Efficacy and Safety of Biphasic Insulin Aspart 30 FlexPen® in Insulin Naive Subjects With Type 2 Diabetes
1 other identifier
interventional
71
1 country
4
Brief Summary
This trial is conducted in Europe. The aim of this trial is to investigate the efficacy of biphasic insulin aspart 30 on blood glucose control in insulin naive type 2 diabetes failing on secondary oral hypoglycaemic agent (OHA).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 diabetes
Started Mar 2004
Shorter than P25 for phase_4 diabetes
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2005
CompletedFirst Submitted
Initial submission to the registry
January 14, 2008
CompletedFirst Posted
Study publicly available on registry
January 25, 2008
CompletedJanuary 6, 2017
January 1, 2017
10 months
January 14, 2008
January 5, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
HbA1c
after 12 weeks of treatment
Secondary Outcomes (3)
Blood glucose profiles
Incidence of hypoglycaemic episodes
Incidence of adverse events
Interventions
Eligibility Criteria
You may qualify if:
- Type 2 diabetes
- Insulin naive diabetes
- Current treatment with OHA, secondary failure
- Body mass index (BMI) below 40 kg/m2
- HbA1c over 8.5%
- Willing and able to start with insulin therapy and to perform self-blood glucose monitoring
You may not qualify if:
- History of drug or alcohol abuse
- Receipt of the investigational drug within the last month prior to this trial
- Known or suspected allergy to trial products or related products
- Severe uncontrolled hypertension
- Any disease or condition, which the Investigator feels, would interfere with the trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (4)
Novo Nordisk Investigational Site
Belgrade, 11000, Serbia and Montenegro
Novo Nordisk Investigational Site
Kragujevac, 34000, Serbia and Montenegro
Novo Nordisk Investigational Site
Nis, 18000, Serbia and Montenegro
Novo Nordisk Investigational Site
Novi Sad, 21000, Serbia and Montenegro
Related Publications (1)
Lalic NM, Micic D, Antic S, Bajovic L, Pantelinac P, Jotic A, Kendereski A, Dimic D, Djukic A, Mitrovic M, Vujasin M. Effect of biphasic insulin aspart on glucose and lipid control in patients with Type 2 diabetes mellitus. Expert Opin Pharmacother. 2007 Dec;8(17):2895-901. doi: 10.1517/14656566.8.17.2895.
PMID: 18001251RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Global Clinical Registry (GCR, 1452)
Novo Nordisk A/S
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 14, 2008
First Posted
January 25, 2008
Study Start
March 1, 2004
Primary Completion
January 1, 2005
Study Completion
January 1, 2005
Last Updated
January 6, 2017
Record last verified: 2017-01