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Feasibility Study Using Zone-MPC Controller, HMS and Technosphere® Insulin Inhalation System From MannnKind Corp

This study has been completed.
Sponsor:
Collaborator:
Juvenile Diabetes Research Foundation
Information provided by (Responsible Party):
William Sansum Diabetes Center
ClinicalTrials.gov Identifier:
NCT01874392
First received: May 14, 2013
Last updated: November 17, 2014
Last verified: November 2014
  Purpose

This clinical trial is a feasibility study to assess the performance of an Artificial Pancreas (AP) device using the Artificial Pancreas System (APS©) platform for subjects with type 1 diabetes using rapid-acting insulin as well as preprandial inhaled insulin (Technosphere® Insulin Inhalation System by MannKind Corporation). The goal of this proposed study is to explore the feasibility of using multiple insulin delivery routes in order to mimic the physiology of both first- and second-phase insulin secretion. The intent is to exploit the rapid action achieved by inhaled insulin to compensate for part of the meals and utilize the conventional subcutaneous route for management of basal insulin and as second-phase meal-related insulin.


Condition Intervention
Type 1 Diabetes Mellitus
Drug: Investigational inhaled insulin (Technosphere)
Device: Artificial Pancreas (AP) device (APS©)

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Feasibility Study Using Zone-MPC Controller (Zone-Model Predictive Control) and Health Monitoring System (HMS) and Technosphere® Insulin Inhalation System From MannnKind Corp.

Resource links provided by NLM:


Further study details as provided by William Sansum Diabetes Center:

Primary Outcome Measures:
  • Test the safety of the AP device while the subject is under close medical supervision in the Clinical Research Center (CRC) setting. [ Time Frame: 25-28 hours ] [ Designated as safety issue: Yes ]

    This objective will be assessed by subjecting the AP device (combined with the Technosphere® Insulin Inhalation Powder) and the subject to several challenging situations, such as meals, exercise, and nocturnal period. The study will evaluate the percent of time the glucose level of the subject remains within pre-specified target ranges:

    • Target range (unless described otherwise): [80-140] mg/dL
    • Overnight target range: [80-140] mg/dL
    • Target range 5 hours after meal: [70-180] mg/dL
    • Target range during exercise: [70-150] mg/dL
    • Target range 3 hours after exercise: [70-150] mg/dL

    The study will also evaluate the glucose level at 1- and 2-hour postprandial and the area-under-the-curve (AUC) at 6-hour post-prandial.



Secondary Outcome Measures:
  • Test the benefits of the AP device combined with the Technosphere® Insulin Powder System [ Time Frame: 25-28 hours ] [ Designated as safety issue: No ]

    To evaluate the performance of the AP device combined with the Technosphere® Insulin Powder System:

    • when glucose values are outside of the desirable ranges,
    • in analyzing the values and duration of the extremes, in particular if <70 mg/dL and <60 mg/dL.
    • in analyzing adverse events,
    • in analyzing outside interventions not following the recommendation of the HMS,
    • if the same subjects were enrolled in this study and the original IDE G110093 study (protocol revision 2.2): comparing the glucose profile between the two clinical studies with and without the Technosphere® Insulin.


Estimated Enrollment: 20
Study Start Date: October 2012
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: T1DM
Adults aged 21-65 years with type 1 diabetes mellitus for at least one year who are using an insulin infusion pump with rapid-acting insulin for at least six months
Drug: Investigational inhaled insulin (Technosphere)
by MannKind Corp. IND 61,729
Other Name: Technosphere® Insulin Inhalation System (Gen2C inhaler)
Device: Artificial Pancreas (AP) device (APS©)

Device includes:

  • OneTouch® Ping® Glucose Management System with modified Meter-Remote from Animas® Corp or the OmniPod® Insulin Management System from Insulet Corp.
  • Dexcom® G4® CGM System (CGM) from Dexcom® Corp
  • Control algorithm: zone-Model Predictive Control (zone-MPC) with safety Health Monitoring System (HMS)
Other Name: Artificial Pancreas System platform (APS©) from the University of California, Santa Barbara and SDRI

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of type 1 diabetes for at least one year and using an insulin pump for at least 6 months with commercially available rapid actin insulin
  • The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not needed.
  • Age 21 to 65 years
  • For females, not currently known to be pregnant or nursing
  • HbA1c between 5.0% and 10%, as measured with DCA2000 or equivalent device
  • Forced expiratory volume in 1 second (FEV1) ≥ 70% Third National Health and Nutrition Examination Survey (NHANES III) predicted
  • Forced vital capacity (FVC) ≥70% NHANES III predicted
  • Forced expiratory volume in 1 second as a percentage of forced vital capacity(FEVl/FVC)≥NHANES III lower limit of normal (LLN)
  • Willing to perform the calibration of the study CGMs using a finger stick only and willing to follow instructions for insulin pump and CGM wear.
  • Willing to use the study CGM and study insulin pump during closed-loop.
  • Able to and agrees to avoid the following medication starting 24 hours before sensor wear through completion of CRC visit: acetaminophen, and pseudoephedrine.
  • An understanding of and willingness to follow the protocol and sign the informed consent.

Exclusion Criteria:

  • Pregnancy (as determined by a positive blood pregnancy test performed in females of childbearing capacity during screening visit and urine test at time of admission for in-patient visit) or nursing mother.
  • Diabetic ketoacidosis in the past 6 months prior to enrollment requiring emergency room visit or hospitalization
  • Severe hypoglycemia resulting in seizure or loss of consciousness in the 12 months prior to enrollment
  • Current treatment for a seizure disorder;

    o Subjects with a history of seizures may be included in the study if they receive written clearance from their neurologist

  • Cystic fibrosis
  • Active infection
  • A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol such as cognitive deficit.
  • Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation, including subjects not able to read or write.
  • Coronary artery disease or heart failure. oSubjects with a history of coronary artery disease may be included in the study if they receive written clearance from their cardiologist
  • Presence of a known adrenal disorder
  • Active coronary artery disease or heart failure
  • Active gastroparesis
  • If on antihypertensive, thyroid, anti-depressant or lipid lowering medication, lack of stability on the medication for the past 2 months prior to enrollment in the study
  • Uncontrolled thyroid disease

    o Adequately treated thyroid disease and celiac disease do not exclude subjects from enrollment

  • Abuse of alcohol
  • A recent injury to body or limb, muscular disorder, use of any medication, any carcinogenic disease, or other significant medical disorder if that injury, medication or disease in the judgment of the investigator will affect the completion of the exercise protocol
  • Current use of a beta blocker medication
  • Laboratory results:

    • Hematocrit < 30% or >55%
    • A1C > 10%
    • Abnormal liver or renal function (Transaminase >2 times the upper limit of normal, Creatinine> 1.5 mg/dL)
    • Labs drawn at screening visit or within one month prior to screening (for other purposes) will suffice for enrollment purposes related to hematocrit
  • Subject has skin conditions that, in the determination of the investigator, would preclude wearing the study devices (infusion set and sensor), in the abdomen. Examples include but are not limited to: psoriasis, burns, scaring, eczema, tattoos, and significant hypertrophy at sites of device wear; any known allergy to medical adhesives.
  • Currently on long-term treatment using prednisone.
  • If subject had been on short term treatment of prednisone, defer enrollment until underlying condition and prednisone treatment have resolved.
  • Allergy to study drug, food or other study material
  • History of asthma, COPD (chronic obstructive pulmonary disease), or any other clinically relevant chronic lung disease
  • Respiratory track infection within 4 weeks before screening
  • Clinically significant screening ECG, physical examination, laboratory test, or vital sign abnormality
  • Exposure to any investigational drug within 30 days.
  • History of malignancy within the 5 years before screening (other than basal cell carcinoma)
  • Inability, in the opinion of the investigator, to adequately inhale Technosphere® Inhalation powder
  • Abnormal spirometry
  • Currently smoking or discontinued smoking (including cigarettes, cigars, pipes) over the past 6 months.
  • Highly sensitive to insulin: insulin-to-carbohydrate ratio I:C > 1:12.
  • Current participation in another investigational trial (unless participation to original protocol of IDE G110093) or has previously participated to this study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01874392

Locations
United States, California
Sansum Diabetes Research Institute
Santa Barbara, California, United States, 93105
Sponsors and Collaborators
William Sansum Diabetes Center
Juvenile Diabetes Research Foundation
Investigators
Principal Investigator: Howard Zisser, MD William Sansum Diabetes Center
  More Information

No publications provided

Responsible Party: William Sansum Diabetes Center
ClinicalTrials.gov Identifier: NCT01874392     History of Changes
Other Study ID Numbers: JDRF 17-2010-765
Study First Received: May 14, 2013
Last Updated: November 17, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Autoimmune Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases
Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 27, 2014