Therapeutic implications of oral hypoglycaemic agents on the enteroinsular axis in type 2 diabetes

ISRCTN	ISRCTN37245053
DOI	https://doi.org/10.1186/ISRCTN37245053
Secondary identifying numbers	RGHT000140

Submission date: 26/09/2007
Registration date: 28/11/2008
Last edited: 25/09/2013

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

Dr Joy Cuthbertson
Scientific

11 Village Green
Doagh
Ballyclare
Northern Ireland
BT39 0UD
United Kingdom

Phone	+44 (0)77614 01203
Email	joycuthbertson@msn.com

Study information

Study design	Ramdomised cross-over controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title
Study objectives	Metformin inhibits dipeptidyl peptidase IV (DPPIV) degradation and increases physiological effects of glucagon-like peptide-1 (GLP-1).
Ethics approval(s)	Health and Personal Social Services (HPSS) Research Ethics Committee 3, approved on 29th November 2005 (ref: HPSSREC 05/NIR03/181)
Health condition(s) or problem(s) studied	Type 2 diabetes
Intervention	Drugs/placebo administered in Study A and B: A/B 1: one placebo tablet (oral) stat dose A/B 2: 1 g metformin (oral) stat dose A/B 3: 120 mg nateglinide (oral) stat dose In Study A and B all subjects received the two drugs and placebo, one at a time in different orders as single doses, at each visit one week apart. The subjects were given a standard mixed meal. Study B was extended with subjects returning; this time they were kept fasting. In Study A subjects were not on any oral hypoglycaemic agents. In Study B if any of the subjects were on an oral hypoglycaemic agent this was stopped for a 3-week washout period prior to starting the study. In Study C and D the subjects received all three combinations below, one combination as a single dose at a time, one week apart: Cross-over combinations for study C: C1: placebo (oral) and 1.5 nmol/kg body weight GLP-1 subcutaneous (sc) stat dose C2: 120 mg nateglinide (oral) and 1.5 nmol/kg body weight GLP-1 sc stat dose C3: 120 mg nateglinide (oral) and 1 ml normal saline sc stat dose Cross-over combinations for Study D: D1: placebo (oral) and 1.5 nmol/kg body weight GLP-1 sc stat dose D2: 1 g metformin (oral) and 1.5 nmol/kg body weight GLP-1 sc stat dose D3: 1 g metformin (oral) and 1 ml normal saline sc stat dose
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Metformin, nateglinide, glucagon-like peptide-1 (GLP-1)
Primary outcome measure	Blood samples were collected from the participants at -5, 0, 30, 60, 120, 180 and 240 minutes for the measurements of the following: 1. Glucose 2. Insulin 3. C-peptide 4. DPPIV activity 5. GLP-1
Secondary outcome measures	Serum metformin levels, measured by high performance liquid chromatography on blood samples collected at 0, 60, 120 and 240 minutes.
Overall study start date	03/08/2005
Completion date	01/08/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	40
Key inclusion criteria	1. Both males and females, aged greater than 18 years 2. Type 2 diabetes controlled by diet or a single oral hypoglycaemic agent 3. HbA1c less than 7.5% 4. No significant liver, cardiac or renal problems (creatinine greater than 150 mmol/l)
Key exclusion criteria	Type 2 diabetes on two or more hypoglycaemic agents or requiring insulin.
Date of first enrolment	03/08/2005
Date of final enrolment	01/08/2007

Locations

Countries of recruitment

Northern Ireland
United Kingdom

Study participating centre

11 Village Green

Northern Ireland
BT39 0UD
United Kingdom

Sponsor information

Royal Victoria Hospital (UK)
Other

274 Grosvenor Road
Belfast
Northern Ireland
BT12 6BA
United Kingdom

Website	http://www.belfasttrust.hscni.net/hospitals/RVHIntro.htm
"ROR"	https://ror.org/03rq50d77

Funders

Funder type

Government

Northern Ireland Health and Social Services Central Services Agency (UK) - Research and Development Fellowship (ref: EAT/2955/04)

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

Study outputs

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Results article	results	01/06/2009	Yes	No
Results article	results	01/01/2011	Yes	No
Results article	results	01/03/2011	Yes	No