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

NCT ID: NCT01152242

Last Updated: 2015-07-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2012-05-31

Brief 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.

Conditions

Diabetes

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Part 1

Part I of the trial

Group Type: ACTIVE_COMPARATOR

Isoglycemic Clamp

Intervention Type: DRUG

Isoglycemic Clamp, a procedure that includes IV infusion of short-acting Insulin (Part I) and glucose (Part I and 2)

Comparator: insulin glargine

Intervention Type: DRUG

Insulin glargine at 0.4 U/kg

Part 2

Part II of the trial

Group Type: ACTIVE_COMPARATOR

Isoglycemic Clamp

Intervention Type: DRUG

Isoglycemic Clamp, a procedure that includes IV infusion of short-acting Insulin (Part I) and glucose (Part I and 2)

Comparator: insulin glargine

Intervention Type: DRUG

Insulin glargine at 0.4 U/kg

Interventions

Isoglycemic Clamp

Isoglycemic Clamp, a procedure that includes IV infusion of short-acting Insulin (Part I) and glucose (Part I and 2)

Intervention Type: DRUG

Comparator: insulin glargine

Insulin glargine at 0.4 U/kg

Intervention Type: DRUG

Other Intervention Names

LANTUS

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Other Identifiers

2010_541

Identifier Type: OTHER

Identifier Source: secondary_id

0000-168

Identifier Type: -

Identifier Source: org_study_id