Liquid Meal Study With Insulin Lispro With/Without rHuPH20 and Regular Human Insulin With rHuPH20 to Compare Pharmacokinetics, Postprandial Glycemic Response, and Optimal Insulin Dose in Patients With T2DM

This study has been completed.
Sponsor:
Information provided by:
Halozyme Therapeutics
ClinicalTrials.gov Identifier:
NCT00916357
First received: June 5, 2009
Last updated: June 22, 2010
Last verified: June 2010
  Purpose

This is a single center, phase 2, randomized, double-blind, 3-way crossover meal study in patients with Type 2 diabetes mellitus to determine the optimum dose and compare the pharmacokinetics and postprandial glycemic response of lispro + rHuPH20, lispro alone, and insulin + rHuPH20 administered subcutaneously.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: Lispro, Regular Human Insulin, rHuPH20
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: Phase 2, Double-Blind Randomized, 3-way Cross-Over Liquid Meal Study With Optimal Doses of SC Administered Insulin Lispro With and Without rHuPH20 and Regular Human Insulin With rHuPH20 to Compare Pharmacokinetics, Postprandial Glycemic Response, and Optimal Insulin Dose in Patients With T2DM

Resource links provided by NLM:


Further study details as provided by Halozyme Therapeutics:

Primary Outcome Measures:
  • To compare postprandial glycemic excursions within the first 4 hours after dosing between treatment groups (lispro + rHuPH20 to lispro alone and insulin +rHuPH20 to lispro alone). [ Time Frame: 4 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Compare optimal doses of lispro with rHuPH20, lispro without rHuPH20, and regular insulin with rHuPH20 for PD Endpoints; PK Endpoints, and Safety Endpoints. [ Time Frame: 6 to 8 hours ] [ Designated as safety issue: Yes ]

Enrollment: 23
Study Start Date: June 2009
Study Completion Date: May 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Subcutaneously Administered Insulin Lispro Without Recombinant Human Hyaluronidase (rHuPH20)
Drug: Lispro, Regular Human Insulin, rHuPH20
Up to 12 injections of study drug
Other Names:
  • Lispro
  • Regular Human Insulin
Active Comparator: 2
Subcutaneously Administered Insulin Lispro With Recombinant Human Hyaluronidase (rHuPH20)
Drug: Lispro, Regular Human Insulin, rHuPH20
Up to 12 injections of study drug
Other Names:
  • Lispro
  • Regular Human Insulin
Active Comparator: 3
Subcutaneously Administered Regular Human Insulin With Recombinant Human Hyaluronidase (rHuPH20)
Drug: Lispro, Regular Human Insulin, rHuPH20
Up to 12 injections of study drug
Other Names:
  • Lispro
  • Regular Human Insulin

Detailed Description:

This study design was chosen to assess the differences between PK and PD (postprandial glycemic response) parameters of lispro +rHuPH20, lispro alone, and insulin +rHuPH20 at optimal doses following a liquid meal.

  Eligibility

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

Inclusion Criteria:

  • Male or female of age 18 to 70 years, inclusive.
  • Patients with Type 2 diabetes mellitus per WHO criteria treated with basal and/or bolus insulin for ≥ 12 months.
  • BMI between 18-45 kg/m2, inclusive.
  • HbA1c (glycosylated hemoglobin A1c) ≤ 10%.
  • Current treatment with insulin ≥ 60 Units/Day.
  • A patient taking oral hypoglycemic agents must be on a stable dose for >8 weeks, with the exception of thiazolidinediones (TZD), which should be >12 weeks.
  • Total body weight >65 kg (143 lb) for men and >46 kg (101 lb) for women.
  • Vital signs (BP, Pulse Rate, and Body Temperature) within normal range or, if out of range, assessed by the Investigator as not clinically significant (NCS).
  • Patients should be in good general health based on medical history and physical examination, without medical conditions that might prevent the completion of study drug injections and assessments in this protocol.
  • Decision making capacity and willingness to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures including adequate venous access.
  • Signed, written IRB-approved informed consent.

Exclusion Criteria:

  • Known or suspected allergy to any components of any of the study drugs in this study.
  • Previous enrollment in this study.
  • A patient who has proliferative retinopathy or proliferative maculopathy, and/or severe neuropathy, in particular autonomic neuropathy as judged by the Investigator.
  • As judged by the Investigator, clinically significant active disease of the gastrointestinal, cardiovascular (including a history of arrhythmia or conduction delays on ECG, and NYHA Class III/IV heart disease), hepatic, neurological, renal, genitourinary or hematological systems.
  • As judged by the Investigator, uncontrolled hypertension (diastolic blood pressure ≥ 100 mmHg and/or systolic blood pressure ≥ 160 mmHg after 5 minutes in the supine position).
  • As judged by the Investigator, clinically significant findings in routine laboratory data. (Anemia with hematocrit less than 33% at screening is specifically exclusionary).
  • Positive HIV (human immunodeficiency virus) antibody test, hepatitis B (anti-HBsAg) or hepatitis C (anti-HCV) antibody test.
  • Current addiction to alcohol or substances of abuse as determined by the Investigator.
  • Known use of drugs (other than oral hypoglycemic agents) that may interfere with the interpretation of study results or are known to cause clinically relevant interference with insulin action, glucose utilization, or recovery from hypoglycemia.
  • Recurrent major hypoglycemia or hypoglycemic unawareness, as judged by the Investigator.
  • Mental incapacity, unwillingness, or language barriers precluding adequate understanding or cooperation in this study.
  • Symptomatic gastroparesis.
  • Donation of blood in excess of 500 mL within 56 days before dosing.
  • Use of any investigational drug or device 30 days before enrollment in this study.
  • Pregnancy, breast-feeding, the intention of becoming pregnant, or not using adequate contraceptive measures (adequate contraceptive measures consist of sterilization, intra-uterine device [IUD], oral or injectable contraceptives, barrier methods, or remaining abstinent).
  • Any condition (intrinsic or extrinsic) that in the judgment of the Investigator will interfere with study participation or evaluation of data.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00916357

Locations
United States, California
Profil Institute for Clinical Research, Inc.
Chula Vista, California, United States, 91911
Sponsors and Collaborators
Halozyme Therapeutics
Investigators
Principal Investigator: Marcus Hompesch, M.D. Profil Institute for Clinical Research, Inc.
  More Information

No publications provided by Halozyme Therapeutics

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Douglas Muchmore, M.D., Halozyme Therapeutics
ClinicalTrials.gov Identifier: NCT00916357     History of Changes
Other Study ID Numbers: HALO-117-204
Study First Received: June 5, 2009
Last Updated: June 22, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Halozyme Therapeutics:
recombinant human hyaluronidase (rHuPH20)
Insulin lispro
Regular human insulin

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin LISPRO
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014