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
Protocol serial number	N0503172589
Sponsor	Record Provided by the NHSTCT Register - 2006 Update - Department of Health (UK)
Funder	Newcastle upon Tyne Hospitals NHS Trust (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof Philip Home
Scientific

Institute of Cellular Medicine (Diabetes)
The Medical School
Framlington Place
Newcastle
NE2 4HH
United Kingdom

Phone	+44 (0)191 222 7019
Email	philip.home@ncl.ac.uk

Primary study design	Interventional
Study design	Single centre randomised double blind placebo controlled 12 week trial
Secondary study design	Randomised controlled trial
Study type	Participant 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(s)	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
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/12/2004

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
Target sample size at registration	55
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

Institute of Cellular Medicine (Diabetes)

Newcastle
NE2 4HH
United Kingdom

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

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/04/2007		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes