A Study to Compare Pharmacokinetics and Pharmacodynamics of SAR342434 to Insulin Lispro in Subjects With Type 1 Diabetes

NCT02273258 | Completed Phase 1

• 3 other identifiers: PDY127042012-004453-86U1111-1134-4816
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Objective: To compare exposure and activity of SAR342434 to US-approved and EU-approved Humalog®. Secondary Objective: To assess the safety and tolerability of SAR342434.

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (3)

• Maximum plasma concentration (Cmax) of SAR342434, US-approved Humalog and EU-approved Humalog

  12 hours

• Area under the concentration versus time curve (AUC) of SAR342434, US-approved Humalog and EU-approved Humalog

  12 hours

• Area under the body weight standardized glucose infusion rate (GIR) versus time curve from 0 to 12 hours post administration (GIR-AUC0-12)

  12 hours

Secondary Outcomes (9)

• The fractional area under the concentration versus time curve from 0 or y to x hours post administration (INS-AUC0 or Y to X)

  12 hours

• Time to 20% of AUC (t20%-AUC)

  12 hours

• NS-tmax, INS-t1/2z

  12 hours

• The fractional area under the body weight standardized GIR versus time curve from 0 or y to x hours post administration (GIR-AUC0 or Y to X)

  12 hours

• Time to 20% of total GIR-AUC0-12h (t20%-GIR-AUC0-12h)

  12 hours

Study Arms (3)

Test (T)

EXPERIMENTAL

SAR342434: single dose injection

Drug: SAR342434

Reference 1 (R1)

ACTIVE COMPARATOR

US-approved Humalog®: single dose injection

Drug: Insulin Lispro

Reference 2 (R2)

ACTIVE COMPARATOR

EU-approved Humalog®: single dose injection

Drug: Insulin Lispro

Interventions

SAR342434 DRUG

Pharmaceutical form:solution Route of administration: subcutaneous

Test (T)

Insulin Lispro DRUG

Pharmaceutical form:solution Route of administration: subcutaneous

Reference 1 (R1)

Eligibility Criteria

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

You may qualify if:

• Male or female subjects with diabetes mellitus type 1 for more than one year.
• Total insulin dose of \< 1.2 U/kg/day.
• Fasting negative serum C-peptide (\< 0.3 nmol/L).
• Glycohemoglobin (HbA1c) ≤ 9%.
• Stable insulin regimen for at least 2 months prior to study.
• Normal findings in medical history and physical examination (cardiovascular system, chest and lungs, thyroid, abdomen, nervous system, skin and mucosae, and musculo-skeletal system), vital signs, electrocardiogram (ECG) and safety lab.

You may not qualify if:

• Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic (apart from diabetes mellitus type 1), hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, or 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 headaches and/or migraine, recurrent nausea and/or vomiting (more than twice a month.
• Symptomatic postural hypotension, irrespective of the decrease in blood pressure, or asymptomatic postural hypotension defined as a decrease in systolic blood pressure ≥20 mmHg within 3 minutes when changing from supine to standing position.
• Presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician.
• Likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol.
• Positive result on any of the following tests: hepatitis B surface (HBs Ag) antigen, anti-hepatitis C virus (anti-HCV) antibodies, anti-human immunodeficiency virus 1 and 2 antibodies (anti-HIV1 and anti HIV2 Ab.
• Any history or presence of deep leg vein thrombosis or a frequent appearance of deep leg vein thrombosis in 1st degree relatives (parents, siblings or children).
• 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 Administrative Office

Frankfurt, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

SAR342434; Insulin Lispro

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2014
• First Posted: October 23, 2014
• Study Start: March 1, 2013
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: October 23, 2014

Record last verified: 2014-10

Locations

DE (1)