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

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ClinicalTrials.gov Identifier: NCT02139943
Recruitment Status : Completed
First Posted : May 16, 2014
Results First Posted : July 18, 2016
Last Update Posted : July 18, 2016
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Brief 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).

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Drug: Canagliflozin 100 mg Drug: Canagliflozin 300 mg Drug: Placebo Phase 2

Detailed 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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 352 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Study Start Date : May 2014
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: Canagliflozin 100 mg
Each participant will receive 100 mg of canagliflozin once daily for 18 weeks.
Drug: Canagliflozin 100 mg
Canagliflozin capsule of 100 mg dose will be taken orally, before the first meal of the day.

Experimental: Canagliflozin 300 mg
Each participant will receive 300 mg of canagliflozin once daily for 18 weeks.
Drug: Canagliflozin 300 mg
Canagliflozin capsule of 300 mg dose will be taken orally, before the first meal of the day.

Placebo Comparator: Placebo
Each participant will receive matching placebo once daily for 18 weeks
Drug: Placebo
Matching placebo capsule will be taken orally, before the first meal of the day.




Primary Outcome Measures :
  1. Percentage of Participants With Hemoglobin A1c (HbA1c) Reduction Greater Than or Equal to (>=) 0.4 Percent (%) and no Increase in Body Weight [ Time Frame: Week 18 ]
    Clinical response at Weeks 18 was assessed by the percentage of participants with Hemoglobin A1c (HbA1c) reduction greater than or equal to 0.4 % and had no increase in body weight.

  2. Percentage of Participants With Adverse Events [ Time Frame: Up to 22 Weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02139943


  Show 53 Study Locations
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
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Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT02139943     History of Changes
Other Study ID Numbers: CR104173
2013-005078-24 ( EudraCT Number )
28431754DIA2004 ( Other Identifier: Janssen Research & Development, LLC )
First Posted: May 16, 2014    Key Record Dates
Results First Posted: July 18, 2016
Last Update Posted: July 18, 2016
Last Verified: June 2016
Keywords provided by Janssen Research & Development, LLC:
Diabetes Mellitus, Type 1
Canagliflozin
Continuous Glucose Monitoring
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Canagliflozin
Hypoglycemic Agents
Physiological Effects of Drugs
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action