Single Dose Clamp Study To Compare Concentration/Time Profile And Metabolic Activity Profile Of 2 New Formulations Of Insulin Glargine With Lantus

NCT ID: NCT02201199

Last Updated: 2014-12-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2014-11-30

Brief Summary

Primary Objective:

To compare the pharmacokinetic (PK) characteristics of single doses of insulin glargine given as U200 and U500 with those of a single dose (SD) of Lantus® U100 in a euglycemic clamp setting in subjects with type 1 diabetes.

Secondary Objectives:

To compare the metabolic activity characteristics of single doses of insulin glargine given as U200 and U500 with those of a single dose of Lantus® U100 in a euglycemic clamp setting in subjects with type 1 diabetes.

To assess the safety and tolerability of single doses of U200, U500 and Lantus® U100 in subjects with type 1 diabetes.

Detailed Description

Total study duration for each subject is between 3.5 and 12 weeks.

Two overnight stays at the unit in each of 3 treatment periods.

Conditions

Type 1 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

insulin glargine U100

1 single dose

Group Type: ACTIVE_COMPARATOR

insulin glargine U100 HOE901

Intervention Type: DRUG

Pharmaceutical form:solution for injection Route of administration: subcutaneous

insulin glargine U200

1 single dose

Group Type: EXPERIMENTAL

insulin glargine U200 HOE901

Intervention Type: DRUG

Pharmaceutical form:solution for injection Route of administration: subcutaneous

insulin glargine U500

1 single dose

Group Type: EXPERIMENTAL

insulin glargine U500 HOE901

Intervention Type: DRUG

Pharmaceutical form:solution for injection Route of administration: subcutaneous

Interventions

insulin glargine U200 HOE901

Pharmaceutical form:solution for injection Route of administration: subcutaneous

Intervention Type: DRUG

insulin glargine U500 HOE901

Pharmaceutical form:solution for injection Route of administration: subcutaneous

Intervention Type: DRUG

insulin glargine U100 HOE901

Pharmaceutical form:solution for injection Route of administration: subcutaneous

Intervention Type: DRUG

Other Intervention Names

Lantus

Eligibility Criteria

Inclusion Criteria

• Male or female subjects, between 18 and 65 years of age, inclusive, with type 1 diabetes mellitus for more than one year, as defined by the American Diabetes Association.
• Total insulin dose <1.2 U/kg/day.
• Minimum usual basal insulin dose ≥0.2 U/kg/day.
• Body weight between 50.0 kg and 110.0 kg, Body Mass Index between 18.5 and 30.0 kg/m2 inclusive.
• Fasting negative serum C-peptide (<0.3 nmol/L).
• Glycohemoglobin (HbA1c) ≤75 mmol/mol (≤9.0%).
• Stable insulin regimen for at least 2 months prior to inclusion in study.
• Certified as otherwise healthy for Type 1 diabetes mellitus patient.
• Women of childbearing potential with negative pregnancy test and use of a highly effective contraceptive method or women with confirmed postmenopausal status.
• Having given written informed consent prior to undertaking any study-related procedure.

Exclusion Criteria

• More than one episode of severe hypoglycemia with seizure, coma or requiring assistance of another person during the past 6 months.
• Frequent severe headaches and / or migraine, recurrent nausea and / or vomiting (more than twice a month).
• Presence or history of a drug allergy or clinically significant allergic disease according to the Investigator's judgment.
• Presence or history of drug or alcohol abuse (alcohol consumption >40 grams / day).
• Smoking more than 5 cigarettes or equivalent per day, unable to refrain from smoking.
• Any medication (including St John's Wort) within 14 days before inclusion, or within 5 times the elimination half-life or pharmacodynamic half-life of that drug, whichever the longest and regular use of any medication in the last month before study start with the exception of insulin products, thyroid hormones, lipid-lowering and antihypertensive drugs, and, if female, with the exception of hormonal contraception or menopausal hormone replacement therapy; any vaccination within the last 28 days; any biologics (antibody or its derivatives) given within 4 months before randomization.
• Known hypersensitivity to insulin glargine or excipients of the study drug.
• Any history or presence of deep leg vein thrombosis or a frequent appearance of deep leg vein thrombosis in first degree relatives (parents, siblings or children).

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

Investigational Site Number 276001

Neuss, , Germany

Countries

Germany

Other Identifiers

2014-001252-33

Identifier Type: -

Identifier Source: secondary_id

U1111-1153-3712

Identifier Type: OTHER

Identifier Source: secondary_id

PDY13928

Identifier Type: -

Identifier Source: org_study_id