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

Diabetes Clinical Trial

Official title:

A Two-Part Clinical Trial to Assess Pharmacodynamic and Pharmacokinetic Variability of a Basal Insulin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01152242
• Other study ID #: 0000-168
• Secondary ID: 2010_541
• Status: Completed
• Phase: Phase 1
• First received: June 25, 2010
• Last updated: July 22, 2015
• Start date: August 2010
• Est. completion date: May 2012

Study information

• Verified date: July 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes

Intervention

Drug:
• Isoglycemic Clamp
Isoglycemic Clamp, a procedure that includes IV infusion of short-acting Insulin (Part I) and glucose (Part I and 2)
• Comparator: insulin glargine
Insulin glargine at 0.4 U/kg

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Part I: The within-subject standard deviation in duration of action of glargine (the difference between onset of action and end of action)		Baseline and 30 hours	No
Primary	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		Baseline and 30 hours	No
Secondary	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		Baseline and 30 hours	No
Secondary	Part II: The within-subject standard deviation in duration of action of glargine (the difference between onset of action and end of action)		Baseline and 30 hours	No