A Study to Compare LY2963016 to Lantus After a Single Dose to Participants With Type 1 Diabetes Mellitus

NCT01600950 | Completed Phase 1 Results

• 2 other identifiers: 13831I4L-MC-ABEE
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The study involves a single injection of LY2963016 and a single injection of Lantus, on 2 separate occasions in participants with type I diabetes. Following each dose, participants will undergo a glucose clamp which lasts for 42 hours each time. There will be at least 7 days between the two periods, during which time there will be no study treatment, but participants will resume their regular therapy. The duration of this study can be up to 9.5 weeks. The purposes of this study are to understand how the blood sugar lowering effect of LY2963016 compares to that of Lantus, and to determine how LY2963016 and Lantus are metabolized by participants with type I diabetes.

Conditions

Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

• Pharmacodynamics: Duration of Action of LY2963016 and Lantus

  Duration of action is defined as the period of time elapsed between dose administration and the time at which the participant's blood glucose is consistently \>150 milligrams/deciliter (mg/dL) without any glucose infusion. Participants whose blood glucose did not rise to 150 mg/dL were censored 42 hours postdose.

  Periods 1 and 2: Baseline up to 42 hours postdose

Secondary Outcomes (5)

• Maximum Glucose Infusion Rate (Rmax)

  Periods 1 and 2: Baseline up to 42 hours postdose

• Total Glucose Infused (Gtot)

  Periods 1 and 2: Baseline up to 42 hours postdose

• Time of Maximum Glucose Infusion Rate (tRmax)

  Periods 1 and 2: Baseline up to 42 hours postdose

• Pharmacokinetics: Maximum Concentration (Cmax) of LY2963016 and Lantus

  Periods 1 and 2: Baseline up to 42 hours postdose

• Pharmacokinetics: Area Under the Concentration-time Curve (AUC) of LY2963016 and Lantus

  Periods 1 and 2: Baseline up to 42 hours postdose

Study Arms (2)

LY2963016

EXPERIMENTAL

A single 0.3 units per kilogram (U/kg) dose of LY2963016 will be administered subcutaneously followed by a minimum washout period of 7 days.

Drug: LY2963016

Lantus

ACTIVE COMPARATOR

A single 0.3 U/kg dose of Lantus will be administered subcutaneously followed by a minimum washout period of 7 days.

Drug: Lantus

Interventions

LY2963016 DRUG

Single 0.3 U/kg dose administered subcutaneously

LY2963016

Lantus DRUG

Single 0.3 U/kg dose administered subcutaneously

Lantus

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• have type 1 diabetes mellitus (T1DM) based on the disease diagnostic criteria
• have had a duration of diabetes ≥1 year
• have hemoglobin A1c ≤10.0%
• have fasting C-peptide ≤0.3 nanomoles per liter (nmol/L)
• have a body mass index ≤29 kilograms per square meter (kg/m²)
• have venous access sufficient to allow blood sampling and cannulation for clamp procedures

You may not qualify if:

• are currently enrolled in, have completed, or discontinued within the last 30 days from, a clinical trial involving an investigational drug or device or off-label use of a drug or device
• have a total insulin requirement \>1.2 units per kilogram per day (U/kg/day)
• have a history of proliferative retinopathy
• have known allergies to insulin glargine, insulin lispro, heparin, or related compounds
• have an electrocardiogram (ECG) reading considered outside the normal limits
• have an abnormal blood pressure
• have abnormal clinical laboratory tests
• have a history or presence of/significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs
• history of deep leg vein thrombosis or a frequent appearance of deep leg vein thrombosis in first-degree relatives
• show evidence of significant active neuropsychiatric disease
• regular use of known drugs of abuse and/or show positive findings on drug screening
• show evidence of human immunodeficiency virus (HIV) and/or positive human HIV antibodies
• show evidence of hepatitis C and/or positive hepatitis C antibody
• show evidence of hepatitis B and/or positive hepatitis B surface antigen
• are women with a positive pregnancy test or women who are lactating

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

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 1

Interventions

LY2963016 insulin glargine; Insulin Glargine

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune 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 9 AM - 5 PM 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 1
• 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 15, 2012
• First Posted: May 17, 2012
• Study Start: May 1, 2012
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: October 7, 2014
• Results First Posted: October 7, 2014

Record last verified: 2014-10

Locations

DE (1)