Condition category
Nutritional, Metabolic, Endocrine
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
13/09/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Ian Gallen

ORCID ID

Contact details

Diabetes Centre
Wycombe Hospital
Queen Alexander Rd
High Wycombe
Bucks
HP11 2TT
United Kingdom
+44 (0)1494 526161

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

http://www.doh.gov.uk

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

Publication citations

Additional files

Editorial Notes