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

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

A Randomized Phase 2, Double-blind, Placebo-controlled, Treat-to-Target, Parallel-group, 3-arm, Multicenter Study to Assess the Efficacy and Safety of Canagliflozin as Add-on Therapy to Insulin in the Treatment of Subjects With Type 1 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02139943
• Other study ID #: CR104173
• Secondary ID: 2013-005078-2428
• Status: Completed
• Phase: Phase 2
• First received: May 14, 2014
• Last updated: June 15, 2015
• Start date: May 2014
• Est. completion date: June 2015

Study information

• Verified date: June 2015
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 352
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 65 Years

Eligibility

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 ß-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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Drug:
• Canagliflozin 100 mg
Canagliflozin capsule of 100 mg dose will be taken orally, before the first meal of the day.
• Canagliflozin 300 mg
Canagliflozin capsule of 300 mg dose will be taken orally, before the first meal of the day.
• Placebo
Matching placebo capsule will be taken orally, before the first meal of the day.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants with hemoglobin A1c (HbA1c) reduction >=0.4% and no increase in body weight		Baseline, Week 18	No
Secondary	Number of adverse events as a measure of safety and tolerability		Baseline, up to Week 18	No