A Study to Compare the Effect of a Double Dose of Two Long-acting Insulin Therapies in Participants With Type 2 Diabetes

NCT02132637 | Completed Phase 3 Results

• 3 other identifiers: 14288I2R-MC-BIDD2012-005174-56
• Study Type: interventional
• Target: 68
• Locations: 2 countries
• Sites: 3

Brief Summary

The primary purpose of this study is to compare the effect of a double dose of a study drug known as insulin peglispro to a double dose of insulin glargine in participants who have type 2 diabetes. Participants will be treated with study insulin daily, in two 4-week study periods. Each participant will receive insulin peglispro during one treatment period and insulin glargine during the other treatment period.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Clinically Significant Hypoglycemia

  The percentage was calculated by dividing the number of participants with clinically significant hypoglycemia events defined as blood glucose \<54 milligrams per deciliter (mg/dL) (3.0 millimole per liter \[mmol/L\]) or symptoms of severe hypoglycemia by the total number of participants analyzed, multiplied by 100.

  Predose to 84 Hours Post Double Dose

Secondary Outcomes (9)

• Percentage of Participants With Clinically Significant Hypoglycemia 12 Hours Post Double Dose

  Predose to 12 Hours Post Double Dose

• Percentage of Participants With Hypoglycemia

  Predose to 12 Hours Post Double Dose and 84 Hours Post Double Dose

• Nadir Glucose

  Predose to 84 Hours Post Double Dose

• Time to the Nadir Glucose

  Predose to 84 Hours Post Double Dose

• Duration of Glucose ≤70 mg/dL

  Predose to 84 Hours Post Double Dose

Study Arms (2)

Insulin Peglispro

EXPERIMENTAL

Standard dose of insulin peglispro administered subcutaneously (SQ) once daily for 4 weeks in one of two study periods. Double dose of insulin peglispro administered once, SQ on day 3 of the inpatient stay.

Drug: Insulin Peglispro

Insulin Glargine

EXPERIMENTAL

Standard dose of insulin glargine administered subcutaneously (SQ) once daily for 4 weeks in one of two study periods. Double dose of insulin glargine administered once, SQ on day 3 of the inpatient stay.

Drug: Insulin Glargine

Interventions

Insulin Peglispro DRUG

Administered SQ

Also known as: LY2605541

Insulin Peglispro

Insulin Glargine DRUG

Administered SQ

Insulin Glargine

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have type 2 diabetes mellitus (T2DM), based on the World Health Organization (WHO) classification, for ≥1 year.
• Use any type of basal insulin (except degludec), including once-or twice-daily human insulin neutral protamine Hagedom (NPH), insulin detemir, or insulin glargine.
• Have hemoglobin A1c (HbA1c) levels ≤9.0% according to local laboratory testing at screening.
• Have body mass index (BMI) ≤40.0 kilograms/square meter (kg/m\^2).
• Have been treated with stable doses of insulin for at least 30 days before screening with:
• Basal insulin with daily doses ±30% of mean during the last 4 weeks.
• Doses of a basal insulin must be between 0.3 unit/kg/day and 1 unit/kg/day.
• If on metformin, thiazolidinediones (TZDs), sodium glucose co-transporter 2 (SGLT-2) inhibitors, or dipeptidyl peptidase (DPP4) inhibitors, must be on stable doses for the last 30 days.

You may not qualify if:

• Are using prandial, self-mixed, or premixed insulin. Participants using prandial insulin may be switched to everyday (qd) glargine if investigator judges that the participant will still meet fasting glucose requirements for randomization.
• Are using insulin pump therapy.
• Have excessive insulin resistance: Defined as \>1.0 unit/kg/day as baseline treatment.
• If being treated with sulfonylureas (SUs) before screening, then must have SUs washed out between screening and randomization.
• Use any of these concomitant medications: morphine, codeine, antidiuretics, glucagon-like peptide-1 (GLP-1) receptor agonists (for example, exenatide, exenatide once weekly, lixisenatide or liraglutide), or pramlintide, used concurrently or within 90 days before screening.
• Have hypoglycemia unawareness, defined as confirmed by laboratory test results or by historical episodes of hypoglycemia \<54 mg/dL (3.0 mmol/L) without symptoms.
• Have fasting hypertriglyceridemia \>400 mg/dL (\>4.5 mmol/L) at screening, as determined by the local laboratory.
• Have had any episode of severe hypoglycemia (defined by requiring assistance due to neurologically disabling hypoglycemia) within 6 months before entry into the study.
• Have had 2 or more emergency room visits or hospitalizations due to poor glucose control in the past 6 months.
• Have had a previous clinically significant episode of ketoacidosis as determined by the investigator (ketone bodies at fasting and without acidosis is acceptable) in the past 6 months.
• Have history of renal transplantation, are currently receiving renal dialysis, or have estimated Glomerular Filtration Rate (eGFR) \<60 milliliters/minute.
• Have obvious clinical signs or symptoms of liver disease (excluding nonalcoholic fatty liver disease), acute or chronic hepatitis, nonalcoholic steatohepatitis, or elevated liver enzyme measurements.
• Have active or untreated malignancy, have been in remission from clinically significant malignancy (other than basal cell or squamous cell skin cancer) for less than 5 years, or are at increased risk for developing cancer or a recurrence of cancer in the opinion of the investigator.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (3)

Profil Institute for Clinical Research Inc

Chula Vista, California, 91911, United States

Location

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.

Mainz, 55116, Germany

Location

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, 41460, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

basal insulin peglispro; LY2605541; Insulin Glargine

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

800-545-5979

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9AM - 5PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2014
• First Posted: May 7, 2014
• Study Start: May 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: September 18, 2019
• Results First Posted: April 20, 2018

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
• Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

Locations

US (1); DE (2)