A Safety and Efficacy Study of Canagliflozin in Older Patients (55 to 80 Years of Age) With Type 2 Diabetes Mellitus

Conditions

• Diabetes Mellitus, Type 2

Eligibility Criteria

Sex

ALL

Age

55 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• Canagliflozin 100 mg — DRUG
  One 100 mg over-encapsulated tablet orally (by mouth) once daily for 104 weeks with/without stable doses of antihyperglycemic agent(s) taken at the time of study entry.
• Canagliflozin 300 mg — DRUG
  One 300 mg over-encapsulated tablet orally (by mouth) once daily for 104 weeks with/without stable doses of antihyperglycemic agent(s) taken at the time of study entry.
• Antihyperglycemic agent(s) — DRUG
  Stable doses of antihyperglycemic agents (sulfonylurea agent, thiazolidinediones, dipeptidyl peptidase 4 \[DPP-4\] inhibitors, metformin, insulin \[all types\]) and their combinations (sulfonylurea agent and insulin \[all types\], metformin and insulin \[all types\], metformin and sulfonylurea, alpha glucosidase inhibitors, thiazolidinediones, dipeptidyl peptidase 4 \[DPP-4\]) are used as per protocol specifications.
• Placebo — DRUG
  One matching placebo capsule orally once daily for 104 weeks with/without stable doses of antihyperglycemic agent(s) taken at the time of study entry.

Study Details

The purpose of this study is to evaluate the efficacy and safety of 2 different doses of canagliflozin compared with placebo in older patients (55 to 80 years of age) with type 2 diabetes mellitus (T2DM) with inadequate control on their current diabetes treatment regimen.

Key Dates

Start date

Jun 30, 2010

Status verified

Oct 2014

Primary completion

Nov 30, 2011

Completion

May 31, 2013

Study Design

Enrollment

716 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Canagliflozin 100 mg
  Each patient will receive 100 mg of canagliflozin once daily for 104 weeks with/without stable doses of antihyperglycemic agent(s) taken at the time of study entry.
• Experimental: Canagliflozin 300 mg
  Each patient will receive 300 mg of canagliflozin once daily for 104 weeks with/without stable doses of antihyperglycemic agent(s) taken at the time of study entry.
• Placebo Comparator: Placebo
  Each patient will receive matching placebo once daily for 104 weeks with/without stable doses of antihyperglycemic agent(s) taken at the time of study entry.

Primary Outcome Measure

Change in HbA1c From Baseline to Week 26 [ Time Frame: Day 1 (Baseline) and Week 26 ]

Locations (34)

Find similar trials in Glendale, AZ

Related Studies

• Pre-diabetes in Subject With Impaired Fasting Glucose (IFG) and Impaired Glucose Tolerance (IGT)
  Recruiting · The University of Texas Health Science Center at San Antonio · San Antonio, Texas
• Use of CGM in Kidney Transplant Recipients
  Recruiting · University of California, Davis · Sacramento, California
• Food as Medicine for HIV and Diabetes
  Recruiting · University of North Carolina, Chapel Hill · Chapel Hill, North Carolina
• The ELG Analysis of Glucose a Correlational to Blood Glucose Assay
  Enrolling By Invitation · XP Technology, LLC · Springdale, Arkansas