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NCT00280046 Clinical Trial

Effect of Biphasic Insulin Aspart 30 on Blood Glucose Control in Subjects With Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

Official title:
Effect of Biphasic Insulin Aspart 30 on Glycaemic Control in Subjects With Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00280046
Other study ID # BIASP-1554
Secondary ID
Status Completed
Phase Phase 3
First received January 19, 2006
Last updated January 5, 2017
Start date November 2003
Est. completion date July 2004

Study information
Verified date January 2017
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority Russia: Federal Service for control in Health and Social development
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 307
Est. completion date July 2004
Est. primary completion date July 2004
Accepts healthy volunteers No
Gender All
Age group 40 Years to 70 Years
Eligibility Inclusion Criteria:

- Type 2 diabetes, currently treated with one or more oral hypoglycemic agent

- HbA1c: At least 8.0%

Exclusion Criteria:

- Impaired hepatic, renal or cardiac function

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• biphasic insulin aspart

Locations
Country Name City State
Russian Federation Novo Nordisk Investigational Site Arkhangelsk
Russian Federation Novo Nordisk Investigational Site Belgorod
Russian Federation Novo Nordisk Investigational Site Ekaterinburg
Russian Federation Novo Nordisk Investigational Site Kazan
Russian Federation Novo Nordisk Investigational Site Khabarovsk
Russian Federation Novo Nordisk Investigational Site Nizhniy Novgorod
Russian Federation Novo Nordisk Investigational Site Novosibirsk
Russian Federation Novo Nordisk Investigational Site Omsk
Russian Federation Novo Nordisk Investigational Site Saint-Petersburg
Russian Federation Novo Nordisk Investigational Site Vladivostok
Russian Federation Novo Nordisk Investigational Site Voronezh

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Russian Federation, 

References & 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 — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary HbA1c after 16 weeks of treatment No
Secondary Self-measured 7-point capillary plasma glucose profile No
Secondary Change in body weight No
Secondary Incidence of hypoglycaemic episodes and adverse events No
Secondary Quality of Life No
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