Effect of Inhaled Insulin (AERx® iDMS) on Blood Glucose Control in Type 2 Diabetes

Phase 3TerminatedNCT00411892

Novo Nordisk A/S196 enrolled

Overview

This trial is conducted in the United States of America (USA). This trial will compare the changes in HbA1c after 26 weeks of inhaled insulin and pioglitazone combination therapy versus pioglitazone treatment alone.

The decision to discontinue the development of AERx® is not due to any safety concerns. An analysis concluded that fast-acting inhaled insulin in the form it is known today, is unlikely to offer significant clinical or convenience benefits over injections of modern insulin with pen devices.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

196

Conditions

Diabetes Diabetes Mellitus, Type 2

Interventions

pioglitazoneDRUG

Tablets, 45 mg/day.

inhaled human insulinDRUG

Treat-to-target dose titration scheme, inhalation.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Type 2 diabetes * Current treatment with oral antidiabetes drugs (OADs) for at least 2 months * HbA1c between 7.0-11.0% if on OAD monotherapy * HbA1c between 7.0-10.0% if on OAD combination therapy * BMI less than or equal to 40 kg/m2 Exclusion Criteria: * Current regular smoking or regular smoking within the last 6 months * Current acute or chronic pulmonary disease (except for asthma) * Proliferative retinopathy requiring treatment * Clinically significant disease history including kidney or liver disease, or heart disease which limits physical activity or results in discomfort with physical activity * Pregnancy

Locations (110)

Outcomes

Primary Outcomes

HbA1c change from baseline

Time frame: After 26 weeks of treatment

Secondary Outcomes

Fasting plasma glucose

Time frame: after 26 weeks of treatment

Lipid profiles

Time frame: after 26 weeks of treatment

Frequency of hypoglycaemic episodes

Time frame: after 26 weeks of treatment

Glucose profiles

Time frame: at pre- and post meals, bedtime and 3:00 am

Change in body weight

Time frame: after 26 weeks of treatment

Data from ClinicalTrials.gov

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