At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 191 enrolled

Drug / intervention

Insulin Lispro +1 moredrug

Likely dose

Not stated in record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00348374

NCT00348374Phase 3Completed

Compare CT.gov

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

Pfizer·interventional·Posted Jul 4, 2006·Updated Mar 16, 2010

In Brief

A Phase 3 clinical trial evaluating Insulin Lispro and Exubera for Diabetes Mellitus. Completed, enrolled 191 participants across 63 sites in 2 countries.

Detailed Summary

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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsDiabetes Mellitus

CountriesPuerto Rico, United States

Collaborators--

Timeline

Phase 3CompletedFinished

2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartJun 2006

First PostedJul 2006

Primary CompletionAug 2008

TodayJul 2026

First PostedJul 4, 2006

Enrollment StartJun 1, 2006

Primary CompletionAug 1, 2008

TodayJul 2, 2026

Enrollment to primary: 2.2 yearsPosted 20.0 years ago

Interventions

Insulin Lisprodrug

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.

Exuberadrug

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.