Efficacy and Safety of Inhaled Insulin Compared to Metformin and Glimepiride in Type 2 Diabetes (iINHALE 7)

Novo Nordisk

Status and phase: Terminated; Phase 3

Conditions: Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: inhaled human insulin; Drug: metformin; Drug: glimepiride

Study type: Interventional

Funder types: Industry

Identifiers

NCT00469586

NN1998-1787

2006-004623-12 (EudraCT Number)

Details and patient eligibility

About

This trial is conducted in Europe, Asia, North America and South America. The aim of this research trial is to compare the efficacy of inhaled insulin to glimepiride and metformin combination therapy in treatment of subjects with type 2 diabetes and to verify the safety of use (hypoglycaemia, pulmonary function, body weight, insulin antibodies and side effects).

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: 174 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 2 diabetes
• Treated with OADs for more than or equal to 3 months
• HbA1c greater than or equal to 8.0% and less than or equal to 11.0%
• Body Mass Index (BMI) less than or equal to 40.0 kg/m2

Exclusion criteria

• Recurrent major hypoglycaemia
• Current smoking or smoking within the last 6 months
• Impaired hepatic or renal function
• Cardiac problems
• Uncontrolled hypertension
• Proliferative retinopathy or maculopathy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

174 participants in 3 patient groups

A

Experimental group

Treatment:

Drug: inhaled human insulin

Drug: inhaled human insulin

B

Experimental group

Treatment:

Drug: inhaled human insulin

Drug: inhaled human insulin

C

Active Comparator group

Treatment:

Drug: metformin

Drug: glimepiride