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

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ClinicalTrials.gov Identifier: NCT02227875
Recruitment Status : Completed
First Posted : August 28, 2014
Results First Posted : August 13, 2020
Last Update Posted : August 13, 2020
Sponsor:
Collaborator:
Mylan GmbH
Information provided by (Responsible Party):
Mylan Inc.

Tracking Information
First Submitted Date  ICMJE August 26, 2014
First Posted Date  ICMJE August 28, 2014
Results First Submitted Date  ICMJE February 24, 2020
Results First Posted Date  ICMJE August 13, 2020
Last Update Posted Date August 13, 2020
Study Start Date  ICMJE August 2014
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 26, 2014)
Change in HbA1c From Baseline to 24 Weeks [ Time Frame: 24 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 30, 2020)
  • Rate of Hypoglycemic Events Per 30 Days [ Time Frame: Baseline and up to 24 weeks ]
    The change from baseline at 12 and 24 weeks is reported
  • Hypoglycemia Occurrence [ Time Frame: 24 weeks ]
    Overall hypoglycemic incidence during treatment period
  • Change in Total Insulin Antibody Percent Binding for Mylan's Insulin Glargine Assay Over Time [ Time Frame: Week 12 and week 24 ]
    Comparison of change from Baseline in Immunogenicity
  • Change in Total Insulin Antibody Percent Binding for Lantus Assay Over Time [ Time Frame: week 12 and week 24 ]
    Comparison of change from Baseline in Immunogenicity
  • Change in Cross-Reactive Insulin Antibody Percent Binding for Mylan's Insulin Glargine Assay Over Time [ Time Frame: week 12 and week 24 ]
    Comparison of change from Baseline in Immunogenicity
  • Change in Cross-Reactive Insulin Antibody Percent Binding for Lantus Assay Over Time [ Time Frame: Week 12 and week 24 ]
    Comparison of change from Baseline in Immunogenicity
Original Secondary Outcome Measures  ICMJE
 (submitted: August 26, 2014)
  • Rate of hypoglycemic events per 30 days and hypoglycemia occurrence [ Time Frame: Baseline and up to 24 weeks ]
  • Immunogenicity: Change in antibody titer [ Time Frame: Baseline and up to 24 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Non-inferiority Study to Compare the Efficacy and Safety of Mylan's Insulin Glargine With Lantus® in Type 2 Diabetes Mellitus Patients (INSTRIDE 2)
Official Title  ICMJE 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
Brief 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
Detailed 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Type 2 Diabetes
Intervention  ICMJE
  • 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.
  • Drug: 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.
Study Arms  ICMJE
  • Experimental: Mylan's insulin Glargine
    receive Mylan's insulin Glargine
    Intervention: Drug: Mylan's insulin glargine
  • Active Comparator: Lantus®
    receive Lantus®
    Intervention: Drug: Lantus®
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 3, 2017)
560
Original Estimated Enrollment  ICMJE
 (submitted: August 26, 2014)
600
Actual Study Completion Date  ICMJE December 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Jordan,   Korea, Republic of,   Slovakia,   South Africa,   Taiwan,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02227875
Other Study ID Numbers  ICMJE MYL-GAI-3002
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mylan Inc.
Study Sponsor  ICMJE Mylan Inc.
Collaborators  ICMJE Mylan GmbH
Investigators  ICMJE
Principal Investigator: Thomas Blevins, MD Texas Diabetes & Endocrinology
PRS Account Mylan Inc.
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP