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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) logo

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

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

Trial contacts and locations

57

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Data sourced from clinicaltrials.gov

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