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Diabetes Mellitus, Type 1Phase 3NCT03376789

Mylan Insulin Glargine Study

A Phase 3 study testing MYL-1501D product using manufacture process V and MYL-1501D product using manufacture process VI in people with Diabetes Mellitus, Type 1, run by Mylan Inc. at 38 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Diabetes Mellitus, Type 1
What is being tested?
MYL-1501D product using manufacture process V and MYL-1501D product using manufacture process VI
Could I receive a placebo?
No, everyone receives an active treatment
How many people
219 participants
Where
38 sitesUnited States
Study dates
29 Nov 2017to 10 Jan 2019
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 19Show fewer
  • 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.
  • Postmenopausal females must have had no regular menstrual bleeding for at least 1 year prior to screening.
  • Female subjects who report surgical sterilization must have had the procedure at least 6 months prior to screening.
  • All female subjects of childbearing potential must have negative pregnancy test results at screening and at clinic visits, as per the SCHEDULE OF ACTIVITIES (SOA).
  • If female subjects have male partners who have undergone vasectomy, the vasectomy must have occurred more than 6 months prior to screening

Who cannot join

  • 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.
Show all 35Show fewer
  • 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.
  • Subjects with a history of limb amputation as a complication of diabetes (at any time), or any vascular procedure during the 1 year prior to screening.
  • History of diabetic foot or diabetic ulcers in the 1 year prior to screening.
  • Any elective surgery requiring hospitalization planned during the study period.
  • Clinically significant major organ disorder at the time of screening including:
  • Uncontrolled hypertension, defined as stage 2 hypertension by Joint National Committee VII (even if therapy is ongoing, blood pressure ≥160 mm Hg systolic or ≥100 mm Hg diastolic).
  • Uncontrolled hyperlipidemia (even if therapy is ongoing, LDL >160 mg/dL or triglycerides >500 mg/dL).
  • Uncontrolled hyperthyroidism or hypothyroidism (subjects can be included if these conditions are controlled with thyroid hormones or anti-thyroid drugs).
  • Impaired hepatic function (alanine transaminase [ALT] or aspartate transaminase [AST] value >2 times the upper limit of the reference range and/or serum bilirubin 1.5 times the upper limit of the reference range at the screening visit). Subjects with evidence of Gilberts disease may be included in the study if they have total bilirubin of <3 mg/dL with indirect bilirubin contributing to >80% of the total bilirubin.
  • History of a significant medical condition, such as:
  • Clinically significant cardiac disease like unstable angina, myocardial infarction, grade 3 or 4 congestive heart failure (CHF) according to New York Heart Association criteria, valvular heart disease, cardiac arrhythmia requiring treatment, and pulmonary hypertension; during the year prior to screening.
  • Stroke or transient ischemic attack (TIA) in the 6 months before screening.
  • Subjects with major depressive illness in the last 3 years (those who have well-controlled depression for 3 months on a stable dose of antidepressants, with no major depressive episodes in the last 3 years, can be included, even if they are on medication), subjects with history of other severe psychiatric diseases (manic depressive psychosis [MDP], schizophrenia), which in the opinion of the investigator precludes the subject from participating in the study (recorded while collecting subject history).
  • History of hematological disorders that can affect the reliability of HbA1c estimation (hemoglobinopathies, hemolytic anemia, sickle cell anemia, etc.).
  • Subjects using the following in the 3 months prior to screening:
  • Insulin pump therapy
  • Any anti-diabetic drugs other than the study insulins allowed by the protocol.
  • Moderate insulin resistance, defined as requiring insulin of ≥1.5 U/IU/kg/day.
  • Subjects who have received ≥14 consecutive days of glucocorticoid therapy by oral, intravenous, inhaled or other routes that produce systemic effects within the past 1 year, or who have received steroids by any route (except intra-nasal, intra-ocular, and topical) within the 4 weeks immediately preceding screening.
  • Subjects diagnosed as having cancer (subjects with history of basal cell carcinoma, carcinoma in situ or squamous cell cancer of skin, or in remission >5 years, will be allowed).
  • Subjects who have donated blood or plasma in the 1 month prior to screening

Trial locations and contacts

38 sites in 1 country.

38 sites in 1 country

United States38 sites

  • Mylan Investigator Site

    Atlanta, Georgia, 30318

  • Mylan Investigator Site

    Austin, Texas, 78731

  • Mylan Investigator Site

    Bradenton, Florida, 34201

  • Mylan Investigator Site

    Columbus, Georgia, 31904

  • Mylan Investigator Site

    Council Bluffs, Iowa, 51501

  • Mylan Investigator Site

    Dallas, Texas, 75231

  • Mylan Investigator Site

    Denver, Colorado, 80246

  • Mylan Investigator Site

    Fort Lauderdale, Florida, 33312

  • Mylan Investigator Site

    Fort Myers, Florida, 33912

  • Mylan Investigator Site

    Fresno, California, 93720

  • Mylan Investigator Site

    Greenbrae, California, 94904

  • Mylan Investigator Site

    Hialeah, Florida, 33012

  • Mylan Investigator Site

    Huntington Beach, California, 92648

  • Mylan Investigator Site

    Idaho Falls, Idaho, 83404

  • Mylan Investigator Site

    La Mesa, California, 91942

  • Mylan Investigator Site

    Lawrenceville, Georgia, 30045

  • Mylan Investigator Site

    Los Gatos, California, 95032

  • Mylan Investigator Site

    Maitland, Florida, 32751

  • Mylan Investigator Site

    Meridian, Idaho, 83642

  • Mylan Investigator Site

    Miami, Florida, 33126

  • Mylan Investigator Site

    Miami, Florida, 33156

  • Mylan Investigator Site

    Miami, Florida, 33175

  • Mylan Investigator Site

    Mission Hills, California, 91345

  • Mylan Investigator Site

    Montclair, California, 91763

  • Mylan Investigator Site

    New Port Richey, Florida, 34652

  • Mylan Investigator Site

    Northridge, California, 91324

  • Mylan Investigator Site

    Oakland, California, 94607

  • Mylan Investigator Site

    Palm Harbor, Florida, 34684

  • Mylan Investigator Site

    Roswell, Georgia, 30076

  • Mylan Investigator Site

    Santa Monica, California, 90404

  • Mylan Investigator Site

    Spring Hill, Florida, 34609

  • Mylan Investigator Site

    Springfield, Illinois, 62701

  • Mylan Investigator Site

    St. Petersburg, Florida, 33709

  • Mylan Investigator Site

    Tampa, Florida, 33634

  • Mylan Investigator Site

    Tarzana, California, 91356

  • Mylan Investigator Site

    Tustin, California, 92780

  • Mylan Investigator Site

    Walnut Creek, California, 94598

  • Mylan Investigator Site

    West Palm Beach, Florida, 33401

Other trials in United States

About this study

Official title: A Randomized, Multi-center, Double-Blind, Parallel-Group Clinical Study Comparing the Efficacy and Safety of MYL-1501D Produced by Two Manufacturing Processes in Type 1 Diabetes Mellitus Patients

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).

Read the detailed description

This is a multicenter, double-blind, randomized, parallel-group Phase 3 study in subjects with type 1 diabetes mellitus (T1DM) comparing the efficacy, immunogenicity, and safety of MYL-1501D products from 2 manufacturing processes (Process V and Process VI). After a 2-week screening period, all subjects will be titrated on Lantus® during a 4-week run-in period and shifted from their current mealtime insulin to insulin lispro (Humalog®). Subjects will then be randomized (stratified by time of administration of glargine [morning and evening]) to 1 of 2 groups:

  • MYL-1501D product from Process V
  • MYL-1501D product from Process VI Treatment with MYL-1501D is for 18 weeks. A follow-up visit is scheduled 2 weeks after last dose of MYL 1501D.
Being tested
MYL-1501D product using manufacture process V, MYL-1501D product using manufacture process VI
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MYL-1501D product using manufacture process VDrug

    MYL-1501D product using manufacture process V

  • MYL-1501D product using manufacture process VIDrug

    MYL-1501D product using manufacture process VI

Study groups in NCT03376789
Study groupRoleWhat they receive
MYL-1501D (Process V Product)Active comparatorMYL-1501D (Process V Product)
Receives: Drug: MYL-1501D product using manufacture process V
MYL-1501D (Process VI Product)Active comparatorMYL-1501D (Process VI Product)
Receives: Drug: MYL-1501D product using manufacture process VI

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in HbA1c

    Change in HbA1c from baseline

    Measured: Baseline to Week 18

Secondary outcomes (3)

  1. Change in FPG

    Change in fasting plasma glucose from baseline

    Measured: Baseline to Week 18

  2. Change in Insulin Dose

    Change in daily total insulin dose per unit body weight (U/kg) from baseline

    Measured: Baseline to Week 18

  3. Change in 8-point SMBG

    Change in 8-point self-monitored blood glucose (SMBG) daily average

    Measured: Baseline to Week 18

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Dec 2017
  2. Study start29 Nov 2017
  3. Primary completion25 Sep 2018
  4. Study completion10 Jan 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
219 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03376789
Sponsor's protocol ID
MYL-1501D-3004
Status last verified
Mar 2022
First submitted
13 Dec 2017
Last updated
3 Mar 2022
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing MYL-1501D product using manufacture process V and MYL-1501D product using manufacture process VI in people with Diabetes Mellitus, Type 1, run by Mylan Inc. at 38 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 38 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in HbA1c (time frame: Baseline to Week 18). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03376789.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2022; AzTrials last refreshed its copy on 2 Nov 2026.

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