NCT03558867Completed
Personalised Medicine in Pre-diabetes and Early Type 2 Diabetes
Personalised Medicine in Prediabetes - Towards Preventing Diabetes in Individuals at Risk
Source: ClinicalTrials.gov · Last updated 5 Oct 2026
Brief summary (registry, in English)
Prediabetes is a common condition in overweight individuals affecting approximately 35% of American adults and 30% of Australian adults. Like diabetes, prediabetes is a serious risk factor for cardiovascular disease, eye, kidney and liver disease, and some types of cancer. Appropriate blood glucose control is crucial in preventing pre-diabetes complications and onset of diabetes, yet clinical practice, backed by randomised trials, reports that many patients treated with standard dietary guidelines or with the first-line treatment of diabetes patients, metformin, do not improve blood glucose control sufficiently. The overarching goal of the present project is to improve the efficacy of metformin mono-therapy in pre-diabetes and early type 2 diabetes.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 138 (actual)
- First submitted
- 5 Jun 2018
- Start date
- 5 Jun 2018
- Primary completion date
- 15 Dec 2023
- Lead sponsor
- Garvan Institute of Medical Research
- Diseases
- Type 2 diabetes
- NCT number
- NCT03558867
What you commit to
- Study type: Interventional
- Participants enrolled: 138
- From 5 Jun 2018 to the primary completion date, 15 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with type 1 diabetes, chronically active inflammatory disease, neoplastic disease in the previous 3 years, chronic gastrointestinal disorders, including inflammatory bowel disease or celiac.
- Cardiovascular event in the previous 6 months.
- Current or recent (within 3 months) treatment with metformin.
- Treatment with an oral steroid.
- Treatment with antibiotics in the last 3 months.
- Treatment with immunosuppressive medications.
- Treatment with medications known to interact with metformin, including cimetidine, vitamin K antagonists and nifedipine.
- Participants who had received an investigational new drug within the last 6 months.
- Participants who had a bariatric surgery.
Other illness
- Individuals with a history of a psychological illness or condition that may interfere with the individual's ability to understand the requirements of the study.
Lab values
- Liver enzymes ALT and/or AST\>3-times normal range limit.
- Abnormal renal function as measured by (eGFR\<45 mL/min/1.73m\^2).
- HbA1c\>8.0%
- Current or recent (within 24 months) treatment with a glucose lowering medication (i.e. GLP-1 receptor agonist, SGLT2 inhibitor, thiazolidinedione, sulfonylurea, DPP-4 inhibitor or insulin).
Other
- Females planning a pregnancy during the course of the research or 3 months after completion of the research project. Females who breastfeed.
- Normo-glycaemia.
- Substance abuse.
- Participants involved in another clinical study.
- Participants who actively lose weight.
- Any reason the Investigator believes the participant is not likely to be adherent to the study treatment and protocol, including non-adherence to run-in.
Who the study is looking for
- Prediabetes or early-stage type 2 diabetes according to the American Diabetes Association (2019) diagnostic criteria, with HbA1c ≤8.0% (64 mmol/mol).
- Women of childbearing potential willing to take precautions to avoid pregnancy throughout the study and for 3 months after the end of treatment.
- Willingness to provide written informed consent and willingness to participate and comply with the study.
Age in the registry: 20 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Garvan Institute of Medical Research Coordinator of this site? Confirm its status | Sydney | Australia | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.