Comparison of Technosphere Insulin Inhalation Powder & Subcutaneous Rapid-Acting Analog in Subjects With Type 1 Diabetes

NCT01544881 | Completed Phase 1

• 1 other identifier: MKC-TI-177
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Pharmacokinetics; Pharmacodynamics; Hyperglycemia; Insulin

Outcome Measures

Primary Outcomes (2)

• PK measures for TI Inhalation Powder (20U) as measured by area under the concentration-time curve (AUC 0-360) - timepoints: 0, 3, 6, 9, 12, 15, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 240, 300 and 360 minutes post-TI dosing

  Crossover 1 time within 3 - 10 days

• PK measures for RAA (8U) as measured by area under the concentration-time curve (AUC 0-360) - timepoints 0, 5, 10, 15, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210, 240, 270, 300 and 360 minutes post-RAA dosing

  Crossover 1 time within 3 - 10 days

Secondary Outcomes (3)

• Safety variables including adverse events (AEs), clinical laboratory tests, vital signs and physical examinations

  Crossover 1 time within 3 - 10 days

• Area under serum glucose infusion rate (GIR AUC 0-360) for TI Inhalation Powder (20U) as measured by: GIR AUC 0-360 timepoints: 0, 3, 6, 9, 12, 15, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 240, 300 and 360 minutes post-TI dosing

  Crossover 1 time within 3 - 10 days

• Area under serum glucose infusion rate (GIR AUC 0-360) for RAA (8U) as measured by: GIR AUC 0-360 timepoints: 0, 5, 10, 15, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210, 240, 270, 300 and 360 minutes post-RAA dosing

  Crossover 1 time within 3 - 10 days

Study Arms (2)

TI Inhalation Powder

EXPERIMENTAL

Technosphere Insulin Inhalation Powder using the Gen2C inhaler

Drug: Technosphere Insulin Inhalation Powder

RAA

ACTIVE COMPARATOR

Rapid Acting Analog

Drug: Rapid Acting Analog

Interventions

Technosphere Insulin Inhalation Powder DRUG

Inhalation Powder using the Gen2C inhaler

Also known as: TI

TI Inhalation Powder

Rapid Acting Analog DRUG

Subcutaneous Injection

Also known as: RAA

RAA

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Men and women aged 18 to 60 years
• One of more daily sc insulin injections of any insulin type or insulin pump use
• Body mass index (BMI) = 30 kg/m2
• Pulmonary function tests (PFTs) conducted at Visit 1:
• FEV1 ≥ 80% of the Third National Health and Nutrition Examination Survey (NHANES III) predicted
• FVC ≥ 80% of the Third National Health and Nutrition Examination Survey (NHANES III) predicted
• Diagnosis of type 1 diabetes for at least 12 months
• Good venous access for blood draws
• Written informed consent provided
• No smoking in the previous 6 months (including cigarette, cigars, pipes) and negative urine cotinine testing (\<100 ng/mL)
• C-peptide \< 0.3 ng/mL
• Hemoglobin A1c (HbA1c) = 10.0%

You may not qualify if:

• Total daily insulin requirement of = 1.4 U/kg body weight
• Serum creatinine = 2.0 mg/dL in men and \> 1.8 mg/dL in women
• Blood donation of 500 mL within the previous 56 days
• Current treatment with pramlintide acetate or exenatide
• Unstable diabetes control and evidence of severe complications of diabetes (ie, autonomic neuropathy)
• History of chronic obstructive pulmonary disease (COPD) or asthma, or any other clinically important pulmonary disease confirmed by pulmonary function testing or radiologic findings
• Upper respiratory tract infection within 8 weeks before screening
• History of coronary artery disease, peripheral vascular disease, or congestive heart failure
• Allergy to study drug, food, or other study material (eg, peanuts, soy products)
• Clinically significant active or chronic illness
• History of drug or alcohol abuse
• Positive urine drug screen
• Clinically significant screening ECG, physical examination, laboratory test, or vital sign abnormality
• Exposure to any other investigational drug or device within 30 days before treatment or within 90 days before treatment for drugs known to modify glucose metabolism (except metformin)
• History of malignancy within the 5 years before screening (other than basal cell carcinoma)

Sponsors & Collaborators

• Mannkind Corporation: lead

Study Sites (1)

Profil Institute for Clinical Research

Chula Vista, California, 91911, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Hyperglycemia; Insulin Resistance

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Hyperinsulinism

Study Officials

• Chief Medical Officer

  Mannkind Corporation

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2012
• First Posted: March 6, 2012
• Study Start: March 1, 2012
• Primary Completion: September 1, 2012
• Study Completion: January 1, 2013
• Last Updated: January 25, 2013

Record last verified: 2013-01

Locations

US (1)