A Study to Evaluate the Effect of JNJ-28431754 (Canagliflozin) on Post-Meal Glucose in Patients With Type 2 Diabetes Mellitus

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT01381887
First received: June 9, 2011
Last updated: April 19, 2013
Last verified: April 2013
  Purpose

The purpose of this study is to evaluate the effect of canagliflozin on post-meal glucose blood levels in patients with Type 2 Diabetes Mellitus.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: Placebo
Drug: Canagliflozin 300mg/Placebo
Drug: Canagliflozin 300mg/Canagliflozin 150mg
Drug: Canagliflozin 300mg
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Blind, Placebo-Controlled, Randomized, Crossover, Multicenter Study to Evaluate the Effect of JNJ-28431754 (Canagliflozin) on Post-Meal Glucose in Subjects With Type 2 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:
  • Plasma concentrations of glucose [ Time Frame: Up to Day 44 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rate of insulin secretion [ Time Frame: Up to Day 44 ] [ Designated as safety issue: No ]
  • Urinary glucose excretion (UGE) [ Time Frame: Up to Day 44 ] [ Designated as safety issue: No ]
  • Renal threshold of glucose excretion (RTG) [ Time Frame: Up to Day 44 ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: Up to approximately Day 44 ] [ Designated as safety issue: No ]

Enrollment: 37
Study Start Date: June 2011
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 001
Placebo Treatment A: Form=capsule route=oral administration. Capsule is taken once daily on Day 1 and Day 2 in 1 of 4 treatment periods.
Drug: Placebo
Treatment A: Form=capsule, route=oral administration. Capsule is taken once daily on Day 1 and Day 2 in 1 of 4 treatment periods.
Experimental: 002

Canagliflozin 300mg/Placebo Treatment B: Type=1 unit=mg number=300 form=capsule route=oral use. Capsule is taken once on Day 1 in 1 of 4 treatment periods.

Form=capsule route=oral administration. Capsule is taken once on Day 2 in 1 of 4 treatment periods.

Drug: Canagliflozin 300mg/Placebo

Treatment B: Type=1, unit=mg, number=300, form=capsule, route=oral use. Capsule is taken once on Day 1 in 1 of 4 treatment periods.

Form=capsule, route=oral administration. Capsule is taken once on Day 2 in 1 of 4 treatment periods.

Experimental: 003
Canagliflozin 300mg Treatment C: Type=1 unit=mg number=300 form=capsule route=oral use. Capsule is taken once daily on Day 1 and Day 2 in 1 of 4 treatment periods.
Drug: Canagliflozin 300mg
Treatment C: Type=1, unit=mg, number=300, form=capsule, route=oral use. Capsule is taken once daily on Day 1 and Day 2 in 1 of 4 treatment periods.
Experimental: 004

Canagliflozin 300mg/Canagliflozin 150mg Treatment D: Type=1 unit=mg number=300 form=capsule route=oral use. Capsule is taken once on Day 1 in 1 of 4 treatment periods.

Type=1 unit=mg number=150 form=capsule route=oral use. Capsule is taken once on Day 2 in 1 of 4 treatment periods.

Drug: Canagliflozin 300mg/Canagliflozin 150mg

Treatment D: Type=1, unit=mg, number=300, form=capsule, route=oral use. Capsule is taken once on Day 1 in 1 of 4 treatment periods.

Type=1, unit=mg, number=150, form=capsule, route=oral use. Capsule is taken once on Day 2 in 1 of 4 treatment periods.


Detailed Description:

This is a double-blind (neither study staff or the patient will know the identity of the treatment assigned) study of canagliflozin in patients with Type 2 Diabetes Mellitus (T2DM) who are currently taking metformin at a stable dose of >=1500 mg/day. Patients will participate in the study for up to approximately 16 weeks. During the study, patients will receive 4 treatments (A, B, C, and D); each treatment will be administered during a 3-day treatment period. Patients will receive 1 dose of study medication in the morning of Day 1 and Day 2 of each treatment period and treatment periods will be separated by approximately 2 weeks. Treatments will consist of placebo (A), canagliflozin 300 mg and placebo (B), canagliflozin 300mg (C), and canagliflozin 300mg and canagliflozin 150mg (D).

  Eligibility

Ages Eligible for Study:   25 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with T2DM with inadequate glycemic control (based upon fasting glucose measurements >=130 mg/dL and <=250 mg/dL) on metformin monotherapy or on metformin in dual combination with other glucose lowering agents (sulphonylurea [SU] or a meglitinide or a dipeptidyl peptidase-4 [DPP-4] inhibitor) are eligible for enrollment in the study.

Exclusion Criteria:

  • History of diabetic ketoacidosis, type 1 diabetes mellitus (T1DM), pancreas or beta cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy
  • history of a severe hypoglycemic episode within 6 months before screening
  • Has repeated (ie, 2 or more over a 1-week period) fasting plasma glucose (FPG) and/or fasting self-monitored blood glucose (SMBG) measurements >=250 mg/dL (13.88 mmol/L) during the pre-treatment phase, despite reinforcement of diet and exercise counseling
  • History of or current illness considered to be clinically significant by the investigator
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01381887

Locations
United States, California
Chula Vista, California, United States
United States, Florida
Miramar, Florida, United States
United States, Ohio
Cincinnati, Ohio, United States
United States, Texas
Dallas, Texas, United States
San Antonio, Texas, United States
Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Investigators
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  More Information

Additional Information:
No publications provided

Responsible Party: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier: NCT01381887     History of Changes
Other Study ID Numbers: CR018373, 28431754DIA1045
Study First Received: June 9, 2011
Last Updated: April 19, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Canagliflozin
Placebo
Type 2 diabetes mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 20, 2014