Last updated: June 29, 2022
Sponsor: Tan Tock Seng Hospital
Overall Status: Active - Recruiting
Phase
4
Condition
Diabetic Vitreous Hemorrhage
Diabetic Foot Ulcers
Diabetic Retinopathy
Treatment
N/AClinical Study ID
NCT05440591
DMV001
Ages 30-65 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Ability to give informed consent
- Age 30-65 years
- Newly diagnosed (within the past 1 - 2 years) to have T2DM and not started on diabetesmedications, HbA1c 6.4% to 10% (both inclusive) and/or OGTT 0 min glucose ≥7.0mmol/Land/or 120 min glucose ≥11.8mmol/L OR Recently diagnosed to have T2DM and treated withMetformin for not more than 5 years, HbA1c ≤ 8%
- No recent change in medications or new medications
- eGFR>60mL/min/1.73m2
- Patient is otherwise well with no acute systemic illness in the last 2 weeks.
- Female participants of child bearing potential and male participants whose partner isof child bearing potential must be willing to ensure that they or their partner useeffective contraception during the trial
Exclusion
Exclusion Criteria: 1. History of ketoacidosis or any other conditions causing acidosis e.g. Alcoholdependence 2. Has a history of urinary tract infections or is at risk for urinary tract infections (e.g prostatomegaly, vesicoureteric reflux, kidney stones) 3. Patients on corticosteroids or immunosuppressive agents 4. Patients known to have HIV infection and/or on anti-retroviral agents 5. Patients with typical clinical features suggestive of T1DM (young onset with no familyhistory of diabetes or first presentation as DKA were excluded). The endocrinologist (PI or co-I) will look at the patient profile to confirm diagnosis of T2DM. 6. Has severe liver dysfunction 7. Considered inappropriate by investigators due to any other reason. 8. Female participant who is pregnant, lactating or planning pregnancy during the courseof the trial. 9. Significant renal impairment. 10. Scheduled elective surgery or other procedures requiring general anaesthesia duringthe trial. 11. Participants who have participated in another research trial involving aninvestigational product in the past 12 weeks. 12. Participants who have a history of Peripheral Arterial Disease or peripheral vasculardisease or complains of lower limb claudication pain.
Study Design
Total Participants: 150
Study Start date:
April 01, 2019
Estimated Completion Date:
May 10, 2023
Study Description
Connect with a study center
Tan Tock Seng Hospital
Singapore, 308433
SingaporeActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.