--- title: Comparison of Two Basal Insulins for Patients With Type 2 Diabetes on Anti-Hyperglycemic Medications (IOPE) nct_id: NCT00510952 overall_status: COMPLETED phase: PHASE3 sponsor: Eli Lilly and Company study_type: INTERVENTIONAL primary_condition: Diabetes Mellitus, Type 2 countries: United States, Brazil, Canada, Puerto Rico canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00510952.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00510952" ct_last_update_post_date: 2010-10-21 last_seen_at: "2026-05-12T06:42:59.185Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # Comparison of Two Basal Insulins for Patients With Type 2 Diabetes on Anti-Hyperglycemic Medications (IOPE) **Official Title:** The PERSISTENT Trial: A Prospective Randomized Trial Comparing Insulin Lispro Protamine Suspension to Insulin Glargine in Patients With Type 2 Diabetes on Anti-hyperglycemic Medications **NCT ID:** [NCT00510952](https://clinicaltrials.gov/study/NCT00510952) ## Key Facts - **Status:** COMPLETED - **Phase:** PHASE3 - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 471 - **Lead Sponsor:** Eli Lilly and Company - **Conditions:** Diabetes Mellitus, Type 2 - **Start Date:** 2007-08 - **Completion Date:** 2008-10 - **CT.gov Last Update:** 2010-10-21 ## Brief Summary The purpose of this study is to examine the effectiveness and safety of insulin lispro protamine suspension (ILPS) as compared to insulin glargine as basal insulin therapy in adults with type 2 diabetes. ## Eligibility - **Minimum age:** 18 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` Inclusion Criteria: * Have type 2 diabetes mellitus for at least 1 year. * Are greater than or equal to 18 years old. * Have been receiving oral antihyperglycemic medications (OAMs), without insulin, for at least 3 months immediately prior to the study and have been on stable doses of at least 2 of the following OAMs for the 6 weeks prior to Visit 1: Metformin- Sulfonylureas-Dipeptidyl peptidase-IV (DPP-IV) inhibitors-Thiazolidinediones (TZDs) * Have a hemoglobin A1c (HbA1c) greater than or equal to 7.5% and less than or equal to 10.0%, as measured by a central laboratory before Visit 2. * Body mass index (BMI) greater than or equal to 25 and less than or equal to 45 kg/meter squared. Exclusion Criteria: * Have used insulin therapy (outside of pregnancy) any time in the past 2 years, except for short-term treatment of acute conditions, and up to a maximum of 4 weeks. * Have taken any glucose-lowering medications not included in Inclusion Criterion #3; (for example, acarbose, miglitol, pramlintide, exenatide, repaglinide, or nateglinide) in the past 3 months before Visit 1. * Have had more than 1 episode of severe hypoglycemia, within 6 months prior to entry into the study, or is currently diagnosed as having hypoglycemia unawareness. * Have had 2 or more emergency room visits or hospitalizations due to poor glucose control in the past 6 months. * Are pregnant or intend to become pregnant during the course of the study or are sexually active women of childbearing potential not actively practicing birth control by a method determined by the investigator to be medically acceptable. ``` ## Arms - **Lispro** (EXPERIMENTAL) — Insulin Lispro protamine suspension: Patient adjusted dose, once daily (QD) or twice daily (BID), injected subcutaneous (SC) x 24 weeks - **Glargine** (ACTIVE_COMPARATOR) — Insulin glargine: Patient adjusted dose, once daily (QD), injected subcutaneous (SC) x 24 weeks ## Interventions - **Insulin Lispro Protamine Suspension** (DRUG) — Patient adjusted dose, once daily (QD) or twice daily (BID), injected subcutaneous (SC) x 24 weeks - **Insulin Glargine** (DRUG) — Patient adjusted dose, once daily (QD), injected subcutaneous (SC) x 24 weeks ## Primary Outcomes - **Change From Baseline to 24 Week Endpoint in Hemoglobin A1c (HbA1c)** _(time frame: Baseline, 24 Weeks)_ ## Secondary Outcomes - **Actual and Change From Baseline to 12 Week and 24 Week Endpoint in HbAlc Value** _(time frame: Baseline, 12 Weeks, 24 Weeks)_ - **Percentage of Patients With HbAlc Less Than 7.0 Percent and HbAlc Less Than or Equal to 6.5 Percent at Endpoint** _(time frame: 24 weeks)_ - **Glycemic Variability at Endpoint** _(time frame: 24 weeks)_ - **7-Point Self-Monitored Blood Glucose (SMBG) Profile at Endpoint** _(time frame: 24 weeks)_ - **Number of Participants With Self-Reported Hypoglycemic Episodes (Including All, Nocturnal, and Severe Hypoglycemia) Overall** _(time frame: Baseline to 24 weeks)_ - **1-Year Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including All, Nocturnal, and Severe) Overall** _(time frame: Baseline to 24 weeks)_ - **30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including All, Nocturnal, and Severe) Overall** _(time frame: Baseline to 24 Weeks)_ - **Change in Absolute Body Weight (kg) From Baseline to 24 Week Endpoint** _(time frame: Baseline, 24 weeks)_ - **Total Daily Insulin Dose (Units) at Endpoint** _(time frame: 24 weeks)_ - **Total Daily Insulin Dose Per Body Weight (Units/Kilograms) at Endpoint** _(time frame: 24 Weeks)_ ## Locations (17) - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Jonesboro, Arkansas, United States - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Huntington Park, California, United States - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Miami, Florida, United States - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Atlanta, Georgia, United States - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Indianapolis, Indiana, United States - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Wichita, Kansas, United States - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Lexington, Kentucky, United States - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Slidell, Louisiana, United States - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Toms River, New Jersey, United States - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Brooklyn, New York, United States - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Tacoma, Washington, United States - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Brasília, Brazil - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Fortaleza, Brazil - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Joinville, Brazil - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., São Paulo, Brazil - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Victoria, British Columbia, Canada - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Ponce, Puerto Rico ## Recent Field Changes (last 30 days) - `locations.for additional information regarding investigative sites for this trial, contact 1-877-ctlilly (1-877-285-4559, 1-317-615-4559) mon - fri from 9 am to 5 pm eastern time (utc/gmt - 5 hours, est), or speak with your personal physician.|wichita|kansas|united states` — added _(2026-05-12)_ - `locations.for additional information regarding investigative sites for this trial, contact 1-877-ctlilly (1-877-285-4559, 1-317-615-4559) mon - fri from 9 am to 5 pm eastern time (utc/gmt - 5 hours, est), or speak with your personal physician.|lexington|kentucky|united states` — added _(2026-05-12)_ - `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.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.for additional information regarding investigative sites for this trial, contact 1-877-ctlilly (1-877-285-4559, 1-317-615-4559) mon - fri from 9 am to 5 pm eastern time (utc/gmt - 5 hours, est), or speak with your personal physician.|jonesboro|arkansas|united states` — added _(2026-05-12)_ - `locations.for additional information regarding investigative sites for this trial, contact 1-877-ctlilly (1-877-285-4559, 1-317-615-4559) mon - fri from 9 am to 5 pm eastern time (utc/gmt - 5 hours, est), or speak with your personal physician.|huntington park|california|united states` — added _(2026-05-12)_ - `locations.for additional information regarding investigative sites for this trial, contact 1-877-ctlilly (1-877-285-4559, 1-317-615-4559) mon - fri from 9 am to 5 pm eastern time (utc/gmt - 5 hours, est), or speak with your personal physician.|miami|florida|united states` — added _(2026-05-12)_ - `locations.for additional information regarding investigative sites for this trial, contact 1-877-ctlilly (1-877-285-4559, 1-317-615-4559) mon - fri from 9 am to 5 pm eastern time (utc/gmt - 5 hours, est), or speak with your personal physician.|atlanta|georgia|united states` — added _(2026-05-12)_ - `locations.for additional information regarding investigative sites for this trial, contact 1-877-ctlilly (1-877-285-4559, 1-317-615-4559) mon - fri from 9 am to 5 pm eastern time (utc/gmt - 5 hours, est), or speak with your personal physician.|indianapolis|indiana|united states` — added _(2026-05-12)_ - `locations.for additional information regarding investigative sites for this trial, contact 1-877-ctlilly (1-877-285-4559, 1-317-615-4559) mon - fri from 9 am to 5 pm eastern time (utc/gmt - 5 hours, est), or speak with your personal physician.|slidell|louisiana|united states` — added _(2026-05-12)_ - `locations.for additional information regarding investigative sites for this trial, contact 1-877-ctlilly (1-877-285-4559, 1-317-615-4559) mon - fri from 9 am to 5 pm eastern time (utc/gmt - 5 hours, est), or speak with your personal physician.|toms river|new jersey|united states` — added _(2026-05-12)_ - `locations.for additional information regarding investigative sites for this trial, contact 1-877-ctlilly (1-877-285-4559, 1-317-615-4559) mon - fri from 9 am to 5 pm eastern time (utc/gmt - 5 hours, est), or speak with your personal physician.|brooklyn|new york|united states` — added _(2026-05-12)_ - `locations.for additional information regarding investigative sites for this trial, contact 1-877-ctlilly (1-877-285-4559, 1-317-615-4559) mon - fri from 9 am to 5 pm eastern time (utc/gmt - 5 hours, est), or speak with your personal physician.|tacoma|washington|united states` — added _(2026-05-12)_ - `locations.for additional information regarding investigative sites for this trial, contact 1-877-ctlilly (1-877-285-4559, 1-317-615-4559) mon - fri from 9 am to 5 pm eastern time (utc/gmt - 5 hours, est), or speak with your personal physician.|brasília||brazil` — added _(2026-05-12)_ - `locations.for additional information regarding investigative sites for this trial, contact 1-877-ctlilly (1-877-285-4559, 1-317-615-4559) mon - fri from 9 am to 5 pm eastern time (utc/gmt - 5 hours, est), or speak with your personal physician.|fortaleza||brazil` — added _(2026-05-12)_ - `locations.for additional information regarding investigative sites for this trial, contact 1-877-ctlilly (1-877-285-4559, 1-317-615-4559) mon - fri from 9 am to 5 pm eastern time (utc/gmt - 5 hours, est), or speak with your personal physician.|joinville||brazil` — added _(2026-05-12)_ - `locations.for additional information regarding investigative sites for this trial, contact 1-877-ctlilly (1-877-285-4559, 1-317-615-4559) mon - fri from 9 am to 5 pm eastern time (utc/gmt - 5 hours, est), or speak with your personal physician.|são paulo||brazil` — added _(2026-05-12)_ - `locations.for additional information regarding investigative sites for this trial, contact 1-877-ctlilly (1-877-285-4559, 1-317-615-4559) mon - fri from 9 am to 5 pm eastern time (utc/gmt - 5 hours, est), or speak with your personal physician.|victoria|british columbia|canada` — added _(2026-05-12)_ - `locations.for additional information regarding investigative sites for this trial, contact 1-877-ctlilly (1-877-285-4559, 1-317-615-4559) mon - fri from 9 am to 5 pm eastern time (utc/gmt - 5 hours, est), or speak with your personal physician.|ponce||puerto rico` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT00510952.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT00510952* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*