A double-blind, randomised, crossover study to investigate the difference in frequency of episodes of hypoglycaemia during treatment with Biphasic Insulin Aspart 30 (NovoMix®30) compared to Biphasic Human Insulin 30 (Mixtard® 30) in patients with well-controlled, type 2 diabetes

Completed

• Conditions: Type 2 diabetes requiring insulin; Nutritional, Metabolic, Endocrine; Diabetes

• Registration Number: ISRCTN34091554
• Lead Sponsor: ovo Nordisk Ltd (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06-19
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

1. 160 male or female, adult subjects, with type 2 diabetes and treated with 1 - 3 injections of insulin daily for at least six months
2. HbA1c less than 9.5% at screening and 6.5 - 8.5 at randomisation
3. Judged by the investigator to be eligible for a twice a day (BID) mixed-insulin treatment regimen

Exclusion Criteria

1. Impaired hepatic, renal or cardiac function
2. Concomitant oral hypoglycaemic agents
3. History of frequent severe hypoglycaemic episodes requiring external assistance within the last six months

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Frequency of hypoglycaemic episodes measured by CGMS for three days.

Secondary Outcome Measures

Name	Time	Method
1. Frequency of reported severe hypoglycaemic episodes, minor hypoglycaemic events and nocturnal hypoglycaemia, during the last 12 weeks of each treatment period<br>2. HbA1c<br>3. Diabetes treatment satisfaction questionnaire <br>4. Adverse event recording