Condition category
Nutritional, Metabolic, Endocrine
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
28/10/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.dh.gov.uk/Home/fs/en

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

Results - basic reporting

Publication summary

2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17298589

Publication citations

  1. 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.

Additional files

Editorial Notes