- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01349855
Repeated Dosing Study With a New Insulin Glargine Formulation and Lantus® in Patients With Type 1 Diabetes Mellitus
A Randomized, Double-blind, 2x2 Cross-over Euglycemic Clamp Study in Two Parallel Cohorts to Assess the Safety and Tolerability of Two Dose Levels of a New Formulation of Insulin Glargine and to Compare Its Pharmacodynamic and Pharmacokinetic Properties With 0.4 U/kg/Day Lantus® in an 8-days Multiple Dosing Regimen in Patients With Diabetes Mellitus Type 1
Primary Objective:
To assess the safety and tolerability of two dose levels of a new insulin glargine formulation in a once-daily multiple dosing regimen
Secondary Objective:
To compare the pharmacokinetic and pharmacodynamic properties of two dose levels of a new insulin glargine formulation with 0.4 U/kg Lantus® in a once-daily multiple dosing regimen
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
-
Neuss, Germany
- Investigational Site Number 276001
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion criteria:
- Male or female subjects, between 18 and 65 years of age, inclusive, with diabetes mellitus type 1 for more than one year, as defined by the American Diabetes Association
- Body weight between 50.0 kg and 110.0 kg,
- Body Mass Index between 18.0 and 30.0 kg/m2 inclusive
- Stable insulin regimen for at least 2 months prior to study
- Certified as otherwise healthy for Type-1 Diabetes mellitus patient by assessment of medical history and physical examination
- Women of childbearing potential must have a negative pregnancy test and must use a highly effective method of birth control. During the entire study female subjects of child bearing potential must use two independent methods of contraception. The accepted double contraception methods include use of an intra-uterine device or hormonal contraception in addition to one of the following contraceptive options: 1) condom; 2) diaphragm; cervical/vault cap; 3) spermicide.
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
- Presence or history of a drug allergy or clinically significant allergic disease according to the Investigator's judgment
- Participation in a trial with any investigational drug during the past three months
- Symptoms of a clinically significant illness in the 3 months before the study, which, according to the investigator's opinion, could interfere with the purposes of the study
- 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
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cohort 1
Dose Level 1
|
Pharmaceutical form:solution for injection: new formulation and marketed formulation Route of administration: subcutaneous
|
Experimental: Cohort 2
Dose Level 2
|
Pharmaceutical form:solution for injection: new formulation and marketed formulation Route of administration: subcutaneous
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety in terms of adverse and serious adverse events, vital signs, ECG, safety laboratory
Time Frame: up to day 10 of each period
|
up to day 10 of each period
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Glucose infusion rate
Time Frame: up to day 10 of each period
|
up to day 10 of each period
|
Pharmacokinetic parameter : Cmax
Time Frame: up to day 10 of each period
|
up to day 10 of each period
|
Pharmacokinetic parameter : Tmax
Time Frame: up to day 10 of each period
|
up to day 10 of each period
|
Pharmacokinetic parameter : AUC
Time Frame: up to day 10 of each period
|
up to day 10 of each period
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TDR11626
- 2010-023771-26 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Type 1 Diabetes Mellitus
-
SanofiCompletedType 1 Diabetes Mellitus-Type 2 Diabetes MellitusHungary, Russian Federation, Germany, Poland, Japan, United States, Finland
-
University of Colorado, DenverMassachusetts General Hospital; Beta Bionics, Inc.CompletedDiabetes Mellitus, Type 1 | Type 1 Diabetes | Diabetes type1 | Type 1 Diabetes Mellitus | Autoimmune Diabetes | Diabetes Mellitus, Insulin-Dependent | Juvenile-Onset Diabetes | Diabetes, Autoimmune | Insulin-Dependent Diabetes Mellitus 1 | Diabetes Mellitus, Insulin-Dependent, 1 | Diabetes Mellitus, Brittle | Diabetes Mellitus, Juvenile-Onset and other conditionsUnited States
-
University of California, San FranciscoJuvenile Diabetes Research FoundationCompletedType 1 Diabetes Mellitus | Diabetes Mellitus, Type I | Insulin-Dependent Diabetes Mellitus 1 | Diabetes Mellitus, Insulin-Dependent, 1 | IDDMUnited States, Australia
-
AstraZenecaCompletedType 2 Diabetes Mellitus | Type 1 Diabetes MellitusUnited States
-
Capillary Biomedical, Inc.TerminatedType 1 Diabetes | Type 1 Diabetes Mellitus | Diabetes Mellitus, Type I | Diabetes Mellitus, Insulin-Dependent, 1 | IDDMAustria
-
National Institute of Allergy and Infectious Diseases...PPD; Rho Federal Systems Division, Inc.; Immune Tolerance Network (ITN)CompletedType 1 Diabetes Mellitus | T1DM | T1D | New-onset Type 1 Diabetes MellitusUnited States, Australia
-
Shanghai Changzheng HospitalRecruitingBrittle Type 1 Diabetes MellitusChina
-
Capillary Biomedical, Inc.CompletedDiabetes Mellitus, Type 1 | Type 1 Diabetes | Type 1 Diabetes Mellitus | Diabetes Mellitus, Insulin-Dependent, 1Australia
-
Spiden AGDCB Research AGRecruitingType 1 Diabetes Mellitus | Type 1 Diabetes Mellitus With Hypoglycemia | Type 1 Diabetes Mellitus With HyperglycemiaSwitzerland
-
Instytut Diabetologii Sp. z o.o.National Center for Research and Development, Poland; Nalecz Institute of Biocybernetics...UnknownType 1 Diabetes Mellitus With Hyperglycemia | Type 1 Diabetes Mellitus With HypoglycaemiaPoland
Clinical Trials on Insulin glargine HOE901
-
SanofiCompleted
-
SanofiCompleted
-
SanofiCompletedType 1 Diabetes MellitusJapan
-
SanofiTerminated
-
SanofiCompleted
-
SanofiCompleted
-
SanofiCompletedType 2 Diabetes MellitusUnited States, Australia, Spain, Korea, Republic of, Hungary, Mexico, Italy, Poland, Argentina, Canada, Colombia, France, Germany, Japan, Peru, Romania, Sweden, United Kingdom
-
SanofiCompleted