GLP-1 Peptide Atlas, by Delfa

CompletedPhase 1

Relative Bioavailability and Activity of Different Formulations of Insulin Glargine and Lixisenatide in Patients With Diabetes Mellitus Type 1

A Randomized, Cross-over, Open, Euglycemic Clamp Study on the Relative Bioavailability and Activity of 0.6 U/kg Insulin Glargine and 20 μg Lixisenatide, Given as On-site Mix Compared to Separate Simultaneous Injections in Subjects With Type 1 Diabetes Mellitus

Lead sponsor

Sanofi

Asset

Lixisenatide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

estimated

Study population

Type 1 diabetes

Key I/E criterion

•HbA1c ≤9%

Primary endpoints

•Area under the plasma lixisenatide concentration curve (LIX-AUClast)•Lixisenatide maximum plasma/serum peak concentration (LIX-Cmax)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT01146678

Org study IDBDR11578

Secondary ID2010-019228-30

Secondary IDU1111-1116-8960UTN

Timeline

Milestones

Study first posted2010-06-17estimated

Last update posted2011-03-02estimated

Study start2010-06 (month precision)

Primary completion2010-09actual (month precision)

Study completion2011-01actual (month precision)

Assets

Investigational agents

Lixisenatide

Study populations

Who this study enrolls

Type 1 diabetes

Eligibility

Who can enroll

Minimum age18 Years

Maximum age65 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Subjects with type 1 diabetes mellitus for more than one year with total insulin dose of <1.2 U.kg/day, but otherwise healthy with glycohemoglobin (HbA1c) ≤ 9.0%, stable insulin regimen for at least 2 months prior to study, normal finding in medical history and physical examination.

Exclusion criteria

•any history or presence of clinically relevant cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic (apart from diabetes mellitus type I), 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, or asymptomatic postural hypotension defined by a decrease in systolic blood pressure (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 to 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 within 14 days before inclusion, or within 5 times the elimination 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)

•History of unexplained pancreatitis, chronic pancreatitis and/or pancreatectomy

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

Endpoints (8)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Glycemic / diabetes

Safety / tolerability / PK