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

Primary Purpose

Diabetes, Diabetes Mellitus, Type 2

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
rosiglitazone
inhaled human insulin
metformin
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 - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
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Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

A

B

Arm Description

Outcomes

Primary Outcome Measures

Treatment difference in HbA1c

Secondary Outcome Measures

Adverse events
Body weight
Lung function
Blood glucose
Hypoglycaemia

Full Information

First Posted
July 5, 2006
Last Updated
February 28, 2017
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT00348712
Brief Title
Efficacy and Safety of Inhaled Pre-prandial Human Insulin in Type 2 Diabetes
Official Title
Efficacy and Safety of Inhaled Pre-prandial Human Insulin Plus Metformin Versus Rosiglitazone Plus Metformin in Type 2 Diabetes
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
October 30, 2006 (Actual)
Primary Completion Date
March 5, 2008 (Actual)
Study Completion Date
March 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 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.

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
301 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Arm Title
B
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
rosiglitazone
Intervention Description
Tablets, 4 mg once or twice daily.
Intervention Type
Drug
Intervention Name(s)
inhaled human insulin
Other Intervention Name(s)
NN1998
Intervention Description
Treat-to-target dose titration scheme, inhalation.
Intervention Type
Drug
Intervention Name(s)
metformin
Intervention Description
Tablets, 2000 mg/day.
Primary Outcome Measure Information:
Title
Treatment difference in HbA1c
Time Frame
After 26 weeks
Secondary Outcome Measure Information:
Title
Adverse events
Time Frame
For the duration of the trial
Title
Body weight
Time Frame
For the duration of the trial
Title
Lung function
Time Frame
For the duration of the trial
Title
Blood glucose
Time Frame
For the duration of the trial
Title
Hypoglycaemia
Time Frame
For the duration of the trial

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
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
Ebreichsdorf
ZIP/Postal Code
2483
Country
Austria
Facility Name
Novo Nordisk Investigational Site
City
Wien
ZIP/Postal Code
1030
Country
Austria
Facility Name
Novo Nordisk Investigational Site
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Novo Nordisk Investigational Site
City
Joensuu
ZIP/Postal Code
80130
Country
Finland
Facility Name
Novo Nordisk Investigational Site
City
Kirkkonummi
ZIP/Postal Code
02400
Country
Finland
Facility Name
Novo Nordisk Investigational Site
City
Turku
ZIP/Postal Code
FI-20520
Country
Finland
Facility Name
Novo Nordisk Investigational Site
City
Corbeil Essonnes
ZIP/Postal Code
91106
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
Mougins
ZIP/Postal Code
06250
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
Pessac
ZIP/Postal Code
33600
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Pointe à Pitre
ZIP/Postal Code
97159
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Roubaix
ZIP/Postal Code
59100
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Tours
ZIP/Postal Code
37044
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Venissieux
ZIP/Postal Code
69200
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Aschaffenburg
ZIP/Postal Code
63739
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Augsburg
ZIP/Postal Code
86150
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Bad Mergentheim
ZIP/Postal Code
97980
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Berlin
ZIP/Postal Code
13355
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Darmstadt
ZIP/Postal Code
64283
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Dormagen
ZIP/Postal Code
41539
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Duisburg
ZIP/Postal Code
47051
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Flörsheim
ZIP/Postal Code
65439
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Fulda
ZIP/Postal Code
36037
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Genthin
ZIP/Postal Code
39307
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Hermaringen
ZIP/Postal Code
89568
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Kutenholz-Mulsum
ZIP/Postal Code
27449
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Münster
ZIP/Postal Code
48145
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Pirna
ZIP/Postal Code
01796
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Schkeuditz
ZIP/Postal Code
04435
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Wangen
ZIP/Postal Code
88239
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Wiesbaden
ZIP/Postal Code
65191
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Dublin
ZIP/Postal Code
DUBLIN 7
Country
Ireland
Facility Name
Novo Nordisk Investigational Site
City
Dublin
ZIP/Postal Code
DUBLIN 8
Country
Ireland
Facility Name
Novo Nordisk Investigational Site
City
Waterford
Country
Ireland
Facility Name
Novo Nordisk Investigational Site
City
Delft
ZIP/Postal Code
2625 AD
Country
Netherlands
Facility Name
Novo Nordisk Investigational Site
City
Den Haag
ZIP/Postal Code
2582 LJ
Country
Netherlands
Facility Name
Novo Nordisk Investigational Site
City
Den Haag
ZIP/Postal Code
2597 AX
Country
Netherlands
Facility Name
Novo Nordisk Investigational Site
City
Drachten
ZIP/Postal Code
9202 NN
Country
Netherlands
Facility Name
Novo Nordisk Investigational Site
City
Rijswijk
ZIP/Postal Code
2281 AK
Country
Netherlands
Facility Name
Novo Nordisk Investigational Site
City
Roelofarendsveen
ZIP/Postal Code
2371 RB
Country
Netherlands
Facility Name
Novo Nordisk Investigational Site
City
Vlodrop
ZIP/Postal Code
6063 DA
Country
Netherlands
Facility Name
Novo Nordisk Investigational Site
City
Zwijndrecht
ZIP/Postal Code
3331 LZ
Country
Netherlands
Facility Name
Novo Nordisk Investigational Site
City
Alcira
ZIP/Postal Code
46600
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Gijón
ZIP/Postal Code
33206
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Majadahonda
ZIP/Postal Code
28222
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Palma de Mallorca
ZIP/Postal Code
07010
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Partida de Bacarot
ZIP/Postal Code
03114
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Pontevedra
ZIP/Postal Code
36071
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Reus
ZIP/Postal Code
43201
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
San Juan
ZIP/Postal Code
03550
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Interlaken-Unterseen
ZIP/Postal Code
3800
Country
Switzerland
Facility Name
Novo Nordisk Investigational Site
City
Olten
ZIP/Postal Code
4600
Country
Switzerland
Facility Name
Novo Nordisk Investigational Site
City
Zürich
ZIP/Postal Code
8032
Country
Switzerland
Facility Name
Novo Nordisk Investigational Site
City
Aberdeen
ZIP/Postal Code
AB25 1LD
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Bath
ZIP/Postal Code
BA1 2SR
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Belfast
ZIP/Postal Code
BT12 6BA
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Birmingham
ZIP/Postal Code
B9 5SS
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Bradford-on-Avon
ZIP/Postal Code
BA15 1DQ
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Guildford
ZIP/Postal Code
GU2 7XX
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Hull
ZIP/Postal Code
HU3 2JZ
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Northampton
ZIP/Postal Code
NN1 5BD
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
Swansea
ZIP/Postal Code
SA6 6NL
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Trowbridge
ZIP/Postal Code
BA14 8QA
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Trowbridge
ZIP/Postal Code
BA14 9AR
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Wirral, Merseyside
ZIP/Postal Code
CH63 4JY
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
York
ZIP/Postal Code
YO3 7HE
Country
United Kingdom

12. IPD Sharing Statement

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

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

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