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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01152242
First Posted: June 29, 2010
Last Update Posted: July 23, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  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
Intervention Model: Single Group Assignment
Masking: None (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 ]
  • 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 ]

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 ]
  • 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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01152242


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

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01152242     History of Changes
Other Study ID Numbers: 0000-168
2010_541 ( Other Identifier: Merck )
First Submitted: June 25, 2010
First Posted: June 29, 2010
Last Update Posted: July 23, 2015
Last Verified: July 2015

Keywords provided by Merck Sharp & Dohme Corp.:
Insulin

Additional relevant MeSH terms:
Insulin, Globin Zinc
Insulin
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs