A Clinical Trial Comparing Efficacy and Safety of Exubera® and Humalog®

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00356421
• Date of registration: 24/07/2006
• Prospective Registration: Yes
• Primary sponsor: Pfizer
• Public title: A Clinical Trial Comparing Efficacy and Safety of Exubera® and Humalog®
• Scientific title: A 52-Week Multicenter, Open-Label, Randomized, Parallel, Two - Arm Study Comparing Exubera® (Inhaled Human Insulin) Vs. Humalog® (Insulin Lispro), Both In Combination With Insulin Glargine In Subjects With Type 1 Diabetes Mellitus
• Date of first enrolment: November 2006
• Target sample size: 58
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT00356421
• Study type: Interventional
• Phase: Phase 4

Countries of recruitment

Austria, Belgium, Denmark, Finland, France, Germany, Ireland, Netherlands, Norway, Portugal, Spain, Sweden, United Kingdom, United States

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion criteria

Inclusion Criteria:

- Diabetes mellitus Type 1

Exclusion Criteria:

- Severe Asthma, severe Chronic Obstructive Pulmonary Disease (COPD)

- Smoking



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Diabetes Mellitus, Type 1

Intervention(s)

Drug: Inhaled Human Insulin (Exubera®)

Drug: Insulin lispro (Humalog)

Primary Outcome(s)

Change From Baseline in Glycosylated Hemoglobin (HbA1c) Percent (%) [Time Frame: At 52 weeks]

Secondary Outcome(s)

Change From Baseline in Fasting Blood Glucose Based on Glucometer Data and In-hospital Assessments [Time Frame: To 52 weeks]

Change From Baseline in Post-prandial Blood Glucose Based on Glucometer Data and In-hospital Assessments [Time Frame: To 52 weeks]

Blood Glucose Values From Baseline Determined by Home-monitored Blood Glucose (Subject Recorded Worksheet Values) [Time Frame: To 52 weeks.]

Change From Baseline in Prandial Insulin Doses [Time Frame: To 52 weeks]

Percentage of Subjects Who Attained HbA1c Levels of <8%, <7%, <6.5%, and >=8% [Time Frame: At 52 weeks]

Change From Baseline in Insulin Antibody Levels [Time Frame: At weeks 24 and 52 or last observation.]

Percentage of Subjects With Absolute Reduction in HbA1c Levels From Baseline of >0.5%, >0.7% and >1.0% [Time Frame: At 52 weeks]

Change From Baseline in Basal Insulin Doses [Time Frame: To 52 weeks]

Change From Baseline in Body Mass Index [Time Frame: At weeks 12, 24, 36, and 52 or last observation.]

Change From Baseline in FPG [Time Frame: At 52 weeks or last observation]

Change From Baseline in Body Weight [Time Frame: At weeks 12, 24, 36, and 52 or last observation.]

Percentage of Subjects Who Attained Target Fasting Plasma Glucose (FPG) Values (4.0 to 6.5 mmol/l; 72 to 117 mg/dl) From Baseline [Time Frame: At weeks 2, 4, 6, 12, 24, 36, and 52 or last observation.]

Change in Fasting Lipids From Baseline [Time Frame: At weeks 24 and 52 or last observation]

Secondary ID(s)

A2171035

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 11/08/2009
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00356421