Effects of Dapagliflozin and Metformin on Vascular Function in Newly-Diagnosed Treatment-Naive Type 2 Diabetes

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/A

Clinical Study ID

NCT05440591
DMV001
  • Ages 30-65
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

Trial Design: This is a 12 week randomised controlled open label trial comparing the impact of Dapagliflozin, Metformin and combination therapy on vascular function in newly diagnosed T2DM patients.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Ability to give informed consent
  2. Age 30-65 years
  3. 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%
  4. No recent change in medications or new medications
  5. eGFR>60mL/min/1.73m2
  6. Patient is otherwise well with no acute systemic illness in the last 2 weeks.
  7. 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

Trial Design: This is a 12 week randomised controlled open label trial comparing the impact of Dapagliflozin, Metformin and combination therapy on vascular function in newly diagnosed T2DM patients.

Trial Participants: Approximately 150 newly diagnosed T2DM patients with randomization 1:1:1 to Metformin XR 500mg twice daily, Dapagliflozin 10 mg daily or Metformin XR 500/Dapagliflozin 5 mg daily

Primary Aim : To evaluate the influence of intervention on vascular function.

Secondary Aims:

  1. To evaluate the influence on other parameters of vascular function and beds.

  2. To evaluate the haemodynamics involving blood pressure regulation.

  3. To evaluate the effects of SGLT2i versus Metformin on endothelial interactions (vascular permeability) and leukocyte-endothelial interactions (leukocyte rolling, adherence), endothelial regenerative capacity and other endothelial related pathways.

Connect with a study center

  • Tan Tock Seng Hospital

    Singapore, 308433
    Singapore

    Active - Recruiting

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