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

Sponsor

Novo Nordisk A/S (Industry)

Overall Status

Completed

CT.gov ID

NCT00280046

Collaborator

(none)

307

Enrollment

Locations

Duration (Months)

27.9

Patients Per Site

3.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Diabetes Mellitus, Type 2	Drug: biphasic insulin aspart	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

307 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Nov 1, 2003

Actual Primary Completion Date :

Jul 1, 2004

Actual Study Completion Date :

Jul 1, 2004

Outcome Measures

Primary Outcome Measures

HbA1c [after 16 weeks of treatment]

Secondary Outcome Measures

Self-measured 7-point capillary plasma glucose profile []
Change in body weight []
Incidence of hypoglycaemic episodes and adverse events []
Quality of Life []

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Novo Nordisk Investigational Site	Arkhangelsk	Russian Federation	163045
2	Novo Nordisk Investigational Site	Belgorod	Russian Federation	308007
3	Novo Nordisk Investigational Site	Ekaterinburg	Russian Federation	620102
4	Novo Nordisk Investigational Site	Kazan	Russian Federation	420064
5	Novo Nordisk Investigational Site	Khabarovsk	Russian Federation	680067
6	Novo Nordisk Investigational Site	Nizhniy Novgorod	Russian Federation	603126
7	Novo Nordisk Investigational Site	Novosibirsk	Russian Federation	630090
8	Novo Nordisk Investigational Site	Omsk	Russian Federation	644070
9	Novo Nordisk Investigational Site	Saint-Petersburg	Russian Federation	194291
10	Novo Nordisk Investigational Site	Vladivostok	Russian Federation	690105
11	Novo Nordisk Investigational Site	Voronezh	Russian Federation	394053