Efficacy and Safety of Inhaled Pre-prandial Human Insulin in Type 2 Diabetes

Overview[ - collapse ][ - ]

Purpose This trial is conducted in Europe. The aim of this research study is to compare the efficacy of adding inhaled preprandial insulin to metformin compared to adding rosiglitazone to metformin for the treatment of type 2 diabetes and to verify its safety (hypoglycaemia, pulmonary function, body weight, insulin antibodies and side effects).
ConditionDiabetes
Diabetes Mellitus, Type 2
InterventionDrug: rosiglitazone
Drug: inhaled human insulin
Drug: metformin
PhasePhase 3
SponsorNovo Nordisk A/S
Responsible PartyNovo Nordisk A/S
ClinicalTrials.gov IdentifierNCT00348712
First ReceivedJuly 5, 2006
Last UpdatedJuly 9, 2012
Last verifiedJuly 2012

Tracking Information[ + expand ][ + ]

First Received DateJuly 5, 2006
Last Updated DateJuly 9, 2012
Start DateOctober 2006
Estimated Primary Completion DateMarch 2008
Current Primary Outcome MeasuresTreatment difference in HbA1c [Time Frame: After 26 weeks] [Designated as safety issue: No]
Current Secondary Outcome Measures
  • Adverse events [Time Frame: For the duration of the trial] [Designated as safety issue: No]
  • Body weight [Time Frame: For the duration of the trial] [Designated as safety issue: No]
  • Lung function [Time Frame: For the duration of the trial] [Designated as safety issue: No]
  • Blood glucose [Time Frame: For the duration of the trial] [Designated as safety issue: No]
  • Hypoglycaemia [Time Frame: For the duration of the trial] [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief TitleEfficacy and Safety of Inhaled Pre-prandial Human Insulin in Type 2 Diabetes
Official TitleEfficacy and Safety of Inhaled Pre-prandial Human Insulin Plus Metformin Versus Rosiglitazone Plus Metformin in Type 2 Diabetes
Brief Summary
This trial is conducted in Europe.

The aim of this research study is to compare the efficacy of adding inhaled preprandial
insulin to metformin compared to adding rosiglitazone to metformin for the treatment of type
2 diabetes and to verify its safety (hypoglycaemia, pulmonary function, body weight, insulin
antibodies and side effects).
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 TypeInterventional
Study PhasePhase 3
Study DesignAllocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition
  • Diabetes
  • Diabetes Mellitus, Type 2
InterventionDrug: rosiglitazone
Tablets, 4 mg once or twice daily.
Drug: inhaled human insulin
Treat-to-target dose titration scheme, inhalation.
Other Names:
NN1998Drug: metformin
Tablets, 2000 mg/day.
Study Arm (s)
  • Active Comparator: A
  • Active Comparator: B

Recruitment Information[ + expand ][ + ]

Recruitment StatusTerminated
Estimated Enrollment301
Estimated Completion DateMarch 2008
Estimated Primary Completion DateMarch 2008
Eligibility Criteria
Inclusion Criteria:

- Type 2 diabetes

- Treated with OAD(s) for more than or equal to 2 months

- Body mass index of (BMI) less than or equal to 40.0 kg/m2

- HbA1c greater than or equal to 7.5% and less than or equal to 11.0 % for subjects in
OAD monotherapy and HbA1c greater than or equal to 7.0% and less than or equal to
10.0 % for subjects on OAD combination therapy

Exclusion Criteria:

- Recurrent major hypoglycaemia

- Current smoking or smoking within the last 6 months

- Impaired hepatic or renal function

- Cardiac disorders

- Uncontrolled hypertension

- Proliferative retinopathy or maculopathy
GenderBoth
Ages18 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesAustria, Finland, France, Germany, Ireland, Netherlands, Spain, Switzerland, United Kingdom

Administrative Information[ + expand ][ + ]

NCT Number NCT00348712
Other Study ID NumbersNN1998-1390
Has Data Monitoring CommitteeNo
Information Provided ByNovo Nordisk A/S
Study SponsorNovo Nordisk A/S
CollaboratorsNot Provided
Investigators Study Director: Gitte S. Fuchs, BSc Novo Nordisk A/S
Verification DateJuly 2012

Locations[ + expand ][ + ]

Austria
Vienna, Austria
Finland
Turku, Finland
France
Paris, France
Germany
Flörsheim, Germany
Ireland
Dublin, Ireland
Netherlands
Den Haag, Netherlands
Spain
San Juan de Alicante (Alicante), Spain
Switzerland
Zürich, Switzerland
United Kingdom
Swansea, United Kingdom