Efficacy and Safety of NovoMix® 30 in Subjects With Type 2 Diabetes

NCT01467401 | Completed Phase 4

• 1 other identifier: BIASP-1394
• Study Type: interventional
• Target: 292
• Locations: 3 countries
• Sites: 57

Brief Summary

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.

Conditions

Diabetes; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• HbA1c (glycolated haemoglobin)

Secondary Outcomes (5)

• Prandial increment in blood glucose

• 7-point blood glucose profile

• Number and severity of adverse events

• Number and severity of local tolerability issues at the injection site

• Number and severity of hypoglycaemic episodes

Study Arms (2)

A

EXPERIMENTAL

Drug: biphasic insulin aspart

B

ACTIVE COMPARATOR

Drug: biphasic human insulin

Interventions

biphasic insulin aspart DRUG

Individually adjusted dose. Injected subcutaneously (s.c., under the skin) twice daily

A

biphasic human insulin DRUG

Individually adjusted dose. Injected subcutaneously (s.c., under the skin) twice daily

B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (57)

Novo Nordisk Investigational Site

Århus C, 8000, Denmark

Location

Novo Nordisk Investigational Site

Esbjerg, 6700, Denmark

Location

Novo Nordisk Investigational Site

Herning, 7400, Denmark

Location

Novo Nordisk Investigational Site

Holbæk, 4300, Denmark

Location

Novo Nordisk Investigational Site

Næstved, 4700, Denmark

Location

Novo Nordisk Investigational Site

Randers, Denmark

Location

Novo Nordisk Investigational Site

Silkeborg, 8600, Denmark

Location

Novo Nordisk Investigational Site

Skive, 7800, Denmark

Location

Novo Nordisk Investigational Site

Viborg, Denmark

Location

Novo Nordisk Investigational Site

Åsgårdstrand, Norway

Location

Novo Nordisk Investigational Site

Bekkestua, 1357, Norway

Location

Novo Nordisk Investigational Site

Bergen, NO-5012, Norway

Location

Novo Nordisk Investigational Site

Haugesund, Norway

Location

Novo Nordisk Investigational Site

Hønefoss, Norway

Location

Novo Nordisk Investigational Site

Moelv, Norway

Location

Novo Nordisk Investigational Site

Oslo, 0370, Norway

Location

Novo Nordisk Investigational Site

Tromsø, 9038, Norway

Location

Novo Nordisk Investigational Site

Vennesla, Norway

Location

Novo Nordisk Investigational Site

Arvika, 671 80, Sweden

Location

Novo Nordisk Investigational Site

Avesta, 774 82, Sweden

Location

Novo Nordisk Investigational Site

Bjuv, 267 38, Sweden

Location

Novo Nordisk Investigational Site

Broby, 280 60, Sweden

Location

Novo Nordisk Investigational Site

Färgelanda, 458 32, Sweden

Location

Novo Nordisk Investigational Site

Gothenburg, 416 65, Sweden

Location

Novo Nordisk Investigational Site

Gothenburg, 416 85, Sweden

Location

Novo Nordisk Investigational Site

Gothenburg, 417 02, Sweden

Location

Novo Nordisk Investigational Site

Gothenburg, 417 17, Sweden

Location

Novo Nordisk Investigational Site

Grästorp, 467 22, Sweden

Location

Novo Nordisk Investigational Site

Habo, 566 32, Sweden

Location

Novo Nordisk Investigational Site

Härnösand, 871 82, Sweden

Location

Novo Nordisk Investigational Site

Hässleholm, 281 25, Sweden

Location

Novo Nordisk Investigational Site

Helsingborg, 254 57, Sweden

Location

Novo Nordisk Investigational Site

Jönköping, 551 11, Sweden

Location

Novo Nordisk Investigational Site

Karlstad, 651 85, Sweden

Location

Novo Nordisk Investigational Site

Karlstad, 652 24, Sweden

Location

Novo Nordisk Investigational Site

Kristianstad, 291 38, Sweden

Location

Novo Nordisk Investigational Site

Kristinehamn, 681 80, Sweden

Location

Novo Nordisk Investigational Site

Kungsbacka, 434 80, Sweden

Location

Novo Nordisk Investigational Site

Malmo, 205 02, Sweden

Location

Novo Nordisk Investigational Site

Mellerud, 464 30, Sweden

Location

Novo Nordisk Investigational Site

Mölndal, 431 80, Sweden

Location

Novo Nordisk Investigational Site

Norrköping, 602 36, Sweden

Location

Novo Nordisk Investigational Site

Örebro, 701 85, Sweden

Location

Novo Nordisk Investigational Site

Örebro, 702 15, Sweden

Location

Novo Nordisk Investigational Site

Örebro, 703 51, Sweden

Location

Novo Nordisk Investigational Site

Östersund, 831 62, Sweden

Location

Novo Nordisk Investigational Site

Östersund, 831 83, Sweden

Location

Novo Nordisk Investigational Site

Säffle, 661 81, Sweden

Location

Novo Nordisk Investigational Site

Skövde, 541 85, Sweden

Location

Novo Nordisk Investigational Site

Stockholm, 116 91, Sweden

Location

Novo Nordisk Investigational Site

Tomelilla, 273 34, Sweden

Location

Novo Nordisk Investigational Site

Torsby, 685 29, Sweden

Location

Novo Nordisk Investigational Site

Trollhättan, 461 40, Sweden

Location

Novo Nordisk Investigational Site

Trollhättan, 461 85, Sweden

Location

Novo Nordisk Investigational Site

Tyresö, 135 21, Sweden

Location

Novo Nordisk Investigational Site

Uddevalla, 451 80, Sweden

Location

Novo Nordisk Investigational Site

Värnamo, 331 85, Sweden

Location

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2

Interventions

insulin aspart, insulin aspart protamine drug combination 30:70; biphasic human insulin 30

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2011
• First Posted: November 8, 2011
• Study Start: August 19, 2002
• Primary Completion: May 15, 2003
• Study Completion: May 15, 2003
• Last Updated: February 24, 2017

Record last verified: 2017-02

Locations

SE (39); NO (9); DK (9)