Diabetes Mellitus, Type 2 Clinical Trial
Official title:
A Multi-National, Multi-Centre, Randomised, Open-Labelled, Parallel Trial Comparing Efficacy and Safety of NovoMix® 30 FlexPen® and Mixtard® 30 Twice Daily Injections in Subjects With 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 trial is to investigate the efficacy and safety of biphasic insulin aspart (NovoMix®30) to that of biphasic human insulin (Mixtard® 30) in subjects with type 2 diabetes.
| Status | Completed |
| Enrollment | 292 |
| Est. completion date | May 15, 2003 |
| Est. primary completion date | May 15, 2003 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Type 2 diabetes for at least 24 months - Insulin treatment for the pase 3 months - HbA1c (glycosylated haemoglobin) below 13% - BMI (Body Mass Index) below 40 kg/m^2 - Ability and willingness to perform self-blood glucose monitoring Exclusion Criteria: - Receipt of any investigational drug within 4 weeks prior to this trial - Treatment of OHAs (Oral Hypoglycaemic Agents) within 4 weeks prior to this trial - Total daily insulin dosage less than or equal to 1.8 IU/kg |
| Country | Name | City | State |
|---|---|---|---|
| Denmark | Novo Nordisk Investigational Site | Århus C | |
| Denmark | Novo Nordisk Investigational Site | Esbjerg | |
| Denmark | Novo Nordisk Investigational Site | Herning | |
| Denmark | Novo Nordisk Investigational Site | Holbæk | |
| Denmark | Novo Nordisk Investigational Site | Næstved | |
| Denmark | Novo Nordisk Investigational Site | Randers | |
| Denmark | Novo Nordisk Investigational Site | Silkeborg | |
| Denmark | Novo Nordisk Investigational Site | Skive | |
| Denmark | Novo Nordisk Investigational Site | Viborg | |
| Norway | Novo Nordisk Investigational Site | Åsgårdstrand | |
| Norway | Novo Nordisk Investigational Site | Bekkestua | |
| Norway | Novo Nordisk Investigational Site | Bergen | |
| Norway | Novo Nordisk Investigational Site | Haugesund | |
| Norway | Novo Nordisk Investigational Site | Hønefoss | |
| Norway | Novo Nordisk Investigational Site | Moelv | |
| Norway | Novo Nordisk Investigational Site | Oslo | |
| Norway | Novo Nordisk Investigational Site | Tromsø | |
| Norway | Novo Nordisk Investigational Site | Vennesla | |
| Sweden | Novo Nordisk Investigational Site | Arvika | |
| Sweden | Novo Nordisk Investigational Site | Avesta | |
| Sweden | Novo Nordisk Investigational Site | Bjuv | |
| Sweden | Novo Nordisk Investigational Site | Broby | |
| Sweden | Novo Nordisk Investigational Site | Färgelanda | |
| Sweden | Novo Nordisk Investigational Site | Göteborg | |
| Sweden | Novo Nordisk Investigational Site | Göteborg | |
| Sweden | Novo Nordisk Investigational Site | Göteborg | |
| Sweden | Novo Nordisk Investigational Site | Göteborg | |
| Sweden | Novo Nordisk Investigational Site | Grästorp | |
| Sweden | Novo Nordisk Investigational Site | Habo | |
| Sweden | Novo Nordisk Investigational Site | Härnösand | |
| Sweden | Novo Nordisk Investigational Site | Hässleholm | |
| Sweden | Novo Nordisk Investigational Site | Helsingborg | |
| Sweden | Novo Nordisk Investigational Site | Jönköping | |
| Sweden | Novo Nordisk Investigational Site | Karlstad | |
| Sweden | Novo Nordisk Investigational Site | Karlstad | |
| Sweden | Novo Nordisk Investigational Site | Kristianstad | |
| Sweden | Novo Nordisk Investigational Site | Kristinehamn | |
| Sweden | Novo Nordisk Investigational Site | Kungsbacka | |
| Sweden | Novo Nordisk Investigational Site | Malmö | |
| Sweden | Novo Nordisk Investigational Site | Mellerud | |
| Sweden | Novo Nordisk Investigational Site | Mölndal | |
| Sweden | Novo Nordisk Investigational Site | Norrköping | |
| Sweden | Novo Nordisk Investigational Site | Örebro | |
| Sweden | Novo Nordisk Investigational Site | Örebro | |
| Sweden | Novo Nordisk Investigational Site | Örebro | |
| Sweden | Novo Nordisk Investigational Site | Östersund | |
| Sweden | Novo Nordisk Investigational Site | Östersund | |
| Sweden | Novo Nordisk Investigational Site | Säffle | |
| Sweden | Novo Nordisk Investigational Site | Skövde | |
| Sweden | Novo Nordisk Investigational Site | Stockholm | |
| Sweden | Novo Nordisk Investigational Site | Tomelilla | |
| Sweden | Novo Nordisk Investigational Site | Torsby | |
| Sweden | Novo Nordisk Investigational Site | Trollhättan | |
| Sweden | Novo Nordisk Investigational Site | Trollhättan | |
| Sweden | Novo Nordisk Investigational Site | Tyresö | |
| Sweden | Novo Nordisk Investigational Site | Uddevalla | |
| Sweden | Novo Nordisk Investigational Site | Värnamo |
| Lead Sponsor | Collaborator |
|---|---|
| Novo Nordisk A/S |
Denmark, Norway, Sweden,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | HbA1c (glycolated haemoglobin) | |||
| Secondary | Prandial increment in blood glucose | |||
| Secondary | 7-point blood glucose profile | |||
| Secondary | Number and severity of adverse events | |||
| Secondary | Number and severity of local tolerability issues at the injection site | |||
| Secondary | Number and severity of hypoglycaemic episodes |
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|---|---|---|---|
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