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Euglycemic Clamp Dose-response Study Comparing a New Insulin Glargine Formulation With Lantus®

Information source: Sanofi
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Type 1 Diabetes Mellitus

Intervention: Insulin glargine (HOE901) (Drug); Insulin glargine (HOE901) (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Sanofi

Official(s) and/or principal investigator(s):
Clinical Sciences & Operations, Study Director, Affiliation: Sanofi

Summary

Primary Objective:

- To assess the total metabolic effect ratios of a new insulin glargine formulation versus

Lantus Secondary Objectives:

- To assess the exposure ratios of a new insulin glargine formulation versus Lantus

- To compare the duration of action of a new insulin glargine formulation versus Lantus

- To explore the dose response and dose exposure relationship of a new insulin glargine

formulation

- To assess the safety and tolerability of a new insulin glargine formulation

Clinical Details

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: The area under the body weight standardized glucose infusion rate curve (GIR) within 36 hours (GIR-AUC0-36)

Secondary outcome:

The area under the insulin glargine concentration curve within 36 hours (INS-AUC0-36) -

Time to 50% of the GIR-AUC0-36 (T50%-GIR AUC0-36)

Time to 50% of INS-AUC0-36 (T50% INS-AUC0-36)

Duration of blood glucose control (time to elevation of smoothed blood glucose profile above clamp level and to elevation above different pre-specified blood glucose levels)

Maximum smoothed body weight standardized glucose infusion rate GIRmax, and time to GIRmax (GIR-Tmax)

Maximum insulin concentration INS-Cmax, and time to Cmax (INS-Tmax)

Detailed description: The study period for one patient is one month in average and it can last up to 11 weeks broken down as follows:

- Screening: 3 to 28 days

- Treatment period: 1 to 4 days: 2 days (1 overnight stay)

- Washout period: 5 to 18 days (preferentially 7 days between consecutive dosings)

- End of study: 1 day after the last dosing

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion criteria:

- Male or female subjects with diabetes mellitus type 1 for more than one year,

- Total insulin dose of <1. 2 U/kg/day,

- Glycohemoglobin (HbA1c) ≤ 9. 0%,

- Fasting negative serum C-peptide (< 0. 3 nmol/L),

- Stable insulin regimen for at least 2 months prior to study,

- Normal findings in medical history and physical examination (cardiovascular system,

chest and lungs, thyroid, abdomen, nervous system, skin and mucosae, and musculo-skeletal system), vital signs, electrocardiogram (ECG) and safety lab,

- Women of childbearing potential with negative pregnancy test and use of a highly

effective contraceptive method or women with confirmed postmenopausal status. Exclusion criteria:

- Any history or presence of clinically relevant cardiovascular, pulmonary,

gastro-intestinal, hepatic, renal, metabolic (apart from diabetes mellitus type 1), hematological, neurological, psychiatric, systemic (affecting the body as a whole), ocular, gynecologic (if female), or infectious disease; any acute infectious disease or signs of acute illness,

- 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),

- Symptomatic hypotension (whatever the decrease in blood pressure), or asymptomatic

postural hypotension defined by a decrease in SBP equal to or greater than 20 mmHg within three minutes when changing from the supine to the standing position,

- Presence or history of a drug allergy or clinically significant allergic disease,

- Likelihood of requiring treatment during the study period with drugs not permitted by

the clinical study protocol,

- Pregnant or breast feeding women,

- 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 other than insulins in the last month before study start with the exception of 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,

- Positive reaction to any of the following tests: hepatitis B surface (HBs Ag)

antigen, antihepatitis B core antibodies (anti-HBc Ab) if compound having possible immune activities, anti-hepatitis C virus (anti-HCV2) antibodies, anti-human immunodeficiency virus 1 and 2 antibodies (anti-HIV1 and anti HIV2 Ab),

- Known hypersensitivity to insulin glargine and excipients,

- Any history or presence of deep leg vein thrombosis.

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

Locations and Contacts

Sanofi-Aventis Administrative Office, Berlin, Germany
Additional Information

Starting date: August 2010
Last updated: October 28, 2011

Page last updated: August 23, 2015

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