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

NCT01152242 | Completed Phase 1

• 2 other identifiers: 0000-1682010_541
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

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

Keywords

Insulin

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (2)

• 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

• 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

Study Arms (2)

Part 1

ACTIVE COMPARATOR

Part I of the trial

Drug: Isoglycemic Clamp; Drug: Comparator: insulin glargine

Part 2

ACTIVE COMPARATOR

Part II of the trial

Drug: Isoglycemic Clamp; Drug: Comparator: insulin glargine

Interventions

Isoglycemic Clamp DRUG

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

Part 1; Part 2

Comparator: insulin glargine DRUG

Insulin glargine at 0.4 U/kg

Also known as: LANTUS

Part 1; Part 2

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Diabetes Mellitus; Insulin Resistance

Interventions

Insulin Glargine

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2010
• First Posted: June 29, 2010
• Study Start: August 1, 2010
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: July 23, 2015

Record last verified: 2015-07