Diabetes Clinical Trial
Official title:
A Multi-centre, Multinational, Open-labelled, Randomised, Parallel-Group Comparison of Insulin Detemir Plus Insulin Aspart With NPH Insulin Plus Human Soluble Insulin in Subjects With Type 1 Diabetes on a Basal-Bolus Regimen
| Verified date | January 2017 |
| Source | Novo Nordisk A/S |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This trial is conducted in Europe and South America. The aim of this trial is to compare the glycaemic control of insulin detemir plus insulin aspart with that of insulin NPH plus human soluble insulin in subjects with type 1 diabetes on a basal/bolus regimen.
| Status | Completed |
| Enrollment | 598 |
| Est. completion date | October 2002 |
| Est. primary completion date | October 2002 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Type 1 diabetes for at least 12 months - Current treatment with any basal/bolus regimen or any biphasic insulin treatment for at least 6 months - BMI below or equal to 35 kg/m^2 - HbA1c below or equal to 12% Exclusion Criteria: - Proliferative retinopathy or maculopathy requiring acute treatment - Recurrent major hypoglycaemia that may interfere with trial participation (as judged by the Investigator) - Subjects with known hypoglycaemic unawareness as judged by the Investigator |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Novo Nordisk Investigational Site | Junin | |
| Argentina | Novo Nordisk Investigational Site | Moron | |
| Croatia | Novo Nordisk Investigational Site | Varazdin | |
| Czech Republic | Novo Nordisk Investigational Site | Hradec Kralove | |
| Czech Republic | Novo Nordisk Investigational Site | Liberec | |
| Czech Republic | Novo Nordisk Investigational Site | Plzen - Lochotin | |
| Czech Republic | Novo Nordisk Investigational Site | Praha 10 | |
| Czech Republic | Novo Nordisk Investigational Site | Praha 2 | |
| Czech Republic | Novo Nordisk Investigational Site | Praha 4 | |
| Czech Republic | Novo Nordisk Investigational Site | Praha 5 | |
| Denmark | Novo Nordisk Investigational Site | Århus C | |
| Denmark | Novo Nordisk Investigational Site | Hillerød | |
| Denmark | Novo Nordisk Investigational Site | Hjørring | |
| Denmark | Novo Nordisk Investigational Site | Holbæk | |
| Denmark | Novo Nordisk Investigational Site | København | |
| Denmark | Novo Nordisk Investigational Site | Køge | |
| Denmark | Novo Nordisk Investigational Site | Silkeborg | |
| Denmark | Novo Nordisk Investigational Site | Slagelse | |
| Denmark | Novo Nordisk Investigational Site | Svendborg | |
| Finland | Novo Nordisk Investigational Site | Kemi | |
| Finland | Novo Nordisk Investigational Site | Kokkola | |
| Finland | Novo Nordisk Investigational Site | Kuopio | |
| Finland | Novo Nordisk Investigational Site | Oulu | |
| Finland | Novo Nordisk Investigational Site | Pärnu | |
| Finland | Novo Nordisk Investigational Site | Rovaniemi | |
| Finland | Novo Nordisk Investigational Site | Viljandi | |
| France | Novo Nordisk Investigational Site | Angers | |
| France | Novo Nordisk Investigational Site | GRENOBLE cedex | |
| France | Novo Nordisk Investigational Site | Lille | |
| France | Novo Nordisk Investigational Site | Lorient | |
| France | Novo Nordisk Investigational Site | MONTPELLIER cedex 5 | |
| France | Novo Nordisk Investigational Site | Mougins | |
| France | Novo Nordisk Investigational Site | Narbonne | |
| France | Novo Nordisk Investigational Site | Paris | |
| France | Novo Nordisk Investigational Site | Paris | |
| France | Novo Nordisk Investigational Site | Paris Cedex 10 | |
| France | Novo Nordisk Investigational Site | Poitiers | |
| Greece | Novo Nordisk Investigational Site | Athens | |
| Greece | Novo Nordisk Investigational Site | Athens | |
| Greece | Novo Nordisk Investigational Site | Athens | |
| Italy | Novo Nordisk Investigational Site | Alessandria | |
| Italy | Novo Nordisk Investigational Site | Asti | |
| Italy | Novo Nordisk Investigational Site | Bari | |
| Italy | Novo Nordisk Investigational Site | Bergamo | |
| Italy | Novo Nordisk Investigational Site | Catania | |
| Italy | Novo Nordisk Investigational Site | Catania | |
| Italy | Novo Nordisk Investigational Site | Genova | |
| Italy | Novo Nordisk Investigational Site | Lucca | |
| Italy | Novo Nordisk Investigational Site | Milano | |
| Italy | Novo Nordisk Investigational Site | Padova | |
| Italy | Novo Nordisk Investigational Site | Prato | |
| Italy | Novo Nordisk Investigational Site | Ravenna | |
| Italy | Novo Nordisk Investigational Site | Roma | |
| Italy | Novo Nordisk Investigational Site | Torino | |
| Macedonia, The Former Yugoslav Republic of | Novo Nordisk Investigational Site | Skopje | |
| Norway | Novo Nordisk Investigational Site | Arendal | |
| Norway | Novo Nordisk Investigational Site | Gjettum | |
| Norway | Novo Nordisk Investigational Site | Gjøvik | |
| Norway | Novo Nordisk Investigational Site | Kongsberg | |
| Norway | Novo Nordisk Investigational Site | Kongsvinger | |
| Norway | Novo Nordisk Investigational Site | Kristiansand S | |
| Norway | Novo Nordisk Investigational Site | Rådal | |
| Poland | Novo Nordisk Investigational Site | Bydgoszcz | |
| Poland | Novo Nordisk Investigational Site | Bydgoszcz | |
| Poland | Novo Nordisk Investigational Site | Gdansk | |
| Poland | Novo Nordisk Investigational Site | Krakow | |
| Poland | Novo Nordisk Investigational Site | Lodz | |
| Poland | Novo Nordisk Investigational Site | Lublin | |
| Poland | Novo Nordisk Investigational Site | Szczecin | |
| Romania | Novo Nordisk Investigational Site | Timisoara | |
| Russian Federation | Novo Nordisk Investigational Site | Moscow | |
| Russian Federation | Novo Nordisk Investigational Site | Moscow | |
| Slovakia | Novo Nordisk Investigational Site | Kosice | |
| Slovakia | Novo Nordisk Investigational Site | Moldava nad Bodvou | |
| Sweden | Novo Nordisk Investigational Site | Falun |
| Lead Sponsor | Collaborator |
|---|---|
| Novo Nordisk A/S |
Argentina, Croatia, Czech Republic, Denmark, Finland, France, Greece, Italy, Macedonia, The Former Yugoslav Republic of, Norway, Poland, Romania, Russian Federation, Slovakia, Sweden,
Hermansen K, Fontaine P, Kukolja KK, Peterkova V, Leth G, Gall MA. Insulin analogues (insulin detemir and insulin aspart) versus traditional human insulins (NPH insulin and regular human insulin) in basal-bolus therapy for patients with type 1 diabetes. D — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | HbA1c (glycosylated haemoglobin) | |||
| Secondary | Intra-subject variation in home measured blood glucose (3-point blood glucose profiles) | |||
| Secondary | 8-point blood glucose profiles | |||
| Secondary | Incidence of self-recorded hypoglycaemic episodes | |||
| Secondary | Incidence of adverse events |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05594446 -
Morphometric Study of the Legs and Feet of Diabetic Patients in Order to Collect Data Intended to be Used to Measure by Dynamometry the Pressures Exerted by Several Medical Compression Socks at the Level of the Forefoot
|
||
| Completed |
NCT03975309 -
DHS MIND Metabolomics
|
||
| Completed |
NCT01855399 -
Technologically Enhanced Coaching: A Program to Improve Diabetes Outcomes
|
N/A | |
| 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 | |
| Recruiting |
NCT04984226 -
Sodium Bicarbonate and Mitochondrial Energetics in Persons With CKD
|
Phase 2 | |
| Recruiting |
NCT05007990 -
Caregiving Networks Across Disease Context and the Life Course
|
||
| Active, not recruiting |
NCT04420936 -
Pragmatic Research in Healthcare Settings to Improve Diabetes and Obesity Prevention and Care for Our Program
|
N/A | |
| Recruiting |
NCT03549559 -
Imaging Histone Deacetylase in the Heart
|
N/A | |
| Completed |
NCT04903496 -
Clinical Characteristics and Disease Burden of Diabetic Patients Based on Tianjin Regional Database
|
||
| Completed |
NCT01437592 -
Investigating the Pharmacokinetic Properties of NN1250 in Healthy Chinese Subjects
|
Phase 1 | |
| Completed |
NCT01696266 -
An International Survey on Hypoglycaemia Among Insulin-treated Patients With Diabetes
|
||
| Completed |
NCT04082585 -
Total Health Improvement Program Research Project
|
||
| Completed |
NCT03390179 -
Hyperglycemic Response and Steroid Administration After Surgery (DexGlySurgery)
|
||
| Not yet recruiting |
NCT05029804 -
Effect of Walking Exercise Training on Adherence to Disease Management and Metabolic Control in Diabetes
|
N/A | |
| Recruiting |
NCT05294822 -
Autologous Regenerative Islet Transplantation for Insulin-dependent Diabetes
|
N/A | |
| Completed |
NCT04427982 -
Dance and Diabetes/Prediabetes Self-Management
|
N/A | |
| Completed |
NCT02356848 -
STEP UP to Avert Amputation in Diabetes
|
N/A | |
| Completed |
NCT03292185 -
A Trial to Investigate the Single Dose Pharmacokinetics of Insulin Degludec/Liraglutide Compared With Insulin Degludec and Liraglutide in Healthy Chinese Subjects
|
Phase 1 | |
| Active, not recruiting |
NCT05477368 -
Examining the Feasibility of Prolonged Ketone Supplement Drink Consumption in Adults With Type 2 Diabetes
|
N/A | |
| Completed |
NCT04496401 -
PK Study in Diabetic Transplant récipients : From Twice-daily Tacrolimus to Once-daily Extended-release Tacrolimus
|
Phase 4 |