Current partner codePEPTIDESDE
NCT01146678·Phase 1·INTERVENTIONAL

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

Status

Completed

Phase

Phase 1

Enrollment

22

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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

Full detailed description

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

Treatment arms and agents.

DRUG

Insulin glargine HOE901

Pharmaceutical form:solution for injection Route of administration: subcutaneous

DRUG

Lixisenatide AVE0010

Pharmaceutical form:solution for injection Route of administration: subcutaneous

Timeline

From registration to results.

  1. First posted

    Jun 17, 2010

  2. Study start

    Jun 2010

  3. Primary completion

    Sep 2010

  4. Study completion

    Jan 2011

  5. Results posted

    Not reported

  6. Registry updated

    Mar 2, 2011

Outcomes

What the study measures.

Primary 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

Secondary outcomes

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

Who can take part.

Minimum age
18 Years
Maximum age
65 Years
Sex
ALL
Healthy volunteers
No

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

1 registered sites.

Germany. Showing up to 24 locations stored in the fast local snapshot.

Sanofi-Aventis Administrative Office

Berlin, Germany

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Lixisenatide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.