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

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ClinicalTrials.gov Identifier: NCT01146678
Recruitment Status : Completed
First Posted : June 17, 2010
Last Update Posted : March 2, 2011
Sponsor:
Information provided by:
Sanofi

Brief 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

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Drug: Insulin glargine HOE901 Drug: Lixisenatide AVE0010 Phase 1

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : June 2010
Actual Primary Completion Date : September 2010
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: Lantus(insulin glargine)/lixisenatide on-site mix
Single dose injection of an on site mix of Lantus U100 and lixisenatide (800µg/mL in Lantus U100) at one peri-umbilical site under fasting conditions
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


Active Comparator: lixisenatide + Lantus (insulin glargine)
Single dose, separate injection simultaneous injections of Lantus U100 and lixisenatide (100µg/mL) at opposite peri-umbilical sites within 1 minute under fasting conditions
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





Primary Outcome Measures :
  1. 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 ]
  2. 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 Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]
  6. 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 ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01146678


Locations
Germany
Sanofi-Aventis Administrative Office
Berlin, Germany
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi

Responsible Party: Trial Transparency Team, sanofi-aventis
ClinicalTrials.gov Identifier: NCT01146678     History of Changes
Other Study ID Numbers: BDR11578
2010-019228-30 ( EudraCT Number )
U1111-1116-8960 ( Other Identifier: UTN )
First Posted: June 17, 2010    Key Record Dates
Last Update Posted: March 2, 2011
Last Verified: March 2011

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Lixisenatide
Insulin
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs