm Type

Experimental

Arm Description

Arm Title

Treatment Sequence BA

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Canagliflozin 300 mg

Other Intervention Name(s)

JNJ-28431754

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Sitagliptin 100 mg

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Metformin

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

Time Frame

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

Title

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

Description

Time Frame

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

Secondary Outcome Measure Information:

Title

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

Description

Time Frame