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

NCT03267576 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: CR10834628431754DIA4026
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 5

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

Outcome Measures

Primary Outcomes (2)

• 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.

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

• 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.

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

Secondary Outcomes (13)

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

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

• Change From Baseline in Mean 24-hour Glucose Profile

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

• Change From Baseline in Fasting Plasma Glucose Levels

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

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

  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 70 to 139 mg/dL

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

Study Arms (2)

Treatment Sequence AB

EXPERIMENTAL

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; Drug: Sitagliptin 100 mg; Drug: Metformin

Treatment Sequence BA

EXPERIMENTAL

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; Drug: Sitagliptin 100 mg; Drug: Metformin

Interventions

Canagliflozin 300 mg DRUG

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

Also known as: JNJ-28431754

Treatment Sequence AB; Treatment Sequence BA

Sitagliptin 100 mg DRUG

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

Treatment Sequence AB; Treatment Sequence BA

Metformin 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 AB; Treatment Sequence BA

Eligibility Criteria

• Age: 19 Years - 54 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (5)

Consultorio Privado

Guadalajara, 44150, Mexico

Location

Investigación Clínica Especializada

Guadalajara, 44600, Mexico

Location

Consultorio Privado en Unidad de Patología Clínica

Guadalajara, 44650, Mexico

Location

Instituto Nacional de Ciencias Medicas y Nutrición Salvador Zubirán

Mexico City, 14080, Mexico

Location

Hospital Universitario 'Dr. Jose Eleuterio Gonzalez'

Monterrey, 64460, Mexico

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Canagliflozin; Sitagliptin Phosphate; Metformin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Glucosides; Glycosides; Carbohydrates; Triazoles; Azoles; Pyrazines; Biguanides; Guanidines; Amidines

Limitations and Caveats

The main limitation of the study was the sample size limited to demonstrate any significant difference.

Results Point of Contact

• Title: Senior Director
• Organization: Janssen Research & Development, LLC

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2017
• First Posted: August 30, 2017
• Study Start: October 27, 2017
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: November 29, 2019
• Results First Posted: November 29, 2019

Record last verified: 2019-11

Locations

ME (5)