DRUG
Insulin glargine HOE901
Pharmaceutical form:solution for injection Route of administration: subcutaneous
Status
Completed
Phase
Phase 1
Enrollment
22
Locations
1
Results
Not posted
Publications
0
Study summary
Primary Objective: * to assess the relative bioavailability of a single dose of insulin glargine (Lantus) and lixisenatide given subcutaneously as on-site mix versus separate and simultaneous injections of each drug Secondary Objectives: * to compare the activity of a single dose of insulin glargine and lixisenatide given subcutaneously as on-site mix versus separate and simultaneous injections of each drug * to assess the safety and tolerability of insulin glargine and lixisenatide given subcutaneously as on-site mix
The study period for one patient is one month in average and it can last up to 7 months (+ 2 weeks) with post-study and follow-up visits
Interventions
DRUG
Pharmaceutical form:solution for injection Route of administration: subcutaneous
DRUG
Pharmaceutical form:solution for injection Route of administration: subcutaneous
Timeline
First posted
Jun 17, 2010
Study start
Jun 2010
Primary completion
Sep 2010
Study completion
Jan 2011
Results posted
Not reported
Registry updated
Mar 2, 2011
Outcomes
Area under the plasma lixisenatide concentration curve (LIX-AUClast)
Time frame · 1 day (D1 to D2) in the first treatment period and 1 day (D1 to D2) during the second treatment period
Lixisenatide maximum plasma/serum peak concentration (LIX-Cmax)
Time frame · 1 day (D1 to D2) in the first treatment period and 1 day (D1 to D2) during the second treatment period
Area under the plasma lixisenatide concentration curve (AUC)
Time frame · 1 day (D1 to D2) in the first treatment period and 1 day (D1 to D2) during the second treatment period
Time to Cmax (Tmax ) for lixisenatide
Time frame · 1 day (D1 to D2) in the first treatment period and 1 day (D1 to D2) during the second treatment period
Area under the body weight standardized glucose infusion rate curve (GIR) within 24 h (GIR-AUC0-24)
Time frame · 1 day (D1 to D2) in the first treatment period and 1 day (D1 to D2) during the second treatment period
Time to 50% of the GIR-AUC within 24 h (T50%-GIR AUC0-24)
Time frame · 1 day (D1 to D2) in the first treatment period and 1 day (D1 to D2) during the second treatment period
Maximum smoothed body weight standardized glucose infusion rate GIRmax
Time frame · 1 day (D1 to D2) in the first treatment period and 1 day (D1 to D2) during the second treatment period
Time to GIRmax (GIR-Tmax)
Time frame · 1 day (D1 to D2) in the first treatment period and 1 day (D1 to D2) during the second treatment period
Eligibility
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.
Study locations
Germany. Showing up to 24 locations stored in the fast local snapshot.
Sanofi-Aventis Administrative Office
Berlin, Germany
Publications
No PMID-linked publications were present in this registry snapshot.
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