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

Phase 3

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 2

• Registration Number: NCT00280046
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-11
• Primary Completion: 2004-07
• Study Completion: 2004-07
• Study First Submitted: 2006-01-19
• Study First Submitted QC: 2006-01-19
• Study First Posted: 2006-01-20
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-05
• Last Update Posted: 2017-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 307

Inclusion Criteria

• Type 2 diabetes, currently treated with one or more oral hypoglycemic agent
• HbA1c: At least 8.0%

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Exclusion Criteria

• Impaired hepatic, renal or cardiac function

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
HbA1c	after 16 weeks of treatment

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇷🇺 Voronezh, Russian Federation