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A Pilot Study of Intensive Supplemental Insulin Therapy: Novorapid vs Actrapid

A Pilot Study of the Safety and Efficacy of Intensive Supplemental Insulin Therapy with Novorapid vs Actrapid in people with diabetes

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12608000402347
Enrollment
24
Registered
2008-08-13
Start date
2006-04-01
Completion date
Unknown
Last updated
2020-01-13

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

Conditions

None listed

Brief summary

This randomised controlled trial compares the safety and efficacy of using supplemental Insulin Aspart (Novorapid) vs Actrapid to maintain tight glycaemic control in hospitalised patients with diabetes.

Interventions

The aim is to achieve tight glycaemic control with supplemental subcutaneous insulin, either Novorapid, or Actrapid. For subjects randomised to Novorapid, they will receive supplemental Novorapid if their glucose level is >8 mmol/L at a standard testing time (before meals/after meals/2200), in accordance with an algorithm which takes into consideration the subject's weight, glucose level and time of day. Subjects randomised to Actrapid will be administered supplemental insulin if their glucose l

The aim is to achieve tight glycaemic control with supplemental subcutaneous insulin, either Novorapid, or Actrapid. For subjects randomised to Novorapid, they will receive supplemental Novorapid if their glucose level is >8 mmol/L at a standard testing time (before meals/after meals/2200), in accordance with an algorithm which takes into consideration the subject's weight, glucose level and time of day. Subjects randomised to Actrapid will be administered supplemental insulin if their glucose level is >10 mmol/L, in accordance with a similar algorithm. The intervention will continue until discharge, or the occurence of an event which mandates withdrawal (eg becomes nil by mouth, insulin infusion commenced). This is a hospital based intervention only.

Sponsors

NW Cheung
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

diabetes on oral agents or insulin

Exclusion criteria

pregnant ketoacidosis nil by mouth

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026