A Study Comparing Subcutaneous Rapid Acting Insulin and One Formulation of Inhaled Insulin in Subjects With Type 2 Diabetes

NCT00570687 | Completed Phase 2 Results

• 1 other identifier: MKC-TI-118
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The original protocol was a randomized, open-label, 3-way cross-over study with 9 scheduled visits. The visits comprised an initial screening visit, 3 treatment visits for the meal challenge followed by a 2-6-week blood-loss recovery period, an interim safety visit, 3 sequential visits for the glucose clamp, and a final close-out visit. Protocol Amendment 1 was a randomized, open-label, 2-way cross-over study with 7 visits for each completed subject. The visits comprise an initial screening visit, 2 treatment visits for the meal challenge followed by a 2-6-week blood-loss recovery period, an interim safety visit, 2 sequential visits for the glucose clamp, and a final close-out visit. For both the original protocol and Protocol Amendment 1, subjects were hospitalized in the clinical unit for all procedures.

Conditions

Diabetes Mellitus, Type 2

Keywords

Inhaled Insulin

Outcome Measures

Primary Outcomes (3)

• Time to Minimum Endogenous Glucose Production (EGP) - Meal Challenge

  Time to minimum EGP post dose

  0-480 minutes

• Minimum EGP - Meal Challenge

  Minimum calculated EGP per subject as change from baseline

  0-480 minutes

• EGP AOC0-480 - Meal Challenge

  EGP area over the curve from 0 to 480 minutes postdose

  0-480 minutes

Study Arms (1)

1

EXPERIMENTAL

Technosphere Insulin

Drug: Technosphere Insulin

Interventions

Technosphere Insulin DRUG

Inhalation 15U/30U

1

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Receiving diabetes treatment with insulin for a minimum of 3 months
• Body Mass Index (BMI) of ≤ 34 kg/m2 and ≥ 25 kg/m2
• HbA1c ≤ 8.5% based upon results from a central laboratory
• Non-smoking Males and females ≥ 18 and ≤ 70 years of age
• A clinical diagnosis of type 2 diabetes mellitus for ≥ 12 months

You may not qualify if:

• Total daily insulin requirement of ≥ 1.2 U/kg body weight
• Use of Symlin® (pramlintide acetate) and/or Byetta® (exenatide) within the preceding 8 weeks
• Two or more severe hypoglycemic episodes within 6 months of screening
• Any hospitalization or emergency room visit due to poor diabetic control within 6 months of Screening
• Severe complications of diabetes
• Previous exposure to any inhaled insulin product
• Currently using an insulin delivery pump
• Allergy or known hypersensitivity to insulin or to any of the drugs to be used in the trial
• Any clinically important pulmonary disease, confirmed by documented history, pulmonary function testing, or radiologic findings
• Chronic use of systemic steroids
• Inability to perform PFT maneuvers to meet the recommended American Thoracic Society (ATS) standards of acceptability and repeatability
• Significant improvement in spirometry following bronchodilation
• Active respiratory infection
• Seizure disorder
• Significant cardiovascular dysfunction and/or history within 3 months of Screening

Sponsors & Collaborators

• Mannkind Corporation: lead

Study Sites (1)

Profil Institute for Metabolic Research

Neuss, GER, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Chief Medical Officer
• Organization: MannKind Corporation

aboss@mannkindcorp.com

201-983-5000

Study Officials

• Klaus Rave, MD

  Profil Institute for Metabolic Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2007
• First Posted: December 11, 2007
• Study Start: September 1, 2007
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: October 16, 2014
• Results First Posted: October 16, 2014

Record last verified: 2014-10

Locations

DE (1)