Effect of Inhaled Pre-prandial Human Insulin on Blood Glucose Control in Type 2 Diabetes

Phase 3TerminatedNCT00427154

Novo Nordisk A/S227 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 or rosiglitazone treatment, both in combination with metformin and glimepiride.

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

227

Conditions

Diabetes Diabetes Mellitus, Type 2

Interventions

rosiglitazoneDRUG

Tablets, 4 mg once or twice daily.

inhaled human insulinDRUG

Treat-to-target dose titration scheme, inhalation.

metforminDRUG

Tablets, 2000 mg/day.

glimepiride

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Type 2 diabetes * Currently treated with antidiabetes drugs (including Exenatide) for at least 2 months * HbA1c between 7.5 and 11.0% (both inclusive) on antidiabetes combination therapy * BMI less than or equal to 40 kg/m2 Exclusion Criteria: * Current smoking or smoking within the last 6 months * Current acute or chronic pulmonary disease (except for asthma) * Proliferative retinopathy requiring acute treatment * Clinically significant disease history including kidney or liver disease * Heart disease which limits physical activity or results in discomfort with physical activity * Pregnancy

Locations (103)

Outcomes

Primary Outcomes

Change in HbA1c

Time frame: After 26 weeks

Secondary Outcomes

Fasting plasma glucose

Time frame: For the duration of the trial

Lipid profiles

Time frame: For the duration of the trial

Hypoglycaemic episodes

Time frame: For the duration of the trial

Glucose profiles

Time frame: For the duration of the trial

Change in body weight

Time frame: For the duration of the trial

Data from ClinicalTrials.gov

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