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Safety and Efficacy of Inhaled Insulin in Type 2 Diabetes

Primary Purpose

Diabetes, Diabetes Mellitus, Type 2

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
inhaled human insulin
insulin detemir
insulin aspart
insulin aspart
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Type 2 diabetes Currently treated with insulin Body mass index of (BMI) less than or equal to 40.0 kg/m2 HbA1c less than or equal to 11.0% Exclusion Criteria: Total daily insulin dosage less than or equal to 100 IU or U/day Current smoking or smoking within the last 6 months Cardiac problems Uncontrolled hypertension Current proliferative retinopathy or maculopathy

Sites / Locations

  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
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  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

A

B

C

Arm Description

Outcomes

Primary Outcome Measures

Treatment difference in HbA1c

Secondary Outcome Measures

Adverse events
Blood glucose
Body weight
Lung function
Hypoglycaemia

Full Information

First Posted
May 24, 2006
Last Updated
February 28, 2017
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT00331604
Brief Title
Safety and Efficacy of Inhaled Insulin in Type 2 Diabetes
Official Title
Inhaled Pre-prandial Human Insulin With the AERx® iDMS Versus s.c. Insulin Aspart in Type 2 Diabetes: A 104 Week, Open-label, Multicenter, Randomised, Trial Followed by a 12 Week Re-randomised Extension to Investigate Safety and Efficacy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Terminated
Why Stopped
See termination reason in detailed description
Study Start Date
August 31, 2006 (Actual)
Primary Completion Date
May 5, 2008 (Actual)
Study Completion Date
May 5, 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This trial is conducted in Asia, Europe and South America. The aim of this research is to compare the efficacy (reduction in HbA1c and blood glucose) and pulmonary safety (pulmonary function tests, chest x-rays) of mealtime inhaled insulin with subcutaneous insulin aspart both in combination with insulin detemir in Type 2 Diabetes.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
618 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Title
B
Arm Type
Active Comparator
Arm Title
C
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
inhaled human insulin
Intervention Description
Treat-to-target dose titration scheme, inhalation.
Intervention Type
Drug
Intervention Name(s)
insulin detemir
Other Intervention Name(s)
NN304, Levemir
Intervention Description
Injection s.c., 50% of daily dose.
Intervention Type
Drug
Intervention Name(s)
insulin aspart
Intervention Description
Treat-to-target dose titration scheme, injection s.c.
Intervention Type
Drug
Intervention Name(s)
insulin aspart
Intervention Description
Treat-to-target dose titration scheme, injection s.c. After 2 years.
Primary Outcome Measure Information:
Title
Treatment difference in HbA1c
Time Frame
After 52 weeks
Secondary Outcome Measure Information:
Title
Adverse events
Time Frame
For the duration of the trial
Title
Blood glucose
Time Frame
After 52, 104 and 116 weeks of treatment
Title
Body weight
Time Frame
During treatment
Title
Lung function
Time Frame
After 52, 104 and 116 weeks of treatment
Title
Hypoglycaemia
Time Frame
From 12 weeks of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Type 2 diabetes Currently treated with insulin Body mass index of (BMI) less than or equal to 40.0 kg/m2 HbA1c less than or equal to 11.0% Exclusion Criteria: Total daily insulin dosage less than or equal to 100 IU or U/day Current smoking or smoking within the last 6 months Cardiac problems Uncontrolled hypertension Current proliferative retinopathy or maculopathy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Campinas
ZIP/Postal Code
13083-900
Country
Brazil
Facility Name
Novo Nordisk Investigational Site
City
Higienopolis
ZIP/Postal Code
01244-030
Country
Brazil
Facility Name
Novo Nordisk Investigational Site
City
Porto Alegre
ZIP/Postal Code
90035-170
Country
Brazil
Facility Name
Novo Nordisk Investigational Site
City
Sao Paulo
ZIP/Postal Code
04022-001
Country
Brazil
Facility Name
Novo Nordisk Investigational Site
City
Hillerød
ZIP/Postal Code
3400
Country
Denmark
Facility Name
Novo Nordisk Investigational Site
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark
Facility Name
Novo Nordisk Investigational Site
City
Århus C
ZIP/Postal Code
8000
Country
Denmark
Facility Name
Novo Nordisk Investigational Site
City
Brest
ZIP/Postal Code
29200
Country
France
Facility Name
Novo Nordisk Investigational Site
City
GRENOBLE cedex
ZIP/Postal Code
38043
Country
France
Facility Name
Novo Nordisk Investigational Site
City
LA ROCHELLE cedex
ZIP/Postal Code
17019
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Nanterre
ZIP/Postal Code
92014
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Narbonne
ZIP/Postal Code
11108
Country
France
Facility Name
Novo Nordisk Investigational Site
City
NEVERS cedex
ZIP/Postal Code
58033
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Facility Name
Novo Nordisk Investigational Site
City
TOULOUSE cedex
ZIP/Postal Code
31054
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Bad Harzburg
ZIP/Postal Code
38667
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Bad Kreuznach
ZIP/Postal Code
55545
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Bad Lauterberg
ZIP/Postal Code
37431
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Dresden
ZIP/Postal Code
01219
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Friedrichsthal
ZIP/Postal Code
66299
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Hamburg
ZIP/Postal Code
21073
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Hamburg
ZIP/Postal Code
22607
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Herrenberg
ZIP/Postal Code
71083
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Hohenmölsen
ZIP/Postal Code
06679
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Neumünster
ZIP/Postal Code
24534
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Neuwied
ZIP/Postal Code
56564
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Schkeuditz
ZIP/Postal Code
04435
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Speyer
ZIP/Postal Code
67346
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
St. Ingbert
ZIP/Postal Code
66386
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Völklingen
ZIP/Postal Code
66333
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Warburg
ZIP/Postal Code
34414
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Shatin, New Territories
Country
Hong Kong
Facility Name
Novo Nordisk Investigational Site
City
Beer Sheva
ZIP/Postal Code
84101
Country
Israel
Facility Name
Novo Nordisk Investigational Site
City
Holon
ZIP/Postal Code
58100
Country
Israel
Facility Name
Novo Nordisk Investigational Site
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Novo Nordisk Investigational Site
City
Bari
ZIP/Postal Code
70124
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Catania
ZIP/Postal Code
95122
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Catanzaro
ZIP/Postal Code
88100
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Perugia
ZIP/Postal Code
06126
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Pescara
ZIP/Postal Code
65124
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Pisa
ZIP/Postal Code
56100
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Roma
ZIP/Postal Code
00133
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
San Giovanni Rotondo
ZIP/Postal Code
71013
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Verona
ZIP/Postal Code
37126
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
Facility Name
Novo Nordisk Investigational Site
City
Singapore
ZIP/Postal Code
159964
Country
Singapore
Facility Name
Novo Nordisk Investigational Site
City
Almería
ZIP/Postal Code
04001
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Cáceres
ZIP/Postal Code
10004
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Elche
ZIP/Postal Code
3203
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Granada
ZIP/Postal Code
18012
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Lugo
ZIP/Postal Code
27004
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Mostoles - Madrid -
ZIP/Postal Code
28935
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Sevilla
ZIP/Postal Code
41014
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Valladolid
ZIP/Postal Code
47011
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Xátiva
ZIP/Postal Code
46800
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Taichung City
ZIP/Postal Code
407
Country
Taiwan
Facility Name
Novo Nordisk Investigational Site
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Novo Nordisk Investigational Site
City
Taipei
ZIP/Postal Code
114
Country
Taiwan
Facility Name
Novo Nordisk Investigational Site
City
Aberdeen
ZIP/Postal Code
AB25 1LD
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Ayr
ZIP/Postal Code
KA6 6DX
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Bristol
ZIP/Postal Code
BS10 5NB
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Cosham
ZIP/Postal Code
PO6 3LY
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Edgbaston, Birmingham
ZIP/Postal Code
B15 2TH
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Edinburgh
ZIP/Postal Code
EH16 4SA
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Livingstone
ZIP/Postal Code
EH54 6PP
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Nottingham
ZIP/Postal Code
NG7 2UH
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Plymouth
ZIP/Postal Code
PL6 8BQ
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Salford
ZIP/Postal Code
M6 8HD
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Sheffield
ZIP/Postal Code
S5 7AU
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Wirral, Merseyside
ZIP/Postal Code
CH63 4JY
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk

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Safety and Efficacy of Inhaled Insulin in Type 2 Diabetes

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