Immunogenicity Study of Insulin Glargine Ezelin vs Lantus in Type 2 Diabetes Mellitus Patients

Diabetes Mellitus Clinical Trial

Official title:

Open Label Randomized Multicenter Clinical Trial to Compare Immunogenicity of Insulin Glargine Ezelin vs Lantus in Type 2 Diabetes Mellitus Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03352674
• Other study ID #: IndonesiaU-01
• Status: Completed
• Phase: Phase 2
• Start date: September 2016
• Est. completion date: December 1, 2018

Study information

• Verified date: March 2020
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is an open-label randomised multicenter clinical study to compare immunogenicity of the drug products Insulin Glargine (Kalbe Farma) and Lantus (Sanofi -Aventis) in type 2 diabetes mellitus patients

Description:

Previous study has revealed that Insulin Glargine (Kalbe Farma) has similar efficacy with Lantus (Sanofi-Aventis) in controlling blood glucose in type 2 diabetes mellitus patients, but the immunogenicity potential of this product has not been known. Therefore, the present study is aiming to compare immunogenicity of Insulin Glargine (Kalbe Farma) and Lantus (Sanofi-Aventis) in type 2 diabetes mellitus patients in an open-label randomised multicenter clinical study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 133
• Est. completion date: December 1, 2018
• Est. primary completion date: December 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Men or women, 18 years old and above

• Diabetes mellitus type 2 patients who has failed an oral hypoglycemic drug products, insulin-naive, disease duration of at least 6 months, inadequate glycemic control (HbA1c > 7.0 %)

• BMI ranged from 19 - 35 kg/m2

• Consent from patients of childbearing potential to use contraception method throughout the study

• Signed informed consent form

Exclusion Criteria:

• History of diabetic ketoacidosis more than 2 times in the past 1 year

• History of pancreatectomy

• Estimated glomerular filtration rate <30 mL/min

• Positive ZnT8 Antibody

• Treatment with glucocorticoids, immunodepressant or cytostatics in 60 days before study.

• Any malignant disease, including in medical history

• Drugs and alcohol abuse, including in medical history

• Hipersensitivity to insulin glargine or any excipient of the drugs from medical history

• Mental disorders

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Insulin Glargine Ezelin
Insulin Glargine (Ezelin) once daily at individually adjusted dose
• Insulin Glargine Pen Injector [Lantus]
Insulin Glargine (Lantus) once daily at individually adjusted dose

Locations

Country	Name	City	State
Indonesia	Department of Internal Medicine Cipto Mangunkusumo Hospital, Faculty of Medicine Universitas Indonesia	Jakarta Pusat	Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

References & Publications (14)

Bingley PJ. Clinical applications of diabetes antibody testing. J Clin Endocrinol Metab. 2010 Jan;95(1):25-33. doi: 10.1210/jc.2009-1365. Epub 2009 Oct 29. Review. — View Citation

Chakkarwar PN, Manjrekar NA. Insulin glargine: a long acting insulin analog. J Postgrad Med. 2005 Jan-Mar;51(1):68-71. Review. — View Citation

Garber AJ, Abrahamson MJ, Barzilay JI, Blonde L, Bloomgarden ZT, Bush MA, Dagogo-Jack S, Davidson MB, Einhorn D, Garvey WT, Grunberger G, Handelsman Y, Hirsch IB, Jellinger PS, McGill JB, Mechanick JI, Rosenblit PD, Umpierrez G, Davidson MH; American Asso — View Citation

McKeage K, Goa KL. Insulin glargine: a review of its therapeutic use as a long-acting agent for the management of type 1 and 2 diabetes mellitus. Drugs. 2001;61(11):1599-624. Review. — View Citation

Pan CY, Sinnassamy P, Chung KD, Kim KW; LEAD Study Investigators Group. Insulin glargine versus NPH insulin therapy in Asian Type 2 diabetes patients. Diabetes Res Clin Pract. 2007 Apr;76(1):111-8. Epub 2006 Oct 2. — View Citation

Pihoker C, Gilliam LK, Hampe CS, Lernmark A. Autoantibodies in diabetes. Diabetes. 2005 Dec;54 Suppl 2:S52-61. Review. — View Citation

Rosenstock J, Dailey G, Massi-Benedetti M, Fritsche A, Lin Z, Salzman A. Reduced hypoglycemia risk with insulin glargine: a meta-analysis comparing insulin glargine with human NPH insulin in type 2 diabetes. Diabetes Care. 2005 Apr;28(4):950-5. — View Citation

Rosenstock J, Davies M, Home PD, Larsen J, Koenen C, Schernthaner G. A randomised, 52-week, treat-to-target trial comparing insulin detemir with insulin glargine when administered as add-on to glucose-lowering drugs in insulin-naive people with type 2 dia — View Citation

Rosenstock J, Schwartz SL, Clark CM Jr, Park GD, Donley DW, Edwards MB. Basal insulin therapy in type 2 diabetes: 28-week comparison of insulin glargine (HOE 901) and NPH insulin. Diabetes Care. 2001 Apr;24(4):631-6. — View Citation

Rubin RR, Peyrot M, Siminerio LM. Health care and patient-reported outcomes: results of the cross-national Diabetes Attitudes, Wishes and Needs (DAWN) study. Diabetes Care. 2006 Jun;29(6):1249-55. — View Citation

Stumvoll M, Goldstein BJ, van Haeften TW. Type 2 diabetes: principles of pathogenesis and therapy. Lancet. 2005 Apr 9-15;365(9467):1333-46. Review. — View Citation

Vaziri-Sani F, Oak S, Radtke J, Lernmark K, Lynch K, Agardh CD, Cilio CM, Lethagen AL, Ortqvist E, Landin-Olsson M, Törn C, Hampe CS. ZnT8 autoantibody titers in type 1 diabetes patients decline rapidly after clinical onset. Autoimmunity. 2010 Dec;43(8):5 — View Citation

Wild S, Roglic G, Green A, Sicree R, King H. Global prevalence of diabetes: estimates for the year 2000 and projections for 2030. Diabetes Care. 2004 May;27(5):1047-53. — View Citation

Yki-Järvinen H, Juurinen L, Alvarsson M, Bystedt T, Caldwell I, Davies M, Lahdenperä S, Nijpels G, Vähätalo M. Initiate Insulin by Aggressive Titration and Education (INITIATE): a randomized study to compare initiation of insulin combination therapy in ty — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of immune response	Production of antibodies against insulin /IAA and ZnT8 antibody in investigational drug product and comparator groups	6 months
Secondary	HbA1c	change in HbA1c level after 6 months of therapy compared to baseline value	6 months
Secondary	Fasting blood glucose	Change in fasting blood glucose	6 months
Secondary	Hypoglycemia	Incidence and severity of hypoglycaemia cases	6 months
Secondary	Adverse events	Incidence and severity of adverse events	6 months