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Authors
Mohan, Viswanathan https://orcid.org/0000-0001-5038-6210
Sethi, Bipin
Jain, Sunil M.
Sahay, Rakesh
Ramanathan, Balamurugan
Murthy, Sreenivasa
Singh, Kiran Pal
Menon, Shalini
Gadekar, Arvind
Salvi, Vaibhav
Gandhi, Kedar
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Clinical Trials BETA
Clinical trials referenced in this document:
nct04980027 at ClinicalTrials.govDocuments that mention this clinical trial
Multicenter, Phase 4 Clinical Study from India to Evaluate the Safety and Efficacy of Insulin Glargine 300 U/ml in Insulin-Naïve People with Type 2 Diabetes Uncontrolled on Oral Anti-hyperglycemic Drugs: SAFEGUARD Study
https://doi.org/10.1007/s13300-025-01736-5
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Funding
Funding for this research was provided by:
Sanofi
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Article History
Received: 20 December 2024
Accepted: 25 March 2025
First Online: 8 May 2025
Declarations
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: Viswanathan Mohan has acted as a consultant and speaker and received research or educational grants from Sanofi, Servier, Novo Nordisk, Abbott, Boehringer Ingelheim, Eli Lilly, Lifescan, Roche, MSD, Novartis, Aventis, Bayer, USV, Dr. Reddy’s Laboratories, Sun Pharma, INTAS, Lupin, Glenmark, Zydus, IPCA, Torrent, Cipla, Biocon, Primus, Franco Indian, Wockhardt, Emcure, Mankind, Medtronics, Fourrts, Apex, GSK, and Alembic. Bipin Sethi has been an advisory board member or received speaker fees from Abbot, Bayer, Boehringer Ingelheim, MSD, USV, and Novo Nordisk. Rakesh Sahay is an advisory board member for Boehringer Ingelheim, Dr. Reddy’s Laboratories, Eli Lilly, and Sanofi and speaker for Boehringer Ingelheim, Eli Lilly, Novo Nordisk, and Sanofi. Balamurugan Ramanathan, Sunil Jain, Sreenivasa Murthy, and Kiran Pal Singh have nothing to disclose. Shalini Menon was an employee of Sanofi at the time of study conduct and preparation of this manuscript. Shalini Menon’s current affiliation is – Medical Affairs, GlaxoSmithKline, Mumbai, India. Arvind Gadekar, Vaibhav Salvi, and Kedar Gandhi are employees of Sanofi and may hold stock options.
: This study was performed in compliance with the International Council for Haromonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) and the principles laid down in the 1964 Declaration of Helsinki by the 18 th World Medical Assembly and its later amendments. The study is prospectively registered at the Clinical Trials Registry—India (CTRI number: CTRI/2021/07/035244) and at the International Clinical Trials Registry Platform – the WHO Registry Network (WHO identifier number: U1111 - 1255–5143). The study protocol was reviewed and approved by the Institutional Review Board/Institutional Ethics Committee at each study site in accordance with the country’s local regulations. All participants provided written informed consent.
