The CANTATA-MP Trial (CANagliflozin Treatment and Trial Analysis - Metformin and Pioglitazone)

Conditions

• Diabetes Mellitus, Type 2

Eligibility Criteria

Sex

ALL

Age

18 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• Placebo — DRUG
  One matching placebo capsule orally (by mouth) once daily for 26 weeks with stable doses of metformin and pioglitazone.
• Canagliflozin — DRUG
  One 100 mg or 300 mg over-encapsulated tablet orally once daily for 52 weeks with stable doses of metformin and pioglitazone.
• Sitagliptin — DRUG
  One 100 mg over-encapsulated tablet orally once daily beginning at Week 26 until Week 52 with stable doses of metformin and pioglitazone.
• Metformin — DRUG
  The patient's stable dose of metformin background therapy should be continued throughout the study.
• Pioglitazone — DRUG
  The patient's stable dose of pioglitazone background therapy should be continued throughout the study.

Study Details

The purpose of this study is to evaluate the efficacy and safety of 2 different doses of canagliflozin compared with placebo in patients with type 2 diabetes mellitus who are receving treatment with metformin and pioglitazone and have inadequate glycemic (blood sugar) control.

Key Dates

Start date

Jun 30, 2010

Status verified

Jun 2013

Primary completion

Nov 30, 2011

Completion

Jul 31, 2012

Study Design

Enrollment

344 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Other: Placebo/Sitagliptin
  Each patient will receive matching placebo once daily for 26 weeks with stable doses of metformin and pioglitazone. At Week 26, patients will be switched from placebo to 100 mg of sitagliptin once daily with stable doses of metformin and pioglitazone until Week 52.
• Experimental: Canagliflozin 100 mg
  Each patient will receive 100 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.
• Experimental: Canagliflozin 300 mg
  Each patient will receive 300 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.

Primary Outcome Measure

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

Locations (41)

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