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

Primary Purpose

Diabetes, Diabetes Mellitus, Type 2

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
inhaled human insulin
metformin
glimepiride
inhaled human insulin
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 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

A

B

C

Arm Description

Outcomes

Primary Outcome Measures

HbA1c change from baseline

Secondary Outcome Measures

Adverse events
Body weight
Lung function
Blood glucose
Hypoglycaemia

Full Information

First Posted
May 3, 2007
Last Updated
February 28, 2017
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT00469586
Brief Title
Efficacy and Safety of Inhaled Insulin Compared to Metformin and Glimepiride in Type 2 Diabetes
Acronym
iINHALE 7
Official Title
Efficacy and Safety of Inhaled Prandial Insulin Compared to Metformin Plus Glimepiride 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
April 26, 2007 (Actual)
Primary Completion Date
April 24, 2008 (Actual)
Study Completion Date
April 24, 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, 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).
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
174 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Title
B
Arm Type
Experimental
Arm Title
C
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
inhaled human insulin
Other Intervention Name(s)
NN1998
Intervention Description
Treat-to-target dose titration scheme, pre-prandial, inhalation.
Intervention Type
Drug
Intervention Name(s)
metformin
Intervention Description
Tablets, 2000 mg/day.
Intervention Type
Drug
Intervention Name(s)
glimepiride
Intervention Description
Tablets, 4 mg/day.
Intervention Type
Drug
Intervention Name(s)
inhaled human insulin
Other Intervention Name(s)
NN1998
Intervention Description
Treat-to-target dose titration scheme, post-prandial, inhalation.
Primary Outcome Measure Information:
Title
HbA1c change from baseline
Time Frame
After 18 weeks of treatment
Secondary Outcome Measure Information:
Title
Adverse events
Time Frame
For the duration of the trial
Title
Body weight
Time Frame
after 18 weeks of treatment
Title
Lung function
Time Frame
after 18 weeks of treatment
Title
Blood glucose
Time Frame
after 18 weeks of treatment
Title
Hypoglycaemia
Time Frame
after 18 weeks of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
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
Buenos Aires
ZIP/Postal Code
B1636DSU
Country
Argentina
Facility Name
Novo Nordisk Investigational Site
City
Buenos Aires
ZIP/Postal Code
C1425AGC
Country
Argentina
Facility Name
Novo Nordisk Investigational Site
City
Ciudad de Mendoza
ZIP/Postal Code
5500
Country
Argentina
Facility Name
Novo Nordisk Investigational Site
City
Mar del Plata
ZIP/Postal Code
B7600FZN
Country
Argentina
Facility Name
Novo Nordisk Investigational Site
City
Ebreichsdorf
ZIP/Postal Code
2483
Country
Austria
Facility Name
Novo Nordisk Investigational Site
City
Kittsee
ZIP/Postal Code
A 2421
Country
Austria
Facility Name
Novo Nordisk Investigational Site
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
Novo Nordisk Investigational Site
City
Wien
ZIP/Postal Code
1130
Country
Austria
Facility Name
Novo Nordisk Investigational Site
City
Wien
ZIP/Postal Code
A 1160
Country
Austria
Facility Name
Novo Nordisk Investigational Site
City
Arlon
ZIP/Postal Code
6700
Country
Belgium
Facility Name
Novo Nordisk Investigational Site
City
Bonheiden
ZIP/Postal Code
2820
Country
Belgium
Facility Name
Novo Nordisk Investigational Site
City
Borsbeek
ZIP/Postal Code
2150
Country
Belgium
Facility Name
Novo Nordisk Investigational Site
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Novo Nordisk Investigational Site
City
Huy
ZIP/Postal Code
4500
Country
Belgium
Facility Name
Novo Nordisk Investigational Site
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Novo Nordisk Investigational Site
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
Novo Nordisk Investigational Site
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Facility Name
Novo Nordisk Investigational Site
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5J 3N4
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 3P4
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2Y9
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 2X2
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Smiths Falls
State/Province
Ontario
ZIP/Postal Code
K7A 4W8
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Laval
State/Province
Quebec
ZIP/Postal Code
H7T 2P5
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Mississauga
ZIP/Postal Code
L5M 2V8
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Oshawa
ZIP/Postal Code
L1J 2K1
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Saskatoon
ZIP/Postal Code
S7N 0W8
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Trois-Rivieres
ZIP/Postal Code
G8T 7A1
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Corbeil Essonnes
ZIP/Postal Code
91106
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Nantes
ZIP/Postal Code
44093
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
Paris
ZIP/Postal Code
75877
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Roubaix
ZIP/Postal Code
59100
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Indore
State/Province
Madhya Pradesh
ZIP/Postal Code
452010
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Bangalore
ZIP/Postal Code
560041
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Coimbatore
ZIP/Postal Code
641002
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Hyderabad
ZIP/Postal Code
600034
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Thriruvananthapuram
ZIP/Postal Code
695 032
Country
India
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
Mexico City
State/Province
México, D.F.
ZIP/Postal Code
14000
Country
Mexico
Facility Name
Novo Nordisk Investigational Site
City
Monterrey
State/Province
Nuevo León
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Novo Nordisk Investigational Site
City
Guadalajara
ZIP/Postal Code
44600
Country
Mexico
Facility Name
Novo Nordisk Investigational Site
City
Mexico city
ZIP/Postal Code
03100
Country
Mexico
Facility Name
Novo Nordisk Investigational Site
City
Mexico city
ZIP/Postal Code
11650
Country
Mexico
Facility Name
Novo Nordisk Investigational Site
City
Gdansk
ZIP/Postal Code
80-858
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Lodz
ZIP/Postal Code
90-030
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Lublin
ZIP/Postal Code
20-044
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Lublin
ZIP/Postal Code
20-538
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Mazowieckie
ZIP/Postal Code
09-400
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Rawa Mazowiecka
ZIP/Postal Code
96-200
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Warszawa
ZIP/Postal Code
02-097
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Zabrze
ZIP/Postal Code
41-800
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Istanbul
ZIP/Postal Code
34093
Country
Turkey
Facility Name
Novo Nordisk Investigational Site
City
Istanbul
ZIP/Postal Code
34371
Country
Turkey
Facility Name
Novo Nordisk Investigational Site
City
Istanbul
ZIP/Postal Code
34718
Country
Turkey
Facility Name
Novo Nordisk Investigational Site
City
Konya
ZIP/Postal Code
42001
Country
Turkey

12. IPD Sharing Statement

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

Learn more about this trial

Efficacy and Safety of Inhaled Insulin Compared to Metformin and Glimepiride in Type 2 Diabetes

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