Expired Study
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Santa Barbara, California 93105


Purpose:

The purpose of this study is to determine if, once a favorable dose of TI Inhalation Powder is established for either a type 1 or 2 patient, based on a average diabetic meal, the patient's favorable dose can be used safely, regardless of change in meal carbohydrate content.


Criteria:

Inclusion Criteria: - Clinical diagnoses of type 1 or type 2 diabetes mellitus - Fasting Plasma Glucose (FPG) 80, 140 mg/dL and glycated hemoglobin (A1C) > 6.5% and < or = 10.0%. - Body mass index (BMI) of < or = 40 kg/m2 - Non-smokers (never smoked or former smokers [= 6 months since cessation]) and a urine cotinine level < or = 100 ng/dL - Forced expiratory volume in 1 second (FEV1) = 70% Third National Health and Nutrition Examination Survey (NHANES III) Predicted; pre-bronchodilator FEV1 as a percentage of forced vital capacity (FEV1/Forced vital capacity(FVC)) = 70% - For subjects with type 2 diabetes mellitus: Currently receiving oral diabetic treatment or basal insulin +/- oral diabetic treatment Exclusion Criteria: - History of chronic obstructive pulmonary disease (COPD), clinically proven asthma, and/or any other clinically important pulmonary disease confirmed by pulmonary function test (PFT) and/or radiologic findings - Elevated liver function test (alanine aminotransferase [ALT] or aspartate aminotransferase [AST] > 3 times the normal reference range or bilirubin > 1.5 times the reference range) - Previous use of Exubera; use of Symlin (pramlintide acetate) and/or Byetta (exenatide) within the past 12 weeks - Unstable diabetes control and evidence of severe complications of diabetes mellitus (ie, autonomic neuropathy) - Exposure to any investigational product(s) in the past 12 weeks - For subjects with type 2 diabetes mellitus: In subjects taking metformin, serum creatinine > 1.4 mg/dL in female subjects and > 1.5 mg/dL in male subjects


Study is Available At:


Original ID:

MKC-TI-119


NCT ID:

NCT00747006


Secondary ID:


Study Acronym:


Brief Title:

Safety and Efficacy of Technosphere® Insulin Inhalation Powder (TI Inhalation Powder)When an Optimal Dose is Taken With Varied Carbohydrate Intake


Official Title:

A Phase 2, Single-Center, Open-Label, Pharmacodynamic Clinical Trial to Evaluate the Effect of Technosphere® Insulin Inhalation Powder Safety and Efficacy of Technosphere® Insulin Inhalation Powder (TI Inhalation Powder) Safety and Efficacy of Technospher


Overall Status:

Terminated


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

70 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Mannkind Corporation


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:

Business reasons


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: S


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

18


Enrollment Type:

Actual


Study Dates

Start Date:September 2008
Completion Date:May 2011
Completion Type:Actual
Primary Completion Date:February 2011
Primary Completion Type:Actual
Verification Date:October 2014
Last Changed Date:October 20, 2014
First Received Date:September 3, 2008
First Results Date:July 22, 2014

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Lunch Plasma Glucose AOC(0-240) - Amendment 1 (Humalog Treated Type 2 Subjects)
Time Frame:0 to 240 minutes
Safety Issues:False
Description:Lunch area over the plasma glucose - time curve from time 0 (immediately before breakfast) to 240 minutes after start of lunch
Outcome Type:Secondary Outcome
Measure:Lunch Plasma Glucose AOC(0-240) - Amendment 1 (TI Treated Type 2 Subjects)
Time Frame:0 to 240 minutes
Safety Issues:False
Description:Lunch area over the plasma glucose - time curve from time 0 (immediately before breakfast) to 240 minutes after start of lunch
Outcome Type:Secondary Outcome
Measure:Breakfast Plasma Glucose AOC(0-240) - Original Protocol (TI Treated Type 1 Subjects)
Time Frame:0 to 240 minutes
Safety Issues:False
Description:Breakfast area over the plasma glucose - time curve from time 0 (immediately before breakfast) to 240 minutes after start of breakfast
Outcome Type:Secondary Outcome
Measure:Lunch Plasma Glucose AOC (0-240) - Original Protocol (TI Treated Type 1 Subjects)
Time Frame:0 to 240 minutes
Safety Issues:False
Description:Area over the plasma glucose - time curve from time 0 (immediately before starting lunch) to 240 minutes after the start of the lunch
Outcome Type:Primary Outcome
Measure:Lunch Plasma Glucose Excursion - Amendment 1 (Humalog Treated Type 2 Subjects)
Time Frame:0 to 240 minutes
Safety Issues:False
Description:Excursion is the difference between plasma glucose Cmax and Cmin (Cmax-Cmin) at lunch
Outcome Type:Primary Outcome
Measure:Lunch Plasma Glucose Excursion - Amendment 1 ( TI Treated Type 2 Subjects)
Time Frame:0 to 240 minutes
Safety Issues:False
Description:Excursion is the difference between plasma glucose Cmax and Cmin (Cmax-Cmin) at lunch
Outcome Type:Primary Outcome
Measure:Breakfast Plasma Glucose Excursion - Original Protocol (TI Treated - Type 1 Subjects)
Time Frame:0 to 240 minutes
Safety Issues:False
Description:Excursion is the difference between plasma glucose Cmax and Cmin (Cmax - Cmin) at breakfast
Outcome Type:Primary Outcome
Measure:Lunch Plasma Glucose Excursion - Original Protocol (TI Treated Type 1 Subjects)
Time Frame:0 to 240 minutes
Safety Issues:False
Description:Excursion is the difference between plasma glucose Cmax and Cmin (Cmax - Cmin) at lunch
Outcome Type:Primary Outcome
Measure:Lunch Plasma Glucose Time 0 Corrected AUC(0-240) - Amendment 1 (Humalog Treated Type 2 Subjects)
Time Frame:0 to 240 minutes
Safety Issues:False
Description:AUC (area under the plasma glucose - time curve) from time 0 (immediately before starting meal) to 240 minutes after the start of the meal when the curve is above time 0 value. AOC (area over the plasma glucose - time curve) from time 0 (immediately befo
Outcome Type:Primary Outcome
Measure:Lunch Plasma Glucose Time 0 Corrected AUC(0-240) - Amendment 1 (TI Treated Type 2 Subjects)
Time Frame:0 to 240 minutes
Safety Issues:False
Description:AUC (area under the plasma glucose - time curve) from time 0 (immediately before starting meal) to 240 minutes after the start of the meal when the curve is above time 0 value. AOC (area over the plasma glucose - time curve) from time 0 (immediately befo
Outcome Type:Primary Outcome
Measure:Breakfast Plasma Glucose Time 0 Corrected AUC(0-240) - Original Protocol (TI Treated Type 1 Subjects)
Time Frame:0 to 240 minutes
Safety Issues:False
Description:AUC (area under the plasma glucose - time curve) from time 0 (immediately before starting meal) to 240 minutes after the start of the meal when the curve is above time 0 value. AOC (area over the plasma glucose - time curve) from time 0 (immediately befo
Outcome Type:Primary Outcome
Measure:Lunch Plasma Glucose Time 0 Corrected AUC (0-240) - Original Protocol (TI Treated Type 1 Subjects)
Time Frame:0 to 240 minutes
Safety Issues:False
Description:AUC (area under the plasma glucose - time curve) from time 0 (immediately before starting meal) to 240 minutes after the start of the meal when the curve is above time 0 value. AOC (area over the plasma glucose - time curve) from time 0 (immediately befo

Study Interventions

Intervention Type:Drug
Name:TI Inhalation Powder and Humalog (Amendment 1)
Description:Subcutaneous (sc) rapid acting analog to be administered at one half of the meal challenge visits 15 minutes before a meal. Only the last 5 - 10 patients (Type 2) will be undergoing this amendment to the protocol.
Arm Name:TI Inhalation Powder and Humalog (Amendment 1)
Intervention Type:Drug
Name:TI Inhalation Powder (original protocol)
Description:Inhaled insulin technology to be administered immediately before a meal (prandially) for glucose control in Type 1 or Type 2 diabetics
Arm Name:TI Inhalation Powder (original protocol)

Study Arms

Study Arm Type:Other
Arm Name:TI Inhalation Powder and Humalog (Amendment 1)
Description:Under Amendment 1, TI Inhalation Powder will be administered prandially to a new subset of subjects with Type 2 diabetes during TI dose optimization visits and TI meal challenge visits (with meals of varying carbohydrate contents). Subjects will be crossed over to administration of Humalog 15 minutes before meals during Humalog dose optimization visits and Humalog meal challenge visits (with meals of varying carbohydrate contents). Subjects will also use TI Inhalation Powder daily at each meal
Study Arm Type:Experimental
Arm Name:TI Inhalation Powder (original protocol)
Description:Under the original protocol, subjects with Type 1 and Type 2 diabetes will have TI Inhalation Powder administered prandially during dose optimization visits and meal challenge visits (with meals of varying carbohydrate contents). Subjects with Type 2 diabetes will also use TI Inhalation Powder daily at each meal between visits.

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Mannkind Corporation

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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