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

Johnson & Johnson (J&J)

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Canagliflozin 300mg; Drug: Placebo; Drug: Canagliflozin 300mg/Placebo; Drug: Canagliflozin 300mg/Canagliflozin 150mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01381887

28431754DIA1045

CR018373

Details and patient eligibility

About

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.

Full 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).

Enrollment: 37 patients

Sex: All

Ages: 25 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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37 participants in 4 patient groups, including a placebo group

001

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo

002

Experimental group

Description:

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.

Treatment:

Drug: Canagliflozin 300mg/Placebo

003

Experimental group

Description:

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.

Treatment:

Drug: Canagliflozin 300mg

004

Experimental group

Description:

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.

Treatment:

Drug: Canagliflozin 300mg/Canagliflozin 150mg