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

NCT ID: NCT03267576

Last Updated: 2019-11-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-27
• Study Completion Date: 2018-10-01

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.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Canagliflozin 300 mg

Intervention Type: DRUG

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

Sitagliptin 100 mg

Intervention Type: DRUG

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

Metformin

Intervention Type: DRUG

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

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.

Group Type: EXPERIMENTAL

Canagliflozin 300 mg

Intervention Type: DRUG

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

Sitagliptin 100 mg

Intervention Type: DRUG

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

Metformin

Intervention Type: DRUG

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

Interventions

Canagliflozin 300 mg

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

Intervention Type: DRUG

Sitagliptin 100 mg

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

Intervention Type: DRUG

Metformin

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

Intervention Type: DRUG

Other Intervention Names

JNJ-28431754

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)

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 54 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

Consultorio Privado

Guadalajara, , Mexico

Investigación Clínica Especializada

Guadalajara, , Mexico

Consultorio Privado en Unidad de Patología Clínica

Guadalajara, , Mexico

Instituto Nacional de Ciencias Medicas y Nutrición Salvador Zubirán

Mexico City, , Mexico

Hospital Universitario 'Dr. Jose Eleuterio Gonzalez'

Monterrey, , Mexico

Countries

Mexico

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

28431754DIA4026

Identifier Type: OTHER

Identifier Source: secondary_id

CR108346

Identifier Type: -

Identifier Source: org_study_id