Type 1 DiabetesNCT02673138
Effect of Canagliflozin in T1DM (Type 1 Diabetes Melitus) After Interruption of Continuous Subcutaneous Insulin Infusion
A study testing canagliflozin and basal interruption without canagliflozin in people with Type 1 Diabetes, run by Yale University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- canagliflozin and basal interruption without canagliflozin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to Jul 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Show all 10Show fewer
- 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.
Who cannot join
- 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)
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale University School of Medicine
New Haven, Connecticut, 06520
About this study
Official title: 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.
Read the 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).
- Conditions
- Type 1 Diabetes
- Being tested
- canagliflozin, basal interruption without canagliflozin
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
canagliflozinDrug
Also called Invokana
basal interruption with canagliflozin
basal interruption without canagliflozinOther
basal interruption
| Study group | Role | What they receive |
|---|---|---|
| Basal interruption | Active comparator | Subjects will undergo basal interruption without canagliflozin during an overnight stay on the research unit Receives: 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 Receives: Drug: canagliflozin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 20 hours
Differences in BHB (Beta-hydroxybutyrate) Levels Following Interruption of Basal
Measured: 20 hours
Secondary outcomes (2)
Differences in Free Fatty Acid Levels Following Interruption of Basal Subcutaneous Insulin Infusion
Measured: 20 hours
Differences in Glucagon Levels Following the Interruption of the Basal Subcutaneous Insulin Infusion
Measured: 20 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2016 (estimated)
- Study startJan 2016
- Primary completionJan 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Neha Patel, DO, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02673138
- Sponsor's protocol ID
- 1508016333
- Other IDs
- 1K12DK094714-01
- Status last verified
- Sep 2021
- First submitted
- 1 Feb 2016
- Last updated
- 13 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Canagliflozin in T1DM After Interruption of Continuous Subcutaneous Insulin Infusion
- ClinicalTrials.gov ID
- NCT02673138
- Acronym / sponsor ID
- 1508016333
- Conditions
- Type 1 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Jan 2016
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 3 Feb 2016 (estimated)
- Results
- Posted 29 Nov 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Basal interruption | Active comparator | Other: basal interruption without canagliflozinSubjects will undergo basal interruption without canagliflozin during an overnight stay on the research unit |
| Basal interruption with canagliflozin | Experimental | Drug: canagliflozinSubjects will undergo basal interruption with canagliflozin during an overnight stay on the research unit |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (18 listed)
- 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
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| canagliflozinAlso: Invokanabasal interruption with canagliflozin | Drug | Basal interruption with canagliflozin |
| basal interruption without canagliflozinbasal interruption | Other | Basal interruption |
Primary outcome
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.
Differences in BHB (Beta-hydroxybutyrate) Levels Following Interruption of Basal
Time frame: 20 hours
2 secondary outcomes
Differences in Free Fatty Acid Levels Following Interruption of Basal Subcutaneous Insulin Infusion
Time frame: 20 hours
Differences in Glucagon Levels Following the Interruption of the Basal Subcutaneous Insulin Infusion
Time frame: 20 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neha Patel, DO principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing canagliflozin and basal interruption without canagliflozin in people with Type 1 Diabetes, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in Plasma Glucose Levels Following the Interruption of Basal Subcutaneous Infusion of Insulin (time frame: 20 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2021.