Status:
COMPLETED
Euglycemic Clamp Dose-response Study Comparing a New Insulin Glargine Formulation With Lantus®
Lead Sponsor:
Sanofi
Conditions:
Type 1 Diabetes Mellitus
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
Primary Objective: \- To assess the total metabolic effect ratios of a new insulin glargine formulation versus Lantus® Secondary Objectives: * To assess the exposure ratios of a new insulin glargin...
Detailed Description
The study period for one patient is one month in average and it can last up to 11 weeks broken down as follows: * Screening: 3 to 28 days * Treatment period: 1 to 4 days: 2 days (1 overnight stay) * ...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Male or female subjects with diabetes mellitus type 1 for more than one year,
- Total insulin dose of \<1.2 U/kg/day,
- Glycohemoglobin (HbA1c) ≤ 9.0%,
- Fasting negative serum C-peptide (\< 0.3 nmol/L),
- 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,
- 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 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 or 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 (including St John's Wort) within 14 days before inclusion, or within 5 times the elimination half-life or pharmacodynamic 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),
- Known hypersensitivity to insulin glargine and excipients,
- Any history or presence of deep leg vein thrombosis.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Exclusion
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01195454
Start Date
August 1 2010
End Date
December 1 2010
Last Update
October 31 2011
Active Locations (1)
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1
Sanofi-Aventis Administrative Office
Berlin, Germany