Clinical Trials Register

Summary
EudraCT Number:	2017-001450-34
Sponsor's Protocol Code Number:	GL-GLAT1-3001
National Competent Authority:	Czechia - SUKL
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2017-12-13
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Czechia - SUKL

A.2

EudraCT number

2017-001450-34

A.3

Full title of the trial

An Open-label, Randomized, Multicenter, Phase III Study to Compare the
Immunogenicity, Efficacy, and Safety of Gan & Lee Pharmaceuticals Insulin Glargine Injection to Lantus® (Insulin Glargine Injection) in Adult Subjects with Type 1 Diabetes Mellitus

Nezaslepená, randomizovaná, multicentrická studie fáze III porovnávající imunogenitu, účinnost a bezpečnost injekce inzulinu glargin společnosti Gan & Lee Pharmaceuticals s přípravkem Lantus® (injekce inzulinu glargin) u dospělých pacientů s diabetes mellitus 1. typu

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

A Clinical Trial to Compare the effectiveness and safety of Gan & Lee Pharmaceuticals Insulin Glargine Injection to Lantus® (Insulin Glargine Injection) in Adults with Type 1 Diabetes Mellitus

Klinické hodnocení porovnávající účinnost a bezpečnost injekce inzulinu glargin společnosti Gan & Lee Pharmaceuticals s přípravkem Lantus® (injekce inzulinu glargin) u dospělých pacientů s diabetes mellitus 1. typu

A.3.2

Name or abbreviated title of the trial where available

GLITTER 1

A.4.1

Sponsor's protocol code number

GL-GLAT1-3001

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Gan & Lee Pharmaceuticals, USA
B.1.3.4	Country	United States
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Gan & Lee Pharmaceuticals, USA
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Gan & Lee Pharmaceuticals, USA
B.5.2	Functional name of contact point	Lawrence A. Hill, President and CEO
B.5.3	Address:
B.5.3.1	Street Address	520 US Highway 22 East, Suite 302
B.5.3.2	Town/ city	Bridgewater, NJ
B.5.3.3	Post code	08807
B.5.3.4	Country	United States
B.5.4	Telephone number	18882885395
B.5.6	E-mail	Lawrence.Hill@ganlee.us

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Gan & Lee Insulin Glargine
D.3.2	Product code	Gan & Lee Insulin Glargine
D.3.4	Pharmaceutical form	Solution for injection in pre-filled pen
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Insulin Glargine
D.3.9.1	CAS number	160337-95-1
D.3.9.2	Current sponsor code	Insulin Glargine
D.3.10	Strength
D.3.10.1	Concentration unit	U/ml unit(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	100
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Yes
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Lantus
D.2.1.1.2	Name of the Marketing Authorisation holder	Sanofi-Aventis Deutschland GmbH
D.2.1.2	Country which granted the Marketing Authorisation	Germany
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Insulin Glargine
D.3.4	Pharmaceutical form	Solution for injection in pre-filled pen
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	INSULIN GLARGINE
D.3.9.1	CAS number	160337-95-1
D.3.9.4	EV Substance Code	SUB08196MIG
D.3.10	Strength
D.3.10.1	Concentration unit	U/ml unit(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	100
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Type 1 diabetes mellitus

E.1.1.1

Medical condition in easily understood language

Type 1 diabetes mellitus

E.1.1.2

Therapeutic area

Diseases [C] - Nutritional and Metabolic Diseases [C18]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.1
E.1.2	Level	PT
E.1.2	Classification code	10067584
E.1.2	Term	Type 1 diabetes mellitus
E.1.2	System Organ Class	10027433 - Metabolism and nutrition disorders

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To evaluate equivalence of Gan & Lee Pharmaceuticals Insulin Glargine and Lantus® in terms of immunogenicity.

E.2.2

Secondary objectives of the trial

- Immunogenicity: To evaluate the percentage of subjects with negative anti-insulin antibodies (AIAs) at baseline who develop confirmed positive AIA up to visit Week 26, the percentage of subjects with at least a 4-fold increase in titers compared to baseline value, mean change from baseline in AIA titers between treatment groups, the percentage of subjects with confirmed positive AIA who develop any anti-insulin neutralizing antibodies up to visit Week 26, and the percentage of subjects who develop positive AIA up to visit Week 26 of Gan & Lee Pharmaceuticals insulin glargine injection in comparison with that of Lantus®.
- Safety: To evaluate the safety of Gan & Lee Pharmaceuticals insulin glargine injection in comparison with that of Lantus®
- Efficacy: To evaluate the efficacy of Gan & Lee Pharmaceuticals insulin glargine injection in comparison with that of Lantus®

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Male or nonpregnant, nonlactating female subjects between the ages of 18 and 75 years, inclusive
2. Ability to provide written, personally signed, and dated informed consent to participate in the study, in accordance with the ICH GCP Guideline E6 and all applicable regulations, before completing any study-related
procedures
3. Ability to understand and fully comply with all study procedures and restrictions
4. Subjects with a confirmed diagnosis of type 1 diabetes mellitus who have been on an approved basal and bolus insulin regimen for at least 6 months (the type or brand of insulin should not have changed in the 6 months before screening)
5. HbA1c < 11.0%
6. BMI ≥ 19 kg/m2 and ≤ 35 kg/m2
7. Adherence to a prudent diet and exercise regimen recommended by the medical provider, and willingness to maintain these consistently for the duration of the study
8. Concomitant medications are allowed, provided that no significant dosing changes are anticipated during the study (see the exclusion criteria below for specific prohibited concomitant medications); for concomitant thyroid medications, subjects must have been on a stable dosage for 90 days before screening

E.4

Principal exclusion criteria

1. Participation in another clinical study or use of any study drug within 30 days before screening
2. Previous use of a biosimilar insulin, either basal or bolus
3. Diabetic ketoacidosis within a year before screening
4. Brittle type 1 diabetes mellitus within the year before screening (eg, multiple hospitalizations related to diabetes mellitus and/or severe hypoglycemia for which the subject required 3rd party assistance)
5. Any severe, delayed sequela of diabetes mellitus, eg, worsening end-stage renal disease, advanced coronary artery disease, or myocardial infarction within the year before screening, or autonomic peristaltic problems, eg, gastroparesis
6. Anticipated change in insulin used during the study (change in dosage is allowed, but change in type or brand of insulin will result in the subject being withdrawn from the study)
7. Inadequately controlled thyroid disease, defined as a TSH or free T4 value > the upper limit of normal
8. BMI < 19 kg/m2 or > 35 kg/m2
9. Any clinically significant (in the opinion of the Investigator) hematology or chemistry test results at screening, including any liver function test > 3x the upper limit of normal (subjects with elevated
bilirubin due to Gilbert syndrome are eligible to participate)
10. Documented history of anti-insulin antibodies
11. Treatment with glucocorticosteroids, immunosuppressants, or cytostatic agents within 60 days before screening (newly-prescribed or high-dose corticosteroids are prohibited; chronically administered oral,
inhaled, topical, or intra-articular corticosteroids at a stable dosage are allowed if no increase in dose is anticipated during the study
12. Current use of medication intended to cause weight loss or weight gain
13. Alcohol or substance use disorder within the 2 years before screening
14. Any previous or anticipated treatment with interferons
15. Any history of malignant disease within 5 years before screening, except for adequately treated basal cell carcinoma
16. Severe concomitant physical or psychiatric diseases or conditions
17. A history of a positive test result for HIV, hepatitis B, or hepatitis C; any subject who has a positive test result during the study may continue at the discretion of the Investigator
18. Any history of pancreatitis or pancreatectomy
19. Any diagnosis or condition that requires the subject to undergo procedures that could decrease antibodies in plasma or that would require treatment with immunosuppressant agents
20. Any condition eg, splenectomy, autoimmune disease, or rheumatologic disease, that could affect immunologic responses, could indicate an altered immune system, or could require treatment with a
prohibited medication
21. Any unresolved infection or a history of active infection within 30 days before screening other than mild or viral illness (as judged by the Investigator)
22. Any other disease or condition that in the opinion of the Investigator could confound the study results or limit the subject’s ability to participate in the study or comply with follow-up procedures; or any other factor that would indicate a significant risk of loss to follow up
23. Intolerance or history of hypersensitivity to insulin glargine or any excipient of the IP
24. Inability or unwillingness to wear the CGM sensor as required for the study, or to comply with the concomitant medication requirements in the FreeStyle Libre Pro Indications and Important Safety Information, during the CGM periods

E.5 End points

E.5.1

Primary end point(s)

- Immunogenicity: The percentage of subjects in each treatment group who develop treatment induced AIA defined as treatment-emergent AIA development or important (at least a 4-fold) increase in titers and up to visit Week 26

E.5.1.1

Timepoint(s) of evaluation of this end point

26 weeks

E.5.2

Secondary end point(s)

- Efficacy:
o The change in HbA1c from baseline at visit 26 weeks
- Immunogenicity:
o The percentage of subjects in each treatment group with negative AIA at baseline who develop confirmed positive AIA after baseline up to visit Week 26
o The percentage of subjects in each treatment group with confirmed positive AIA at baseline and at least a 4-fold increase in titers after baseline and up to visit Week 26
o The mean change from baseline in each treatment group in AIA titers after baseline and up to visit Week 26
o The percentage of subjects in each treatment group with confirmed positive AIA after baseline and up to visit Week 26 who develop any anti-insulin neutralizing antibodies after baseline and up to visit Week 26
o The percentage of subjects in each treatment group with confirmed positive AIA after baseline and up to visit Week 26
- Safety:
o The incidence and severity of all treatment-emergent adverse events and the following subgroups:
• Hypoglycemia, which will be fully documented prospectively in the Hypoglycemic Events Record
• Serious adverse events, including fatal events
• Adverse events leading to termination of the study treatment and/or early withdrawal from the study
• IP-related adverse events
• Injection site reactions
o The incidence of clinically significant laboratory abnormalities
o The incidence of clinically significant abnormalities in ECG and vital signs
- Efficacy:
o The number and percentage of subjects who achieve an FBG test result of ≤ 6.0 mmol/L (< 108.0 mg/dL) at visit Week 26
o The number and percentage of subjects who achieve a HbA1c of < 7.0% at visit Week 26

E.5.2.1

Timepoint(s) of evaluation of this end point

Week 26,
Safety - throughout study

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Czech Republic

Germany

Hungary

Poland

Russian Federation

Spain

Ukraine

United States

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

Last Patient Last Treatment Visit

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

495

F.1.3

Elderly (>=65 years)

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

126

F.4.2.2

In the whole clinical trial

550

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

return to Standard of Care

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2018-02-19

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-12-13

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2019-07-17

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