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

NCT ID: NCT05440591

Last Updated: 2022-07-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-01
• Study Completion Date: 2023-05-10

Brief 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.

Detailed 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.

Conditions

Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Metformin

Metformin XR 500 mg tablets - up-to twice daily orally.

Group Type: ACTIVE_COMPARATOR

MetFORMIN 500 Mg Oral Tablet

Intervention Type: DRUG

Metformin 500 mg tablets twice daily

Dapagliflozin

Dapagliflozin 10 mg tablets - once daily

Group Type: EXPERIMENTAL

Dapagliflozin

Intervention Type: DRUG

Dapagliflozin 10mg tablets

MetforminXR 500/Dapagliflozin 5mg

MetforminXR 500/Dapagliflozin 5mg , tablets- once daily

Group Type: EXPERIMENTAL

Dapagliflozin / metFORMIN Pill

Intervention Type: DRUG

Combination pill

Interventions

Dapagliflozin

Dapagliflozin 10mg tablets

Intervention Type: DRUG

MetFORMIN 500 Mg Oral Tablet

Metformin 500 mg tablets twice daily

Intervention Type: DRUG

Dapagliflozin / metFORMIN Pill

Combination pill

Intervention Type: DRUG

Eligibility Criteria

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.

-

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Tan Tock Seng Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rinkoo Dalan

Role: PRINCIPAL_INVESTIGATOR

Tan Tock Seng Hospital

Locations

Tan Tock Seng Hospital

Singapore, , Singapore

Site Status: RECRUITING

Countries

Singapore

Central Contacts

Rinkoo Dalan, MBBS

Role: CONTACT

rinkoo_dalan@ttsh.com.sg

63571000

Siti Zaidah

Role: CONTACT

Siti_zaidah_abu_bakar@ttsh.com.sg

Facility Contacts

Siti Zaidah

Role: primary

siti_zaidah_abu_bakar@ttsh.com.sg

Other Identifiers

DMV001

Identifier Type: -

Identifier Source: org_study_id