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

• Status: Completed
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Research & Development, LLC
• Treatments: Canagliflozin

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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