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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT01340664 |
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Date of registration:
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21/04/2011 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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An Efficacy, Safety, and Tolerability Study of Canagliflozin in the Treatment of Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin Monotherapy
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Scientific title:
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A Randomized, Double-Blind, Placebo-Controlled, 3-Arm, Parallel-Group, Multicenter 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 |
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Date of first enrolment:
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July 2011 |
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Target sample size:
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279 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01340664 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 2
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Countries of recruitment
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Canada
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Czech Republic
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Mexico
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Poland
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Romania
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Russian Federation
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Slovakia
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United States
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Contacts
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Name:
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Janssen Research & Development, LLC Clinical Trial |
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Address:
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Telephone:
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Email:
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Affiliation:
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Janssen Research & Development, LLC |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- All patients must have a diagnosis of T2DM and be currently treated with metformin
- Patients in the study must have a HbA1c between >=7 and <=10.5%
- Patients must have a fasting plasma glucose (FPG) <270 mg/dL (15 mmol/L)
Exclusion Criteria:
- History of diabetic ketoacidosis, type 1 diabetes mellitus (T1DM), pancreas or beta
cell transplantation, diabetes secondary to pancreatitis or pancreatectomy, or a
severe hypoglycemic episode within 6 months before screening
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Diabetes Mellitus, Type 2
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Intervention(s)
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Drug: Metformin
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Drug: Placebo
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Drug: Canagliflozin 50 mg
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Drug: Canagliflozin 150 mg
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Primary Outcome(s)
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Change in HbA1c From Baseline to Week 18
[Time Frame: Day 1 (Baseline) and Week 18]
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Secondary Outcome(s)
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Percent Change in Body Weight From Baseline to Week 18
[Time Frame: Day 1 (Baseline) and Week 18]
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Change in Fasting Plasma Glucose (FPG) From Baseline to Week 18
[Time Frame: Day 1 (Baseline) and Week 18]
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Percentage of Patients With HbA1c <7% at Week 18
[Time Frame: Week 18]
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Secondary ID(s)
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2010-024256-28
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28431754DIA2003
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CR017914
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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