Evidence mapPaperPMID 42219226Full record

Trial reportDiabetes, obesity & metabolism2026

Semaglutide Injection in Indian Patients With Type 2 Diabetes Mellitus: A Randomised, Phase III, Active-Controlled Study.

Unnikrishnan Ambika Gopalakrishnan, Ameya Sudhakar Joshi, Richa Giri, Shalin Jagdeep Shah, Jitendra Shukla, Sanjiv Maheshwari, Rekha M Chowdaiah, Manish Kumar Singh, Aditya Srirang Bari, Niranjan Pandurang Pathak and 24 more

Abstract readRandomized Controlled TrialClinical Trial, Phase IIIMulticenter Study
In one paragraph

Trial report in Diabetes, obesity & metabolism, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Trial
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

34 authors.

Unnikrishnan Ambika GopalakrishnanChellaram Diabetes Institute, Pune, Maharashtra, India.
Ameya Sudhakar JoshiBhaktivedanta Hospital and Research Institute, Thane, Maharashtra, India.
Richa GiriGSVM Medical College, Kanpur, Uttar Pradesh, India.
Shalin Jagdeep ShahRatan Multi-Speciality Hospital, Ahmedabad, Gujarat, India.
Jitendra ShuklaMotilal Nehru Medical College, Prayagraj, Uttar Pradesh, India.
Sanjiv MaheshwariJawahar Lal Nehru Medical College, Ajmer, Rajasthan, India.
Rekha M ChowdaiahMandya Institute of Medical Science, Mandya, Karnataka, India.
Manish Kumar SinghMaya Hospital and Maternity Centre, Kanpur, Uttar Pradesh, India.
Aditya Srirang BariPulse Multispeciality Hospital, Pune, Maharashtra, India.
Niranjan Pandurang PathakOjas Multispeciality Hospital, Pune, Maharashtra, India.
Akash Nitinbhai ShahHealth 1 Super Speciality Hospital, Ahmedabad, Gujarat, India.
Shweta BhandariVincare Hospital, Bathinda, Punjab, India.ORCID https://orcid.org/0000-0002-0008-7949
Ambanna GowdaCitizen Hospital, Bangalore, Karnataka, India.
Ambrish ChandrappaMedstar Speciality Hospital, Bangalore, Karnataka, India.
Pravin Dinkar SupeSupe Heart & Diabetes Hospital & Research Centre, Nashik, Maharashtra, India.
Bharat DasSparsh Hospitals and Critical Care, Bhubaneswar, Odisha, India.
Prabhat Kumar SharmaMaharaja Agrasen Superspeciality Hospital, Jaipur, Rajasthan, India.
Mehul Kalubhai ViraniGlobal Hospital, Surat, Gujarat, India.
Prakash Harishchandra KurmiShivam Hospital, Ahmedabad, Gujarat, India.
Gayatri Amit GhanekarAsian Institute of Medical Sciences, Dombivli, Maharashtra, India.
Mani Deepathi DasariRajalakshmi Hospital & Research Center, Bangalore, Karnataka, India.
Banshidhar SahooKanungo Institute of Diabetes Specialities, Bhubaneshwar, Odisha, India.
Sanjay Kumar JangidHi-Tech Medical College & Hospital, Bhubaneswar, Odisha, India.
Prakash Sadashiv ShendeLokmanya Medical Research Center, Pune, Maharashtra, India.
Sandesh Sahebarao PatilShree Siddhivinayak Maternity & Nursing Home, Nashik, Maharashtra, India.
Avinash Narayan KumbharAster Aadhar Hospital (Prerna Hospital), Kolhapur, Maharashtra, India.
Shrikant Vishnu DeshpandeAshirwad Hospital and Research Centre, Ulhasnagar, Maharashtra, India.
Madhusudhan ChennappaNRR Hospital, Bangalore, Karnataka, India.
Nitesh Chandubhai PatelSamarpan Hospital, Ahmedabad, Gujarat, India.
Dipesh SonawaneSun Pharma Laboratories Limited, Mumbai, Maharashtra, India.ORCID https://orcid.org/0009-0006-9837-006X
Dipak PatilSun Pharma Laboratories Limited, Mumbai, Maharashtra, India.ORCID https://orcid.org/0009-0008-8690-3302
Sucheta PanditSun Pharma Laboratories Limited, Mumbai, Maharashtra, India.
Pravin GhadgeSun Pharma Laboratories Limited, Mumbai, Maharashtra, India.
Suyog MehtaSun Pharma Laboratories Limited, Mumbai, Maharashtra, India.

Funding

Sun Pharmaceutical Industries Limited
6 · The paper itself

Abstract

aimTo evaluate the efficacy, safety and immunogenicity of semaglutide injection (synthetic) (Test group) compared with the Reference semaglutide injection [Ozempic, (Reference group)] in Indian patients with Type 2 diabetes mellitus (T2DM). MATERIALS AND

methodsThis Phase III, randomised, open-label, multi-centre, parallel-group, active-controlled non-inferiority study was conducted across 35 centres in India. Adults aged 18-65 years with T2DM and baseline glycated haemoglobin (HbA1c) ≥ 7.0% to ≤ 10.5% despite stable metformin therapy and diet & exercise control were randomised (1:1) to receive subcutaneous injections of Test semaglutide or Reference semaglutide once weekly for 24 weeks, using an identical dose-escalation regimen (from 0.25 to 2.0 mg per week). The primary endpoint was change in HbA1c from baseline to Week 24. Secondary endpoints included changes in fasting and post-prandial blood glucose, bodyweight and HbA1c < 7.0% achievers, safety and immunogenicity.

resultsA total of 314 patients were randomised, and 290 patients completed the study. At Week 24, both treatments produced significant and comparable reductions in HbA1c (Test: -2.04%, Reference: -1.95%; p < 0.0001 within groups). The least-squares mean difference (Test-Reference) was -0.09% (95% CI: -0.26 to 0.09), meeting the pre-specified non-inferiority criterion. Improvements in fasting and post-prandial blood glucose, patients achieving HbA1c < 7.0% and bodyweight were similar between the two groups. The most common treatment-emergent adverse events were predominantly mild-to-moderate gastrointestinal events (Test vs. Reference: 43.3% vs. 46.5%). No anti-drug or neutralising antibodies were detected.

conclusionsThe Test synthetic semaglutide injection demonstrated non-inferior glycaemic efficacy, comparable safety in comparison to Reference semaglutide, supporting its use as an effective therapeutic option for patients with T2DM. Prospectively registered on the Clinical Trials Registry-India, CTRI/2025/02/080592 [Registered on: 14/02/2025], URL: https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=MTIwODUw&Enc=&userName=.

Indexed as

Diabetes Mellitus, Type 2Glucagon-Like PeptidesHypoglycemic AgentsAdolescentAdultAgedBlood GlucoseFemaleGlycated HemoglobinHumansIndiaInjections, SubcutaneousMaleMiddle AgedSemaglutideTreatment OutcomeBlood GlucoseGlucagon-Like PeptidesGlycated Hemoglobinhemoglobin A1c protein, humanHypoglycemic AgentsSemaglutideGLP‐1 receptor agonistglycaemic controlimmunogenicitynon‐inferiority trialsemaglutidetype 2 diabetes mellitus

Identifiers

PMID42219226
PMCPMC13341390

What Socratic holds

Texttitle and abstract
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.