Lilly Insulin Glargine Versus Lantus ®  in Type 2 Diabetes Mellitus Patients: India and East Asia Subpopulation Analyses of the ELEMENT 5 Study

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Abstract

Background and Objectives

Lilly insulin glargine (LY IGlar; Basaglar ^®) and the reference insulin glargine product (IGlar; Lantus ^®) are basal insulin glargine analogs with identical amino acid sequence and similar pharmacological profiles. ELEMENT 5, a Phase 3, prospective, randomized, multinational, two-arm, active-controlled, open-label, parallel-design study in type 2 diabetes mellitus (T2DM) patients ( N = 493) showed similar efficacy and safety profiles with LY IGlar and IGlar. This study reports results from India ( N = 100) and East Asia ( N = 134) subpopulations.

Methods

Patients from India and East Asia (Korea and Taiwan) with T2DM who were insulin naïve (glycated hemoglobin (HbA1c) ≥ 7.0% and ≤ 11.0%) or on basal insulin (HbA1c ≤ 11.0%) were randomized to receive LY IGlar or IGlar along with oral antihyperglycemic medications (OAMs) for 24 weeks. Patients were instructed to self-titrate from the starting dose by 1 unit/day until fasting blood glucose (FBG) ≤ 5.6 mmol/L (100 mg/dL) was achieved. The key outcome was HbA1c change from baseline to Week 24.

Results

Within-group least-squares mean (LSM) decrease (baseline to Week 24) in HbA1c was similar between treatments. The upper limit of confidence interval (CI) for treatment difference was below the defined 0.4% noninferiority margin in India (LY IGlar: − 0.83%; IGlar: − 0.62%; difference [95% CI] − 0.21 [− 0.70, 0.28]) and East Asia (LY IGlar: − 1.28%; IGlar: − 1.26%; difference [95% CI] − 0.02 [− 0.34, 0.30]) subpopulations. Results of other efficacy and safety endpoints at Week 24 were similar between treatments in both subpopulations. LSM self-monitored FBG levels were similar between treatments at all visits in both subpopulations except at Week 24 in the India subpopulation (LY IGlar: 5.65 [0.10] mmol/L or 101.8 [1.86] mg/dL; IGlar: 5.18 [0.10] mmol/L or 93.3 [1.75] mg/dL; p = 0.002).

Conclusion

Efficacy and safety profiles of LY IGlar and IGlar, in combination with OAMs, were similar in India and East Asia subpopulations. This was consistent with the ELEMENT 5 total population.

Clinical Trial Registration

NCT02302716.

Electronic supplementary material

The online version of this article (10.1007/s40261-019-00798-1) contains supplementary material, which is available to authorized users.

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Most cited references 18

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Pharmacokinetics and pharmacodynamics of subcutaneous injection of long-acting human insulin analog glargine, NPH insulin, and ultralente human insulin and continuous subcutaneous infusion of insulin lispro.

M Lepore, S Pampanelli, C Fanelli … (2000)

To compare the pharmacokinetics/dynamics of the long-acting insulin analog glargine with NPH, ultralente, and continuous subcutaneous (SC) infusion of insulin lispro (continuous subcutaneous insulin infusion [CSII]), 20 C-peptide-negative type 1 diabetic patients were studied on four occasions during an isoglycemic 24-h clamp. Patients received SC injection of either 0.3 U/kg glargine or NPH insulin (random sequence, crossover design). On two subsequent occasions, they received either an SC injection of ultralente (0.3 U/kg) or CSII (0.3 U x kg(-1) x 24 h(-1)) (random sequence, crossover design). After SC insulin injection or CSII, intravenous (IV) insulin was tapered, and glucose was infused to clamp plasma glucose at 130 mg/dl for 24 h. Onset of action (defined as reduction of IV insulin >50%) was earlier with NPH (0.8 +/- 0.2 h), CSII (0.5 +/- 0.1 h), and ultralente (1 +/- 0.2 h) versus glargine (1.5 +/- 0.3 h) (P 150 mg/dl) occurred later with glargine (22 +/- 4 h) than with NPH (14 +/- 3 h) (P < 0.05) but was similar with ultralente (20 +/- 6 h). NPH and ultralente exhibited a peak concentration and action (at 4.5 +/- 0.5 and 10.1 +/- 1 h, respectively) followed by waning, whereas glargine had no peak but had a flat concentration/action profile mimicking CSII. Interindividual variability (calculated as differences in SD of plasma insulin concentrations and glucose infusion rates in different treatments) was lower with glargine than with NPH and ultralente (P < 0.05) but was similar with glargine and CSII (NS). In conclusion, NPH and ultralente are both peak insulins. Duration of action of ultralente is greater, but intersubject variability is also greater than that of NPH. Glargine is a peakless insulin, it lasts nearly 24 h, it has lower intersubject variability than NPH and ultralente, and it closely mimics CSII, the gold standard of basal insulin replacement.

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Diabetes mellitus and its complications in India.

Ranjit Unnikrishnan, Ranjit Mohan Anjana, Viswanathan Mohan (2016)

India is one of the epicentres of the global diabetes mellitus pandemic. Rapid socioeconomic development and demographic changes, along with increased susceptibility for Indian individuals, have led to the explosive increase in the prevalence of diabetes mellitus in India over the past four decades. Type 2 diabetes mellitus in Asian Indian people is characterized by a young age of onset and occurrence at low levels of BMI. Available data also suggest that the susceptibility of Asian Indian people to the complications of diabetes mellitus differs from that of white populations. Management of this disease in India faces multiple challenges, such as low levels of awareness, paucity of trained medical and paramedical staff and unaffordability of medications and services. Novel interventions using readily available resources and technology promise to revolutionise the care of patients with diabetes mellitus in India. As many of these challenges are common to most developing countries of the world, the lessons learnt from India's experience with diabetes mellitus are likely to be of immense global relevance. In this Review, we discuss the epidemiology of diabetes mellitus and its complications in India and outline the advances made in the country to ensure adequate care. We make specific references to novel, cost-effective interventions, which might be of relevance to other low-income and middle-income countries of the world.

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Is Open Access

Diabetes in Asians

Eun-Jung Rhee (2015)

The prevalence of diabetes is increasing globally, particularly in Asia. According to the 2013 Diabetes Atlas, an estimated 366 million people are affected by diabetes worldwide; 36% of those affected live in the Western Pacific region, with a significant proportion in East Asia. The reasons for this marked increase in the prevalence of diabetes can be extrapolated from several distinct features of the Asian region. First, the two most populated countries, China and India, are located in Asia. Second, Asians have experienced extremely rapid economic growth, including rapid changes in dietary patterns, during the past decades. As a result, Asians tend to have more visceral fat within the same body mass index range compared with Westerners. In addition, increased insulin resistance relative to reduced insulin secretory function is another important feature of Asian individuals with diabetes. Young age of disease onset is also a distinctive characteristic of these patients. Moreover, changing dietary patterns, such as increased consumption of white rice and processed red meat, contributes to the deteriorated lifestyle of this region. Recent studies suggest a distinctive responsiveness to novel anti-diabetic agents in Asia; however, further research and efforts to reverse the increasing prevalence of diabetes are needed worldwide.

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Author and article information

Contributors

Indranil Bhattacharya:

ORCID: http://orcid.org/0000-0002-6074-6272

bhattacharya_indranil@lilly.com

Journal

Journal ID (nlm-ta): Clin Drug Investig

Journal ID (iso-abbrev): Clin Drug Investig

Title: Clinical Drug Investigation

Publisher: Springer International Publishing (Cham )

ISSN (Print): 1173-2563

ISSN (Electronic): 1179-1918

Publication date (Electronic): 22 May 2019

Publication date PMC-release: 22 May 2019

Publication date (Print): 2019

Volume: 39

Issue: 8

Pages: 745-756

Affiliations

[1 ]ISNI 0000 0004 1805 2183, GRID grid.410867.c, Dr. Mohan’s Diabetes Specialities Centre and Madras Diabetes Research Foundation, ; Chennai, India

[2 ]ISNI 0000 0001 2171 7818, GRID grid.289247.2, Kyung Hee University Hospital at Gangdong, Kyung Hee University School of Medicine, ; Seoul, South Korea

[3 ]ISNI 0000 0001 0302 820X, GRID grid.412484.f, Department of Endocrinology and Metabolism, , Seoul National University Hospital, ; Seoul, South Korea

[4 ]ISNI 0000 0001 2112 3753, GRID grid.417029.9, Osmania Medical College and Osmania General Hospital, ; Hyderabad, India

[5 ]ISNI 0000 0004 0638 9256, GRID grid.411645.3, Chung Shan Medical University Hospital, ; Taichung, Taiwan

[6 ]ISNI 0000 0004 1803 0590, GRID grid.470178.d, Bharti Hospital, ; Karnal, India

[7 ]GRID grid.417189.2, P. D. Hinduja National Hospital and Medical Research Centre, ; Mumbai, India

[8 ]GRID grid.459511.d, Eli Lilly and Company (India) Pvt. Ltd, ; Plot No 92, Sector 32, Institutional Area, Gurgaon, Haryana 122001 India

[9 ]Eli Lilly and Company, Seoul, South Korea

[10 ]ISNI 0000 0004 0533 9169, GRID grid.435900.b, Eli Lilly Deutschland GmbH, ; Bad Homburg, Germany

Author information

Indranil Bhattacharya http://orcid.org/0000-0002-6074-6272

Article

Publisher ID: 798

DOI: 10.1007/s40261-019-00798-1

PMC ID: 6656918

PubMed ID: 31119716

SO-VID: 249bdef1-2268-45e6-91d8-118e856b1392

License:

Open AccessThis article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License ( http://creativecommons.org/licenses/by-nc/4.0/), which permits any noncommercial use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.

History

Funding

Funded by: FundRef http://dx.doi.org/10.13039/100004312, Eli Lilly and Company;

Funded by: FundRef http://dx.doi.org/10.13039/100001003, Boehringer Ingelheim;

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Lilly Insulin Glargine Versus Lantus ^® in Type 2 Diabetes Mellitus Patients: India and East Asia Subpopulation Analyses of the ELEMENT 5 Study

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Abstract

Background and Objectives

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Results

Conclusion

Clinical Trial Registration

Electronic supplementary material

Related collections

RNA drug delivery

Most cited references 18

Pharmacokinetics and pharmacodynamics of subcutaneous injection of long-acting human insulin analog glargine, NPH insulin, and ultralente human insulin and continuous subcutaneous infusion of insulin lispro.

Diabetes mellitus and its complications in India.

Diabetes in Asians

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