Therapeutic implications of oral hypoglycaemic agents on the enteroinsular axis in type 2 diabetes
| ISRCTN | ISRCTN37245053 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN37245053 |
| Protocol serial number | RGHT000140 |
| Sponsor | Royal Victoria Hospital (UK) |
| Funder | Northern Ireland Health and Social Services Central Services Agency (UK) - Research and Development Fellowship (ref: EAT/2955/04) |
- 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
Scientific
11 Village Green
Doagh
Ballyclare
Northern Ireland
BT39 0UD
United Kingdom
| Phone | +44 (0)77614 01203 |
|---|---|
| joycuthbertson@msn.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Ramdomised cross-over controlled trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Metformin, nateglinide, glucagon-like peptide-1 (GLP-1) |
| Primary outcome measure(s) |
Blood samples were collected from the participants at -5, 0, 30, 60, 120, 180 and 240 minutes for the measurements of the following: |
| Key secondary outcome measure(s) |
Serum metformin levels, measured by high performance liquid chromatography on blood samples collected at 0, 60, 120 and 240 minutes. |
| Completion date | 01/08/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- Northern Ireland
Study participating centre
11 Village Green
Northern Ireland
BT39 0UD
United Kingdom
BT39 0UD
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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 |
