ArticleDiabetes therapy : research, treatment and education of diabetes and related disorders2025
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.
Article in Diabetes therapy : research, treatment and education of diabetes and related disorders, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04980027 (Multicentre Phase IV Single Arm Clinical Trial to evaluAte the saFety and Efficacy of Gla-300 in insUlin-naïve Patients With Type 2 DiAbetes uncontRolled on Oral Antihyperglycemic Drugs), which is not on this map. Not yet cited in PubMed.
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.
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.
Multicentre Phase IV Single Arm Clinical Trial to evaluAte the saFety and Efficacy of Gla-300 in insUlin-naïve Patients With Type 2 DiAbetes uncontRolled on Oral Antihyperglycemic Drugs
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionThe clinical benefits of insulin glargine 300 U/ml (Gla-300) have been confirmed in randomized clinical trials (EDITION and BRIGHT) and real-world studies (ATOS, Toujeo-1, and ORION) in different regions of the world. However, safety data for the Indian population are lacking. The current post-marketing surveillance study evaluated the safety and efficacy of Gla-300 in people with type 2 diabetes (T2D) from India.
methodsSAFEGUARD was a multicenter, phase 4, single-arm, open-label, 24-week study conducted at 15 centers across India between August 10, 2021 and December 26, 2022. The study included insulin-naïve participants (aged ≥ 18 years) with T2D uncontrolled (HbA1c ≥ 7.5% and ≤ 10%) on oral anti-hyperglycemic drugs. The primary endpoint was the percentage of participants with treatment-emergent adverse events (TEAEs), including serious adverse events (SAEs) and hypoglycemic episodes.
resultsOf the 220 participants included, 218 (36.8% female) were eligible for efficacy analysis. The mean ± standard deviation age was 54.0 ± 9.6 years, the baseline HbA1c was 8.8 ± 0.9%, and the duration of T2D was 9.3 ± 7.0 years. Among the 220 participants who took at least one dose of Gla-300, 24.5% (n = 54) reported 64 TEAEs, which included one (0.5%) SAE. The most reported event was infections (10.9%). In total, 29.5% of participants (n = 65) reported a level 1 hypoglycemic event, and 27.7% of participants (n = 18) reported the main symptom of sweating. Glycemic control improved with reductions in mean HbA1c levels (- 1.14 ± 1.2%), fasting plasma glucose (- 37.0 ± 59.3 mg/dl), and fasting self-monitored blood glucose (- 52.0 ± 44.1 mg/dl) from baseline to week 24.
conclusionsGla-300 was well tolerated with improved glycemic control and a low hypoglycemia risk in insulin-naïve people with T2D living in India.
trial registrationClinical Trials Registry-India (CTRI number): CTRI/2021/07/035244. WHO identifier number: U1111-1255-5143. NCT number: NCT04980027.
Indexed as
Identifiers
What Socratic holds
Registered trials
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.