Comparison of Technosphere Insulin Inhalation Powder & Subcutaneous Rapid-Acting Analog in Subjects With Type 1 Diabetes
NCT01544881 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 17
Last updated 2013-01-25
Summary
This is an Open-label, randomized study in Type 1 diabetics looking at exposure and response (PK/PD) of TI using GEN2C Inhaler versus rapid acting analog.
Conditions
- Type 1 Diabetes Mellitus
Interventions
- DRUG
-
Technosphere Insulin Inhalation Powder
Inhalation Powder using the Gen2C inhaler
- DRUG
-
Rapid Acting Analog
Subcutaneous Injection
Sponsors & Collaborators
-
Mannkind Corporation
lead INDUSTRY
Principal Investigators
-
Chief Medical Officer · Mannkind Corporation
Study Design
- Allocation
- RANDOMIZED
- Purpose
- BASIC_SCIENCE
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-03-31
- Primary Completion
- 2012-09-30
- Completion
- 2013-01-31
Countries
- United States
Study Locations
More Related Trials
-
Comparison of 30 Units of TI (Technosphere® Insulin) Prepared With Insulin From Two Different Suppliers
NCT01982604 ·Status: COMPLETED ·Phase: PHASE1
-
Bioavailability of Technosphere® Insulin Versus Subcutaneous Regular Human Insulin in Type 2 Diabetes
NCT00511719 ·Status: COMPLETED ·Phase: PHASE2
-
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
NCT03143816 ·Status: COMPLETED ·Phase: PHASE4
-
Study of the Efficacy and Safety of Inhaled Technosphere Insulin in Patients With Type 2 Diabetes
NCT00511602 ·Status: COMPLETED ·Phase: PHASE2
-
Clamp Study Comparing Inhalation of Technosphere®/Insulin in Smokers and Non-Smokers With Type 2 Diabetes
NCT00934414 ·Status: COMPLETED ·Phase: PHASE2
-
Clinical Trial Evaluating the Efficacy and Safety of Technosphere® Inhalation Insulin (TI) Inhalation Powder Using the Gen2 Inhaler
NCT01196104 ·Status: TERMINATED ·Phase: PHASE3
-
18-Week, Randomized, Double-blind, Placebo Controlled, Forced Titration Study of Patients With Type 2 Diabetes
NCT00511732 ·Status: COMPLETED ·Phase: PHASE2
-
Efficacy and Safety in Subjects With Type 2 Diabetes Receiving Subcutaneous Basal Insulin and Prandial Inhalation of Technosphere/Insulin Versus Subcutaneous Premixed Insulin Therapy Over a 52-Week Treatment Period and a 4-Week Follow-up
NCT00309244 ·Status: COMPLETED ·Phase: PHASE3
-
Patient Transitioning From Exubera® Inhalation Powder to Technosphere® Insulin Inhalation Powder
NCT01798914 ·Status: NO_LONGER_AVAILABLE
-
A Study of CT-868 in Type 1 Diabetes Mellitus
NCT06062069 ·Status: COMPLETED ·Phase: PHASE2
-
Efficacy & Safety of Inhaled Insulin in Type 1 Diabetes
NCT00308308 ·Status: COMPLETED ·Phase: PHASE3
-
Compare the Same Dosage of Insulin Using a Combination of Cartridges, 30 Units as 2 Cartridges vs. 1 Cartridge
NCT01902121 ·Status: COMPLETED ·Phase: PHASE1
-
To Compare the Effect of Inhaled Insulin With Subcutaneously Injected Insulin in Subjects With Type 2 Diabetes Mellitus.
NCT00419302 ·Status: COMPLETED ·Phase: PHASE2
-
Safety of Inhaled Insulin With Type 1 and Type 2 Diabetes
NCT00308737 ·Status: COMPLETED ·Phase: PHASE3
-
Safety Study of Subcutaneously-Injected Prandial INSULIN-PH20 NP Compared to Insulin Lispro Injection in Participants With Type 1 Diabetes Mellitus
NCT00883558 ·Status: COMPLETED ·Phase: PHASE2
-
Evaluate Safety of Technosphere® Insulin (TI) in Diabetic Subjects With Moderate Obstructive Pulmonary Disease
NCT00642616 ·Status: TERMINATED ·Phase: PHASE3
-
Efficacy and Safety of Prandial Inhalation of Technosphere/Insulin in Combination With Metformin or Technosphere/Insulin Alone Versus 2 Oral Anti-Diabetic Agents in Subjects With Type 2 Diabetes
NCT00332488 ·Status: COMPLETED ·Phase: PHASE3
-
Subcutaneous Administration of Teplizumab in Adults With Type 1 Diabetes
NCT01189422 ·Status: TERMINATED ·Phase: PHASE1
-
A Study to Evaluate Insulin in the Blood After Inhalation of a Dry Powder Insulin Formulation (Called Technosphere®/Insulin) in Non-diabetic Patients With & Without Chronic Obstructive Pulmonary Disease (COPD)
NCT01021891 ·Status: COMPLETED ·Phase: PHASE1
-
PK and PD Within-Subject Variability of a Single Dose of Afrezza Inhaled Technosphere Insulin in Patients With Diabetes Mellitus Type 1 (T1DM)
NCT02485327 ·Status: COMPLETED ·Phase: PHASE1
-
An Open-label, Multi-center, International, Three-year, Safety and Tolerability 'Follow on' Trial
NCT00754624 ·Status: COMPLETED ·Phase: PHASE2
-
Safety and Efficacy of Technosphere® Insulin Inhalation Powder and Lantus® Compared to Humalog® and Lantus® Over 16-Weeks
NCT00700622 ·Status: TERMINATED ·Phase: PHASE3
-
Pharmacokinetic Study in Healthy Volunteers
NCT01365117 ·Status: COMPLETED ·Phase: PHASE1
-
Six Month Clinical Trial Assessing Efficacy And Safety Of Inhaled Insulin In Type 1 Diabetes Mellitus.
NCT00424437 ·Status: COMPLETED ·Phase: PHASE3
-
Benefit/Risk Evaluation of Insuman Implantable Versus Insuplant Using Medtronic MiniMed Implantable Pump System in Patients With Type 1 Diabetes
NCT01194882 ·Status: COMPLETED ·Phase: PHASE3