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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT01152242
First received: June 25, 2010
Last updated: July 5, 2012
Last verified: June 2012
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Merck:

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01152242

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

No publications provided

Responsible Party: Merck
ClinicalTrials.gov Identifier: NCT01152242     History of Changes
Other Study ID Numbers: 0000-168, 2010_541
Study First Received: June 25, 2010
Last Updated: July 5, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Merck:
Insulin

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

ClinicalTrials.gov processed this record on May 21, 2013