Diabetes remission trial with intensive lifestyle modification.

A randomized control trial to study remission of type 2 diabetes with intensive lifestyle modification versus a combination of oral semaglutide and dapagliflozin as an add-on to metformin monotherapy in comparison to standard medical management.A randomized control trial to study remission of type 2 diabetes with intensive lifestyle modification versus a combination of oral semaglutide and dapagliflozin as an add-on to metformin monotherapy in comparison to standard medical management. - DIAREM 3

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/06/069280

Enrollment

Registered

2024-06-20

Start date

Unknown

Completion date

Unknown

Last updated

2025-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E119- Type 2 diabetes mellitus without complications

Interventions

Intervention1: ORAL SEMAGLUTIDE PLUS DAPAGLIFLOZIN PLUS METFORMIN: patients will receive Dapagliflozin 5 mg and that will be escalated to 10 mg after one week, Semaglutide will be titrated as 3 mg for

Eligibility

Inclusion criteria

Inclusion criteria: TYPE 2 DIABETES DIAGNOSED LESS THAN 2 YEARS BACK AND HBA1C LESS THAN 9% WERE THE INCLUSION CRITERIA

Exclusion criteria

Exclusion criteria: CHRONIC DISEASE GAD65 POSITIVE CKD,CLD,NEPHROPATHY, RETINOPATHY.

Design outcomes

Primary

Measure	Time frame
1)To determine the remission rates of Type 2 Diabetes in participants undergoing intensive lifestyle modification compared to those receiving combination therapy of oral Semaglutide and Dapagliflozin as an add-on to Metformin monotherapy, in comparison to control arm receiving glimepride and vildagliptin in combination with Metformin. 2)Exploration of transcriptome and epigenome landscape and determine its correlation with the remission of diabetes. Timepoint: At 3 months and at 6 months.	—

Measure

Time frame

1)To determine the remission rates of Type 2 Diabetes in participants undergoing intensive lifestyle modification compared to those receiving combination therapy of oral Semaglutide and Dapagliflozin as an add-on to Metformin monotherapy, in comparison to control arm receiving glimepride and vildagliptin in combination with Metformin. 2)Exploration of transcriptome and epigenome landscape and determine its correlation with the remission of diabetes. Timepoint: At 3 months and at 6 months.

—

Secondary

Measure	Time frame
Secondary outcome: To measure changes in beta- cell function following treatment, as assessed by mixed meal tolerance test. Timepoint: At 3 months & at 6 months	—

Countries

India

Contacts

Public ContactRAMA WALIA

PGIMER

ramawaliapgimer@gmail.com9872997438

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026