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

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 Technosphere® Insulin Inhalation Powder (TI Inhalation Powder) on Postprandial Glucose Levels in Subjects With Type 1 and Type 2 Diabetes Mellitus Ingesting Meals With Varied Carbohydrate Content

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00747006

Enrollment

Registered

2008-09-04

Start date

2008-09-30

Completion date

2011-05-31

Last updated

2014-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

Brief summary

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. Patients were randomly assigned to various carbohydrate loads (0%, 50%, 100%, 150% or 200%). The 100% carbohydrate load was determined based upon their standard insulin dose for their normal meal.

Interventions

DRUGTI Inhalation Powder and Humalog (Amendment 1)

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.

DRUGTI Inhalation Powder (original protocol)

Inhaled insulin technology to be administered immediately before a meal (prandially) for glucose control in Type 1 or Type 2 diabetics

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Lunch Plasma Glucose Excursion - Amendment 1 (Humalog Treated Type 2 Subjects)	0 to 240 minutes	Excursion is the difference between plasma glucose Cmax and Cmin (Cmax-Cmin) at lunch
Lunch Plasma Glucose Time 0 Corrected AUC(0-240) - Amendment 1 (Humalog Treated Type 2 Subjects)	0 to 240 minutes	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 before starting meal) to 240 minutes after the start of the meal when the curve is below time 0 value. TIme 0 corrected AUC (0-240) = AUC - AOC
Lunch Plasma Glucose Excursion - Original Protocol (TI Treated Type 1 Subjects)	0 to 240 minutes	Excursion is the difference between plasma glucose Cmax and Cmin (Cmax - Cmin) at lunch
Breakfast Plasma Glucose Excursion - Original Protocol (TI Treated - Type 1 Subjects)	0 to 240 minutes	Excursion is the difference between plasma glucose Cmax and Cmin (Cmax - Cmin) at breakfast
Lunch Plasma Glucose Excursion - Amendment 1 ( TI Treated Type 2 Subjects)	0 to 240 minutes	Excursion is the difference between plasma glucose Cmax and Cmin (Cmax-Cmin) at lunch
Lunch Plasma Glucose Time 0 Corrected AUC (0-240) - Original Protocol (TI Treated Type 1 Subjects)	0 to 240 minutes	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 before starting meal) to 240 minutes after the start of the meal when the curve is below time 0 value. TIme 0 corrected AUC (0-240) = AUC - AOC
Breakfast Plasma Glucose Time 0 Corrected AUC(0-240) - Original Protocol (TI Treated Type 1 Subjects)	0 to 240 minutes	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 before starting meal) to 240 minutes after the start of the meal when the curve is below time 0 value. TIme 0 corrected AUC (0-240) = AUC - AOC
Lunch Plasma Glucose Time 0 Corrected AUC(0-240) - Amendment 1 (TI Treated Type 2 Subjects)	0 to 240 minutes	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 before starting meal) to 240 minutes after the start of the meal when the curve is below time 0 value. TIme 0 corrected AUC (0-240) = AUC - AOC

Secondary

Measure	Time frame	Description
Lunch Plasma Glucose AOC (0-240) - Original Protocol (TI Treated Type 1 Subjects)	0 to 240 minutes	Area over the plasma glucose - time curve from time 0 (immediately before starting lunch) to 240 minutes after the start of the lunch
Lunch Plasma Glucose AOC(0-240) - Amendment 1 (TI Treated Type 2 Subjects)	0 to 240 minutes	Lunch area over the plasma glucose - time curve from time 0 (immediately before breakfast) to 240 minutes after start of lunch
Lunch Plasma Glucose AOC(0-240) - Amendment 1 (Humalog Treated Type 2 Subjects)	0 to 240 minutes	Lunch area over the plasma glucose - time curve from time 0 (immediately before breakfast) to 240 minutes after start of lunch
Breakfast Plasma Glucose AOC(0-240) - Original Protocol (TI Treated Type 1 Subjects)	0 to 240 minutes	Breakfast area over the plasma glucose - time curve from time 0 (immediately before breakfast) to 240 minutes after start of breakfast

Countries

United States

Participant flow

Participants by arm

Arm	Count
Original Protocol Type 1 Diabetes Original protocol participants with Type 1 diabetes given Technosphere Insulin (TI - doses individualized for each patient) at various carbohydrate loads \[0%, 50%, 100% (reference), 200%, and if necessary, 150%)	7
Original Protocol Type 2 Diabetes Original protocol participants with Type 2 diabetes given Technosphere Insulin (TI - doses individualized for each patient) at various carbohydrate loads \[0%, 50%, 100% (reference), 200%, and if necessary, 150%)	8
Amendment 1 Type 2 Diabetes Protocol amendment 1 participants with Type 2 diabetes given humalog (doses individualized for each patient) or Technosphere Insulin (doses individualized for each patient) at various carbohydrate loads \[0%, 50%, 100% (reference), 200%, and if necessary, 150%)	3
Total	18

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002
Overall Study	Adverse Event	1	0	0
Overall Study	Lost to Follow-up	0	1	0
Overall Study	Physician Decision	2	0	1

Baseline characteristics

Characteristic	Original Protocol Type 1 Diabetes	Original Protocol Type 2 Diabetes	Amendment 1 Type 2 Diabetes	Total
Age, Continuous	40.7 years	59.4 years	50.7 years	50.7 years
Sex: Female, Male Female	2 Participants	1 Participants	1 Participants	4 Participants
Sex: Female, Male Male	5 Participants	7 Participants	2 Participants	14 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —	— / —
other Total, other adverse events	7 / 7	7 / 8	3 / 3	1 / 2
serious Total, serious adverse events	0 / 7	3 / 8	0 / 3	0 / 2

Outcome results

Primary

Breakfast Plasma Glucose Excursion - Original Protocol (TI Treated - Type 1 Subjects)

Excursion is the difference between plasma glucose Cmax and Cmin (Cmax - Cmin) at breakfast

Time frame: 0 to 240 minutes

Population: Original Protocol Type 1 Diabetes Mellitus Technosphere Insulin Treated; 0% carbohydrate load was deemed unsafe by PI

Arm	Measure	Value (MEAN)
100% Carbohydrate Load	Breakfast Plasma Glucose Excursion - Original Protocol (TI Treated - Type 1 Subjects)	53.50 mg/dL
50% Carbohydrate Load	Breakfast Plasma Glucose Excursion - Original Protocol (TI Treated - Type 1 Subjects)	44.33 mg/dL
150% Carbohydrate Load	Breakfast Plasma Glucose Excursion - Original Protocol (TI Treated - Type 1 Subjects)	89.50 mg/dL
200% Carbohydrate Load	Breakfast Plasma Glucose Excursion - Original Protocol (TI Treated - Type 1 Subjects)	186.33 mg/dL

Primary

Breakfast Plasma Glucose Time 0 Corrected AUC(0-240) - Original Protocol (TI Treated Type 1 Subjects)

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 before starting meal) to 240 minutes after the start of the meal when the curve is below time 0 value. TIme 0 corrected AUC (0-240) = AUC - AOC

Time frame: 0 to 240 minutes

Population: Original Protocol Type 1 Diabetes Mellitus Technosphere Insulin Treated; 0% carbohydrate load was deemed unsafe by PI

Arm	Measure	Value (MEAN)
100% Carbohydrate Load	Breakfast Plasma Glucose Time 0 Corrected AUC(0-240) - Original Protocol (TI Treated Type 1 Subjects)	104.32 min*mg/dL
50% Carbohydrate Load	Breakfast Plasma Glucose Time 0 Corrected AUC(0-240) - Original Protocol (TI Treated Type 1 Subjects)	10.80 min*mg/dL
150% Carbohydrate Load	Breakfast Plasma Glucose Time 0 Corrected AUC(0-240) - Original Protocol (TI Treated Type 1 Subjects)	199.35 min*mg/dL
200% Carbohydrate Load	Breakfast Plasma Glucose Time 0 Corrected AUC(0-240) - Original Protocol (TI Treated Type 1 Subjects)	440.90 min*mg/dL

Primary

Lunch Plasma Glucose Excursion - Amendment 1 (Humalog Treated Type 2 Subjects)

Excursion is the difference between plasma glucose Cmax and Cmin (Cmax-Cmin) at lunch

Time frame: 0 to 240 minutes

Population: Protocol Amendment 1 Type 2 Diabetes Mellitus Humalog Treated Subjects; 150% carbohydrate load was not done per protocol since the 200% carbohydrate load was administered

Arm	Measure	Value (MEAN)
100% Carbohydrate Load	Lunch Plasma Glucose Excursion - Amendment 1 (Humalog Treated Type 2 Subjects)	44.50 mg/dL
0% Carbohydrate Load	Lunch Plasma Glucose Excursion - Amendment 1 (Humalog Treated Type 2 Subjects)	20.00 mg/dL
50% Carbohydrate Load	Lunch Plasma Glucose Excursion - Amendment 1 (Humalog Treated Type 2 Subjects)	23.50 mg/dL
200% Carbohydrate Load	Lunch Plasma Glucose Excursion - Amendment 1 (Humalog Treated Type 2 Subjects)	45.50 mg/dL

Primary

Lunch Plasma Glucose Excursion - Amendment 1 ( TI Treated Type 2 Subjects)

Excursion is the difference between plasma glucose Cmax and Cmin (Cmax-Cmin) at lunch

Time frame: 0 to 240 minutes

Population: Protocol Amendment 1 Type 2 Diabetes Mellitus TI Treated Subjects; 150% carbohydrate load was not done per protocol since the 200% carbohydrate load was administered

Arm	Measure	Value (MEAN)
100% Carbohydrate Load	Lunch Plasma Glucose Excursion - Amendment 1 ( TI Treated Type 2 Subjects)	29.50 mg/dL
0% Carbohydrate Load	Lunch Plasma Glucose Excursion - Amendment 1 ( TI Treated Type 2 Subjects)	14.50 mg/dL
50% Carbohydrate Load	Lunch Plasma Glucose Excursion - Amendment 1 ( TI Treated Type 2 Subjects)	16.00 mg/dL
200% Carbohydrate Load	Lunch Plasma Glucose Excursion - Amendment 1 ( TI Treated Type 2 Subjects)	18.50 mg/dL

Primary

Lunch Plasma Glucose Excursion - Original Protocol (TI Treated Type 1 Subjects)

Excursion is the difference between plasma glucose Cmax and Cmin (Cmax - Cmin) at lunch

Time frame: 0 to 240 minutes

Population: Original Protocol Type 1 Diabetes Mellitus Technosphere Insulin Treated; 50% carbohydrate load was administered but not completed due to all subjects having hypoglycemia, 0% carbohydrate load was deemed unsafe by PI

Arm	Measure	Value (MEAN)
100% Carbohydrate Load	Lunch Plasma Glucose Excursion - Original Protocol (TI Treated Type 1 Subjects)	54.00 mg/dL
150% Carbohydrate Load	Lunch Plasma Glucose Excursion - Original Protocol (TI Treated Type 1 Subjects)	129.67 mg/dL
200% Carbohydrate Load	Lunch Plasma Glucose Excursion - Original Protocol (TI Treated Type 1 Subjects)	201.00 mg/dL

Primary

Lunch Plasma Glucose Time 0 Corrected AUC(0-240) - Amendment 1 (Humalog Treated Type 2 Subjects)

Time frame: 0 to 240 minutes

Population: Protocol Amendment 1 Type 2 Diabetes Mellitus Humalog Treated Subjects; 150% carbohydrate load was not done per protocol since the 200% carbohydrate load was administered

Arm	Measure	Value (MEAN)
100% Carbohydrate Load	Lunch Plasma Glucose Time 0 Corrected AUC(0-240) - Amendment 1 (Humalog Treated Type 2 Subjects)	15.77 min*mg/dL
0% Carbohydrate Load	Lunch Plasma Glucose Time 0 Corrected AUC(0-240) - Amendment 1 (Humalog Treated Type 2 Subjects)	-51.26 min*mg/dL
50% Carbohydrate Load	Lunch Plasma Glucose Time 0 Corrected AUC(0-240) - Amendment 1 (Humalog Treated Type 2 Subjects)	4.18 min*mg/dL
200% Carbohydrate Load	Lunch Plasma Glucose Time 0 Corrected AUC(0-240) - Amendment 1 (Humalog Treated Type 2 Subjects)	-8.15 min*mg/dL

Primary

Lunch Plasma Glucose Time 0 Corrected AUC(0-240) - Amendment 1 (TI Treated Type 2 Subjects)

Time frame: 0 to 240 minutes

Population: Protocol Amendment 1 Type 2 Diabetes Mellitus Technosphere Insulin Treated Subjects; 150% carbohydrate load was not done per protocol since the 200% carbohydrate load was administered

Arm	Measure	Value (MEAN)
100% Carbohydrate Load	Lunch Plasma Glucose Time 0 Corrected AUC(0-240) - Amendment 1 (TI Treated Type 2 Subjects)	-6.11 min*mg/dL
0% Carbohydrate Load	Lunch Plasma Glucose Time 0 Corrected AUC(0-240) - Amendment 1 (TI Treated Type 2 Subjects)	-74.26 min*mg/dL
50% Carbohydrate Load	Lunch Plasma Glucose Time 0 Corrected AUC(0-240) - Amendment 1 (TI Treated Type 2 Subjects)	-22.80 min*mg/dL
200% Carbohydrate Load	Lunch Plasma Glucose Time 0 Corrected AUC(0-240) - Amendment 1 (TI Treated Type 2 Subjects)	11.56 min*mg/dL

Primary

Lunch Plasma Glucose Time 0 Corrected AUC (0-240) - Original Protocol (TI Treated Type 1 Subjects)

Time frame: 0 to 240 minutes

Arm	Measure	Value (MEAN)
100% Carbohydrate Load	Lunch Plasma Glucose Time 0 Corrected AUC (0-240) - Original Protocol (TI Treated Type 1 Subjects)	-41.44 min*mg/dL
150% Carbohydrate Load	Lunch Plasma Glucose Time 0 Corrected AUC (0-240) - Original Protocol (TI Treated Type 1 Subjects)	251.65 min*mg/dL
200% Carbohydrate Load	Lunch Plasma Glucose Time 0 Corrected AUC (0-240) - Original Protocol (TI Treated Type 1 Subjects)	454.07 min*mg/dL

Secondary

Breakfast Plasma Glucose AOC(0-240) - Original Protocol (TI Treated Type 1 Subjects)

Breakfast area over the plasma glucose - time curve from time 0 (immediately before breakfast) to 240 minutes after start of breakfast

Time frame: 0 to 240 minutes

Population: Original Protocol Type 1 Diabetes Mellitus Technosphere Insulin Treated; 0% carbohydrate load was deemed unsafe by PI

Arm	Measure	Value (MEAN)
100% Carbohydrate Load	Breakfast Plasma Glucose AOC(0-240) - Original Protocol (TI Treated Type 1 Subjects)	10.25 min*mg/dL
50% Carbohydrate Load	Breakfast Plasma Glucose AOC(0-240) - Original Protocol (TI Treated Type 1 Subjects)	30.45 min*mg/dL
150% Carbohydrate Load	Breakfast Plasma Glucose AOC(0-240) - Original Protocol (TI Treated Type 1 Subjects)	6.30 min*mg/dL
200% Carbohydrate Load	Breakfast Plasma Glucose AOC(0-240) - Original Protocol (TI Treated Type 1 Subjects)	3.18 min*mg/dL

Secondary

Lunch Plasma Glucose AOC(0-240) - Amendment 1 (Humalog Treated Type 2 Subjects)

Lunch area over the plasma glucose - time curve from time 0 (immediately before breakfast) to 240 minutes after start of lunch

Time frame: 0 to 240 minutes

Population: Protocol Amendment 1 Type 2 Diabetes Mellitus Humalog Treated Subjects; 150% carbohydrate load was not done per protocol since the 200% carbohydrate load was administered

Arm	Measure	Value (MEAN)
100% Carbohydrate Load	Lunch Plasma Glucose AOC(0-240) - Amendment 1 (Humalog Treated Type 2 Subjects)	14.60 min*mg/dL
0% Carbohydrate Load	Lunch Plasma Glucose AOC(0-240) - Amendment 1 (Humalog Treated Type 2 Subjects)	51.63 min*mg/dL
50% Carbohydrate Load	Lunch Plasma Glucose AOC(0-240) - Amendment 1 (Humalog Treated Type 2 Subjects)	12.52 min*mg/dL
200% Carbohydrate Load	Lunch Plasma Glucose AOC(0-240) - Amendment 1 (Humalog Treated Type 2 Subjects)	40.84 min*mg/dL

Secondary

Lunch Plasma Glucose AOC(0-240) - Amendment 1 (TI Treated Type 2 Subjects)

Lunch area over the plasma glucose - time curve from time 0 (immediately before breakfast) to 240 minutes after start of lunch

Time frame: 0 to 240 minutes

Population: Protocol Amendment 1 Type 2 Diabetes Mellitus Technosphere Insulin Treated Subjects; 150% carbohydrate load was not done per protocol since the 200% carbohydrate load was administered

Arm	Measure	Value (MEAN)
100% Carbohydrate Load	Lunch Plasma Glucose AOC(0-240) - Amendment 1 (TI Treated Type 2 Subjects)	18.00 min*mg/dL
0% Carbohydrate Load	Lunch Plasma Glucose AOC(0-240) - Amendment 1 (TI Treated Type 2 Subjects)	74.26 min*mg/dL
50% Carbohydrate Load	Lunch Plasma Glucose AOC(0-240) - Amendment 1 (TI Treated Type 2 Subjects)	24.04 min*mg/dL
200% Carbohydrate Load	Lunch Plasma Glucose AOC(0-240) - Amendment 1 (TI Treated Type 2 Subjects)	5.65 min*mg/dL

Secondary

Lunch Plasma Glucose AOC (0-240) - Original Protocol (TI Treated Type 1 Subjects)

Area over the plasma glucose - time curve from time 0 (immediately before starting lunch) to 240 minutes after the start of the lunch

Time frame: 0 to 240 minutes

Arm	Measure	Value (MEAN)
100% Carbohydrate Load	Lunch Plasma Glucose AOC (0-240) - Original Protocol (TI Treated Type 1 Subjects)	53.89 min*mg/dL
150% Carbohydrate Load	Lunch Plasma Glucose AOC (0-240) - Original Protocol (TI Treated Type 1 Subjects)	19.16 min*mg/dL
200% Carbohydrate Load	Lunch Plasma Glucose AOC (0-240) - Original Protocol (TI Treated Type 1 Subjects)	8.77 min*mg/dL

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026

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

Conditions

Brief summary

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Breakfast Plasma Glucose Excursion - Original Protocol (TI Treated - Type 1 Subjects)

Breakfast Plasma Glucose Time 0 Corrected AUC(0-240) - Original Protocol (TI Treated Type 1 Subjects)

Lunch Plasma Glucose Excursion - Amendment 1 (Humalog Treated Type 2 Subjects)

Lunch Plasma Glucose Excursion - Amendment 1 ( TI Treated Type 2 Subjects)

Lunch Plasma Glucose Excursion - Original Protocol (TI Treated Type 1 Subjects)

Lunch Plasma Glucose Time 0 Corrected AUC(0-240) - Amendment 1 (Humalog Treated Type 2 Subjects)

Lunch Plasma Glucose Time 0 Corrected AUC(0-240) - Amendment 1 (TI Treated Type 2 Subjects)

Lunch Plasma Glucose Time 0 Corrected AUC (0-240) - Original Protocol (TI Treated Type 1 Subjects)

Breakfast Plasma Glucose AOC(0-240) - Original Protocol (TI Treated Type 1 Subjects)

Lunch Plasma Glucose AOC(0-240) - Amendment 1 (Humalog Treated Type 2 Subjects)

Lunch Plasma Glucose AOC(0-240) - Amendment 1 (TI Treated Type 2 Subjects)

Lunch Plasma Glucose AOC (0-240) - Original Protocol (TI Treated Type 1 Subjects)