Evaluation of Blood Pressure Reduction, Safety, and Tolerability of Canagliflozin in Patients With Hypertension and Type 2 Diabetes Mellitus on Stable Doses of Anti-hyperglycemic and Anti-hypertensive Agents

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 4

Conditions: Hypertension; Diabetes Mellitus, Type 2

Treatments: Drug: Placebo; Drug: Canagliflozin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01939496

28431754DIA4002 (Other Identifier)

CR102208

Details and patient eligibility

About

The purpose of this study is to evaluate the effect of canagliflozin (JNJ-28431754) on blood pressure reduction, compared to placebo, in patients with hypertension and type 2 diabetes mellitus and who are on stable doses of anti-hyperglycemic and anti-hypertensive agents. Overall safety and tolerability of canagliflozin will be assessed.

Full description

This is a randomized (study drug assigned by chance), double blind (neither the patient nor the study doctor will know the name of the assigned treatment), parallel-group, 3-arm (patients will be assigned to 1 of 3 treatment groups) multicenter study to determine the effect of canagliflozin (100 mg and 300 mg) on blood pressure (BP) reduction compared to placebo (a pill that looks like all the other treatments but has no real medicine) in patients with hypertension and type 2 diabetes mellitus (T2DM). The study will consist of 3 phases: a screening phase, a double-blind treatment phase and a follow-up period. Approximately 153 participants will be randomly assigned to 1 of 3 treatment groups (in a 1:1:1 ratio) in the double-blind treatment phase to receive canagliflozin 100 mg, canagliflozin 300 mg or placebo for 6 weeks. The total duration of participation in this study will be approximately 13 weeks.

Enrollment: 171 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients with a diagnosis of type 2 diabetes mellitus
• patients with hypertension (seated office SBP of >=130 mmHg and <160 mmHg and seated office DBP of >= 70 mmHg at screening and at Week -2
• patients on stable doses of 1 to 3 anti-hypertensive agents for at least 5 weeks before screening
• patients on stable doses of 1 to 3 oral anti-hyperglycemic agents which must include metformin, for at least 8 weeks before screening

Exclusion criteria

• a history of diabetic ketoacidosis
• type 1 diabetes mellitus (T1DM)
• pancreas or beta-cell transplantation
• fasting C-peptide <0.70 ng/mL (0.23 nmol/L)
• body mass index <30 kg/m2
• has ongoing, inadequately controlled thyroid disorder
• has a history of cardio-renal disease that required treatment with immunosuppressive therapy.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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171 participants in 3 patient groups, including a placebo group

Canagliflozin 100 mg

Experimental group

Description:

Each patient will receive 100 mg of canagliflozin once daily for 6 weeks.

Treatment:

Drug: Canagliflozin

Canagliflozin 300 mg

Experimental group

Description:

Each patient will receive 300 mg of canagliflozin once daily for 6 weeks.

Treatment:

Drug: Canagliflozin

Placebo

Placebo Comparator group

Description:

Each patient will receive matching placebo once daily for 6 weeks.

Treatment:

Drug: Placebo