Insulin Lispro mixtures (mid mixture and low mixture) administered three times daily compared with human insulin 30/70 administered twice daily in insulin-requiring patients with type 2 diabetes

ISRCTN	ISRCTN77659599
DOI	https://doi.org/10.1186/ISRCTN77659599
Protocol serial number	N0245131033
Sponsor	Department of Health (UK)
Funder	South Buckinghamshire NHS Trust (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr Ian Gallen
Scientific

Diabetes Centre
Wycombe Hospital
Queen Alexander Rd
High Wycombe, Bucks
HP11 2TT
United Kingdom

Phone	+44 (0)1494 526161
Email	abc@email.com

Primary study design	Interventional
Study design	Randomised active controlled crossover group trial
Secondary study design	Randomised controlled trial
Scientific title	Insulin Lispro mixtures (mid mixture and low mixture) administered three times daily compared with human insulin 30/70 administered twice daily in insulin-requiring patients with type 2 diabetes
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	30/06/2002

Participant type(s)	Patient
Age group	Adult
Sex	All
Key inclusion criteria	Patients aged 35 years and over with type 2 diabetes and using insulin.
Key exclusion criteria	Does not match inclusion criteria
Date of first enrolment	11/05/2000
Date of final enrolment	30/06/2002

Diabetes Centre

High Wycombe, Bucks
HP11 2TT
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

28/02/2020: No publications found, verifying study status with principal investigator.