A Study of Effects of Canagliflozin as Add-on Therapy to Insulin in the Treatment of Participants With Type 1 Diabetes Mellitus (T1DM)

Completed · Phase 2 · Has a placebo group

Conditions studied: Diabetes Mellitus, Type 1

In brief

The purpose of this study is to assess the effects of administration of canagliflozin 100 mg and 300 mg, compared with placebo as an addition to insulin therapy for the treatment of Type 1 Diabetes Mellitus (T1DM).

Key facts

Study ID

NCT02139943

Run by

Janssen Research & Development, LLC

People needed

352

Starts

2014-05-01

Expected to finish

2015-06-01

Last updated by the study team

2016-07-18

Who can join

Age: 25 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Must have type 1 diabetes mellitus (T1DM) for at least 1 year
• Must have have inadequate glycemic control (as defined by glycosylated hemoglobin level of >= 7.0% to <= 9.0%) on basal plus bolus insulin at screening
• Must have body mass index 21 to 35 kg/m2 inclusive
• Must be on a total daily dose of insulin >= 0.6 IU/kg at screening
• Must be on a stable insulin regimen for at least 8 weeks prior to screening

You may not qualify if…

• History of T2DM, pancreas or β-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy
• Severe hypoglycemia (defined as an event required assistance from another person, or which resulted in seizure or loss of consciousness) within 6 months prior to study start
• Diabetic ketoacidosis within 6 months prior to study start
• History of hereditary glucose-galactose malabsorption or primary renal glycosuria
• An ongoing, inadequately controlled thyroid disorder

Where it is running

• Study site — Concord, California, United States
• Study site — La Jolla, California, United States
• Study site — Los Angeles, California, United States
• Study site — Los Gatos, California, United States
• Study site — Northridge, California, United States
• Study site — Orange, California, United States
• Study site — San Francisco, California, United States
• Study site — Temecula, California, United States
• Study site — Tustin, California, United States
• Study site — Ventura, California, United States
• Study site — Walnut Creek, California, United States
• Study site — Denver, Colorado, United States
• Study site — Miami, Florida, United States
• Study site — Palm Harbor, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Honolulu, Hawaii, United States
• Study site — Council Bluffs, Iowa, United States
• Study site — Des Moines, Iowa, United States
• Study site — Baton Rouge, Louisiana, United States
• Study site — Rockville, Maryland, United States
• Study site — Billings, Montana, United States
• Study site — Omaha, Nebraska, United States
• Study site — El Paso, Nevada, United States
• Study site — Las Vegas, Nevada, United States
• Study site — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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