Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

PK/PD Biosimilarity Study of Gan & Lee Insulin Glargine Injection vs.US & EU Lantus® in Type 1 Diabetes Mellitus Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04236895
Recruitment Status : Completed
First Posted : January 22, 2020
Last Update Posted : January 22, 2020
Sponsor:
Information provided by (Responsible Party):
Gan and Lee Pharmaceuticals, USA

Brief Summary:

Primary objectives:

To demonstrate biosimilarity with regard to the total and maximum pharmacokinetic exposure during one dosing interval (AUC ins. 0-24h, Cins.

max) of Gan & Lee Insulin Glargine with Lantus® (US RLD / EU RP) in subjects with type 1 diabetes

To demonstrate biosimilarity with regard to the total and maximum pharmacodynamic response during one dosing interval (AUC GIR.0-24h, GIR max) of Gan & Lee Insulin Glargine with Lantus® (US RLD / EU RP) in subjects with type 1 diabetes

Secondary objectives:

To compare the pharmacokinetic and pharmacodynamic properties of Gan & Lee Insulin Glargine and of Lantus® (US RLD / EU RP)

To assess the safety and tolerability of Gan & Lee Insulin Glargine and of Lantus® (US RLD / EU RP)


Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Drug: Gan & Lee Insulin Glargine Injection Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 114 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: The trial will be a randomized, double-blind, multicenter, single-dose, 3-way crossover, 3-treatment, euglycemic glucose clamp trial in male subjects with type 1 diabetes mellitus
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Glucose Clamp Trial Investigating the Biosimilarity of Gan & Lee Insulin Glargine Injection (Insulin Glargine 100 U/mL) With US and EU Lantus® Comparator Products in Patients With Type 1 Diabetes Mellitus
Actual Study Start Date : July 10, 2018
Actual Primary Completion Date : November 28, 2018
Actual Study Completion Date : November 28, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Active Comparator: Lantus ® US
Insulin glargine (Lantus®, product approved and marketed in the USA (US RLD)), 100 U/mL in 3 mL pre-filled pens
Drug: Gan & Lee Insulin Glargine Injection
All IMPs will be administered as a 0.5 U/kg single subcutaneous dose by a pre-filled pen.

Active Comparator: Lantus ® EU
Insulin glargine (Lantus®, product marketed in Germany (EU RP)), 100 U/mL in 3 ml pre-filled pens
Drug: Gan & Lee Insulin Glargine Injection
All IMPs will be administered as a 0.5 U/kg single subcutaneous dose by a pre-filled pen.

Experimental: Gan & Lee Insulin Glargine
Insulin glargine 100 U/mL in 3 mL pre-filled pens
Drug: Gan & Lee Insulin Glargine Injection
All IMPs will be administered as a 0.5 U/kg single subcutaneous dose by a pre-filled pen.




Primary Outcome Measures :
  1. PK endpoint [ Time Frame: Up to 24 hours ]
    AUCins. 0 - 24h, area under the serum insulin concentration curve from 0 to 24. hours

  2. PK endpoint [ Time Frame: Up to 30 hrs ]
    Cins.max, maximum observed insulin concentration.

  3. PD endpoint [ Time Frame: Up to 24 hours ]
    AUC GIR.0-24h, area under the glucose infusion rate curve from 0 to 24 hours.

  4. PD endpoint [ Time Frame: Up to 30 hrs ]
    GIR max, maximum observed glucose infusion rate


Secondary Outcome Measures :
  1. Secondary PK endpoint [ Time Frame: Up to 24 hrs ]
    AUC ins.0-12h, AUC ins.12 - 24h, AUC ins.0 -inf., areas under the serum insulin concentration curve in the indicated time intervals

  2. Secondary PK endpoint [ Time Frame: Up to 30 hrs ]
    tmax.ins, time to maximum observed serum insulin concentration

  3. Exploratory PK endpoint [ Time Frame: Up to 30 hrs ]
    t½, terminal serum elimination half-life calculated as t½=ln2/λz and

  4. Exploratory PK endpoint [ Time Frame: Up to 30 hrs ]
    λz, terminal elimination rate constant

  5. Secondary PD endpoint [ Time Frame: Up to 24 hrs ]
    AUC GIR.0 - 12h, AUC GIR.12 - 24h, areas under the glucose infusion rate curve in the indicated time-intervals

  6. Secondary PD endpoint [ Time Frame: Up to 30 hrs ]
    AUC GIR.0 - last, area under the glucose infusion rate curve from 0 hours until the end of clamp

  7. Secondary PD endpoint [ Time Frame: Up to 30 hrs ]
    t max.GIR, time to maximum glucose infusion rate

  8. Exploratory PD endpoint [ Time Frame: Up to 30 hrs ]
    Duration of action, time until blood glucose levels is consistently above 150 mg/dL

  9. Exploratory PD endpoint [ Time Frame: Up to 30 hrs ]
    Time to onset of action, time from trial product administration until blood glucose concentration has decreased at least 5 mg/dL from baseline, where baseline is defined as the mean of blood glucose levels from - 6 to - 2 minutes before trial product administration as measured by ClampArt.

  10. Safety endpoints [ Time Frame: Up to 12 Weeks ]
    As measured by treatment-emergent adverse events



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed and dated informed consent obtained before any trial-related activities. (Trial-related activities are any procedures that would not have been performed during normal management of the subject).
  • Male subjects with type 1 diabetes mellitus for at least 12 months prior to screening as diagnosed clinically.
  • Age between 18 and 64 years, both inclusive.
  • Body Mass Index (BMI) between 18.5 and 29.0 kg/m^2, both inclusive.
  • HbA1c <= 9.0%.
  • Fasting negative C-peptide (<= 0.30 nmol/L).
  • Total insulin dose of < 1.2 (I)U/kg/day.
  • Stable insulin regimen for at least 2 months prior to screening (with respect to safety of the subject and scientific integrity of the trial).
  • Considered generally healthy (apart from type 1 diabetes mellitus) upon completion of medical history, physical examination, vital signs, ECG and analysis of laboratory safety variables, as judged by the Investigator

Exclusion Criteria:

  • Known or suspected hypersensitivity to IMPs or related products
  • Previous participation in this trial. Participation is defined as randomized
  • Receipt of any medicinal product in clinical development within 30 days or 5 half-lives (whichever is longer) before randomization in this trial
  • History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction
  • Any history or presence of cancer except basal cell skin cancer or squamous cell skin cancer as judged by the Investigator
  • Any history or presence of clinically relevant comorbidity (with the exception of conditions associated with diabetes mellitus), or signs of acute illness, as judged by the Investigator
  • Proliferative retinopathy or maculopathy (based on a recent (<1.5 years) ophthalmologic examination) and/or severe neuropathy, in particular autonomic neuropathy, as judged by the Investigator
  • Recurrent severe hypoglycemia (more than 1 severe hypoglycemic event during the past 6 months) or hypoglycemic unawareness as judged by the Investigator
  • Increased risk of thrombosis, e.g. subjects with a history of deep leg vein thrombosis or family history of deep leg vein thrombosis, as judged by the Investigator
  • Significant history of alcoholism or drug abuse as judged by the Investigator or consuming more than 24 grams alcohol/day
  • Symptomatic hypotension or supine blood pressure at screening (after resting for at least 5 min in supine position) outside the range of 90-140 mmHg for systolic or greater than 90 mmHg for diastolic pressure
  • Heart rate at rest outside the range of 50-90 beats per minute
  • Clinically significant abnormal standard 12-lead ECG after 5 minutes resting in supine position at screening, as judged by the Investigator
  • A positive result in the alcohol and/or urine drug screen at the screening visit
  • Not able or willing to refrain from smoking and use of nicotine substitute products one day before and during the inpatient period
  • Positive to the screening test for Hepatitis Bs antigen or Hepatitis C antibodies and/or a positive result to the test for HIV-1/2 antibodies or HIV-1 antigen
  • Any medication (prescription and non-prescription drugs) within 14 days before IMP administration, with the exception of occasional use of Paracetamol or NSAIDs
  • Blood donation or blood loss of more than 500 mL within the last 3 months
  • Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
  • Fertile male with female partner(s) without using a highly effective contraceptive method in combination with spermicide-coated condoms from the first dosing until 1 month after dosing

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04236895


Locations
Layout table for location information
Germany
Profil Mainz GmbH & Co. KG
Mainz, Germany, 55116
Profil Institut für Stoffwechselforschung GmbH
Neuss, Germany, 41460
Sponsors and Collaborators
Gan and Lee Pharmaceuticals, USA
Investigators
Layout table for investigator information
Study Director: Jia Lu, PhD Gan & Lee Pharmaceuticals, USA
Principal Investigator: Leona Plum - Mörschel, MD, PD Profil Mainz GmbH & Co KG

Layout table for additonal information
Responsible Party: Gan and Lee Pharmaceuticals, USA
ClinicalTrials.gov Identifier: NCT04236895    
Other Study ID Numbers: GL-GLA-CT1002
First Posted: January 22, 2020    Key Record Dates
Last Update Posted: January 22, 2020
Last Verified: January 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gan and Lee Pharmaceuticals, USA:
Diabetes
Diabetes Type 1
Type 1
Basal
Insulin
Glargine
T1DM
Diabetes Mellitus
Insulin Dependent Diabetes
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Insulin, Globin Zinc
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs