- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02673138
Effect of Canagliflozin in T1DM (Type 1 Diabetes Melitus) After Interruption of Continuous Subcutaneous Insulin Infusion
September 17, 2021 updated by: Yale University
Effect of Canagliflozin in T1DM After Interruption of Continuous Subcutaneous Insulin Infusion
This study will be an open-label, cross-over study as subjects will be studied under both study conditions - suspension of subcutaneous insulin infusion via pump during treatment with insulin alone (control) vs. suspension of subcutaneous insulin via pump during treatment with insulin and canagliflozin.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The study will consist of 4 visits: an enrollment/screening visit, a control visit with pump suspension prior to treatment with canagliflozin, a visit with pump suspension while on canagliflozin and an end of study visit.
Each of the pump suspension visits will be approximately 20-hour overnight admissions to the Hospital Research Unit (HRU).
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Connecticut
-
New Haven, Connecticut, United States, 06520
- Yale University School of Medicine
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age 18-45 years
- Clinical diagnosis of T1D (type 1 diabetes) (formal antibody and/or genetic testing will not be required)
- Duration of T1D ≥ 1 year
- HbA1c ≤ 9 %
- Treated with continuous subcutaneous insulin infusion (with or without adjunctive treatment with a SGLT2 inhibitor) for at least 3 months
- Body weight > 40 kg
- Be in good general health without other acute or chronic illness that in the judgment of the investigator could interfere with the study or jeopardize subject safety
- Normal hematocrit
- Able to give consent
- Female subjects of reproductive potential must be abstinent or consistently using appropriate family planning methods.
Exclusion Criteria:
- Insulin resistant (defined as requiring > 1.5 units/kg/day at time of study enrollment)
Renal impairment, determined as eGFR < 60 ml/minute/1.73m2
- History of unstable or rapidly progressing renal disease
- Conditions of congenital renal glucosuria
- Renal allograft
- Recurrent UTI (urinary tract infection)
- History of Vesico-ureteral-reflux disease
- Presence of any medical or psychiatric disorder that may interfere with subject safety or study conduct
- Use of metformin, thiazolidinedione or GLP1 agonist within 1 month prior to screening visit. For those subjects on canagliflozin or other SGLT2 inhibitors, an alternate study procedure may be utilized as described above
- Use of any medications (besides insulin or SGLT2 inhibitor) known to effect blood glucose levels, including oral or other systemic glucocorticoid therapy. Inhaled, intranasal, or rectal corticosteroid use is allowed as long as not given within 2 weeks of the closed loop admissions. Use of topical glucocorticoids is allowable as long as affected skin area does not overlap with study device sites
- History of hypoglycemic seizure within last 3 months
- History of diabetic ketoacidosis (DKA) requiring medical intervention (ie. emergency room visit and/or hospitalization) within 1 month prior to the screening visit
- Allergies or contraindication to the contents of canagliflozin tablets or insulin
- Volume depleted subjects. Subjects at risk for volume depletion due to co-existing conditions or concomitant medications, such as loop diuretics who cannot carefully monitor their volume status should be excluded from the study
- Female subjects who are pregnant, lactating, or unwilling to be tested for pregnancy
- Recurrent GU (genitourinary) infections
- Uncircumcised males secondary to increased risk of development of GU infections
- History of hypotension, defined as blood pressure (BP) <10th% for age and sex
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Basal interruption
Subjects will undergo basal interruption without canagliflozin during an overnight stay on the research unit
|
basal interruption
|
Experimental: Basal interruption with canagliflozin
Subjects will undergo basal interruption with canagliflozin during an overnight stay on the research unit
|
basal interruption with canagliflozin
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Differences in Plasma Glucose Levels Following the Interruption of Basal Subcutaneous Infusion of Insulin
Time Frame: 20 hours
|
The primary outcome measure for this study will be differences in plasma glucose levels following the interruption of basal subcutaneous infusion of insulin under the two study conditions; i.e., control study during treatment with insulin alone vs. experimental study during treatment with insulin plus canagliflozin or other SGLT2 inhibitor.
|
20 hours
|
Differences in BHB (Beta-hydroxybutyrate) Levels Following Interruption of Basal
Time Frame: 20 hours
|
20 hours
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Differences in Free Fatty Acid Levels Following Interruption of Basal Subcutaneous Insulin Infusion
Time Frame: 20 hours
|
20 hours
|
Differences in Glucagon Levels Following the Interruption of the Basal Subcutaneous Insulin Infusion
Time Frame: 20 hours
|
20 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Neha Patel, DO, Yale University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2016
Primary Completion (Actual)
January 1, 2017
Study Completion (Actual)
July 1, 2017
Study Registration Dates
First Submitted
February 1, 2016
First Submitted That Met QC Criteria
February 1, 2016
First Posted (Estimate)
February 3, 2016
Study Record Updates
Last Update Posted (Actual)
October 13, 2021
Last Update Submitted That Met QC Criteria
September 17, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Immune System Diseases
- Autoimmune Diseases
- Endocrine System Diseases
- Diabetes Mellitus
- Diabetes Mellitus, Type 1
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Sodium-Glucose Transporter 2 Inhibitors
- Canagliflozin
Other Study ID Numbers
- 1508016333
- 1K12DK094714-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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