Effect of Inhaled Pre-prandial Human Insulin on Blood Glucose Control in Type 2 Diabetes
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
227 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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