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Safety and Efficacy 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
glimepiride
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 (BMI) less than or equal to 40.0 kg/m2 HbA1c greater than or equal to 8.0 % and less than or equal to 11.0 % for subjects in OAD monotherapy HbA1c greater than or equal to 7.5 % 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 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
  • 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 Type

Experimental

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
June 22, 2006
Last Updated
February 28, 2017
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT00343980
Brief Title
Safety and Efficacy of Inhaled Pre-prandial Human Insulin in Type 2 Diabetes
Official Title
Safety and Efficacy of Inhaled Pre-prandial Human Insulin Plus Glimepiride Versus Rosiglitazone 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
October 10, 2006 (Actual)
Primary Completion Date
March 10, 2008 (Actual)
Study Completion Date
March 10, 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 Oceania. The aim of this research study is to compare the efficacy of adding inhaled preprandial insulin to glimepiride compared to adding rosiglitazone to glimepiride 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
363 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Title
B
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
rosiglitazone
Intervention Description
Tablets, 4 mg once or twice a day.
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)
glimepiride
Intervention Description
Tablets, 4 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
during treatment
Title
Lung function
Time Frame
after 26 weeks of treatment
Title
Blood glucose
Time Frame
after 26 weeks of treatment
Title
Hypoglycaemia
Time Frame
from 12-26 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 OAD(s) for more than or equal to 2 months Body mass index (BMI) less than or equal to 40.0 kg/m2 HbA1c greater than or equal to 8.0 % and less than or equal to 11.0 % for subjects in OAD monotherapy HbA1c greater than or equal to 7.5 % 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 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
St Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Facility Name
Novo Nordisk Investigational Site
City
Wollongong
State/Province
New South Wales
ZIP/Postal Code
2500
Country
Australia
Facility Name
Novo Nordisk Investigational Site
City
Garran
ZIP/Postal Code
2605
Country
Australia
Facility Name
Novo Nordisk Investigational Site
City
Kingswood
ZIP/Postal Code
2747
Country
Australia
Facility Name
Novo Nordisk Investigational Site
City
Osijek
ZIP/Postal Code
31 000
Country
Croatia
Facility Name
Novo Nordisk Investigational Site
City
Zagreb
ZIP/Postal Code
10 000
Country
Croatia
Facility Name
Novo Nordisk Investigational Site
City
Chennai
State/Province
Tamil Nadu
ZIP/Postal Code
600086
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Vellore
State/Province
Tamil Nadu
ZIP/Postal Code
632004
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Bangalore
ZIP/Postal Code
560010
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Chennai
ZIP/Postal Code
600020
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Coimbatore
ZIP/Postal Code
641002
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Skopje
ZIP/Postal Code
1000
Country
Macedonia, The Former Yugoslav Republic of
Facility Name
Novo Nordisk Investigational Site
City
Cebu City
ZIP/Postal Code
6000
Country
Philippines
Facility Name
Novo Nordisk Investigational Site
City
Makati City
ZIP/Postal Code
1200
Country
Philippines
Facility Name
Novo Nordisk Investigational Site
City
Manila
ZIP/Postal Code
1000
Country
Philippines
Facility Name
Novo Nordisk Investigational Site
City
Moscow
ZIP/Postal Code
119034
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Moscow
ZIP/Postal Code
121356
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Moscow
ZIP/Postal Code
127486
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Moscow
ZIP/Postal Code
127644
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Saint-Petersburg
ZIP/Postal Code
194354
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Saint-Petersburg
ZIP/Postal Code
198013
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Bornova-IZMIR
ZIP/Postal Code
35100
Country
Turkey
Facility Name
Novo Nordisk Investigational Site
City
Bursa
ZIP/Postal Code
16059
Country
Turkey
Facility Name
Novo Nordisk Investigational Site
City
Istanbul
ZIP/Postal Code
34098
Country
Turkey
Facility Name
Novo Nordisk Investigational Site
City
Istanbul
ZIP/Postal Code
34390
Country
Turkey
Facility Name
Novo Nordisk Investigational Site
City
Istanbul
ZIP/Postal Code
34718
Country
Turkey

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 Pre-prandial Human Insulin in Type 2 Diabetes

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