Repeated Dosing Study With a New Insulin Glargine Formulation and Lantus® in Patients With Type 1 Diabetes Mellitus
Primary Purpose
Type 1 Diabetes Mellitus
Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
Insulin glargine HOE901
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes Mellitus
Eligibility Criteria
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.
Sites / Locations
- Investigational site number 276001
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Cohort 1
Cohort 2
Arm Description
Dose Level 1
Dose Level 2
Outcomes
Primary Outcome Measures
Safety in terms of adverse and serious adverse events, vital signs, ECG, safety laboratory
Secondary Outcome Measures
Glucose infusion rate
Pharmacokinetic parameter : Cmax
Pharmacokinetic parameter : Tmax
Pharmacokinetic parameter : AUC
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01349855
Brief Title
Repeated Dosing Study With a New Insulin Glargine Formulation and Lantus® in Patients With Type 1 Diabetes Mellitus
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sanofi
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
Detailed Description
The study duration per patient will be 33 to 68 days including 2 treatment periods of 10 days each separated by a wash-out period of 7-21 days.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
Dose Level 1
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
Dose Level 2
Intervention Type
Drug
Intervention Name(s)
Insulin glargine HOE901
Intervention Description
Pharmaceutical form:solution for injection: new formulation and marketed formulation Route of administration: subcutaneous
Primary Outcome Measure Information:
Title
Safety in terms of adverse and serious adverse events, vital signs, ECG, safety laboratory
Time Frame
up to day 10 of each period
Secondary Outcome Measure Information:
Title
Glucose infusion rate
Time Frame
up to day 10 of each period
Title
Pharmacokinetic parameter : Cmax
Time Frame
up to day 10 of each period
Title
Pharmacokinetic parameter : Tmax
Time Frame
up to day 10 of each period
Title
Pharmacokinetic parameter : AUC
Time Frame
up to day 10 of each period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Investigational site number 276001
City
Neuss
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
25150159
Citation
Becker RH, Dahmen R, Bergmann K, Lehmann A, Jax T, Heise T. New insulin glargine 300 Units . mL-1 provides a more even activity profile and prolonged glycemic control at steady state compared with insulin glargine 100 Units . mL-1. Diabetes Care. 2015 Apr;38(4):637-43. doi: 10.2337/dc14-0006. Epub 2014 Aug 22.
Results Reference
derived
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Repeated Dosing Study With a New Insulin Glargine Formulation and Lantus® in Patients With Type 1 Diabetes Mellitus
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