Evidence map›Paper›PMID 42070788›Full record

Trial reportDiabetes, obesity & metabolism2026

Sitagliptin, Metformin and Glimepiride Fixed-Dose Combination Compared to Co-Administration of Metformin and High-Dose Glimepiride in Indian Patients With Type 2 Diabetes: A Randomised, Double-Blind, Double-Dummy, Phase 3 Clinical Study.

Rakesh Sahay, Ambanna Gowda, Manish Kumar Singh, A Gopal Rao, Ramesh Duraisamy, Dinesh Gangwani, Jitendra Shukla, Vikas Agarwal, Sandesh Sahebarao Patil, Ambrish C and 13 more

Abstract readRandomized Controlled TrialClinical Trial, Phase IIIComparative Study
PubMed Full text at PMC Publisher
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 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. Trial
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

23 authors.

Rakesh SahayDepartment of Endocrinology, Osmania General Hospital, Hyderabad, Telangana, India.
Ambanna GowdaCitizen Hospital, Bengaluru, Karnataka, India.
Manish Kumar SinghDepartment of Medicine, Maya Hospital and Maternity Centre, Kanpur, Uttar Pradesh, India.
A Gopal RaoDepartment of Medicine, Government Medical College and Government General Hospital, Srikakulam, Andhra Pradesh, India.
Ramesh DuraisamyDepartment of Diabetology, Kovai Diabetes Speciality Centre and Hospital, Coimbatore, Tamil Nadu, India.
Dinesh GangwaniDepartment of Medicine, Priyadarshani Nursing Home, Virar, Maharashtra, India.
Jitendra ShuklaDepartment of Medicine, Moti Lal Nehru Medical College, Prayagraj, Uttar Pradesh, India.
Vikas AgarwalDepartment of Medicine, Surya Super Speciality Hospital, Varanasi, Uttar Pradesh, India.
Sandesh Sahebarao PatilDepartment of Medicine, Shree Siddhivinayak Maternity and Nursing Home, Maharashtra, India.
Ambrish CDepartment of Diabetology, Medstar Speciality Hospital, Bengaluru, Karnataka, India.
Satish Babu K NSparsh Super Speciality Hospital, Bengaluru, Karnataka, India.
Arvind PalawatDepartment of Medicine, Sawai Man Singh Medical College and Attached Hospitals, Jaipur, Rajasthan, India.
Sandip Krishnrao GofneDepartment of Medicine, District Civil Hospital, Aurangabad, Maharashtra, India.
Abhay Kumar SahooDepartment of Endocrinology and Metabolism, Institute of Medical Sciences and Sum Hospital, Bhubaneswar, Odisha, India.
Pradeep Kumar RaiDepartment of Internal Medicine and Nephrology, Opal Hospital Private Limited, Varanasi, Uttar Pradesh, India.
Raisa ShaikhMedical Affairs and Clinical Research, Sun Pharma Laboratories Limited, Mumbai, Maharashtra, India.
Shruti SahaMedical Affairs and Clinical Research, Sun Pharma Laboratories Limited, Mumbai, Maharashtra, India.
Dipak PatilMedical Affairs and Clinical Research, Sun Pharma Laboratories Limited, Mumbai, Maharashtra, India.ORCID https://orcid.org/0009-0008-8690-3302
Pravin GhadgeMedical Affairs and Clinical Research, Sun Pharma Laboratories Limited, Mumbai, Maharashtra, India.
Piyush PatelMedical Affairs and Clinical Research, Sun Pharma Laboratories Limited, Mumbai, Maharashtra, India.
Lalit LakhwaniMedical Affairs and Clinical Research, Sun Pharma Laboratories Limited, Mumbai, Maharashtra, India.
Suyog MehtaMedical Affairs and Clinical Research, Sun Pharma Laboratories Limited, Mumbai, Maharashtra, India.
Sadhna JoglekarMedical Affairs and Clinical Research, Sun Pharma Laboratories Limited, Mumbai, Maharashtra, India.

Funding

Sun Pharma Laboratories Limited
6 · The paper itself

Abstract

aimsThis study assessed the efficacy and safety of a triple fixed-dose combination (FDC) of sitagliptin, metformin, and glimepiride versus co-administered metformin and glimepiride in Indian patients with uncontrolled Type 2 diabetes (T2D). MATERIALS AND

methodsIn this Phase 3, randomised, double-blind, double-dummy study, adult patients with T2D and glycated haemoglobin (HbA

resultsOverall, 190 patients were randomised to the SITA + MET + GLIM group and 202 to the Co-administration group. The least squares mean (standard error) change from baseline in HbA

conclusionsThe triple FDC was superior to co-administered metformin and high-dose glimepiride for achieving glycaemic control and was well tolerated in Indian patients with T2D.

trial registrationClinical Trials Registry-India identifier: CTRI/2021/11/038169 (registered on 22 November 2021); URL: https://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=NjI1Mjk=&Enc=&userName=.

Indexed as

Diabetes Mellitus, Type 2Hypoglycemic AgentsMetforminSitagliptin PhosphateSulfonylurea CompoundsAdultAgedBlood GlucoseDouble-Blind MethodDrug CombinationsDrug Therapy, CombinationFemaleGlycated HemoglobinHumansHypoglycemiaIndiaBlood GlucoseDrug CombinationsglimepirideGlycated Hemoglobinhemoglobin A1c protein, humanHypoglycemic AgentsInsulin SecretagoguesMetforminSitagliptin PhosphateSulfonylurea Compoundsantidiabetic drugclinical trialDPP‐IV inhibitorglycaemic controlPhase III studyType 2 diabetes

Identifiers

PMID42070788
PMCPMC13243998

What Socratic holds

Texttitle and abstract
LicenceCC BY-NC-ND
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.