[No standalone website (unbranded, no questionnaire)] A Study of Subjects With Psoriatic Arthritis to Investigate the Effectiveness of Adalimumab Introduction Compared With Methotrexate Dose Escalation (CONTROL)

How to apply

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Study’s contact

Call center

844-434-4210

Email address

JNJ.CT@sylogent.com

Condition

Diabetes Mellitus, Type 2

Treatment type

Interventional

Investigational product

Canagliflozin 100 mg

Phase

Phase 3

Sponsor

Janssen Research & Development, LLC

ClinicalTrials.gov identifier

NCT03170518

Study number

28431754DIA3018

Understanding clinical trials

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About the study

The purpose of this study is to assess the effect of canagliflozin relative to placebo on glycated hemoglobin (HbA1c) after 26 weeks of treatment, and to assess the overall safety and tolerability of canagliflozin.

Who can take part?

You may be eligible to participate in the study if you meet the following criteria:

Inclusion criteria
  1. Participants with a diagnosis of type 2 diabetes mellitus (T2DM)
  2. Random C-peptide at screening greater than (>)0.6 nanogram/milliliter (ng/mL) (>0.2 nanomole/liter [nmol]/L])
  3. HbA1c of greater than or equal to (>=)6.5 percent (%) to less than or equal to (<=)10.5% and either 1. On diet and exercise alone during the 8 weeks prior to screening 2. On diet and exercise and a stable dose of metformin monotherapy >=1,000 mg per day or MTD per day for at least 8 weeks prior to screening 3. On diet and exercise and a stable insulin monotherapy regimen for at least 8 weeks prior to screening (stable dose is defined as no change in the insulin regimen [ie, type{s} of insulin] and <=15% change in the total daily dose of insulin [averaged over 1 week to account for day to day variability]) 4. On diet and exercise and a stable combination therapy with metformin and insulin for at least 8 weeks prior to screening
Exclusion criteria
  1. History of diabetic ketoacidosis (DKA), type 1 diabetes mellitus (T1DM), pancreas or cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy or maturity onset diabetes of the young (MODY)
  2. Participants on any antihyperglycemic agents (AHAs) other than metformin, or injectable insulin within 8 weeks of the first dose of study drug (that is Day 1)
  3. Repeated (2 or more over a 1-week period) fasting self-monitoring of blood glucose (SMBG) measurements >270 milligram/deciliter (mg/dL) (>15 millimole/liter [mmol/L]) during the pretreatment phase, despite reinforcement of diet and exercise counseling
  4. Severe hypoglycemia within 6 months prior to Day 1
  5. History of hereditary glucose-galactose malabsorption or primary renal glucosuria

For a full list of inclusion/exclusion criteria, please visit ClinicalTrials.gov

Study locations

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How to apply

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