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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT01381900
First received: June 23, 2011
Last updated: April 23, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: Placebo
Drug: Canagliflozin 100mg
Drug: Canagliflozin 300mg
Drug: Metformin
Drug: Sulphonylurea
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Janssen Research & Development, LLC:

Primary Outcome Measures:
  • Change in Glycosylated Hemoglobin (HbA1c) From Baseline to Week 18 [ Time Frame: Day 1 (Baseline) and Week 18 ] [ Designated as safety issue: No ]
    The table below shows the least-squares (LS) mean change in HbA1c from baseline to Week 18 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.


Secondary Outcome Measures:
  • Change in Fasting Plasma Glucose (FPG) From Baseline to Week 18 [ Time Frame: Day 1 (Baseline) and Week 18 ] [ Designated as safety issue: No ]
    The table below shows the least-squares (LS) mean change in FPG from Baseline to Week 18 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.

  • Percent Change in Body Weight From Baseline to Week 18 [ Time Frame: Day 1 (Baseline) and Week 18 ] [ Designated as safety issue: No ]
    The table below shows the least-squares (LS) mean percent change in body weight from Baseline to Week 18 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean percent change.

  • Percentage of Patients With Glycosylated Hemoglobin (HbA1c) <7% at Week 18 [ Time Frame: Day 1 (Baseline) and Week 18 ] [ Designated as safety issue: No ]
    The table below shows the percentage of patients with HbA1c <7% at Week 18 in each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the percentage.

  • Percentage of Patients With Glycosylated Hemoglobin (HbA1c) <6.5% at Week 18 [ Time Frame: Day 1 (Baseline) and Week 18 ] [ Designated as safety issue: No ]
    The table below shows the percentage of patients with HbA1c <6.5% at Week 18 in each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the percentage.


Enrollment: 678
Study Start Date: August 2011
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Canagliflozin 100mg
Each participant will receive 100 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
Drug: Canagliflozin 100mg
Type=1, unit=mg, number=100, form=capsule, route=oral use. One capsule once daily for up to 18 weeks after completing a single-blind placebo run-in period (1 placebo capsule once daily for up to 2 weeks).
Drug: Metformin
The participant's stable dose of background therapy of metformin should be continued throughout the study.
Drug: Sulphonylurea
The participant's stable dose of background therapy of metformin plus sulphonylurea should be continued throughout the study.
Experimental: Canagliflozin 300mg
Each participant will receive 300 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
Drug: Canagliflozin 300mg
Type=1, unit=mg, number=300, form=capsule, route=oral use. One capsule once daily for up to 18 weeks after completing a single-blind placebo run-in period (1 placebo capsule once daily for up to 2 weeks).
Drug: Metformin
The participant's stable dose of background therapy of metformin should be continued throughout the study.
Drug: Sulphonylurea
The participant's stable dose of background therapy of metformin plus sulphonylurea should be continued throughout the study.
Placebo Comparator: Placebo
Each participant will receive matching placebo once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
Drug: Placebo
Form=capsule, route=oral administration. One capsule once daily for up to 18 weeks after completing a single-blind placebo run-in period (1 placebo capsule once daily for up to 2 weeks).
Drug: Metformin
The participant's stable dose of background therapy of metformin should be continued throughout the study.
Drug: Sulphonylurea
The participant's stable dose of background therapy of metformin plus sulphonylurea should be continued throughout the study.

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01381900

Locations
China
Baotou, China
Beijing, China
Changchun, China
Changsha, China
Chengdu, China
Chongqing, China
Guangzhou, China
Hangzhou, China
Harbin, China
Nanchang, China
Nanjing, China
Nanning, China
Shanghai, China
Shenyang, China
Shiyan, China
Siping, China
Su Zhou, China
Tianjin, China
Wuxi, China
Xi'An, China
Malaysia
Kota Bharu, Malaysia
Pulau Pinang, Malaysia
Selangor, Malaysia
Vietnam
Hanoi, Vietnam
Ho Chi Minh, Vietnam
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
  More Information

No publications provided

Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01381900     History of Changes
Other Study ID Numbers: CR018541, 28431754DIA3014
Study First Received: June 23, 2011
Results First Received: November 21, 2013
Last Updated: April 23, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Janssen Research & Development, LLC:
Canagliflozin
Placebo
Type 2 diabetes mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 20, 2014