A single centre randomised double blind placebo controlled 12 week trial in subjects with type 2 diabetes comparing glycaemic control with insulin glargine in combination with nateglinide or placebo
| ISRCTN | ISRCTN10167754 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10167754 |
| Secondary identifying numbers | N0503172589 |
- Submission date
- 29/09/2006
- Registration date
- 29/09/2006
- Last edited
- 28/10/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Philip Home
Scientific
Scientific
Institute of Cellular Medicine (Diabetes)
The Medical School
Framlington Place
Newcastle
NE2 4HH
United Kingdom
| Phone | +44 (0)191 222 7019 |
|---|---|
| philip.home@ncl.ac.uk |
Study information
| Study design | Single centre randomised double blind placebo controlled 12 week trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet. |
| Scientific title | |
| Study objectives | A single centre randomised double blind placebo controlled 12 week trial in subjects with type 2 diabetes comparing glycaemic control with insulin glargine in combination with nateglinide or placebo. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Nutritional, Metabolic, Endocrine: Diabetes |
| Intervention | Insulin glargine titrated to a target pre-breakfast blood glucose level of <6.0 mmol/l (all patients) plus either nateglinidine (60mg increasing to 180mg) (intervention arm) or placebo (control arm) before each meal. Length of follow-up: 12 weeks post randomisation (there was a one week screening period and then four week run in period after recruitment but prior to randomisation) |
| Intervention type | Other |
| Primary outcome measure | 1. Eight-point self-monitored blood glucose profiles (pre- and 1 h post-meals, bed-time, and 0300-0500 h) 2. Hypoglycaemia was classified as symptoms-only (with glucose levels above 3.0 mmol/l [54 mg/dl] or no test data), minor (confirmed ≤3.0 mmol/l), or severe (requiring third party assistance). 3. HbA1c measured by DCCT-aligned HPLC (this was the primary outcome) 4. Body weight |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/04/2003 |
| Completion date | 31/12/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target number of participants | 69 approached, 55 randomised (26 to intervention arm, 29 to control) |
| Key inclusion criteria | 1. Aged 18 years or over 2. Type 2 diabetes (meeting the WHO definition of diabetes) 3. Using a human premix or NPH insulin for at least 3 months 4. HbA1c of 6.1-10.0 % 5. BMI inferior or equal to 42.0 kg/m2 6. Both men & women were eligible for recruitment, but women of childbearing potential were required to be using adequate contraception |
| Key exclusion criteria | 1. Significant hepatic dysfunction 2. Significant renal dysfunction 3. Active cardiovascular disease |
| Date of first enrolment | 01/04/2003 |
| Date of final enrolment | 31/12/2004 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Institute of Cellular Medicine (Diabetes)
Newcastle
NE2 4HH
United Kingdom
NE2 4HH
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2006 Update - Department of Health (UK)
Government
Government
The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
Newcastle upon Tyne Hospitals NHS Trust (UK)
Government organisation / Local government
Government organisation / Local government
- Alternative name(s)
- Newcastle upon Tyne Hospitals NHS Trust
- Location
- United Kingdom
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/04/2007 | Yes | No |
