A Study to Compare the Effect of Double Doses of Long-acting Insulin Therapies in Participants With Type 2 Diabetes (IMAGINE 8)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Eli Lilly and Company
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT02132637
First received: May 5, 2014
Last updated: June 6, 2014
Last verified: June 2014
  Purpose

The primary purpose of this study is to compare the effect of double doses of a study drug known as insulin peglispro and insulin glargine in participants who have type 2 diabetes. Participants will be treated for up to 11 weeks, and will take part in two study periods. Each participant will receive insulin peglispro during one treatment period and insulin glargine during the other treatment period.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: Insulin Peglispro
Drug: Insulin Glargine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Comparison of Pharmacodynamics When Receiving a Double Dose of Insulin Peglispro or Insulin Glargine in Patients With Type 2 Diabetes Mellitus: A Double-Blind, Crossover Design Study

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Incidence of Clinically Significant Hypoglycemia [ Time Frame: Predose to 84 Hours Post Double Dose (Day 3 in each period) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Incidence of Hypoglycemia [ Time Frame: Predose to 84 Hours Post Double Dose (Day 3 in each period) ] [ Designated as safety issue: Yes ]
  • Mean Nadir Glucose [ Time Frame: Predose to 84 Hours Post Double Dose (Day 3 in each period) ] [ Designated as safety issue: Yes ]
  • Time to the Nadir Glucose [ Time Frame: Predose to 84 Hours Post Double Dose (Day 3 in each period) ] [ Designated as safety issue: Yes ]
  • Mean Duration in Minutes that Each Participant Spends with Glucose Less than or Equal to 70 Milligrams per Deciliter (mg/dL) (3.9 Millimoles per Liter [mmol/L]) [ Time Frame: Predose to 84 Hours Post Double Dose (Day 3 in each period) ] [ Designated as safety issue: Yes ]
  • Fasting Blood Glucose (FBG) [ Time Frame: Day 1, Day 2, Day 3 Following Double Dose (Day 3 in each period) ] [ Designated as safety issue: Yes ]
  • Pharmacodynamics: Glucose Area Under the Concentration Time Curve (AUC) Prandial [ Time Frame: Preprandial to 3 Hours Postprandial (Day 2 in each period) ] [ Designated as safety issue: No ]
  • Beta Cell Function [ Time Frame: 0-30 Minutes After Standard Dose (Day 2 in each period) ] [ Designated as safety issue: No ]

Estimated Enrollment: 67
Study Start Date: May 2014
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Insulin Peglispro
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
Administered SQ
Other Name: LY2605541
Experimental: Insulin Glargine
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
Administered SQ

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 central laboratory testing at screening.
  • Have body mass index (BMI) ≤40.0 kilogram/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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. 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: NCT02132637

Contacts
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559

Locations
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. Recruiting
Chula Vista, California, United States, 91911
Contact: Eli Lilly         
Germany
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. Recruiting
Neuss, Germany, 41460
Contact: Eli Lilly         
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 9AM - 5PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
  More Information

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02132637     History of Changes
Other Study ID Numbers: 14288, I2R-MC-BIDD, 2012-005174-56
Study First Received: May 5, 2014
Last Updated: June 6, 2014
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Glargine
Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2014