Long-Term Safety Study Of Inhaled Insulin (CP-464,005, Inhaler) In Japanese Patients With Type1 or Type2 Diabetes

NCT00527397 | Terminated Phase 3 Results

• 1 other identifier: A2171105
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 10

Brief Summary

Assess the safety and toleration of CP-464,005 and Inhaler following 1-year (52 week) administration to Type 1 and Type 2 diabetes patients (non-smokers)

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1

Keywords

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Self-Monitoring Blood Glucose Levels: Change From Baseline

  Self-monitoring blood glucose levels obtained at each observation point minus that at baseline.

  One year

Secondary Outcomes (8)

• Daily Inhaled Insulin Dose

  Up to 26 weeks

• The Values of Hemoglobin A1c:Change From Baseline

  Baseline, Week 6, Week 12, Week 26, End of treatment

• The Value of Fasting Plasma Glucose:Change From Baseline

  Baseline, Week 6, Week 12, Week 26

• The Incidence of Hypoglycaemia at the Cumulative Doses of Inhaled Insulin

  0 month to 12 months

• The Values of Forced Expiratory Volume at 1 Second:Change From Baseline

  Beseline, Week 1, Week 2, Week 6, Week 12, Week 26

Study Arms (3)

B

EXPERIMENTAL

Type 2 Diabetes Mellitus (DM) who has not yet treated by Insulin

Drug: CP-464,005

C

EXPERIMENTAL

Type 2 DM who has already treated by Insulin

Drug: CP-464,005

A

EXPERIMENTAL

Type 1 DM

Drug: CP-464,005

Interventions

CP-464,005 DRUG

Taken for 1 year (52 weeks) immediately before each meal (breakfast, lunch, and supper). Dose: adjusted based on the results of self-monitoring of blood glucose before each meal.

Also known as: Exubera

C

Eligibility Criteria

• Age: 16 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who have been diagnosed with Type 1 or Type 2 diabetes for at least 1 year, based on the diagnostic criteria for diabetes.

You may not qualify if:

• Patients who have smoked during the 6 months prior to screening (smoking shall be prohibited during the term of this study, as well)
• Patients exhibiting pulmonary function test (spirometry) abnormalities (FVC or FEV1 \< 70% of predicted) ) at Week -4.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (10)

Pfizer Investigational Site

Nagoya, Aichi-ken, Japan

Location

Pfizer Investigational Site

Yokohama, Kanagawa, Japan

Location

Pfizer Investigational Site

Kyoto, Kyoto, Japan

Location

Pfizer Investigational Site

Tenri-shi, Nara, Japan

Location

Pfizer Investigational Site

Takatsuki-shi, Oosaka, Japan

Location

Pfizer Investigational Site

Osaka, Osaka, Japan

Location

Pfizer Investigational Site

Bunkyo-ku, Tokyo, Japan

Location

Pfizer Investigational Site

Meguro-ku, Tokyo, Japan

Location

Pfizer Investigational Site

Toyama, Toyama, Japan

Location

Pfizer Investigational Site

Tokyo, Japan

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1; Diabetes Mellitus

Interventions

Exubera

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

As a result of Pfizer's decision (18 Oct 2007) to return the worldwide rights for CP-464,005 (insulin human \[rDNA origin\]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.govCallCenter@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 7, 2007
• First Posted: September 10, 2007
• Study Start: August 1, 2007
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: October 15, 2009
• Results First Posted: October 5, 2009

Record last verified: 2009-07

Locations

JP (10)