Effect of Canagliflozin in T1DM (Type 1 Diabetes Melitus) After Interruption of Continuous Subcutaneous Insulin Infusion

NCT02673138 | Completed Results

• 2 other identifiers: 15080163331K12DK094714-01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (2)

• Differences in Plasma Glucose Levels Following the Interruption of Basal Subcutaneous Infusion of Insulin

  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

  20 hours

Secondary Outcomes (2)

• Differences in Free Fatty Acid Levels Following Interruption of Basal Subcutaneous Insulin Infusion

  20 hours

• Differences in Glucagon Levels Following the Interruption of the Basal Subcutaneous Insulin Infusion

  20 hours

Study Arms (2)

Basal interruption

ACTIVE COMPARATOR

Subjects will undergo basal interruption without canagliflozin during an overnight stay on the research unit

Other: basal interruption without canagliflozin

Basal interruption with canagliflozin

EXPERIMENTAL

Subjects will undergo basal interruption with canagliflozin during an overnight stay on the research unit

Drug: canagliflozin

Interventions

canagliflozin DRUG

basal interruption with canagliflozin

Also known as: Invokana

Basal interruption with canagliflozin

basal interruption without canagliflozin OTHER

basal interruption

Basal interruption

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Yale University School of Medicine

New Haven, Connecticut, 06520, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Canagliflozin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Glucosides; Glycosides; Carbohydrates

Results Point of Contact

• Title: Neha S. Patel, DO
• Organization: Yale Pediatric Diabetes

neha.patel@yale.edu

203-764-6747

Study Officials

• Neha Patel, DO

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2016
• First Posted: February 3, 2016
• Study Start: January 1, 2016
• Primary Completion: January 1, 2017
• Study Completion: July 1, 2017
• Last Updated: October 13, 2021
• Results First Posted: November 29, 2018

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)