A Clinical Trial Comparing the Efficacy and Safety of Exubera® and Lantus®

NCT00391027 | Completed Phase 4 Results

• 1 other identifier: A2171084
• Study Type: interventional
• Target: 261
• Locations: 10 countries
• Sites: 62

Brief Summary

To compare efficacy and safety of Exubera® vs Lantus® in patients with type 2 diabetes mellitus.

Conditions

Diabetes Mellitus, Type 2

Keywords

type 2 diabetes, insulin, glycemic control

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26

  Change (measured as percent): HbA1c at observation minus HbA1c at baseline. Primary objective to demonstrate non-inferiority of inhaled insulin compared to insulin glargine for glycemic control after 26 weeks of treatment not attainable due to early termination of study; analyses were descriptive and graphical.

  Baseline, Week 26

Secondary Outcomes (18)

• Change From Baseline in HbA1c Prior to Week 26

  Baseline, Week 2, Week 4, Week 8, Week 12, and Week 18

• Number of Subjects With HbA1c < 6.5 %

  Week 26

• Number of Subjects With HbA1c < 7.0 %

  Week 26

• Number of Subjects With HbA1c < 8.0 %

  Week 26

• Change From Baseline in Fasting Plasma Glucose (FPG) Level

  Baseline, Week 26

Study Arms (2)

Insulin Glargine (Lantus®)

ACTIVE COMPARATOR

Drug: Insulin Glargine (Lantus®)

Inhaled Human Insulin (Exubera®)

ACTIVE COMPARATOR

Drug: Inhaled Human Insulin (Exubera®)

Interventions

Insulin Glargine (Lantus®) DRUG

Patient will be randomized to Lantus® while remaining on pre-study oral hypoglycemic agents.

Insulin Glargine (Lantus®)

Inhaled Human Insulin (Exubera®) DRUG

Patient will be randomized inhaled insulin while remaining on pre-study oral hypoglycemic agents.

Inhaled Human Insulin (Exubera®)

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diabetes Mellitus, Type 2 on oral agents
• Age \> 30 years

You may not qualify if:

• Severe Asthma, severe Chronic Obstructive Pulmonary Disease
• Smoking

Sponsors & Collaborators

• Pfizer: lead

Study Sites (62)

Pfizer Investigational Site

Bornem, 2800, Belgium

Location

Pfizer Investigational Site

Brussels, 1070, Belgium

Location

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Genk, 3600, Belgium

Location

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Liège, 4000, Belgium

Location

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Kuopio, 70210, Finland

Location

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Lahti, 15110, Finland

Location

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Oulu, 90100, Finland

Location

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Besançon, 25030, France

Location

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Corbeil-Essonnes, 91106, France

Location

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La Rochelle, 17019, France

Location

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Marseille, 13385, France

Location

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Paris, 75475, France

Location

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Valenciennes, 59300, France

Location

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Altenburg, 04600, Germany

Location

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Eisenach, 99817, Germany

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Hamburg, 20253, Germany

Location

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Hohenmölsen, 06679, Germany

Location

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Leipzig, 04103, Germany

Location

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Neuss, 41460, Germany

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Riesa, 01587, Germany

Location

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Wangen / Allgaeu, 88239, Germany

Location

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's-Hertogenbosch, 5233 VG, Netherlands

Location

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Eindhoven, 5631 BM, Netherlands

Location

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Nijmegen, 6525 EC, Netherlands

Location

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The Hague, 2512 VA, Netherlands

Location

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Venlo, 5912 BL, Netherlands

Location

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Hønefoss, Buskerud, 3505, Norway

Location

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Bergen, 5012, Norway

Location

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Jessheim, 2050, Norway

Location

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Lysaker, Norway

Location

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Skedsmokorset, N-2020, Norway

Location

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Lodz, 90-030, Poland

Location

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Lodz, 93-338, Poland

Location

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Lublin, 20-536, Poland

Location

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Warsaw, 02-097, Poland

Location

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Łask, 98-100, Poland

Location

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A Coruña, A Coruña, 15006, Spain

Location

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Palma de Mallorca, Balearic Islands, 07014, Spain

Location

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Huelva, Huelva, 21080, Spain

Location

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Málaga, Malaga, 29006, Spain

Location

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Inca, Mallorca, 07300, Spain

Location

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San Cristóbal de La Laguna, Santa Cruz de Tenerife, 38320, Spain

Location

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Alzira, Valencia, 46600, Spain

Location

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Valencia, Valencia, 46015, Spain

Location

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Borås, 501 82, Sweden

Location

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Eksjö, 575 36, Sweden

Location

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Gothenburg, 412 55, Sweden

Location

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Gothenburg, 41665, Sweden

Location

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Härnösand, 871 82, Sweden

Location

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Helsingborg, 25220, Sweden

Location

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Järfälla, 177 31, Sweden

Location

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Kristianstad, 291 54, Sweden

Location

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Linköping, 581 85, Sweden

Location

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Luleå, 972 33, Sweden

Location

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Malmo, 211 52, Sweden

Location

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Motala, 591 85, Sweden

Location

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Stockholm, 118 83, Sweden

Location

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Uddevalla, 451 50, Sweden

Location

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Umeå, 901 85, Sweden

Location

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Vaxjo, 351 85, Sweden

Location

Pfizer Investigational Site

Bruderholz, 4101, Switzerland

Location

Pfizer Investigational Site

Sankt Gallen, CH-9007, Switzerland

Location

Related Links

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

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Insulin Resistance

Interventions

Insulin Glargine; Exubera

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Limitations and Caveats

Enrollment period concluded earlier than planned due to cancellation of Exubera® program by sponsor; enrollment was undersized to meet requirements of its inferential objectives. Revised analysis approach was descriptive with no inferential analyses.

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 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2006
• First Posted: October 23, 2006
• Study Start: December 1, 2006
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: July 23, 2015
• Results First Posted: October 21, 2009

Record last verified: 2015-06

Locations

ES (8); FI (3); FR (6); SE (16); CH (2); BE (4); DE (8); PL (5); NL (5); NO (5)