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

Phase 3

Terminated

• Conditions: Diabetes; Diabetes Mellitus, Type 2
• Interventions: Drug: inhaled human insulin; Drug: rosiglitazone; Drug: metformin; Drug: glimepiride

• Registration Number: NCT00427154
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2007-01-10
• Study First Submitted: 2007-01-25
• Study First Submitted QC: 2007-01-25
• Study First Posted: 2007-01-26
• Primary Completion: 2008-03-11
• Study Completion: 2008-03-11
• Status Verified: 2018-09
• Disposition First Submitted: 2018-09-03
• Disposition First Submitted QC: 2018-09-03
• Last Update Submitted: 2018-09-03
• Disposition First Posted: 2018-09-05
• Last Update Posted: 2018-09-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 227

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	metformin	-
A	inhaled human insulin	-
A	glimepiride	-
B	rosiglitazone	-
B	metformin	-
B	glimepiride	-

Primary Outcome Measures

Name	Time	Method
Change in HbA1c	After 26 weeks

Secondary Outcome Measures

Name	Time	Method
Lipid profiles	For the duration of the trial
Change in body weight	For the duration of the trial
Fasting plasma glucose	For the duration of the trial
Hypoglycaemic episodes	For the duration of the trial
Glucose profiles	For the duration of the trial

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇺🇸 Tacoma, Washington, United States