Extension Study to Assess Safety and Efficacy of Mylan's Insulin Glargine and Lantus® in Type 1 Diabetes Mellitus (T1DM) Patients

NCT02666430 | Completed Phase 3 Results

• 1 other identifier: MYL-1501D-3003
• Study Type: interventional
• Target: 127
• Locations: 8 countries
• Sites: 81

Brief Summary

The aim of this extension study is to assess the safety and efficacy of Mylan's insulin glargine and Lantus® in T1DM patients.

Conditions

Type 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Change in Hemoglobin A1c (HbA1c) From Baseline

  Baseline to 36 weeks

Secondary Outcomes (10)

• Change From Baseline in Fasting Plasma Glucose

  Baseline to 36 weeks

• Overall Average of Self-monitoring Blood Glucose (SMBG) Change From Baseline

  Baseline to 36 weeks

• Change From Baseline Total Daily Insulin Dose

  Baseline to 36 weeks

• Local and Systemic Allergic Reactions

  Baseline to 40 weeks

• Hypoglycemic Rate

  Baseline to 36 weeks

Study Arms (2)

Mylan's insulin glargine

EXPERIMENTAL

Patients will be administered either Mylan insulin glargine or Lantus® subcutaneously, once daily in combination with lispro and titrated based on blood glucose readings per standard of care for a total of thirty-six (36) weeks, split into three cycles of twelve (12) weeks each.

Drug: Mylan's insulin glargine

Lantus®

ACTIVE COMPARATOR

Patients will be administered either Mylan insulin glargine or Lantus® subcutaneously, once daily in combination with lispro and titrated based on blood glucose readings per standard of care for a total of thirty-six (36) weeks, split into three cycles of twelve (12) weeks each.

Drug: Lantus®

Interventions

Mylan's insulin glargine DRUG

Mylan's insulin glargine

Lantus® DRUG

Lantus®

Eligibility Criteria

• Age: 18 Years - 66 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who have completed the 52-week treatment period (irrespective of their age at the completion of MYL-GAI-3001 trial) of the MYL-GAI-3001 trial and were assigned to Lantus® in that study.
• Patients or their legal representatives must give written and signed informed consent before starting any protocol-specific procedures.
• The patient is able and willing to comply with the requirements of the extension study protocol including the 8-point self-monitoring blood glucose, completion of patient diary records as instructed and following a recommended diet and exercise plan for the entire duration of the extension study.
• Female patients complying with the following:
• Female patients of childbearing potential must be using oral contraception or two other acceptable methods of contraception, (e.g., intra-uterine device plus condom, spermicidal gel plus condom, diaphragm plus condom, etc.) from the time of randomization throughout the entire study.
• Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
• All female patients of childbearing potential, must have negative pregnancy test results at baseline (week 0) and at each clinic visit as per the SCHEDULE OF ACTIVITIES.

You may not qualify if:

• History or presence of a medical condition or disease that in the Investigator's opinion would place the patient at an unacceptable risk from trial participation.
• Patients scheduled to receive another investigational drug during the extension study period
• Any major elective surgery requiring hospitalization planned during the extension study period.
• Moderate insulin resistance, defined as requiring insulin (Basal + Prandial) of ≥1.5 U/kg/day (Lantus® in U/kg/day or Mylan's insulin glargine in IU/kg/day).

Sponsors & Collaborators

• Mylan Inc.: lead
• Mylan GmbH: collaborator

Study Sites (81)

Mylan Investigator Site

Fresno, California, 93720, United States

Location

Mylan Investigator Site

Greenbrae, California, 94904, United States

Location

Mylan Investigator Site

La Jolla, California, 92037, United States

Location

Mylan Investigator Site

Northridge, California, 91324, United States

Location

Mylan Investigator Site

Tustin, California, 92780, United States

Location

Mylan Investigator Site

Fort Lauderdale, Florida, 33312, 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

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

Idaho Falls, Idaho, 83404, United States

Location

Mylan Investigator Site

Crystal Lake, Illinois, 60012, United States

Location

Mylan Investigator Site

Springfield, Illinois, 62711, United States

Location

Mylan Investigator Site

Des Moines, Iowa, 50314, United States

Location

Mylan Investigator Site

Overland Park, Kansas, 66210, United States

Location

Mylan Investigator Site

Lexington, Kentucky, 40503, United States

Location

Mylan Investigator Site

Billings, Montana, 59101, United States

Location

Mylan Investigator Site

Omaha, Nebraska, 68131, United States

Location

Mylan Investigator Site

Albany, New York, 12206, United States

Location

Mylan Investigator Site

Staten Island, New York, 10301, United States

Location

Mylan Investigator Site

Syracuse, New York, 13210, United States

Location

Mylan Investigator Site

Asheville, North Carolina, 28803, United States

Location

Mylan Investigator Site

Burlington, North Carolina, 27215, United States

Location

Mylan Investigator Site

Greenville, North Carolina, 27834, United States

Location

Mylan Investigator Site

Morehead City, North Carolina, 28557, United States

Location

Mylan Investigator Site

Wilmington, North Carolina, 28401, United States

Location

Mylan Investigator Site

Cincinnati, Ohio, 45236, United States

Location

Mylan Investigator Site

Mentor, Ohio, 44060, United States

Location

Mylan Investigator Site

Chattanooga, Tennessee, 37411, United States

Location

Mylan Investigator Site

Austin, Texas, 78731, United States

Location

Mylan Investigator Site

Dallas, Texas, 75231, United States

Location

Mylan Investigator Site

San Antonio, Texas, 78258, United States

Location

Mylan Investigator Site

Ogden, Utah, 84405, United States

Location

Mylan Investigator Site

Salt Lake City, Utah, 84121, United States

Location

Mylan Investigator Site

Chesapeake, Virginia, 23321, United States

Location

Mylan Investigator Site

Renton, Washington, 98057, United States

Location

Mylan Investigator Site

Tacoma, Washington, 98405, United States

Location

Mylan Investigator Site

Vancouver, Washington, 98664, United States

Location

Mylan Investigator Site

Red Deer, Alberta, Canada

Location

Mylan Investigator Site.

Vancouver, British Columbia, Canada

Location

Mylan Investigator Site

Winnipeg, Manitoba, Canada

Location

Mylan Investigator Site

Laval, Quebec, Canada

Location

Mylan Investigator Site

Montreal, Quebec, Canada

Location

Mylan Investigator Site

Brno-Bohunice, 625 00, Czechia

Location

Mylan Investigator Site

České Budějovice, 370 01, Czechia

Location

Mylan Investigator Site

Olomouc, 77900, Czechia

Location

Mylan Investigator Site

Pardubice, 530 02, Czechia

Location

Mylan Investigator Site

Prague, 100 34, Czechia

Location

Mylan Investigator Site

Prague, 120 00, Czechia

Location

Mylan Investigator Site

Pärnu, 80018, Estonia

Location

Mylan Investigator Site

Tallinn, 13419, Estonia

Location

Mylan Investigator Site

Tartu, 51014, Estonia

Location

Mylan Investigator Site

Aschaffenburg, Bavaria, 63739, Germany

Location

Mylan Investigator Site

Münster, North Rhine-Westphalia, 48145, Germany

Location

Mylan Investigator Site

Hohenmölsen, Saxony-Anhalt, 06679, Germany

Location

Mylan Investigator Site

Hamburg, 20173, Germany

Location

Mylan Investigator Site

Hamburg, 22607, Germany

Location

Mylan Investigator Site

Budapest, 1033, Hungary

Location

Mylan Investigator Site

Budapest, 1088, Hungary

Location

Mylan Investigator Site

Eger, 3300, Hungary

Location

Mylan Investigator Site

Létavértes, 4281, Hungary

Location

Mylan Investigator Site

Miskolc, 3530, Hungary

Location

Mylan Investigator Site

Szeged, H-6722, Hungary

Location

Mylan Investigator Site

Limbaži, LV-4001, Latvia

Location

Mylan Investigator Site

Ogre, LV-5001, Latvia

Location

Mylan Investigator Site

Riga, LV-1011, Latvia

Location

Mylan Investigator Site

Riga, LV-1050, Latvia

Location

Mylan Investigator Site

Sigulda, LV-2150, Latvia

Location

Mylan Investigator Site

Talsi, LV-3200, Latvia

Location

Mylan Investigator Site

Bratislava, 82107, Slovakia

Location

Mylan Investigator Site

Bratislava, 85101, Slovakia

Location

Mylan Investigator Site

Dolný Kubín, 02601, Slovakia

Location

Mylan Investigator Site

Levice, 93401, Slovakia

Location

Mylan Investigator Site

Ľubochňa, 03491, Slovakia

Location

Mylan Investigator Site

Nové Zámky, 940 02, Slovakia

Location

Mylan Investigator Site

Prievidza, 97101, Slovakia

Location

Mylan Investigator Site

Rimavská Sobota, 97901, Slovakia

Location

Mylan Investigator Site

Štúrovo, 94301, Slovakia

Location

Mylan Investigator Site

Trebišov, 07501, Slovakia

Location

Mylan Investigator Site

Žilina, 01001, Slovakia

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Insulin Glargine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

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

keri.vaughan@mylan.com

+1 267.980.5015

Study Officials

• Thomas Blevins

  Texas Diabetes & Endocrinology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2016
• First Posted: January 28, 2016
• Study Start: December 1, 2015
• Primary Completion: March 1, 2017
• Study Completion: July 1, 2017
• Last Updated: March 3, 2022
• Results First Posted: September 14, 2020

Record last verified: 2022-03

Locations

LA (6); HU (6); CZ (6); CA (5); ES (3); US (39); DE (5); SL (11)