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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Inhaled Pre-Prandial Human Insulin Plus Metformin & Glimepiride Versus Rosiglitazone Plus Metformin & Glimepiride on HbA1c in Subjects With Type 2 Diabetes

Conditions
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Diabetes, Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: rosiglitazone
* Drug: inhaled human insulin
* Drug: metformin
* Drug: glimepiride


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br> | Drug: inhaled human insulin<br>* Treat-to-target dose titration scheme, inhalation.<br>* Other names: NN1998;Drug: metformin<br>* Tablets, 2000 mg/day.<br>Drug: glimepiride<br>* Tablets, 8 mg/day.<br>|
| Active Comparator: B<br> | Drug: rosiglitazone<br>* Tablets, 4 mg once or twice daily.<br>Drug: metformin<br>* Tablets, 2000 mg/day.<br>Drug: glimepiride<br>* Tablets, 8 mg/day.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c |  | After 26 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting plasma glucose |  | For the duration of the trial | 
| Lipid profiles |  | For the duration of the trial | 
| Hypoglycaemic episodes |  | For the duration of the trial | 
| Glucose profiles |  | For the duration of the trial | 
| Change in body weight |  | For the duration of the trial |