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

Primary Purpose

Diabetes

Status

Recruiting

Phase

Phase 4

Locations

Singapore

Study Type

Interventional

Intervention

Dapagliflozin

MetFORMIN 500 Mg Oral Tablet

Dapagliflozin / metFORMIN Pill

About this trial

This is an interventional treatment trial for Diabetes

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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 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%
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 is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the trial

Exclusion Criteria:

History of ketoacidosis or any other conditions causing acidosis e.g. Alcohol dependence
Has a history of urinary tract infections or is at risk for urinary tract infections (e.g prostatomegaly, vesicoureteric reflux, kidney stones)
Patients on corticosteroids or immunosuppressive agents
Patients known to have HIV infection and/or on anti-retroviral agents
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.
Has severe liver dysfunction
Considered inappropriate by investigators due to any other reason.
Female participant who is pregnant, lactating or planning pregnancy during the course of the trial.
Significant renal impairment.
Scheduled elective surgery or other procedures requiring general anaesthesia during the trial.
Participants who have participated in another research trial involving an investigational product in the past 12 weeks.
Participants who have a history of Peripheral Arterial Disease or peripheral vascular disease or complains of lower limb claudication pain.
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Sites / Locations

Tan Tock Seng HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Arm Label

Metformin

Dapagliflozin

MetforminXR 500/Dapagliflozin 5mg

Arm Description

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

Dapagliflozin 10 mg tablets - once daily

MetforminXR 500/Dapagliflozin 5mg , tablets- once daily

Outcomes

Primary Outcome Measures

Endothelial Function measured as reactive hyperaemia index (RHI-EndoPAT)

Carotid Femoral Pulse Wave Velocity

Sphygmocor determined cf-PWV

Secondary Outcome Measures

Augmentation index

Augmentation index-sphygmocor derived and RHI-endoPAT derived

Central pulse pressure

CPP-Sphygmocor derived

Advanced glycation end products

AGE reader measurements

Full Information

NCT ID

NCT05440591

First Posted

June 27, 2022

Last Updated

June 29, 2022

Sponsor

Tan Tock Seng Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05440591

Brief Title

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

Acronym

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)

Study Type

Interventional

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Recruiting

Study Start Date

April 1, 2019 (Actual)

Primary Completion Date

May 10, 2023 (Anticipated)

Study Completion Date

May 10, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Tan Tock Seng Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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: To evaluate the influence on other parameters of vascular function and beds. To evaluate the haemodynamics involving blood pressure regulation. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Model Description

Open Label Parallel Randomised Controlled Trial

Masking

None (Open Label)

Allocation

Randomized

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Metformin

Arm Type

Active Comparator

Arm Description

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

Arm Title

Dapagliflozin

Arm Type

Experimental

Arm Description

Dapagliflozin 10 mg tablets - once daily

Arm Title

MetforminXR 500/Dapagliflozin 5mg

Arm Type

Experimental

Arm Description

MetforminXR 500/Dapagliflozin 5mg , tablets- once daily

Intervention Type

Drug

Intervention Name(s)

Dapagliflozin

Intervention Description

Dapagliflozin 10mg tablets

Intervention Type

Drug

Intervention Name(s)

MetFORMIN 500 Mg Oral Tablet

Intervention Description

Metformin 500 mg tablets twice daily

Intervention Type

Drug

Intervention Name(s)

Dapagliflozin / metFORMIN Pill

Intervention Description

Combination pill

Primary Outcome Measure Information:

Title

Endothelial Function measured as reactive hyperaemia index (RHI-EndoPAT)

Time Frame

3 months after initiation

Title

Carotid Femoral Pulse Wave Velocity

Description

Sphygmocor determined cf-PWV

Time Frame

3 months after initiation

Secondary Outcome Measure Information:

Title

Augmentation index

Description

Augmentation index-sphygmocor derived and RHI-endoPAT derived

Time Frame

3 months after initiation

Title

Central pulse pressure

Description

CPP-Sphygmocor derived

Time Frame

3 months after initiation

Title

Advanced glycation end products

Description

AGE reader measurements

Time Frame

3 months after initiation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 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% 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 is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the trial Exclusion Criteria: History of ketoacidosis or any other conditions causing acidosis e.g. Alcohol dependence Has a history of urinary tract infections or is at risk for urinary tract infections (e.g prostatomegaly, vesicoureteric reflux, kidney stones) Patients on corticosteroids or immunosuppressive agents Patients known to have HIV infection and/or on anti-retroviral agents 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. Has severe liver dysfunction Considered inappropriate by investigators due to any other reason. Female participant who is pregnant, lactating or planning pregnancy during the course of the trial. Significant renal impairment. Scheduled elective surgery or other procedures requiring general anaesthesia during the trial. Participants who have participated in another research trial involving an investigational product in the past 12 weeks. Participants who have a history of Peripheral Arterial Disease or peripheral vascular disease or complains of lower limb claudication pain. -

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Rinkoo Dalan, MBBS

Phone

63571000

rinkoo_dalan@ttsh.com.sg

First Name & Middle Initial & Last Name or Official Title & Degree

Siti Zaidah

Siti_zaidah_abu_bakar@ttsh.com.sg

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rinkoo Dalan

Organizational Affiliation

Tan Tock Seng Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Tan Tock Seng Hospital

City

Singapore

ZIP/Postal Code

308433

Country

Singapore

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Siti Zaidah

siti_zaidah_abu_bakar@ttsh.com.sg

First Name & Middle Initial & Last Name & Degree

Rnkoo Dalan, MBBS

12. IPD Sharing Statement

Learn more about this trial

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

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