Pharmacodynamic and Pharmacokinetic Variability of a Basal Insulin (0000-168 AM1)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01152242
First received: June 25, 2010
Last updated: August 9, 2013
Last verified: August 2013
  Purpose

The purpose of this study is to evaluate whether the within-subject variation in duration of action and time-action profile of glargine measured by isoglycemic clamp will be below prespecified levels.


Condition Intervention Phase
Diabetes
Drug: Isoglycemic Clamp
Drug: Comparator: insulin glargine
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Two-Part Clinical Trial to Assess Pharmacodynamic and Pharmacokinetic Variability of a Basal Insulin

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Part I: The within-subject standard deviation in duration of action of glargine (the difference between onset of action and end of action) [ Time Frame: Baseline and 30 hours ] [ Designated as safety issue: No ]
  • Part II: The within-subject coefficient of variation in time-action profile of glargine for AUC-GIR (AUC of glucose infusion rate), GIRmax (maximum level of glucose infusion rate), over the duration of action of glargine [ Time Frame: Baseline and 30 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Part I: The within-subject coefficient of variation in time-action profile of glargine for AUC-GIR and GIRmax over the duration of action of glargine [ Time Frame: Baseline and 30 hours ] [ Designated as safety issue: No ]
  • Part II: The within-subject standard deviation in duration of action of glargine (the difference between onset of action and end of action) [ Time Frame: Baseline and 30 hours ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: August 2010
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Part 1
Part I of the trial
Drug: Isoglycemic Clamp
Isoglycemic Clamp, a procedure that includes IV infusion of short-acting Insulin (Part I) and glucose (Part I and 2)
Drug: Comparator: insulin glargine
Insulin glargine at 0.4 U/kg
Other Name: LANTUS
Active Comparator: Part 2
Part II of the trial
Drug: Isoglycemic Clamp
Isoglycemic Clamp, a procedure that includes IV infusion of short-acting Insulin (Part I) and glucose (Part I and 2)
Drug: Comparator: insulin glargine
Insulin glargine at 0.4 U/kg
Other Name: LANTUS

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Part 1:

  • Patient is a male between 18 to 45 years of age (inclusive) at the prestudy (screening) visit
  • Patient has a clinical diagnosis of type 1 diabetes
  • Patient must have been treated with insulin since diagnosis and be on a stable dose of insulin
  • Patient has a Body Mass Index (BMI) of <=27 kg/m2 and >18 kg/m2
  • Patient has been a nonsmoker and/or has not used nicotine or nicotine-containing products for at least approximately 6 months

Part 2:

  • Subject is a male between 18 to 45 years of age at the prestudy (screening) visit
  • Subject has a Body Mass Index (BMI) of <=25 kg/m^2
  • Subject has been a nonsmoker and/or has not used nicotine or nicotine-containing products for at least approximately 6 months

Exclusion Criteria:

Part 1:

  • Patient has a history of stroke, chronic seizures, or major neurological disorder
  • Patient has currently active and untreated clinically significant endocrine, cardiovascular, hematological, hepatic, renal, respiratory, or genitourinary abnormalities or diseases
  • Patient has a history of hypertension requiring treatment
  • Patient has a history of neoplastic disease within the past 5 years
  • Patient is currently being treated with, or has a history of treatment with any oral antihyperglycemic agent
  • Patient has a history of significant multiple and/or severe allergies

Part 2:

  • Subject has a history of stroke, chronic seizures, or major neurological disorder
  • Subject has a history of hypertension requiring treatment
  • Subject has a history of neoplastic disease within the past 5 years
  • Subject has history of diabetes (Type 1, Type 2 or steroid-induced) or family history of diabetes mellitus
  • Subject has a history of hypersensitivity to glargine or any of its inactive ingredients
  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: NCT01152242

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01152242     History of Changes
Other Study ID Numbers: 0000-168, 2010_541
Study First Received: June 25, 2010
Last Updated: August 9, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Merck Sharp & Dohme Corp.:
Insulin

Additional relevant MeSH terms:
Glargine
Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014