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Completed

NCT Number: NCT02197520

A Study To Compare the Effects of Insulin Peglispro and Glargine on Insulin Sensitivity and Meal Time Insulin Requirements in Type 2 Diabetics

This study will look into insulin sensitivity (how the body responds to insulin) and effects of meals on type 2 diabetics comparing insulin peglispro to insulin glargine. The study has two treatment periods, each of which will last about four weeks. One drug (insulin peglispro or insulin glargine) will be administered in each period. Participants will receive both drugs during the study. Participants may remain on stable dose metformin, as prescribed by their personal physician.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Profil Institute for Clinical Research Inc

Chula Vista, California, 91911, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Stable glycated hemoglobin (HbA1c) less than (<) 10.0 percent (%)
  • Stable dose of either 0.2 to 1.5 units per kilogram per day (U/kg/day) basal insulin or a total daily insulin dose l<2.0 units per kilogram (U/kg)
  • C-peptide <0.3 nanomole per liter (nmol/L)
  • Stable body during the last 2 months

Exclusion criteria

  • Corrected QT interval (QTc) prolongation greater than (>) 500 milliseconds (ms) or have any other abnormality in the 12 lead
  • Abnormal blood pressure
  • A history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine (apart from Type 1 Diabetes Mellitus (T1DM)), hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data
  • Currently treated with oral antidiabetic drugs (OADs) (excluding metformin and dipeptidyl peptidase-4 (DPP4) inhibitors), or glucagon-like peptide-1 (GLP-1) agonists or intend to use over-the counter or prescription medication, herbal medications, or nutritional supplements that affect PG or insulin sensitivity, impact on hypoglycemic awareness or promote weight loss within 4 weeks prior to randomization
  • Fasting triglycerides (TGs) >400 milligrams per deciliter (mg/dL) (4.52 millimoles per liter (mmol/L))
  • Have used systemic or inhaled corticosteroids/glucocorticoid therapy (excluding topical, intra-articular, and intraocular preparations) within 4 weeks prior to randomization
  • Currently receive insulin by pump or insulin degludec
  • Poorly controlled diabetes or known to have poor awareness of hypoglycemia
  • History of gastroparesis or gastrointestinal malabsorption
  • Require treatment with any drug other than insulin to treat diabetes
  • Previous history of proliferative retinopathy
  • Excessive consumers of xanthines

Treatment and study plan

Insulin Peglispro

Drug

Administered subcutaneously (SC), (U-100 formulation)

Other names: LY2605541

insulin glargine

Drug

Administered subcutaneously (SC), (U-100 formulation)

Insulin Lispro

Drug

Administered subcutaneously (SC), (U-100 formulation)

Primary outcomes

  1. Pharmacodynamics (PD): Average Glucose Infusion Rate From Euglycemic 2-step Hyperinsulinemic Clamp (M-value)

    Time frame: Day 33, last 30 minutes (final step) of euglycemic 2-step hyperinsulinemic clamp

    During the euglycemic 2-step hyperinsulinemic clamp, both low and high insulin was infused sequentially during the same procedure. The 2-step clamp procedure allowed insulin sensitivity to be measured in participants and uses a lower dose of insulin of which the effect is largely on the liver and a high dose of insulin at which the effect has reached 100% on liver and effects are largely on glucose uptake in peripheral tissues. Measurements for average glucose infusion rate are collected for both steps (low and high) of the clamp procedure.

Secondary outcomes

  1. Pharmacodynamics (PD): Plasma Glucose Area Under the Concentration Curve Zero Through 5 Hours (AUC 0-5h), Above Pre Meal Baseline for Insulin Lispro

    Time frame: Days 30 through 32:Pre-dose, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 210, 240, 270, 300 minutes post-breakfast

  2. Pharmacokinetics (PK): Area Under the Concentration Curve Concentration Curve Zero Through 5 Hours (AUC 0-5h) for Prandial Insulin Lispro

    Time frame: Days 30 through 32:Pre-dose, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 210, 240, 270, 300 minutes post-breakfast

  3. Pharmacokinetics (PK): Area Under the Concentration Curve Zero Through 5 Hours (AUC 0-5h) for Acetaminophen

    Time frame: Day 29:Pre-dose, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 210, 240, 270, 300 minutes post-breakfast

  4. Appetite and Satiety Ratings, as Measured Using Visual Analog Scale (VAS) on Day 29

    Time frame: Day 29:Upon waking, pre-breakfast, 1 hour (hr), 2 hr, 3 hr, 4 hr and 5 hr post breakfast

    VAS was scored from 0 - 100 millimeters (mm) as a perception of appetite and satiety (Flint et al. 2000), 0 being not hungry at all or nothing at all and 100 being extremely hungry and extremely large amount.

    The questions are abbreviated in table from: How hungry do you feel right now? to Hunger and How much food do you think you could eat right now? to Food amount. Scores were averaged and will be presented and calculated by a sum of the scores dividing by the total by the number of scores reported for timepoints.

  5. Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) for Insulin Lispro During Clamp

    Time frame: Day 33 during euglycemic 2-step hyperinsulinemic clamp

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

The Effect of Treatment With Basal Insulin Peglispro or Insulin Glargine on Insulin Sensitivity and the Effect of Prandial Insulin Lispro in Patients With Type 2 Diabetes Mellitus

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jul 22, 2014
Registry last updated
Nov 1, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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