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Canagliflozin in type 2 diabetes mellitus on metformin monotherapy
NCT01106677Phase 3
Key facts
- Status
- Completed
- Start
- May 2010
- Primary completion
- Oct 2011
- Countries
- 22
- Sponsor
- Janssen Pharmaceutical
- Modality
- Small Molecules
- Drugs
- canagliflozin
- Conditions
- type 2 diabetes mellitus (T2DM)
01
Overview
Phase 3, randomised, double-blind trial of canagliflozin in type 2 diabetes mellitus (T2DM) (4 arms), sponsored by Janssen Pharmaceutical. Primary endpoint: Change in Hemoglobin A1c From Baseline to Week 26. Started May 2010; status: completed.
02
Design
4 arms- Study design
- RandomizedDouble-blind
Canagliflozin 100 mg
Canagliflozin 100 mg + Metformin IR
Canagliflozin 300 mg
Canagliflozin 300 mg + Metformin IR
Sitagliptin 100 mg
Sitagliptin 100 mg + Metformin IR
Placebo to Sitagliptin
Placebo (Wk 0-26) then Sitagliptin 100 mg (Wk 26-52) + Metformin IR
03
Who it enrols
Patients with type 2 diabetes mellitus on metformin monotherapy with HbA1c between 7% and 10.5% and FPG < 270 mg/dL.
04
Endpoints
Primary
Change in Hemoglobin A1c From Baseline to Week 26
Secondary
Percentage of Patients With HbA1c < 7% at Week 26
Change in Fasting Plasma Glucose From Baseline to Week 26
Change in 2-hour Post-prandial Glucose From Baseline to Week 26
Percent Change in Body Weight From Baseline to Week 26
Change in Systolic Blood Pressure From Baseline to Week 26
Percent Change in Triglycerides From Baseline to Week 26
Percent Change in High-density Lipoprotein Cholesterol From Baseline to Week 26
Change in Hemoglobin A1c From Baseline to Week 52
05
Results
Primary endpoints met
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