Effect of Biphasic Insulin Aspart 30 on Blood Glucose Control in Subjects With Type 2 Diabetes
1 other identifier
interventional
307
1 country
11
Brief Summary
This trial was conducted in Russian Federation. This trial aimed for a comparison of the effect on glycemic control in subjects with type 2 diabetes of three different treatment regimens: biphasic insulin aspart 30 thrice daily, biphasic insulin aspart 30 twice daily in combination with metformin and treatment with oral anti-diabetic drugs.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 diabetes
Started Nov 2003
Shorter than P25 for phase_3 diabetes
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2004
CompletedFirst Submitted
Initial submission to the registry
January 19, 2006
CompletedFirst Posted
Study publicly available on registry
January 20, 2006
CompletedJanuary 6, 2017
January 1, 2017
8 months
January 19, 2006
January 5, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
HbA1c
after 16 weeks of treatment
Secondary Outcomes (4)
Self-measured 7-point capillary plasma glucose profile
Change in body weight
Incidence of hypoglycaemic episodes and adverse events
Quality of Life
Interventions
Eligibility Criteria
You may qualify if:
- Type 2 diabetes, currently treated with one or more oral hypoglycemic agent
- HbA1c: At least 8.0%
You may not qualify if:
- Impaired hepatic, renal or cardiac function
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (11)
Novo Nordisk Investigational Site
Arkhangelsk, 163045, Russia
Novo Nordisk Investigational Site
Belgorod, 308007, Russia
Novo Nordisk Investigational Site
Kazan', 420064, Russia
Novo Nordisk Investigational Site
Khabarovsk, 680067, Russia
Novo Nordisk Investigational Site
Nizhny Novgorod, 603126, Russia
Novo Nordisk Investigational Site
Novosibirsk, 630090, Russia
Novo Nordisk Investigational Site
Omsk, 644070, Russia
Novo Nordisk Investigational Site
Saint Petersburg, 194291, Russia
Novo Nordisk Investigational Site
Vladivostok, 690105, Russia
Novo Nordisk Investigational Site
Voronezh, 394053, Russia
Novo Nordisk Investigational Site
Yekaterinburg, 620102, Russia
Related Publications (1)
Ushakova O, Sokolovskaya V, Morozova A, Valeeva F, Zanozina O, Sazonova O, Zhadanova E, Starceva M, Kazakova E, Saifullina M, Shapiro I, Tarasov A, Al-Tayar B, Starkova N. Comparison of biphasic insulin aspart 30 given three times daily or twice daily in combination with metformin versus oral antidiabetic drugs alone in patients with poorly controlled type 2 diabetes: a 16-week, randomized, open-label, parallel-group trial conducted in russia. Clin Ther. 2007 Nov;29(11):2374-84. doi: 10.1016/j.clinthera.2007.11.017.
PMID: 18158078RESULT
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 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 19, 2006
First Posted
January 20, 2006
Study Start
November 1, 2003
Primary Completion
July 1, 2004
Study Completion
July 1, 2004
Last Updated
January 6, 2017
Record last verified: 2017-01