Diabetes Mellitus, Type 2 Clinical Trial
Official title:
Efficacy and Safety of Inhaled Pre-prandial Human Insulin Plus Metformin Versus Rosiglitazone Plus Metformin in Type 2 Diabetes
| Verified date | February 2017 |
| Source | Novo Nordisk A/S |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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).
| Status | Terminated |
| Enrollment | 301 |
| Est. completion date | March 5, 2008 |
| Est. primary completion date | March 5, 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 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 |
| Country | Name | City | State |
|---|---|---|---|
| Austria | Novo Nordisk Investigational Site | Ebreichsdorf | |
| Austria | Novo Nordisk Investigational Site | Wien | |
| Austria | Novo Nordisk Investigational Site | Wien | |
| Finland | Novo Nordisk Investigational Site | Joensuu | |
| Finland | Novo Nordisk Investigational Site | Kirkkonummi | |
| Finland | Novo Nordisk Investigational Site | Turku | |
| France | Novo Nordisk Investigational Site | Corbeil Essonnes | |
| France | Novo Nordisk Investigational Site | LA ROCHELLE cedex | |
| France | Novo Nordisk Investigational Site | Mougins | |
| France | Novo Nordisk Investigational Site | Nanterre | |
| France | Novo Nordisk Investigational Site | Narbonne | |
| France | Novo Nordisk Investigational Site | NEVERS cedex | |
| France | Novo Nordisk Investigational Site | Pessac | |
| France | Novo Nordisk Investigational Site | Pointe à Pitre | |
| France | Novo Nordisk Investigational Site | Roubaix | |
| France | Novo Nordisk Investigational Site | Tours | |
| France | Novo Nordisk Investigational Site | Venissieux | |
| Germany | Novo Nordisk Investigational Site | Aschaffenburg | |
| Germany | Novo Nordisk Investigational Site | Augsburg | |
| Germany | Novo Nordisk Investigational Site | Bad Mergentheim | |
| Germany | Novo Nordisk Investigational Site | Berlin | |
| Germany | Novo Nordisk Investigational Site | Darmstadt | |
| Germany | Novo Nordisk Investigational Site | Dormagen | |
| Germany | Novo Nordisk Investigational Site | Dresden | |
| Germany | Novo Nordisk Investigational Site | Duisburg | |
| Germany | Novo Nordisk Investigational Site | Flörsheim | |
| Germany | Novo Nordisk Investigational Site | Frankfurt | |
| Germany | Novo Nordisk Investigational Site | Fulda | |
| Germany | Novo Nordisk Investigational Site | Genthin | |
| Germany | Novo Nordisk Investigational Site | Hermaringen | |
| Germany | Novo Nordisk Investigational Site | Kutenholz-Mulsum | |
| Germany | Novo Nordisk Investigational Site | Münster | |
| Germany | Novo Nordisk Investigational Site | Pirna | |
| Germany | Novo Nordisk Investigational Site | Schkeuditz | |
| Germany | Novo Nordisk Investigational Site | Wangen | |
| Germany | Novo Nordisk Investigational Site | Wiesbaden | |
| Ireland | Novo Nordisk Investigational Site | Dublin | |
| Ireland | Novo Nordisk Investigational Site | Dublin | |
| Ireland | Novo Nordisk Investigational Site | Waterford | |
| Netherlands | Novo Nordisk Investigational Site | Delft | |
| Netherlands | Novo Nordisk Investigational Site | Den Haag | |
| Netherlands | Novo Nordisk Investigational Site | Den Haag | |
| Netherlands | Novo Nordisk Investigational Site | Drachten | |
| Netherlands | Novo Nordisk Investigational Site | Rijswijk | |
| Netherlands | Novo Nordisk Investigational Site | Roelofarendsveen | |
| Netherlands | Novo Nordisk Investigational Site | Vlodrop | |
| Netherlands | Novo Nordisk Investigational Site | Zwijndrecht | |
| Spain | Novo Nordisk Investigational Site | Alcira | |
| Spain | Novo Nordisk Investigational Site | Barcelona | |
| Spain | Novo Nordisk Investigational Site | Gijón | |
| Spain | Novo Nordisk Investigational Site | Majadahonda | |
| Spain | Novo Nordisk Investigational Site | Palma de Mallorca | |
| Spain | Novo Nordisk Investigational Site | Partida de Bacarot | |
| Spain | Novo Nordisk Investigational Site | Pontevedra | |
| Spain | Novo Nordisk Investigational Site | Reus | |
| Spain | Novo Nordisk Investigational Site | San Juan | |
| Spain | Novo Nordisk Investigational Site | Sevilla | |
| Switzerland | Novo Nordisk Investigational Site | Interlaken-Unterseen | |
| Switzerland | Novo Nordisk Investigational Site | Olten | |
| Switzerland | Novo Nordisk Investigational Site | Zürich | |
| United Kingdom | Novo Nordisk Investigational Site | Aberdeen | |
| United Kingdom | Novo Nordisk Investigational Site | Bath | |
| United Kingdom | Novo Nordisk Investigational Site | Belfast | |
| United Kingdom | Novo Nordisk Investigational Site | Birmingham | |
| United Kingdom | Novo Nordisk Investigational Site | Bradford-on-Avon | |
| United Kingdom | Novo Nordisk Investigational Site | Guildford | |
| United Kingdom | Novo Nordisk Investigational Site | Hull | |
| United Kingdom | Novo Nordisk Investigational Site | Northampton | |
| United Kingdom | Novo Nordisk Investigational Site | Salford | |
| United Kingdom | Novo Nordisk Investigational Site | Swansea | |
| United Kingdom | Novo Nordisk Investigational Site | Trowbridge | |
| United Kingdom | Novo Nordisk Investigational Site | Trowbridge | |
| United Kingdom | Novo Nordisk Investigational Site | Wirral, Merseyside | |
| United Kingdom | Novo Nordisk Investigational Site | York |
| Lead Sponsor | Collaborator |
|---|---|
| Novo Nordisk A/S |
Austria, Finland, France, Germany, Ireland, Netherlands, Spain, Switzerland, United Kingdom,
| 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 | For the duration of the trial | ||
| Secondary | Lung function | For the duration of the trial | ||
| Secondary | Blood glucose | For the duration of the trial | ||
| Secondary | Hypoglycaemia | For the duration of the trial |
| 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 | |
| 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 |
NCT04030091 -
Pulsatile Insulin Infusion Therapy in Patients With Type 1 and Type 2 Diabetes Mellitus
|
Phase 4 | |
| 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 |