Exubera vs Lispro in a Lantus-based Regimen for Improved Glycemic Control in Type 2 Diabetes

Pfizer

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus

Treatments: Drug: Exubera; Drug: Insulin Lispro

Study type: Interventional

Funder types: Industry

Identifiers

NCT00348374

A2171093

Details and patient eligibility

About

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 glycosylated hemoglobin (A1C) levels.

Enrollment: 191 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults with type 2 diabetes using Lantus® (insulin glargine) as their basal insulin, not at glycemic goal.

Exclusion criteria

• lung disease
• current smoking or discontinued smoking within past 6 months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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191 participants in 2 patient groups

Insulin Lispro

Active Comparator group

Description:

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.

Treatment:

Drug: Insulin Lispro

Exubera

Experimental group

Description:

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.

Treatment:

Drug: Exubera