Contact information
Type
Scientific
Primary contact
Prof Philip Home
ORCID ID
Contact details
Institute of Cellular Medicine (Diabetes)
The Medical School
Framlington Place
Newcastle
NE2 4HH
United Kingdom
+44 (0)191 222 7019
philip.home@ncl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0503172589
Study information
Scientific title
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Single centre randomised double blind placebo controlled 12 week trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet.
Condition
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
Phase
Not Specified
Drug names
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 trial start date
01/04/2003
Overall trial end date
31/12/2004
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
69 approached, 55 randomised (26 to intervention arm, 29 to control)
Participant exclusion criteria
1. Significant hepatic dysfunction
2. Significant renal dysfunction
3. Active cardiovascular disease
Recruitment start date
01/04/2003
Recruitment end date
31/12/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Institute of Cellular Medicine (Diabetes)
Newcastle
NE2 4HH
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2006 Update - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Newcastle upon Tyne Hospitals NHS Trust (UK)
Alternative name(s)
Newcastle upon Tyne Hospitals NHS Trust
Funding Body Type
government organisation
Funding Body Subtype
government non-federal
Location
United Kingdom
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
Basic results (scientific)
Publication list
2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17298589
Publication citations
-
Results
Dashora UK, Sibal L, Ashwell SG, Home PD, Insulin glargine in combination with nateglinide in people with Type 2 diabetes: a randomized placebo-controlled trial., Diabet. Med., 2007, 24, 4, 344-349, doi: 10.1111/j.1464-5491.2007.02094.x.