Comparison of Two Basal Insulins for Patients With Type 2 Diabetes on Anti-Hyperglycemic Medications (IOPE)
This study has been completed.
Sponsor:
Eli Lilly and Company
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00510952
First received: August 1, 2007
Last updated: October 12, 2010
Last verified: October 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Mellitus, Type 2 |
Drug: Insulin Lispro Protamine Suspension Drug: Insulin Glargine |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Eli Lilly and Company:
Primary Outcome Measures:
- Change From Baseline to 24 Week Endpoint in Hemoglobin A1c (HbA1c) [ Time Frame: Baseline, 24 Weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Actual and Change From Baseline to 12 Week and 24 Week Endpoint in HbAlc Value [ Time Frame: Baseline, 12 Weeks, 24 Weeks ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]Percentage of patients achieving Hemaglobin A1c (HbA1c) targets of less than 7% and less than or equal to 6.5% at endpoint.
- Glycemic Variability at Endpoint [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]Glycemic variability was measured by standard deviation (SD) value of fasting blood glucose as measured by intra-patient glycemic variability (determined by the 7-point self-monitoring blood glucose (SMBG) profiles at endpoint) based on the actual morning pre-meal blood glucose.
- 7-Point Self-Monitored Blood Glucose (SMBG) Profile at Endpoint [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]Actual measurements and daily mean blood glucose levels at endpoint.
- Number of Participants With Self-Reported Hypoglycemic Episodes (Including All, Nocturnal, and Severe Hypoglycemia) Overall [ Time Frame: Baseline to 24 weeks ] [ Designated as safety issue: Yes ]Overall: any time after randomization. Hypoglycemic: any time patient experienced sign/symptom associated with hypoglycemia, or had old Roche blood glucose level <7 mg/dL. Nocturnal: any hypoglycemic event that occurred between bedtime and waking. Severe Hypoglycemia: event with symptoms consistent with neuroglycopenia in which patient requires assistance, and is associated with either a Roche blood glucose value <2.8 millimoles/liter or prompt recovery after oral carbohydrate, glucagon, or intravenous glucose.
- 1-Year Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including All, Nocturnal, and Severe) Overall [ Time Frame: Baseline to 24 weeks ] [ Designated as safety issue: Yes ]Overall: any time after randomization. Hypoglycemic: any time patient experienced sign/symptom associated with hypoglycemia, or had old Roche blood glucose level <7 mg/dL. Nocturnal: any hypoglycemic event that occurred between bedtime and waking. Severe: event with symptoms consistent with neuroglycopenia in which patient requires assistance, and is associated with: a Roche blood glucose value <2.8 mmol/L or prompt recovery after oral carbohydrate, glucagon, or IV glucose. 1-year adjusted rate=(total number of episodes between 2 time intervals/number of days between intervals) X 365.25 days.
- 30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including All, Nocturnal, and Severe) Overall [ Time Frame: Baseline to 24 Weeks ] [ Designated as safety issue: Yes ]Overall: any time after randomization. Hypoglycemic: any time patient experienced sign/symptom associated with hypoglycemia, or had old Roche blood glucose level <7 mg/dL. Nocturnal: any hypoglycemic event that occurred between bedtime and waking. Severe: event with symptoms consistent with neuroglycopenia in which patient requires assistance, and is associated with: a Roche blood glucose value <2.8 mmol/L or prompt recovery after oral carbohydrate, glucagon, or IV glucose. 30-day adjusted rate=(total number of episodes between 2 time intervals/number of days between intervals) X 30 days.
- Change in Absolute Body Weight (kg) From Baseline to 24 Week Endpoint [ Time Frame: Baseline, 24 weeks ] [ Designated as safety issue: Yes ]
- Total Daily Insulin Dose (Units) at Endpoint [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]Insulin dose at endpoint was analyzed by 24-hour total daily insulin (units).
- Total Daily Insulin Dose Per Body Weight (Units/Kilograms) at Endpoint [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]Insulin dose at endpoint was analyzed by 24-hour total daily insulin per body weight (units/kilograms).
| Enrollment: | 471 |
| Study Start Date: | August 2007 |
| Study Completion Date: | October 2008 |
| Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Lispro
Insulin Lispro protamine suspension: Patient adjusted dose, once daily (QD) or twice daily (BID), injected subcutaneous (SC) x 24 weeks
|
Drug: Insulin Lispro Protamine Suspension
Patient adjusted dose, once daily (QD) or twice daily (BID), injected subcutaneous (SC) x 24 weeks
Other Names:
|
|
Active Comparator: Glargine
Insulin glargine: Patient adjusted dose, once daily (QD), injected subcutaneous (SC) x 24 weeks
|
Drug: Insulin Glargine
Patient adjusted dose, once daily (QD), injected subcutaneous (SC) x 24 weeks
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00510952
Please refer to this study by its ClinicalTrials.gov identifier: NCT00510952
Locations
| United States, Arkansas | |
| 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, 72401 | |
| United States, California | |
| 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, 90255 | |
| United States, Florida | |
| 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, 33145 | |
| United States, Georgia | |
| 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, 30312 | |
| United States, Indiana | |
| 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, 46222 | |
| United States, Kansas | |
| 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, 67208 | |
| United States, Kentucky | |
| 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, 40502 | |
| United States, Louisiana | |
| 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, 70458 | |
| United States, New Jersey | |
| 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, 08755 | |
| United States, New York | |
| 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, 11203 | |
| United States, Washington | |
| 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, 98405 | |
| 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. | |
| Brasilia, Brazil, 71625-009 | |
| 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, 60430-350 | |
| 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, 89201-260 | |
| 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. | |
| Sao Paulo, Brazil, 01244-030 | |
| Canada, British Columbia | |
| 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, V8R 6V4 | |
| Puerto Rico | |
| 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, 00716 | |
Sponsors and Collaborators
Eli Lilly and Company
Investigators
| Study Director: | Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM-5 PM Eastern time (UTC/GMT-5 hours, EST) | Eli Lilly and Company |
More Information
Additional Information:
Publications:
Strojek K, Shi C, Carey MA, Jacober SJ. Addition of insulin lispro protamine suspension or insulin glargine to oral type 2 diabetes regimens: a randomized trial. Diabetes Obes Metab. 2010;12(10):916-922.
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Chief Medical Officer, Eli Lilly |
| ClinicalTrials.gov Identifier: | NCT00510952 History of Changes |
| Other Study ID Numbers: | 11813, F3Z-MC-IOPE |
| Study First Received: | August 1, 2007 |
| Results First Received: | September 25, 2009 |
| Last Updated: | October 12, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Eli Lilly and Company:
|
diabetes type 2 |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Glargine Hypoglycemic Agents Insulin Insulin Lispro |
Insulin, Globin Zinc Protamines Coagulants Hematologic Agents Heparin Antagonists Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Therapeutic Uses |
ClinicalTrials.gov processed this record on February 27, 2015