Euglycemic Clamp Study Comparing Two New Insulin Glargine Formulations in Subjects With Type 1 Diabetes Mellitus

• Status: Completed
• Trial end date: 2013-08-01
• Target enrollment: 0
• Participant gender: All

Summary

Primary Objective:

To demonstrate equivalence in exposure to insulin glargine given as test formulation T and reference formulation R in steady state conditions after 6 once-daily subcutaneous (SC) doses

Secondary Objective:

• To assess relative Pharmacodynamic activity of the insulin glargine test formulation T to the insulin glargine reference formulation R in steady state conditions after 6 once-daily SC doses

• To assess the safety and tolerability of the test and reference formulations of two new insulin glargine formulations

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Insulin; Insulin Glargine; Insulin, Globin Zinc

Criteria

Inclusion criteria :

• Male or female subjects, between 18 and 64 years of age, inclusive, with diabetes mellitus type 1 for more than one year

• Total insulin dose of < 1.2 U/kg/day

• Minimum usual basal insulin dose ≥ 0.2 U/kg/day

• Body weight between 50.0 kg and 110.0 kg, Body Mass Index between 18.5 and 30.0 kg/m2 inclusive

• Fasting negative serum C-peptide (< 0.3 nmol/L)

• Glycohemoglobin (HbA1c) ≤ 75 mmol/mol [≤ 9.0%]

• Stable insulin regimen for at least 2 months prior to inclusion in study

• Certified as otherwise healthy for Type-1 Diabetes mellitus patient

• Laboratory parameters within the normal range

• Women of childbearing potential with negative pregnancy test and use of a highly effective contraceptive method or women with confirmed postmenopausal status

Exclusion criteria:

• Any history or presence of clinically relevant cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic (apart from diabetes mellitus type 1), 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 (whatever the decrease in blood pressure), or asymptomatic postural hypotension defined by a decrease in systolic blood pressure 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 or clinically significant allergic disease according to the Investigator's judgment

• Likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol

• Presence or history of drug or alcohol abuse (alcohol consumption > 40 grams / day)

• If female, pregnancy (defined as positive Beta Human Chorionic Gonadotropin test), breast-feeding

• Known hypersensitivity to insulin glargine or excipients of the study drug

• Any history or presence of deep leg vein thrombosis or a frequent appearance of deep leg vein thrombosis in first 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.