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 |
| Secondary identifying numbers | N0245131033 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 28/02/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
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
Contact information
Dr Ian Gallen
Scientific
Scientific
Diabetes Centre
Wycombe Hospital
Queen Alexander Rd
High Wycombe, Bucks
HP11 2TT
United Kingdom
| Phone | +44 (0)1494 526161 |
|---|---|
| abc@email.com |
Study information
| Study design | Randomised active controlled crossover group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 | 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 study start date | 11/05/2000 |
| Completion date | 30/06/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Not provided at time of registration |
| 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 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Diabetes Centre
High Wycombe, Bucks
HP11 2TT
United Kingdom
HP11 2TT
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Hospital/treatment centre
South Buckinghamshire NHS Trust (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
28/02/2020: No publications found, verifying study status with principal investigator.
