The primary objective of this post hoc analysis was to assess the change in HbA1c from baseline to 6 months in insulin-naive participants with T2DM treated with Gla-100 in the Indian subgroups of FINE ASIA and GOAL studies. The secondary objectives were to evaluate the changes in fasting plasma glucose (FPG), body weight, and insulin dose and to assess the incidence of hypoglycemia (from baseline to the end of 6 months). A snapshot of the FINE ASIA and GOAL study is provided in Supplementary Fig. 1. Hypoglycemia was considered according to the definitions in the individual registries [20,21,22].

The analysis of hypoglycemia events included symptomatic or documented events according to the individual registries [20, 21].

This post hoc analysis pooled data from the multinational observational studies, FINE ASIA and GOAL, which included insulin-naïve participants from India who were started on Gla-100 as part of routine clinical practice.

FINE ASIA: This observational study was carried out from 2005 to 2010 in 132 centers/sites across 11 different Asian countries (Bangladesh, China, Hong Kong, India, Indonesia, Korea, Pakistan, Singapore, Taiwan, Thailand, and Vietnam). The Indian data subset and sites were considered for the current study [20]. (Supplementary Fig. 1).

GOAL: This observational study was carried out from October 2012 to January 2015 in ten developing countries from Africa (Egypt, South Africa), the Middle East (Israel, Saudi Arabia, United Arab Emirates, Iran, and Lebanon), and South Asia (Bangladesh, India, and Pakistan). For the current analyses, only the Indian data subset and sites were considered [21]. (Supplementary Fig. 1).

India subset from FINE ASIA and GOAL registries meeting the eligibility criteria (diagnosed with inadequately controlled T2DM, aged ≥ 18 years, insulin-naïve, initiated on Gla-100 treatment, and received consistent treatment with Gla-100 from baseline to 6 months) was considered for the study. The India subset from FINE ASIA and GOAL registries who failed to complete the 6-month follow-up were excluded.

Since this is an analysis of a pre-existing database (FINE ASIA and GOAL), no case report form was used. Statistical analysis software [SAS version 9.4 (SAS Institute, USA)] along with Analysis Data Model (ADaM) format was used. ADaM format defines the standards used for the creation of analysis datasets and associated metadata. It is used for data derivation and analysis. The pooling of two datasets was performed by SAS.

The data were analyzed using descriptive statistics. Quantitative data were presented as mean and median with standard deviation (SD) and ranges, respectively. Qualitative data were presented by frequency and proportions. Study participant characteristics and treatment patterns were analyzed. Mean change from baseline to 6 months was analyzed using paired t-test. A p value < 0.05 was considered statistically significant.

Being a retrospective analysis, as per the applicable local regulations, approval of the study protocol, protocol amendments, and other relevant documents from an independent ethics committee registered with the National Ethics Committee Registry for Biomedical and Health Research, Department of Health Research (NECRBHR, DHR) were obtained prior to the study initiation. The primary studies were conducted in accordance with the ethical principles laid down by the Helsinki Declaration of 1964, and its later amendments, all international applicable guidelines, and national laws and regulations of each country. Written informed consent was provided by study participants for both studies. Appropriate measures were taken to ensure the confidentiality of the data [20, 21].