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 designRamdomised cross-over controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study objectivesMetformin 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) studiedType 2 diabetes
InterventionDrugs/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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Metformin, nateglinide, glucagon-like peptide-1 (GLP-1)
Primary outcome measureBlood 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 measuresSerum metformin levels, measured by high performance liquid chromatography on blood samples collected at 0, 60, 120 and 240 minutes.
Overall study start date03/08/2005
Completion date01/08/2007

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants40
Key inclusion criteria1. 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 criteriaType 2 diabetes on two or more hypoglycaemic agents or requiring insulin.
Date of first enrolment03/08/2005
Date of final enrolment01/08/2007

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 logo "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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

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