--- title: "Non-inferiority Study to Compare the Efficacy and Safety of Mylan's Insulin Glargine With Lantus® in Type 2 Diabetes Mellitus Patients (INSTRIDE 2)" nct_id: NCT02227875 overall_status: COMPLETED phase: PHASE3 sponsor: Mylan Inc. study_type: INTERVENTIONAL primary_condition: Type 2 Diabetes countries: United States, Jordan, Slovakia, South Africa, South Korea, Taiwan canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02227875.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02227875" ct_last_update_post_date: 2022-03-03 last_seen_at: "2026-05-12T07:14:46.286Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # 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:** 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 **NCT ID:** [NCT02227875](https://clinicaltrials.gov/study/NCT02227875) ## Key Facts - **Status:** COMPLETED - **Phase:** PHASE3 - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 560 - **Lead Sponsor:** Mylan Inc. - **Collaborators:** Mylan GmbH - **Conditions:** Type 2 Diabetes - **Start Date:** 2014-08 - **Completion Date:** 2015-12 - **CT.gov Last Update:** 2022-03-03 ## 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. ## Eligibility - **Minimum age:** 18 Years - **Maximum age:** 65 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` 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. ``` ## Arms - **Mylan's insulin Glargine** (EXPERIMENTAL) — receive Mylan's insulin Glargine - **Lantus®** (ACTIVE_COMPARATOR) — receive Lantus® ## Interventions - **Mylan's insulin glargine** (DRUG) — 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®** (DRUG) — 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. ## Primary Outcomes - **Change in HbA1c From Baseline to 24 Weeks** _(time frame: 24 weeks)_ ## Secondary Outcomes - **Rate of Hypoglycemic Events Per 30 Days** _(time frame: Baseline and up to 24 weeks)_ - **Hypoglycemia Occurrence** _(time frame: 24 weeks)_ - **Change in Total Insulin Antibody Percent Binding for Mylan's Insulin Glargine Assay Over Time** _(time frame: Week 12 and week 24)_ - **Change in Total Insulin Antibody Percent Binding for Lantus Assay Over Time** _(time frame: week 12 and week 24)_ - **Change in Cross-Reactive Insulin Antibody Percent Binding for Mylan's Insulin Glargine Assay Over Time** _(time frame: week 12 and week 24)_ - **Change in Cross-Reactive Insulin Antibody Percent Binding for Lantus Assay Over Time** _(time frame: Week 12 and week 24)_ ## Locations (120) - Mylan Investigational Site, Chandler, Arizona, United States - Mylan Investigational Site, Bell Gardens, California, United States - Mylan Investigational Site, Fresno, California, United States - Mylan Investigational Site, Greenbrae, California, 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, Mission Hills, California, United States - Mylan Investigational Site, National City, California, United States - Mylan Investigational Site, Northridge, California, United States - Mylan Investigational Site, Orange, California, United States - Mylan Investigational Site, Palm Springs, California, United States - Mylan Investigational Site, Spring Valley, California, United States - Mylan Investigational Site, Tustin, California, United States - Mylan Investigational Site, Walnut Creek, California, United States - Mylan Investigational Site, West Hills, California, United States - Mylan Investigational Site, Bradenton, Florida, United States - Mylan Investigational Site, Cooper City, Florida, United States - Mylan Investigational Site, Hialeah, Florida, United States - Mylan Investigational Site, Miami, Florida, United States - Mylan Investigational Site, Miami, Florida, United States - Mylan Investigational Site, New Port Richey, Florida, United States - Mylan Investigational Site, Palm Harbor, Florida, United States - Mylan Investigational Site, Pembroke Pines, Florida, United States - Mylan Investigational Site, Port Charlotte, Florida, United States - Mylan Investigational Site, West Palm Beach, Florida, United States - Mylan Investigational Site, Winter Haven, Florida, United States - Mylan Investigational Site, Columbus, Georgia, United States - Mylan Investigational Site, Gainesville, Georgia, United States - Mylan Investigational Site, Honolulu, Hawaii, United States - Mylan Investigational Site, Idaho Falls, Idaho, United States - Mylan Investigational Site, Chicago, Illinois, United States - Mylan Investigational Site, Crystal Lake, Illinois, United States - Mylan Investigational Site, Springfield, Illinois, United States - Mylan Investigational Site, Anderson, Indiana, United States - Mylan Investigational Site, Council Bluffs, Iowa, United States - Mylan Investigational Site, Des Moines, Iowa, United States - Mylan Investigational Site, Augusta, Kansas, United States - Mylan Investigational Site, Topeka, Kansas, United States - Mylan Investigational Site, Wichita, Kansas, United States - Mylan Investigational Site, Crestview Hills, Kentucky, United States - Mylan Investigational Site, Lexington, Kentucky, United States - Mylan Investigational Site, Waltham, Massachusetts, United States - Mylan Investigational Site, Kansas City, Missouri, United States - Mylan Investigational Site, St Louis, Missouri, United States - Mylan Investigational Site, Billings, Montana, United States - Mylan Investigational Site, Lincoln, Nebraska, United States - Mylan Investigational Site, Omaha, Nebraska, United States - Mylan Investigational Site, Omaha, Nebraska, United States - Mylan Investigational Site, Las Vegas, Nevada, United States - Mylan Investigational Site, Las Vegas, Nevada, United States - Mylan Investigational Site, Nashua, New Hampshire, United States - Mylan Investigational Site, Albany, New York, United States - Mylan Investigational Site, Hartsdale, New York, United States - Mylan Investigational Site, Smithtown, New York, United States - Mylan Investigational Site, Staten Island, New York, United States - Mylan Investigational Site, Asheville, North Carolina, United States - Mylan Investigational Site, Burlington, North Carolina, United States - Mylan Investigational Site, Cary, North Carolina, United States - Mylan Investigational Site, Greensboro, North Carolina, United States - Mylan Investigational Site, Greenville, North Carolina, United States - Mylan Investigational Site, Hickory, North Carolina, United States - Mylan Investigational Site, Morehead City, North Carolina, United States - Mylan Investigational Site, Wilmington, North Carolina, 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, Bend, Oregon, United States - Mylan Investigational Site, Charleston, South Carolina, United States - Mylan Investigational Site, Greer, South Carolina, United States - Mylan Investigational Site, Bristol, Tennessee, United States - Mylan Investigational Site, Kingsport, Tennessee, United States - Mylan Investigational Site, Memphis, Tennessee, United States - Mylan Investigational Site, Austin, Texas, United States - Mylan Investigational Site, Corpus Christi, Texas, United States - Mylan Investigational Site, Dallas, Texas, United States - Mylan Investigational Site, Dallas, Texas, United States - Mylan Investigational Site, El Paso, Texas, United States - Mylan Investigational Site, Houston, Texas, United States - Mylan Investigational Site, Houston, Texas, United States - Mylan Investigational Site, McKinney, Texas, United States - Mylan Investigational Site, Round Rock, Texas, United States - Mylan Investigational Site, San Antonio, Texas, United States - Mylan Investigational Site, Spring, Texas, United States - Mylan Investigational Site, Victoria, Texas, United States - Mylan Investigational Site, Ogden, Utah, 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, South Jordan, Utah, United States - Mylan Investigational Site, Chesapeake, Virginia, United States - Mylan Investigational Site, Manassas, Virginia, United States - Mylan Investigational Site, Tacoma, Washington, United States - Mylan Investigational Site, Vancouver, Washington, United States - Mylan Investigational Site, Amman, Jordan - Mylan Investigational Site, Irbid, Jordan - Mylan Investigational Site, Banská Bystrica, Slovakia - Mylan Investigational Site, Bardejov, Slovakia - Mylan Investigational Site, Bratislava, Slovakia - Mylan Investigational Site, Dolný Kubín, Slovakia - Mylan Investigational Site, Košice, Slovakia - Mylan Investigational Site, Levice, Slovakia - Mylan Investigational Site, Sabinov, Slovakia - Mylan Investigational Site, Stropkov, Slovakia - Mylan Investigational Site, Šahy, Slovakia - Mylan Investigational Site, Štúrovo, Slovakia - Mylan Investigational Site, Trebišov, Slovakia - Mylan Investigational Site, Trenčín, Slovakia - Mylan Investigational Site, Žilina, Slovakia - Mylan Investigational Site, Johannesburg, Gauteng, South Africa - Mylan Investigational Site, Durban, KwaZulu-Natal, South Africa - Mylan Investigational Site, Cape Town, Western Cape, South Africa - Mylan Investigational Site, Cape Town, Western Cape, South Africa - Mylan Investigational Site, Worcester, Western Cape, South Africa - Mylan Investigational Site, Bloemfontein, South Africa - Mylan Investigational Site, Seoul, Gyeonggi-do, South Korea - Mylan Investigational Site, Suwon, Gyeonggi-do, South Korea - Mylan Investigational Site, Seoul, South Korea - Mylan Investigational Site, Kaohsiung City, Taiwan - Mylan Investigational Site, Taipei, Taiwan ## Recent Field Changes (last 30 days) - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.maxAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `locations.mylan investigational site|spring valley|california|united states` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `sponsor.collaborators` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.mylan investigational site|chandler|arizona|united states` — added _(2026-05-12)_ - `locations.mylan investigational site|bell gardens|california|united states` — added _(2026-05-12)_ - `locations.mylan investigational site|fresno|california|united states` — added _(2026-05-12)_ - `locations.mylan investigational site|greenbrae|california|united states` — added _(2026-05-12)_ - `locations.mylan investigational site|long beach|california|united states` — added _(2026-05-12)_ - `locations.mylan investigational site|los angeles|california|united states` — added _(2026-05-12)_ - `locations.mylan investigational site|los gatos|california|united states` — added _(2026-05-12)_ - `locations.mylan investigational site|mission hills|california|united states` — added _(2026-05-12)_ - `locations.mylan investigational site|national city|california|united states` — added _(2026-05-12)_ - `locations.mylan investigational site|northridge|california|united states` — added _(2026-05-12)_ - `locations.mylan investigational site|orange|california|united states` — added _(2026-05-12)_ - `locations.mylan investigational site|palm springs|california|united states` — added _(2026-05-12)_ - `locations.mylan investigational site|tustin|california|united states` — added _(2026-05-12)_ - `locations.mylan investigational site|walnut creek|california|united states` — added _(2026-05-12)_ - `locations.mylan investigational site|west hills|california|united states` — added _(2026-05-12)_ - `locations.mylan investigational site|bradenton|florida|united states` — added _(2026-05-12)_ - `locations.mylan investigational site|cooper city|florida|united states` — added _(2026-05-12)_ - `locations.mylan investigational site|hialeah|florida|united states` — added _(2026-05-12)_ - `locations.mylan investigational site|miami|florida|united states` — added _(2026-05-12)_ - `locations.mylan investigational site|new port richey|florida|united states` — added _(2026-05-12)_ - `locations.mylan investigational site|palm harbor|florida|united states` — added _(2026-05-12)_ - `locations.mylan investigational site|pembroke pines|florida|united states` — added _(2026-05-12)_ - `locations.mylan investigational site|port charlotte|florida|united states` — added _(2026-05-12)_ - `locations.mylan investigational site|west palm beach|florida|united states` — added _(2026-05-12)_ - `locations.mylan investigational site|winter haven|florida|united states` — added _(2026-05-12)_ - `locations.mylan investigational site|columbus|georgia|united states` — added _(2026-05-12)_ - `locations.mylan investigational site|gainesville|georgia|united states` — added _(2026-05-12)_ - `locations.mylan investigational site|honolulu|hawaii|united states` — added _(2026-05-12)_ - `locations.mylan investigational site|idaho falls|idaho|united states` — added _(2026-05-12)_ - `locations.mylan investigational site|chicago|illinois|united states` — added _(2026-05-12)_ - `locations.mylan investigational site|crystal lake|illinois|united states` — added _(2026-05-12)_ - `locations.mylan investigational site|springfield|illinois|united states` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT02227875.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT02227875* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*