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Assessment of Pharmacological and Lifestyle Approaches for Inducing Remission in Type 2 Diabetes: The RT2D Trial

Reversing Type 2 Diabetes (RT2D): A Study on the Efficacy of Pharmacotherapy Versus Lifestyle Interventions for Achieving Remission - RT2D: Reversing Type 2 Diabetes

Status
Recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/11/097893
Enrollment
222
Registered
2025-11-21
Start date
Unknown
Completion date
Unknown
Last updated
2026-01-12

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: Combination Therapy Arm : oral semaglutide, dapagliflozin, and metformin along with basic medical nutrition therapy for 30 weeks Control Intervention1: Lifestyle Modification Arm: Metf

Sponsors

Indian Council of Medical Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Adults aged 18 70 years. 2.Diagnosed with Type 2 Diabetes Mellitus (T2DM) for less than two years. 3.HbA1c below 10%. 4.BMI between 25 and 40 kg/m .

Exclusion criteria

Exclusion criteria: 1.Type 1 Diabetes or other forms of diabetes. 2.Previous use of GLP-1 receptor agonists or SGLT-2 inhibitors (within last 3-months). 3.History of pancreatitis or severe gastrointestinal disorders. 4.Planning Pregnancy or Pregnant or breastfeeding. 5.Significant renal impairment (eGFR below 60 mL/min/1.73 m ) and hepatic impairment. 6.Patient suffering from any chronic infection like tuberculosis, hepatitis B and C. 7.Patient suffering from any malignancy. 8.Patients with personal or family history of medullary thyroid carcinoma

Design outcomes

Primary

MeasureTime frame
To determine the proportion of T2DM participants achieving remission(HbA1c below 6.5%)post-withdrawal of combination-therapy(oral semaglutide+dapagliflozin+metformin) along with medical nutrition-therapyTimepoint: Assessment over the period of three years

Secondary

MeasureTime frame
To evaluate the efficacy of lifestyle-modifications in achieving T2DM remission, with a liquid to semisolid-diet followed by gradual introduction of solid-diet and regular moderate exercise along-with metformin.Timepoint: Assessment over the period of three years;To compare the efficacy, and sustainability of remission between combination-pharmacotherapy and lifestyle-interventions.Timepoint: Assessment over the period of three years

Countries

India

Contacts

Public ContactDr Rama Walia

Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh

ramawalia@rediffmail.com9872997438

Outcome results

None listed

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