Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0245131033
Study information
Scientific title
Acronym
Study hypothesis
To compare treatment with insulin lispro mid mixture (MM) before morning and midday meals and insulin lispro low mixture (LM) before the evening meal to treatment with human insulin 30/70 twice daily with respect to haemoglobin A1C (HbA1c) levels in patients with type 2 diabetes.
Ethics approval
Not provided at time of registration
Study design
Randomised active controlled crossover group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Diabetes Type 2
Intervention
4 Weeks on 30/70 insulin bd then randomised to continue with 30/70 or start lispro mixes for 16 weeks. After 16 weeks crossover to comparator treatment.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
1. Improvement in HbA1c levels
2. Improvement in home blood glucose measurements
3. Comparison of fructosamine
4. Comparison of doses
5. Comparison of hypoglycaemic episodes
Secondary outcome measures
Not provided at time of registration
Overall trial start date
11/05/2000
Overall trial end date
30/06/2002
Reason abandoned
Eligibility
Participant inclusion criteria
Patients aged 35 years and over with type 2 diabetes and using insulin.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Does not match inclusion criteria
Recruitment start date
11/05/2000
Recruitment end date
30/06/2002
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Diabetes Centre
High Wycombe, Bucks
HP11 2TT
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Hospital/treatment centre
Funder name
South Buckinghamshire NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary