A Study to Compare and Measure the Effects of Insulin Peglispro (LY2605541) and Glargine on Meal Time Insulin Requirements

NCT ID: NCT02152384

Last Updated: 2019-03-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2014-12-31

Brief Summary

This study will look into how a base dose of insulin peglispro and insulin glargine will affect the meal time dose and efficacy of insulin lispro in type 1 diabetics.

Conditions

Diabetes Mellitus, Type 1

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Insulin peglispro (LY2605541, with Insulin Lispro)

Insulin peglispro (LY2605541) once daily subcutaneous (SC) injection at bedtime. Insulin lispro given SC prandially or as bolus as required

Group Type: EXPERIMENTAL

Insulin Peglispro

Intervention Type: DRUG

Administered SC

Insulin Lispro

Intervention Type: DRUG

Administered SC

Insulin Glargine (with Insulin Lispro)

Insulin glargine once daily SC injection at bedtime. Insulin lispro given SC prandially or as a bolus as required

Group Type: ACTIVE_COMPARATOR

Insulin Lispro

Intervention Type: DRUG

Administered SC

Insulin Glargine

Intervention Type: DRUG

Administered SC

Interventions

Insulin Peglispro

Administered SC

Intervention Type: DRUG

Insulin Lispro

Administered SC

Intervention Type: DRUG

Insulin Glargine

Administered SC

Intervention Type: DRUG

Other Intervention Names

LY2605541

Eligibility Criteria

Inclusion Criteria

• Have a stable (within 0.5 percent (%) from last measure) glycated hemoglobin (HbA1c) <9.0%
• Have a stable (within 30%) basal insulin dose of 0.2 to 1.0 units per kilogram per day (U/kg/day) and a total daily insulin dose (basal + prandial/bolus) <1.5 units per kilogram (U/kg)
• Have C-peptide <0.3 nanomoles per liter (nmol/L)
• Are able and willing to eat the protocol specified standard breakfast and other meals as required

Exclusion Criteria

• Have corrected QT interval (QTc) prolongation >500 milliseconds (ms) or have any other abnormality in the 12 lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study
• Have an abnormal blood pressure as determined by the investigator
• Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine (apart from Type 1 Diabetes Mellitus [T1DM]), hematological, or neurological disorders
• Have fasting triglycerides (TGs) >400 milligrams per deciliter (mg/dL) (4.52 micromoles per liter [mmol/L])
• Have used systemic corticosteroids within 4 weeks prior to randomization
• Currently receive insulin pump or insulin degludec
• Have poorly controlled diabetes or are known to have poor awareness of hypoglycemia
• Have history of gastroparesis or gastrointestinal malabsorption
• Require treatment with any drug other than insulin to treat diabetes
• Have a previous history of proliferative retinopathy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

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.

Neuss, , Germany

Countries

Germany

Other Identifiers

I2R-MC-BIDU

Identifier Type: OTHER

Identifier Source: secondary_id

15406

Identifier Type: -

Identifier Source: org_study_id