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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN34091554

Enrollment

160

Registered

2006-06-19

Start date

2002-06-05

Completion date

Unknown

Last updated

2015-01-13

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

Conditions

Type 2 diabetes requiring insulin Nutritional, Metabolic, Endocrine Diabetes

Interventions

Crossover trial comparing the glucose control of using NovoMix® 30 to Mixtard® 30.

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Frequency of hypoglycaemic episodes measured by CGMS for three days.	—

Secondary

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

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026