Mylan Insulin Glargine Study

NCT03376789 | Completed Phase 3 Results FDA Drug

• 1 other identifier: MYL-1501D-3004
• Study Type: interventional
• Target: 219
• Locations: 1 country
• Sites: 38

Brief Summary

The aim of this study is to demonstrate similar efficacy and safety between MYL-1501D products produced from two manufacturing processes (Process V and Process VI) in combination with insulin lispro in patients with type 1 diabetes mellitus (T1DM).

Conditions

Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c

  Change in HbA1c from baseline

  Baseline to Week 18

Secondary Outcomes (3)

• Change in FPG

  Baseline to Week 18

• Change in Insulin Dose

  Baseline to Week 18

• Change in 8-point SMBG

  Baseline to Week 18

Study Arms (2)

MYL-1501D (Process V Product)

ACTIVE COMPARATOR

MYL-1501D (Process V Product)

Drug: MYL-1501D product using manufacture process V

MYL-1501D (Process VI Product)

ACTIVE COMPARATOR

MYL-1501D (Process VI Product)

Drug: MYL-1501D product using manufacture process VI

Interventions

MYL-1501D product using manufacture process V DRUG

MYL-1501D product using manufacture process V

MYL-1501D (Process V Product)

MYL-1501D product using manufacture process VI DRUG

MYL-1501D product using manufacture process VI

MYL-1501D (Process VI Product)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written and signed informed consent needs to be provided by subjects or their legal representatives before starting any protocol-specific procedures.
• Male and female subjects between the ages of 18 to 65 years, both ages inclusive.
• Subjects with an established diagnosis of T1DM per ADA 2017 criteria who also fulfil the following criteria:
• Initiation of insulin treatment within 6 months of T1DM diagnosis
• Treatment with basal-bolus insulin therapy for at least 1 year before screening
• Fasting plasma C-peptide \<0.3 nmol/L at screening
• Subject has been on once daily Lantus® at stable dose (±15% variation in dose) for at least 3 months at screening
• Body mass index (BMI) of 18.5 to 35 kg/m2 at screening (both values inclusive).
• Stable weight, with no more than 5 kg gain or loss in the 3 months prior to screening, this information will be collected by subject interview during medical history.
• Glycosylated hemoglobin (HbA1c) ≤ 9.5% at screening.
• Hemoglobin ≥9.0 g/dL at screening.
• Subject has the capability of communicating appropriately with the investigator.
• Subject is able and willing to comply with the requirements of the study protocol including the 8-point self-monitored blood glucose (SMBG), completion of subject diary records and following a recommended diet and exercise plan for the entire duration of the study.
• Female subjects of childbearing potential who are willing to use oral contraception or two acceptable methods of contraception, (e.g., intra-uterine device plus condom, spermicidal gel plus condom, diaphragm plus condom, etc.), from the time of screening and for the duration of the study, through study completion.
• Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.

You may not qualify if:

• History or presence of a medical condition or disease that in the investigator's opinion would place the subject at an unacceptable risk from study participation.
• History of hypersensitivity to any of the active or inactive ingredients of the insulin/insulin analogue preparations used in the study, OR history of significant allergic drug reactions.
• History of use of animal insulin within the last 3 years or use of approved biosimilar insulin glargine at any time prior to study entry, except for subject who previously participated in MYL-1501D studies and were compliant with the study protocols.
• History of use of a regular immunomodulator therapy in the 1 year prior to screening.
• History of autoimmune disorders other than T1DM or insufficiently treated autoimmune thyroid disorders judged clinically relevant by the investigator (recorded while collecting subject history).
• History of ≥1 episodes of diabetic ketoacidosis or emergency room visits for uncontrolled diabetes leading to hospitalization within the 6 months prior to screening.
• History of clinically significant acute bacterial, viral or fungal systemic infections in the last 4 weeks prior to screening (recorded while collecting subject history).
• Any clinically significant abnormality in electrocardiogram (ECG) or safety laboratory tests (LFT, RFT, hematology or any other laboratory deemed clinically relevant by the investigator) conducted at screening and considered by the investigator to make the subject ineligible for the study.
• Serological evidence of human immunodeficiency virus (HIV), hepatitis B surface antigen (HbSAg) or hepatitis C antibodies (HCVAb) at screening.
• History of drug or alcohol dependence or abuse during the 1 year prior to screening.
• Receipt of another investigational drug in the 3 months prior to screening (or as per local regulations), or if the screening visit is within 5 half-lives of another investigational drug received (whichever is longer), or scheduled to receive another investigational drug during the current study period.
• Subjects with the following secondary complications of diabetes:
• Active proliferative retinopathy as confirmed by a dilated ophthalmoscopy examination / retinal photography (performed by a person legally authorized to do so) within the 6 months prior to screening.
• Clinical nephrotic syndrome or diabetic nephropathy with a serum creatinine level \>1.5 times of upper limit of reference range at screening
• History of severe form of neuropathy or cardiac autonomic neuropathy, recorded while collecting subject history. Subject's with mild or moderate forms of neuropathy will be allowed.

Sponsors & Collaborators

• Mylan Inc.: lead
• Mylan GmbH: collaborator

Study Sites (38)

Mylan Investigator Site

Fresno, California, 93720, United States

Location

Mylan Investigator Site

Greenbrae, California, 94904, United States

Location

Mylan Investigator Site

Huntington Beach, California, 92648, United States

Location

Mylan Investigator Site

La Mesa, California, 91942, United States

Location

Mylan Investigator Site

Los Gatos, California, 95032, United States

Location

Mylan Investigator Site

Mission Hills, California, 91345, United States

Location

Mylan Investigator Site

Montclair, California, 91763, United States

Location

Mylan Investigator Site

Northridge, California, 91324, United States

Location

Mylan Investigator Site

Oakland, California, 94607, United States

Location

Mylan Investigator Site

Santa Monica, California, 90404, United States

Location

Mylan Investigator Site

Tarzana, California, 91356, United States

Location

Mylan Investigator Site

Tustin, California, 92780, United States

Location

Mylan Investigator Site

Walnut Creek, California, 94598, United States

Location

Mylan Investigator Site

Denver, Colorado, 80246, United States

Location

Mylan Investigator Site

Bradenton, Florida, 34201, United States

Location

Mylan Investigator Site

Fort Lauderdale, Florida, 33312, United States

Location

Mylan Investigator Site

Fort Myers, Florida, 33912, United States

Location

Mylan Investigator Site

Hialeah, Florida, 33012, United States

Location

Mylan Investigator Site

Maitland, Florida, 32751, United States

Location

Mylan Investigator Site

Miami, Florida, 33126, United States

Location

Mylan Investigator Site

Miami, Florida, 33156, United States

Location

Mylan Investigator Site

Miami, Florida, 33175, United States

Location

Mylan Investigator Site

New Port Richey, Florida, 34652, United States

Location

Mylan Investigator Site

Palm Harbor, Florida, 34684, United States

Location

Mylan Investigator Site

Spring Hill, Florida, 34609, United States

Location

Mylan Investigator Site

St. Petersburg, Florida, 33709, United States

Location

Mylan Investigator Site

Tampa, Florida, 33634, United States

Location

Mylan Investigator Site

West Palm Beach, Florida, 33401, United States

Location

Mylan Investigator Site

Atlanta, Georgia, 30318, United States

Location

Mylan Investigator Site

Columbus, Georgia, 31904, United States

Location

Mylan Investigator Site

Lawrenceville, Georgia, 30045, United States

Location

Mylan Investigator Site

Roswell, Georgia, 30076, United States

Location

Mylan Investigator Site

Idaho Falls, Idaho, 83404, United States

Location

Mylan Investigator Site

Meridian, Idaho, 83642, United States

Location

Mylan Investigator Site

Springfield, Illinois, 62701, United States

Location

Mylan Investigator Site

Council Bluffs, Iowa, 51501, United States

Location

Mylan Investigator Site

Austin, Texas, 78731, United States

Location

Mylan Investigator Site

Dallas, Texas, 75231, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Keri L Vaughan
• Organization: Director Global Clinical Operations, General Medicine

keri.vaughan@mylan.com

+1 267.980.5015

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2017
• First Posted: December 18, 2017
• Study Start: November 29, 2017
• Primary Completion: September 25, 2018
• Study Completion: January 10, 2019
• Last Updated: March 3, 2022
• Results First Posted: March 3, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (38)