Status:
COMPLETED
Euglycemic Clamp Study Comparing Two New Insulin Glargine Formulations in Subjects With Type 1 Diabetes Mellitus
Lead Sponsor:
Sanofi
Conditions:
Type1 Diabetes
Eligibility:
All Genders
18-64 years
Phase:
PHASE1
Brief 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) d...
Detailed Description
Total study duration per subject: 29 to 64 days including screening visit Duration of each part of the study for one subject: * Screening: 3 to 21 days before 1st dosing (Day -21 to Day -3) * Treatm...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01838083
Start Date
April 1 2013
End Date
August 1 2013
Last Update
August 13 2013
Active Locations (1)
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1
Investigational Site Number 276001
Neuss, Germany, 41460