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Trial record 10 of 456 for:    subcutaneous | "Diabetes Mellitus, Insulin-Dependent"

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

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ClinicalTrials.gov Identifier: NCT02673138
Recruitment Status : Completed
First Posted : February 3, 2016
Results First Posted : November 29, 2018
Last Update Posted : November 29, 2018
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Yale University

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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Drug: canagliflozin Other: basal interruption without canagliflozin Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Canagliflozin in T1DM After Interruption of Continuous Subcutaneous Insulin Infusion
Study Start Date : January 2016
Actual Primary Completion Date : January 2017
Actual Study Completion Date : July 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Active Comparator: Basal interruption
Subjects will undergo basal interruption without canagliflozin during an overnight stay on the research unit
Other: basal interruption without canagliflozin
basal interruption

Experimental: Basal interruption with canagliflozin
Subjects will undergo basal interruption with canagliflozin during an overnight stay on the research unit
Drug: canagliflozin
basal interruption with canagliflozin
Other Name: Invokana




Primary Outcome Measures :
  1. 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.

  2. Differences in BHB (Beta-hydroxybutyrate) Levels Following Interruption of Basal [ Time Frame: 20 hours ]

Secondary Outcome Measures :
  1. Differences in Free Fatty Acid Levels Following Interruption of Basal Subcutaneous Insulin Infusion [ Time Frame: 20 hours ]
  2. Differences in Glucagon Levels Following the Interruption of the Basal Subcutaneous Insulin Infusion [ Time Frame: 20 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 18-45 years
  2. Clinical diagnosis of T1D (type 1 diabetes) (formal antibody and/or genetic testing will not be required)
  3. Duration of T1D ≥ 1 year
  4. HbA1c ≤ 9 %
  5. Treated with continuous subcutaneous insulin infusion (with or without adjunctive treatment with a SGLT2 inhibitor) for at least 3 months
  6. Body weight > 40 kg
  7. 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
  8. Normal hematocrit
  9. Able to give consent
  10. Female subjects of reproductive potential must be abstinent or consistently using appropriate family planning methods.

Exclusion Criteria:

  1. Insulin resistant (defined as requiring > 1.5 units/kg/day at time of study enrollment)
  2. Renal impairment, determined as eGFR < 60 ml/minute/1.73m2

    1. History of unstable or rapidly progressing renal disease
    2. Conditions of congenital renal glucosuria
    3. Renal allograft
    4. Recurrent UTI (urinary tract infection)
    5. History of Vesico-ureteral-reflux disease
  3. Presence of any medical or psychiatric disorder that may interfere with subject safety or study conduct
  4. 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
  5. 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
  6. History of hypoglycemic seizure within last 3 months
  7. History of diabetic ketoacidosis (DKA) requiring medical intervention (ie. emergency room visit and/or hospitalization) within 1 month prior to the screening visit
  8. Allergies or contraindication to the contents of canagliflozin tablets or insulin
  9. 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
  10. Female subjects who are pregnant, lactating, or unwilling to be tested for pregnancy
  11. Recurrent GU (genitourinary) infections
  12. Uncircumcised males secondary to increased risk of development of GU infections
  13. History of hypotension, defined as blood pressure (BP) <10th% for age and sex

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): NCT02673138


Locations
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United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06520
Sponsors and Collaborators
Yale University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Neha Patel, DO Yale University

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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT02673138     History of Changes
Other Study ID Numbers: 1508016333
1K12DK094714-01 ( U.S. NIH Grant/Contract )
First Posted: February 3, 2016    Key Record Dates
Results First Posted: November 29, 2018
Last Update Posted: November 29, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 1
Diabetes Mellitus
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