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Trial record 4 of 4 for:    mannkind | Recruiting, Not yet recruiting, Active, not recruiting, Enrolling by invitation, Suspended Studies

Study Comparing Prandial Insulin Aspart vs. Technosphere Insulin in Patients With Type 1 Diabetes on Multiple Daily Injections: Investigator-Initiated A Real-life Pilot Study—STAT Study (STAT)

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ClinicalTrials.gov Identifier: NCT03143816
Recruitment Status : Active, not recruiting
First Posted : May 8, 2017
Last Update Posted : November 9, 2017
Sponsor:
Collaborators:
Atlanta Diabetes Associates
University of Southern California
Rainier Clinical Research Center
Mannkind Corporation
Information provided by (Responsible Party):
Satish K. Garg, University of Colorado Denver School of Medicine Barbara Davis Center

Brief Summary:

This is an investigator-initiated, prospective, randomized, multicenter, parallel, open-label, pilot clinical trial evaluating the efficacy of TI for PPBG, PPGE, and time-in-range on CGM download in patients with T1D. TI is an inhaled ultra-rapid-acting insulin, approved by the FDA for use in patients with diabetes. This is a pilot, real-life study where patients will continue their routine diabetes care and use post-meal correction dosages as deemed necessary for normalizing PPBG as per the protocol.

This multi-center study will enroll 60 patients with T1D, A1c values between 6.5 to 10%. The patients will be randomized in 1:1 fashion to either TI or NL. Patients who are randomized into the NL arm will continue using their usual prandial insulin dose before meals. Patients who are randomized into the TI arm will be instructed to dose before the meals and take necessary corrections at 1- and 2-hours after meals to optimize PPBG (Table 1B). There will be a total of 7 study visits (screening visit, randomization visit, 2 clinic, and 3 phone visits). There will be a 4-week treatment comparison between TI and NL and 1-week of post-study follow up. (Phone visit; Figure-1). Standard lab tests (A1c, complete metabolic panel {CMP}, complete blood count {CBC}) will be performed at the screening visit.

All patients will use real-time CGM (Dexcom G5®, San Diego, CA), which will be provided at the randomization visit for their day-to-day diabetes care. CGM data will be downloaded at every clinic visit on a secured computer. The data will be analyzed after the study for different primary and secondary end points. All patients will be allowed to keep the CGM after the study is over for their day-to-day diabetes care.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Drug: Technosphere insulin Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study Comparing Prandial Insulin Aspart vs. Technosphere Insulin in Patients With Type 1 Diabetes on Multiple Daily Injections: Investigator-Initiated A Real-life Pilot Study—STAT Study
Actual Study Start Date : September 30, 2017
Estimated Primary Completion Date : December 15, 2017
Estimated Study Completion Date : December 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Active Comparator: Technosphere insulin (TI, Afrezza) -Treatment arm Drug: Technosphere insulin
This multi-center study will enroll 60 patients with T1D, A1c values between 6.5 to 10%. The patients will be randomized in 1:1 fashion to either TI or NL. Patients who are randomized into the NL arm will continue using their usual prandial insulin dose before meals. Patients who are randomized into the TI arm will be instructed to dose before the meals and take necessary corrections at 1- and 2-hours after meals to optimize PPBG (Table 1B). There will be a total of 7 study visits (screening visit, randomization visit, 2 clinic, and 3 phone visits). There will be a 4-week treatment comparison between TI and NL and 1-week of post-study follow up. (Phone visit; Figure-1). Standard lab tests (A1c, complete metabolic panel {CMP}, complete blood count {CBC}) will be performed at the screening visit.

No Intervention: Insulin Aspart ( Novolog) -Control arm



Primary Outcome Measures :
  1. Improved time in range (70-180 mg/dl) with TI on CGM [ Time Frame: 4 weeks ]
  2. Better post-prandial glucose excursion (1-4 hours after meals) with TI [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Less glucose variability (GV) (standard deviation and/or coefficient variation) [ Time Frame: 4 weeks ]
  2. The area under the curve calculation (AUC) in the PPBG and PPGE, [ Time Frame: 4 weeks ]
  3. Change in HbA1c in one-month treatment [ Time Frame: 4 weeks ]
  4. above the target time (>180 mg/dl) on CGM [ Time Frame: 4 weeks ]
  5. hypoglycemia frequency (below the target <70, <60, <50 mg/dl) on CGM [ Time Frame: 4 weeks ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Signed informed consent before any study-related activities,
  2. Male or female aged 18-70 years,
  3. Type 1 diabetes mellitus (T1D) duration more than six months
  4. Treatment with multiple daily injections (MDI) for at least three months before screening visit; stable insulin dose for the last one month,
  5. No use of any oral anti-diabetics, any other form of insulin other than mentioned in the protocol, or any other type of injections such as glucagon-like-peptide-1 (GLP-1) analogs, pramlintide or insulin/GLP-1 analog combinations,
  6. A1c between 6.5 to 10%,
  7. Willingness to routinely collect at least two blood glucose measurements per day needed to calibrate the CGM. Beyond the calibrations, patients may use CGM for necessary action without having to confirm with fingersticks self-monitoring blood glucose (SMBG), as approved by the Food and Drug Administration (FDA),
  8. BMI ≤35 kg/m2,
  9. Ability and willingness to adhere to the protocol including clinical and phone visits and 4-week-long CGM wear,
  10. Using insulin glargine or insulin degludec as basal insulin,
  11. Able to use and understand CGM data,
  12. Willing to complete phone and clinic visits,
  13. Patients who eat three main meals in a day (breakfast, lunch, and dinner),
  14. Patients who use insulin-carb ratio for bolus,
  15. Ability to speak, read, and write English, and
  16. Patients prandial insulin need must be <18 units per meal

Exclusion Criteria:

  1. Use of any other diabetic medication other than allowed in the protocol,
  2. Pregnant or intention to become pregnant during the study, or not using adequate birth control methods,
  3. Severe unexplained hypoglycemia requiring emergency treatment in the previous three months,
  4. Use of systemic or inhaled corticosteroids,
  5. History of hemoglobinopathies,
  6. Diagnosis of anemia,
  7. Post-renal transplantation, currently undergoing dialysis, creatinine >2.0 mg/dl or a calculated creatinine clearance of <50 mL/min,
  8. Advanced or unstable retinopathy needing laser procedure or vitrectomy,
  9. History of pancreatitis,
  10. Extensive skin changes/diseases that inhibit wearing a sensor on normal skin,
  11. Known allergy to adhesives,
  12. Known allergy to study medication,
  13. Participation in another investigational study protocol within 30 days before enrollment,
  14. Known chronic obstructive pulmonary disease, pulmonary hypertension, asthma, pulmonary fibrosis, or any chronic pulmonary infection, or any systemic disease that primarily affects the lungs. History of any pulmonary nodule will be excluded to participate in the study,
  15. Active smokers,
  16. Marijuana users,
  17. Insulin pump users,
  18. Using insulin detemir or NPH as basal insulin, and
  19. Any other condition, as determined by the investigator, which could make the subject unsuitable for the trial, impairs the subject's suitability for the trial, or impairs the validity of the informed consent -

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): NCT03143816


Locations
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United States, Colorado
Barbara Davis Center
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado Denver School of Medicine Barbara Davis Center
Atlanta Diabetes Associates
University of Southern California
Rainier Clinical Research Center
Mannkind Corporation

Publications:
1. Rathbone M, Hadgraft J, Roberts M, Lane M, Leone-Bay A, Grant M. Technosphere/insulin: mimicking endogenous insulin release. In Modified-Release Drug Delivery Technology. Vol. 2, 2nd ed. Rathbone M, Hadgraft J, Roberts M, Lane M, Eds. New York, Informa Healthcare USA, Inc., 2008, p. 673-679
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022472lbl.pdf, April 2017
Garg SK, Kelly W, Freson B, Ritchie P. Treat-to-target technosphere insulin study in adult subjects with type 1 diabetes. Poster presented at American Diabetes Association 2011 annual meeting.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Satish K. Garg, Professor of Medicine and Pediatrics, University of Colorado Denver School of Medicine Barbara Davis Center
ClinicalTrials.gov Identifier: NCT03143816     History of Changes
Other Study ID Numbers: STAT
First Posted: May 8, 2017    Key Record Dates
Last Update Posted: November 9, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Publishing the data after the study, presenting at national scientific meetings

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Satish K. Garg, University of Colorado Denver School of Medicine Barbara Davis Center:
diabetes
time in range
inhaled insulin
continuous glucose monitoring
type 1 diabetes
hypoglycemia
post prandial hypergylcemia

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Insulin, Globin Zinc
Insulin Aspart
Insulin, Long-Acting
Insulin degludec, insulin aspart drug combination
Hypoglycemic Agents
Physiological Effects of Drugs