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

NCT01146678 | Completed Phase 1

• 3 other identifiers: BDR115782010-019228-30U1111-1116-8960
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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

Conditions

Type 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

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

  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)

  1 day (D1 to D2) in the first treatment period and 1 day (D1 to D2) during the second treatment period

Secondary Outcomes (6)

• Area under the plasma lixisenatide concentration curve (AUC)

  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

  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)

  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)

  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

  1 day (D1 to D2) in the first treatment period and 1 day (D1 to D2) during the second treatment period

Study Arms (2)

Lantus(insulin glargine)/lixisenatide on-site mix

EXPERIMENTAL

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; Drug: Lixisenatide AVE0010

lixisenatide + Lantus (insulin glargine)

ACTIVE COMPARATOR

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; Drug: Lixisenatide AVE0010

Interventions

Insulin glargine HOE901 DRUG

Pharmaceutical form:solution for injection Route of administration: subcutaneous

Lantus(insulin glargine)/lixisenatide on-site mix; lixisenatide + Lantus (insulin glargine)

Lixisenatide AVE0010 DRUG

Pharmaceutical form:solution for injection Route of administration: subcutaneous

Lantus(insulin glargine)/lixisenatide on-site mix; lixisenatide + Lantus (insulin glargine)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi-Aventis Administrative Office

Berlin, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

lixisenatide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 16, 2010
• First Posted: June 17, 2010
• Study Start: June 1, 2010
• Primary Completion: September 1, 2010
• Study Completion: January 1, 2011
• Last Updated: March 2, 2011

Record last verified: 2011-03

Locations

DE (1)