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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00280046

Enrollment

307

Registered

2006-01-20

Start date

2003-11-30

Completion date

2004-07-31

Last updated

2017-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Diabetes Mellitus, Type 2

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.

Interventions

DRUGbiphasic insulin aspart

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

40 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame
HbA1c	after 16 weeks of treatment

Secondary

Measure	Time frame
Self-measured 7-point capillary plasma glucose profile	—
Change in body weight	—
Incidence of hypoglycaemic episodes and adverse events	—
Quality of Life	—

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026