Exubera vs Lispro in a Lantus-Based Regimen for Improved Glycemic Control in Type 2 Diabetes - Full Text View

Purpose

The current trial will examine the efficacy and safety of Exubera administered as a mealtime insulin compared to lispro, when added to an existing regimen of basal insulin glargine + or = Oral Agents (OAs). Dose titrations will be provided which should allow a large proportion of subjects to reach target A1C levels.

Condition	Intervention	Phase
Diabetes Mellitus	Drug: Exubera Drug: Lispro	Phase IV

MedlinePlus related topics:

Diabetes

ChemIDplus related topics:

Insulin Insulin glargine Dextrose Insulin lispro

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Official Title:	A Phase 3b, Randomized, Open-Label, Parallel Group, Multicenter Trial Assessing The Efficacy Of Exubera Vs. Lispro Introduced Into A Lantus Based Regimen In Suboptimally Controlled Patients With Type 2 Diabetes Mellitus

Further study details as provided by Pfizer:

Primary Outcome Measures:

The change in A1C from baseline to Week 24 [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from baseline in fasting and postprandial plasma glucose, lipids, and markers of CV risk as determined by standardized meal tolerance tests performed at Week 12 and Week 24* [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Change in A1C from baseline at each visit [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Percent of subjects that attain an A1C < 7.0%, < 6.5% and < 6.0% at Week 24 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Percent of subjects that attain A1C targets of <7%, < 6.5%, [ Time Frame: 6 months ] [ Designated as safety issue: No ]
< 6.0% at Week 24 without an episode of severe hypoglycemia [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Change from baseline in fasting and 2-hour postprandial glucose at each Visit as determined by 8-point self-monitored blood glucose profiles [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Change from baseline in weight at each Visit [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Change from baseline in fasting plasma lipids at Weeks 12 and 24 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Change from baseline in insulin glargine dose at each Visit (office and/or phone) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Change in baseline prandial insulin dose (at each meal) at each Visit [ Time Frame: 6 months ] [ Designated as safety issue: No ]
The prevalence and severity of hypoglycemia [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Change from baseline in patient treatment satisfaction (as assessed by Patient Satisfaction of Insulin Treatment [PSIT] Questionnaire) at Week 4 and 24 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Change in patient treatment satisfaction (as assessed by PSIT Questionnaire) from Week 4 to Week 24 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Change from baseline in 24-hour mean glucose values, and glycemic variability measured by CGMS* [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment:	450
Study Start Date:	June 2006
Study Completion Date:	July 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Lispro: Active Comparator Weight based initiation dose, and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to insulin glargine and oral agents.	Drug: Lispro Weight based initiation dose, and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to insulin glargine and oral agents.
Exubera: Experimental Weight based initiation dose, and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to insulin glargine and oral agents.	Drug: Exubera Weight based initiation dose, and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to insulin glargine and oral agents.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Adults with type 2 diabetes on basal insulinLantus, not at glycemic goal

Exclusion Criteria:

lung disease
current smoking or discontinued smoking within past 6 months

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00348374

Show 63 Study Locations

Sponsors and Collaborators

Pfizer

Investigators


Study Director:	Pfizer CT.gov Call Center	Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A2171093
First Received:	June 30, 2006
Last Updated:	August 19, 2008
ClinicalTrials.gov Identifier:	NCT00348374
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

type two diabetes, insulin, HbA1c

Study placed in the following topic categories:

Metabolic Diseases

Diabetes Mellitus, Type 2

Glargine

Diabetes Mellitus

Insulin LISPRO

Endocrine System Diseases

Endocrinopathy

Metabolic disorder

Glucose Metabolism Disorders

Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents

Physiological Effects of Drugs

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 10, 2008

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00348374