Non-inferiority Study to Compare the Efficacy and Safety of Mylan's Insulin Glargine With Lantus® in Type 2 Diabetes Mellitus Patients (INSTRIDE 2)

Type 2 Diabetes Clinical Trial

— INSTRIDE 2  

Official title:

An Open-label, Randomized, Multi-center, Parallel Group Clinical Trial Comparing the Efficacy and Safety of Mylan's Insulin Glargine With Lantus® in Type 2 Diabetes Mellitus Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02227875
• Other study ID #: MYL-GAI-3002
• Status: Completed
• Phase: Phase 3
• Start date: August 2014
• Est. completion date: December 2015

Study information

• Verified date: March 2022
• Source: Viatris Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To test whether Mylan's insulin glargine once daily is non-inferior to Lantus® once daily (both administered in combination with other anti-diabetic drugs) based on the change in HbA1c from baseline to 24 weeks

Description:

This trial is a multi-center, open-label, randomized, parallel group trial in patients with T2DM comparing the efficacy and safety of Mylan's insulin glargine with that of Lantus®. Patients with an established diagnosis of T2DM per ADA 2014 criteria and who satisfy the selection criteria will be included in the trial. This will be followed by a 24-week randomized, comparative, parallel-assignment treatment period with Mylan's insulin glargine or Lantus® (in addition to other anti-diabetic drugs). After the treatment period, there will be a follow-up visit; 4 weeks after the patient has been put back on approved medications.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 560
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patients with an established diagnosis of T2DM per ADA 2014 criteria who also fulfill the following:

• Diagnosis established 1 year prior to screening

• Insulin-naïve OR

• On Lantus® once daily at stable dose (±15% variation in dose) for at least 3 months prior to screening

• Body mass index (BMI) of 18.50 to 40.00 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 patient interview during medical history.

• Hemoglobin =9.0 g/dL at screening

• Glycosylated hemoglobin (HbA1c) of <10.5% or between 7.5 to 10.5% for insulin naïve patients at screening.

Exclusion Criteria:

• History of hypersensitivity to any of the active or inactive ingredients of the insulin/insulin analog preparations used in the trial, OR history of significant allergic drug reactions.

• History of use of animal insulin within the last 3 years, any insulin other than Lantus® within the last 3 months prior to screening, or use of biosimilar insulin glargine at any time prior to screening.

• Patients requiring basal-bolus insulin therapy or who in the opinion of the investigator require mealtime insulin in order to achieve glycemic control.

• Regular use of immune-modulator therapy in the 1 year prior to screening.

• History of =2 episodes of severe hypoglycemia within the 6 months before screening or history of hypoglycemia unawareness (a sample questionnaire is provided in Appendix I) as judged by the investigator.

• History of =1 episode of hyperglycemic hyperosmolar coma or emergency room visits for uncontrolled diabetes leading to hospitalization within the 6 months prior to screening.

• Serological evidence of human immunodeficiency virus (HIV), hepatitis B (HbSAg) or hepatitis C (HCVAb) antibodies 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 (whichever is longer), or scheduled to receive another investigational drug during the current trial period.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• Mylan's insulin glargine
Patients who are randomized to receive Mylan's insulin glargine during the comparative phase will receive the same dose as the dose of Lantus® received during the screening period. The recommended starting dose of Mylan's insulin glargine or Lantus®, in patients with T2DM who are not currently treated with insulin is 10 units (or 0.2 Units/kg) once daily, which should subsequently be adjusted every week if essential.
• Lantus®
For patients who are randomized to receive Lantus® during the comparative phase the dose of Lantus® will be equal to the dose received during the screening period.

Locations

Country	Name	City	State
Jordan	Mylan Investigational Site	Amman
Jordan	Mylan Investigational Site	Irbid
Korea, Republic of	Mylan Investigational Site	Seoul	Gyeonggi-do
Korea, Republic of	Mylan Investigational Site	Seoul
Korea, Republic of	Mylan Investigational Site	Suwon-si	Gyeonggi-do
Slovakia	Mylan Investigational Site	Banska Bystrica
Slovakia	Mylan Investigational Site	Bardejov
Slovakia	Mylan Investigational Site	Bratislava
Slovakia	Mylan Investigational Site	Dolny Kubin
Slovakia	Mylan Investigational Site	Kosice
Slovakia	Mylan Investigational Site	Levice
Slovakia	Mylan Investigational Site	Sabinov
Slovakia	Mylan Investigational Site	Sahy
Slovakia	Mylan Investigational Site	Stropkov
Slovakia	Mylan Investigational Site	Sturovo
Slovakia	Mylan Investigational Site	Trebisov
Slovakia	Mylan Investigational Site	Trencin
Slovakia	Mylan Investigational Site	Zilina
South Africa	Mylan Investigational Site	Bloemfontein
South Africa	Mylan Investigational Site	Cape Town	Western Cape
South Africa	Mylan Investigational Site	Cape Town	Western Cape
South Africa	Mylan Investigational Site	Durban	KwaZulu-Natal
South Africa	Mylan Investigational Site	Johannesburg	Gauteng
South Africa	Mylan Investigational Site	Worcester	Western Cape
Taiwan	Mylan Investigational Site	Kaohsiung
Taiwan	Mylan Investigational Site	Taipei
United States	Mylan Investigational Site	Albany	New York
United States	Mylan Investigational Site	Anderson	Indiana
United States	Mylan Investigational Site	Asheville	North Carolina
United States	Mylan Investigational Site	Augusta	Kansas
United States	Mylan Investigational Site	Austin	Texas
United States	Mylan Investigational Site	Bell Gardens	California
United States	Mylan Investigational Site	Bend	Oregon
United States	Mylan Investigational Site	Billings	Montana
United States	Mylan Investigational Site	Bradenton	Florida
United States	Mylan Investigational Site	Bristol	Tennessee
United States	Mylan Investigational Site	Burlington	North Carolina
United States	Mylan Investigational Site	Cary	North Carolina
United States	Mylan Investigational Site	Chandler	Arizona
United States	Mylan Investigational Site	Charleston	South Carolina
United States	Mylan Investigational Site	Chesapeake	Virginia
United States	Mylan Investigational Site	Chicago	Illinois
United States	Mylan Investigational Site	Cincinnati	Ohio
United States	Mylan Investigational Site	Cleveland	Ohio
United States	Mylan Investigational Site	Columbus	Ohio
United States	Mylan Investigational Site	Columbus	Georgia
United States	Mylan Investigational Site	Cooper City	Florida
United States	Mylan Investigational Site	Corpus Christi	Texas
United States	Mylan Investigational Site	Council Bluffs	Iowa
United States	Mylan Investigational Site	Crestview Hills	Kentucky
United States	Mylan Investigational Site	Crystal Lake	Illinois
United States	Mylan Investigational Site	Dallas	Texas
United States	Mylan Investigational Site	Dallas	Texas
United States	Mylan Investigational Site	Des Moines	Iowa
United States	Mylan Investigational Site	El Paso	Texas
United States	Mylan Investigational Site	Fresno	California
United States	Mylan Investigational Site	Gainesville	Georgia
United States	Mylan Investigational Site	Greenbrae	California
United States	Mylan Investigational Site	Greensboro	North Carolina
United States	Mylan Investigational Site	Greenville	North Carolina
United States	Mylan Investigational Site	Greer	South Carolina
United States	Mylan Investigational Site	Hartsdale	New York
United States	Mylan Investigational Site	Hialeah	Florida
United States	Mylan Investigational Site	Hickory	North Carolina
United States	Mylan Investigational Site	Honolulu	Hawaii
United States	Mylan Investigational Site	Houston	Texas
United States	Mylan Investigational Site	Houston	Texas
United States	Mylan Investigational Site	Idaho Falls	Idaho
United States	Mylan Investigational Site	Kansas City	Missouri
United States	Mylan Investigational Site	Kingsport	Tennessee
United States	Mylan Investigational Site	Las Vegas	Nevada
United States	Mylan Investigational Site	Las Vegas	Nevada
United States	Mylan Investigational Site	Lexington	Kentucky
United States	Mylan Investigational Site	Lincoln	Nebraska
United States	Mylan Investigational Site	Long Beach	California
United States	Mylan Investigational Site	Los Angeles	California
United States	Mylan Investigational Site	Los Gatos	California
United States	Mylan Investigational Site	Manassas	Virginia
United States	Mylan Investigational Site	McKinney	Texas
United States	Mylan Investigational Site	Memphis	Tennessee
United States	Mylan Investigational Site	Miami	Florida
United States	Mylan Investigational Site	Miami	Florida
United States	Mylan Investigational Site	Mission Hills	California
United States	Mylan Investigational Site	Morehead City	North Carolina
United States	Mylan Investigational Site	Nashua	New Hampshire
United States	Mylan Investigational Site	National City	California
United States	Mylan Investigational Site	New Port Richey	Florida
United States	Mylan Investigational Site	Northridge	California
United States	Mylan Investigational Site	Ogden	Utah
United States	Mylan Investigational Site	Omaha	Nebraska
United States	Mylan Investigational Site	Omaha	Nebraska
United States	Mylan Investigational Site	Orange	California
United States	Mylan Investigational Site	Palm Harbor	Florida
United States	Mylan Investigational Site	Palm Springs	California
United States	Mylan Investigational Site	Pembroke Pines	Florida
United States	Mylan Investigational Site	Port Charlotte	Florida
United States	Mylan Investigational Site	Round Rock	Texas
United States	Mylan Investigational Site	Saint Louis	Missouri
United States	Mylan Investigational Site	Salt Lake City	Utah
United States	Mylan Investigational Site	Salt Lake City	Utah
United States	Mylan Investigational Site	Salt Lake City	Utah
United States	Mylan Investigational Site	San Antonio	Texas
United States	Mylan Investigational Site	Smithtown	New York
United States	Mylan Investigational Site	South Jordan	Utah
United States	Mylan Investigational Site	Spring	Texas
United States	Mylan Investigational Site	Spring Valley	California
United States	Mylan Investigational Site	Springfield	Illinois
United States	Mylan Investigational Site	Staten Island	New York
United States	Mylan Investigational Site	Tacoma	Washington
United States	Mylan Investigational Site	Topeka	Kansas
United States	Mylan Investigational Site	Tustin	California
United States	Mylan Investigational Site	Vancouver	Washington
United States	Mylan Investigational Site	Victoria	Texas
United States	Mylan Investigational Site	Walnut Creek	California
United States	Mylan Investigational Site	Waltham	Massachusetts
United States	Mylan Investigational Site	West Hills	California
United States	Mylan Investigational Site	West Palm Beach	Florida
United States	Mylan Investigational Site	Wichita	Kansas
United States	Mylan Investigational Site	Wilmington	North Carolina
United States	Mylan Investigational Site	Winter Haven	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Mylan Inc.	Mylan GmbH

Countries where clinical trial is conducted

United States,  Jordan,  Korea, Republic of,  Slovakia,  South Africa,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1c From Baseline to 24 Weeks		24 weeks
Secondary	Rate of Hypoglycemic Events Per 30 Days	The change from baseline at 12 and 24 weeks is reported	Baseline and up to 24 weeks
Secondary	Hypoglycemia Occurrence	Overall hypoglycemic incidence during treatment period	24 weeks
Secondary	Change in Total Insulin Antibody Percent Binding for Mylan's Insulin Glargine Assay Over Time	Comparison of change from Baseline in Immunogenicity	Week 12 and week 24
Secondary	Change in Total Insulin Antibody Percent Binding for Lantus Assay Over Time	Comparison of change from Baseline in Immunogenicity	week 12 and week 24
Secondary	Change in Cross-Reactive Insulin Antibody Percent Binding for Mylan's Insulin Glargine Assay Over Time	Comparison of change from Baseline in Immunogenicity	week 12 and week 24
Secondary	Change in Cross-Reactive Insulin Antibody Percent Binding for Lantus Assay Over Time	Comparison of change from Baseline in Immunogenicity	Week 12 and week 24