Clinical Trials Logo
  1. Home
  2. Diabetes Mellitus, Type 2
  3. NCT00343980
  4. Details
NCT00343980 Clinical Trial

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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:
Safety and Efficacy of Inhaled Pre-prandial Human Insulin Plus Glimepiride Versus Rosiglitazone Plus Glimepiride in Type 2 Diabetes

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00343980
Other study ID # NN1998-1682
Secondary ID
Status Terminated
Phase Phase 3
First received June 22, 2006
Last updated February 28, 2017
Start date October 10, 2006
Est. completion date March 10, 2008

Study information
Verified date February 2017
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility
Status Terminated
Enrollment 363
Est. completion date March 10, 2008
Est. primary completion date March 10, 2008
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• rosiglitazone
Tablets, 4 mg once or twice a day.
• inhaled human insulin
Treat-to-target dose titration scheme, pre-prandial, inhalation.
• glimepiride
Tablets, 4 mg/day.

Locations
Country Name City State
Australia Novo Nordisk Investigational Site Garran
Australia Novo Nordisk Investigational Site Kingswood
Australia Novo Nordisk Investigational Site St Leonards New South Wales
Australia Novo Nordisk Investigational Site Wollongong New South Wales
Croatia Novo Nordisk Investigational Site Osijek
Croatia Novo Nordisk Investigational Site Zagreb
India Novo Nordisk Investigational Site Bangalore
India Novo Nordisk Investigational Site Chennai
India Novo Nordisk Investigational Site Chennai Tamil Nadu
India Novo Nordisk Investigational Site Coimbatore
India Novo Nordisk Investigational Site Vellore Tamil Nadu
Macedonia, The Former Yugoslav Republic of Novo Nordisk Investigational Site Skopje
Philippines Novo Nordisk Investigational Site Cebu City
Philippines Novo Nordisk Investigational Site Makati City
Philippines Novo Nordisk Investigational Site Manila
Russian Federation Novo Nordisk Investigational Site Moscow
Russian Federation Novo Nordisk Investigational Site Moscow
Russian Federation Novo Nordisk Investigational Site Moscow
Russian Federation Novo Nordisk Investigational Site Moscow
Russian Federation Novo Nordisk Investigational Site Saint-Petersburg
Russian Federation Novo Nordisk Investigational Site Saint-Petersburg
Turkey Novo Nordisk Investigational Site Bornova-IZMIR
Turkey Novo Nordisk Investigational Site Bursa
Turkey Novo Nordisk Investigational Site Istanbul
Turkey Novo Nordisk Investigational Site Istanbul
Turkey Novo Nordisk Investigational Site Istanbul

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

Australia,  Croatia,  India,  Macedonia, The Former Yugoslav Republic of,  Philippines,  Russian Federation,  Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary Treatment difference in HbA1c After 26 weeks
Secondary Adverse events For the duration of the trial
Secondary Body weight during treatment
Secondary Lung function after 26 weeks of treatment
Secondary Blood glucose after 26 weeks of treatment
Secondary Hypoglycaemia from 12-26 weeks of treatment
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05666479 - CGM Monitoring in T2DM Patients Undergoing Orthopaedic Replacement Surgery
Completed NCT05647083 - The Effect of Massage on Diabetic Parameters N/A
Active, not recruiting NCT05661799 - Persistence of Physical Activity in People With Type 2 Diabetes Over Time. N/A
Completed NCT03686722 - Effect of Co-administration of Metformin and Daclatasvir on the Pharmacokinetis and Pharmacodynamics of Metformin Phase 1
Completed NCT02836704 - Comparison of Standard vs Higher Starting Dose of Insulin Glargine in Chinese Patients With Type 2 Diabetes (Glargine Starting Dose) Phase 4
Completed NCT01819129 - Efficacy and Safety of FIAsp Compared to Insulin Aspart in Combination With Insulin Glargine and Metformin in Adults With Type 2 Diabetes Phase 3
Completed NCT04562714 - Impact of Flash Glucose Monitoring in People With Type 2 Diabetes Using Non-Insulin Antihyperglycemic Therapy N/A
Completed NCT02009488 - Treatment Differences Between Canagliflozin and Placebo in Insulin Secretion in Subjects With Type 2 Diabetes Mellitus (T2DM) Phase 1
Completed NCT05896319 - Hyaluronic Acid Treatment of the Post-extraction Tooth Socket Healing in Subjects With Diabetes Mellitus Type 2 N/A
Recruiting NCT05598203 - Effect of Nutrition Education Groups in the Treatment of Patients With Type 2 Diabetes N/A
Completed NCT05046873 - A Research Study Looking Into Blood Levels of Semaglutide and NNC0480-0389 When Given in the Same Injection or in Two Separate Injections in Healthy People Phase 1
Completed NCT04030091 - Pulsatile Insulin Infusion Therapy in Patients With Type 1 and Type 2 Diabetes Mellitus Phase 4
Terminated NCT04090242 - Impact of App Based Diabetes Training Program in Conjunction With the BD Nano Pen Needle in People With T2 Diabetes N/A
Completed NCT03604224 - A Study to Observe Clinical Effectiveness of Canagliflozin 300 mg Containing Treatment Regimens in Indian Type 2 Diabetes Participants With BMI>25 kg/m^2, in Real World Clinical Setting
Completed NCT03620357 - Continuous Glucose Monitoring & Management In Type 2 Diabetes (T2D) N/A
Completed NCT01696266 - An International Survey on Hypoglycaemia Among Insulin-treated Patients With Diabetes
Completed NCT03620890 - Detemir Versus NPH for Type 2 Diabetes Mellitus in Pregnancy Phase 4
Withdrawn NCT05473286 - A Research Study Looking at How Oral Semaglutide Works in People With Type 2 Diabetes in Germany, as Part of Local Clinical Practice
Not yet recruiting NCT05029804 - Effect of Walking Exercise Training on Adherence to Disease Management and Metabolic Control in Diabetes N/A
Completed NCT04531631 - Effects of Dorzagliatin on 1st Phase Insulin and Beta-cell Glucose Sensitivity in T2D and Monogenic Diabetes Phase 2

External Links