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

Primary Purpose

Type 1 Diabetes Mellitus

Status

Completed

Phase

Phase 1

Locations

Germany

Study Type

Interventional

Intervention

Insulin glargine HOE901

Lixisenatide AVE0010

About this trial

This is an interventional treatment trial for Type 1 Diabetes Mellitus

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Sanofi-Aventis Administrative Office

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Lantus(insulin glargine)/lixisenatide on-site mix

lixisenatide + Lantus (insulin glargine)

Arm Description

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

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

Outcomes

Primary Outcome Measures

Area under the plasma lixisenatide concentration curve (LIX-AUClast)

Lixisenatide maximum plasma/serum peak concentration (LIX-Cmax)

Secondary Outcome Measures

Area under the plasma lixisenatide concentration curve (AUC)

Time to Cmax (Tmax ) for lixisenatide

Area under the body weight standardized glucose infusion rate curve (GIR) within 24 h (GIR-AUC0-24)

Time to 50% of the GIR-AUC within 24 h (T50%-GIR AUC0-24)

Maximum smoothed body weight standardized glucose infusion rate GIRmax

Time to GIRmax (GIR-Tmax)

Full Information

NCT ID

NCT01146678

First Posted

June 16, 2010

Last Updated

March 1, 2011

Sponsor

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT01146678

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

March 2011

Overall Recruitment Status

Completed

Study Start Date

June 2010 (undefined)

Primary Completion Date

September 2010 (Actual)

Study Completion Date

January 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Sanofi

4. Oversight

Data Monitoring Committee

5. Study Description

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

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 1 Diabetes Mellitus

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

22 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Lantus(insulin glargine)/lixisenatide on-site mix

Arm Type

Experimental

Arm Description

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

Arm Title

lixisenatide + Lantus (insulin glargine)

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Insulin glargine HOE901

Intervention Description

Pharmaceutical form:solution for injection Route of administration: subcutaneous

Intervention Type

Drug

Intervention Name(s)

Lixisenatide AVE0010

Intervention Description

Pharmaceutical form:solution for injection Route of administration: subcutaneous

Primary Outcome Measure Information:

Title

Area under the plasma lixisenatide concentration curve (LIX-AUClast)

Time Frame