NCT05440591

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for phase_4 diabetes

Timeline
Completed

Started Apr 2019

Longer than P75 for phase_4 diabetes

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2019

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

June 27, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 1, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2023

Completed
Last Updated

July 1, 2022

Status Verified

June 1, 2022

Enrollment Period

4.1 years

First QC Date

June 27, 2022

Last Update Submit

June 29, 2022

Conditions

Diabetes

Outcome Measures

Primary Outcomes (2)

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

    3 months after initiation

  • Carotid Femoral Pulse Wave Velocity

    Sphygmocor determined cf-PWV

    3 months after initiation

Secondary Outcomes (3)

  • Augmentation index

    3 months after initiation

  • Central pulse pressure

    3 months after initiation

  • Advanced glycation end products

    3 months after initiation

Study Arms (3)

Metformin

ACTIVE COMPARATOR

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

Drug: MetFORMIN 500 Mg Oral Tablet

Dapagliflozin

EXPERIMENTAL

Dapagliflozin 10 mg tablets - once daily

Drug: Dapagliflozin

MetforminXR 500/Dapagliflozin 5mg

EXPERIMENTAL

MetforminXR 500/Dapagliflozin 5mg , tablets- once daily

Drug: Dapagliflozin / metFORMIN Pill

Interventions

DapagliflozinDRUG

Dapagliflozin 10mg tablets

Dapagliflozin
MetFORMIN 500 Mg Oral TabletDRUG

Metformin 500 mg tablets twice daily

Metformin
Dapagliflozin / metFORMIN PillDRUG

Combination pill

MetforminXR 500/Dapagliflozin 5mg

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tan Tock Seng Hospital

Singapore, 308433, Singapore

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

dapagliflozinMetforminTablets

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic ChemicalsDosage FormsPharmaceutical Preparations

Study Officials

  • Rinkoo Dalan

    Tan Tock Seng Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rinkoo Dalan, MBBS

CONTACT

63571000rinkoo_dalan@ttsh.com.sg

Siti Zaidah

CONTACT

Siti_zaidah_abu_bakar@ttsh.com.sg

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Open Label Parallel Randomised Controlled Trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2022

First Posted

July 1, 2022

Study Start

April 1, 2019

Primary Completion

May 10, 2023

Study Completion

May 10, 2023

Last Updated

July 1, 2022

Record last verified: 2022-06

Locations

SG(1)