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

• Status: Completed
• Trial end date: 2015-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Scientific Affairs, LLC
• Treatments: Antihypertensive Agents; Canagliflozin; Hypoglycemic Agents

Criteria

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.