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

Diabetes Clinical Trial

— DMVascular  

Official title:

Effects of Dapagliflozin and Metformin on Vascular Function in Newly-Diagnosed Treatment-Naive Type 2 Diabetes- A Randomised Controlled Trial (DMVascular Study)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05440591
• Other study ID #: DMV001
• Status: Recruiting
• Phase: Phase 4
• Start date: April 1, 2019
• Est. completion date: May 10, 2023

Study information

• Verified date: June 2022
• Source: Tan Tock Seng Hospital
• Contact: Rinkoo Dalan, MBBS
• Phone: 63571000
• Email: rinkoo_dalan[@]ttsh.com.sg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: May 10, 2023
• Est. primary completion date: May 10, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

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 diabetes medications, HbA1c 6.4% to 10% (both inclusive) and/or OGTT 0 min glucose =7.0mmol/L and/or 120 min glucose =11.8mmol/L OR Recently diagnosed to have T2DM and treated with Metformin 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 is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the trial

Exclusion Criteria:

1. History of ketoacidosis or any other conditions causing acidosis e.g. Alcohol dependence

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 family history 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 course of the trial.

9. Significant renal impairment.

10. Scheduled elective surgery or other procedures requiring general anaesthesia during the trial.

11. Participants who have participated in another research trial involving an investigational product in the past 12 weeks.

12. Participants who have a history of Peripheral Arterial Disease or peripheral vascular disease or complains of lower limb claudication pain. -

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus

Intervention

Drug:
• Dapagliflozin
Dapagliflozin 10mg tablets
• MetFORMIN 500 Mg Oral Tablet
Metformin 500 mg tablets twice daily
• Dapagliflozin / metFORMIN Pill
Combination pill

Locations

Country	Name	City	State
Singapore	Tan Tock Seng Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Tan Tock Seng Hospital

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endothelial Function measured as reactive hyperaemia index (RHI-EndoPAT)		3 months after initiation
Primary	Carotid Femoral Pulse Wave Velocity	Sphygmocor determined cf-PWV	3 months after initiation
Secondary	Augmentation index	Augmentation index-sphygmocor derived and RHI-endoPAT derived	3 months after initiation
Secondary	Central pulse pressure	CPP-Sphygmocor derived	3 months after initiation
Secondary	Advanced glycation end products	AGE reader measurements	3 months after initiation