Clinical trial NCT01381900: A Efficacy, Safety, and Tolerability Study of Canagliflozin in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin Alone or in Combination With a Sulphonylurea
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, 18-Week Study to Evaluate the Efficacy, Safety, and Tolerability of Canagliflozin in the Treatment of Subjects With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin Alone or in Combination With a Sulphonylurea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Keywords: Canagliflozin
Placebo
Type 2 diabetes mellitus
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2011-06-27
Enrollment: 678
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety, tolerability, and efficacy of the addition of canagliflozin relative to the addition of placebo in patients with inadequate glycemic control on metformin alone or in combination with a sulphonylurea.

Detailed description: This is a double-blind (neither study staff or the patient will know the identity of the treatment assigned) study of canagliflozin where Chinese and other Asian adult patients with Type 2 Diabetes Mellitus (T2DM) who have inadequate glycemic control on metformin alone or in combination with a sulphonylurea (SU) will be randomized (assigned to 1 of 3 treatments by chance) to receive the addition of treatment with canagliflozin 100 mg once daily, canagliflozin 300 mg once daily, or matching placebo capsules (placebo is a treatment identical in appearance to canagliflozin but does not contain active drug). All patients will take orally (by mouth) 1 single-blind placebo capsule once daily before the first meal of the day for up to 2 weeks (last dose of single-blind placebo to be taken the day before the baseline (Day 1) visit. On Day 1, patients will take orally, once daily 1 capsule of canagliflozin 100 mg, canagliflozin 300 mg, or placebo before the first meal of the day for up to 18 weeks.

Eligibility criteria: Inclusion Criteria:

* Patients with T2DM with inadequate glycemic control on metformin monotherapy or on metformin in combination with an SU at protocol-specified doses and having HbA1c \>=7.0% and \<=10.5% at Week -2 are eligible for enrollment in the study.

Exclusion Criteria:

* History of diabetic ketoacidosis, type 1 diabetes mellitus (T1DM), pancreas or beta cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy
* Has repeated (ie, 2 or more over a 1-week period) fasting plasma glucose (FPG) and/or fasting self-monitored blood glucose (SMBG) measurements \>=270 mg/dL (15 mmol/L) during the pre-treatment phase, despite reinforcement of diet and exercise counseling
* History of a severe hypoglycemic episode within 6 months before screening
* History of or current illness considered to be clinically significant by the investigator

Primary outcomes:
measure: Change in Glycosylated Hemoglobin (HbA1c) From Baseline to Week 18
timeFrame: Day 1 (Baseline) and Week 18
Secondary outcomes:
measure: Change in Fasting Plasma Glucose (FPG) From Baseline to Week 18
timeFrame: Day 1 (Baseline) and Week 18
measure: Percent Change in Body Weight From Baseline to Week 18
timeFrame: Day 1 (Baseline) and Week 18
measure: Percentage of Patients With Glycosylated Hemoglobin (HbA1c) <7% at Week 18
timeFrame: Day 1 (Baseline) and Week 18
measure: Percentage of Patients With Glycosylated Hemoglobin (HbA1c) <6.5% at Week 18
timeFrame: Day 1 (Baseline) and Week 18
Other outcomes:
Locations:
city: Baotou
country: China
city: Beijing
country: China
city: Changchun
country: China
city: Changsha
country: China
city: Chengdu
country: China
city: Chongqing
country: China
city: Guangzhou
country: China
city: Hangzhou
country: China
city: Harbin
country: China
city: Nanchang
country: China
city: Nanjing
country: China
city: Nanning
country: China
city: Shanghai
country: China
city: Shenyang
country: China
city: Shiyan
country: China
city: Siping
country: China
city: Su Zhou
country: China
city: Tianjin
country: China
city: Wuxi
country: China
city: Xi'An
country: China
city: Kota Bharu
country: Malaysia
city: Pulau Pinang
country: Malaysia
city: Selangor
country: Malaysia
city: Hanoi
country: Vietnam
city: Ho Chi Minh
country: Vietnam
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: