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

June 23, 2011
April 23, 2014
August 2011
November 2012   (final data collection date for primary outcome measure)
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.
Change in hemoglobin A1c (HbA1c) [ Time Frame: From baseline at Week 18 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01381900 on ClinicalTrials.gov Archive Site
  • 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.
  • Fasting plasma glucose (FPG) [ Time Frame: From baseline to Week 18 ] [ Designated as safety issue: No ]
  • Percent change in body weight [ Time Frame: From baseline to Week 18 ] [ Designated as safety issue: No ]
  • Proportions of patients with HbA1c <7.0% and <6.5% [ Time Frame: At Week 18 ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: Up to approximately 20 weeks (includes 2 week single blind placebo run-in period and 18 week double-blind treatment period) ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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
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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • 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: 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: 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.
  • 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.
    Interventions:
    • Drug: Canagliflozin 100mg
    • Drug: Metformin
    • Drug: Sulphonylurea
  • 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.
    Interventions:
    • Drug: Canagliflozin 300mg
    • Drug: Metformin
    • Drug: Sulphonylurea
  • 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.
    Interventions:
    • Drug: Placebo
    • Drug: Metformin
    • Drug: Sulphonylurea
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
678
November 2012
November 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
China,   Vietnam,   Malaysia
 
NCT01381900
CR018541, 28431754DIA3014
Yes
Janssen Research & Development, LLC
Janssen Research & Development, LLC
Not Provided
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
Janssen Research & Development, LLC
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP