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

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 2

Conditions: Diabetes Mellitus, Type 1

Treatments: Drug: Canagliflozin 300 mg; Drug: Canagliflozin 100 mg; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02139943

28431754DIA2004 (Other Identifier)

CR104173

2013-005078-24 (EudraCT Number)

Details and patient eligibility

About

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).

Full description

This is a randomized (the study medication is assigned by chance), double-blind (neither physician nor participant knows the identity of the assigned treatment), placebo-controlled (an inactive substance that is compared with a medication to test whether the medication has a real effect) parallel-group, multicenter study of canagliflozin as an addition to insulin therapy for participants with type 1 diabetes mellitus and inadequate glycemic control.

Approximately 330 participants will be randomly assigned in a 1:1:1 ratio to either canagliflozin 100 mg, canagliflozin 300 mg, or placebo groups. About 90 participants (30 per treatment group) will be selected for a substudy with a purpose of a continuous glucose monitoring (CGM) assessment for 7 days at baseline and 7 days at the end of treatment.

The total duration of the participation will be about 22 weeks, during which participants will need to return to investigational sites for approximately 9 visits. During the study participants will receive advice on treatment of hypoglycemia and diabetic ketoacidosis (DKA), as well as on compliance with diet and exercise.

Enrollment: 352 patients

Sex: All

Ages: 25 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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352 participants in 3 patient groups, including a placebo group

Canagliflozin 100 mg

Experimental group

Description:

Each participant will receive 100 mg of canagliflozin once daily for 18 weeks.

Treatment:

Drug: Canagliflozin 100 mg

Canagliflozin 300 mg

Experimental group

Description:

Each participant will receive 300 mg of canagliflozin once daily for 18 weeks.

Treatment:

Drug: Canagliflozin 300 mg

Placebo

Placebo Comparator group

Description:

Each participant will receive matching placebo once daily for 18 weeks

Treatment:

Drug: Placebo