Back to resultsStudy of How Single Rising Doses of SAR161271 Are Absorbed and Act in Patients With Type 1 Diabetes Mellitus (T1DM)
Primary Purpose
Type 1 Diabetes Mellitus
Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
SAR161271
Insulin glargine HOE901
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes Mellitus
Eligibility Criteria
Inclusion criteria:
- Patients who have type 1 diabetes mellitus (T1DM) as defined by American Diabetes Association average total insulin dose of <1.2 U/kg/day
- Fasting negative serum C-peptide (<0.3 nmol/L)
- Glycated hemoglobin (HbA1c) < or = 9%
- Stable insulin regimen for at least 2 months before the study
- Body weight between 50-110 kg inclusive; body mass index between 18-30 kg/m2, inclusive
- Certified as healthy for T1DM by a comprehensive clinical assessment
Exclusion criteria:
- Any history or presence of clinically relevant (for T1DM) cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, psychiatric, systemic, ocular, or infectious disease, or signs of acute illness, or major diabetic complications such as diabetic retinopathy.
- Blood donation, any volume, within 1 month before inclusion.
- Presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician
- Regular use of any medication other than insulins in the last month before study start with the exception of thyroid hormones, metformin, lipid-lowering and antihypertensive drugs
- Positive reaction to any of the following tests: hepatitis B surface (HBs) antigen, anti-hepatitis C virus (anti-HCV) antibodies, anti-human immunodeficiency virus (HIV) 1 antibodies, anti-HIV2 antibodies.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Sites / Locations
- Sanofi-Aventis Administrative Office
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Cohort 1 : SAR161271 0.3 U/kg
Cohort 2 : SAR161271 0.6 U/kg
Cohort 3 : SAR161271 1.2 U/kg
Arm Description
Cross-over design of four formulation of SAR161271 0.3U/kg or insulin glargine administered as a single dose in the morning between about 11h00 and about 12h00; fasting for about 12h before and for the duration of the clamp
Cross-over design of four formulation of SAR161271 0.6U/kg or insulin glargine administered as a single dose in the morning between about 11h00 and about 12h00; fasting for about 12h before and for the duration of the clamp
Cross-over design of four formulation of SAR161271 1.2 U/kg or insulin glargine administered as a single dose in the morning between about 11h00 and about 12h00; fasting for about 12h before and for the duration of the clamp
Outcomes
Primary Outcome Measures
- Safety in terms of adverse and serious adverse events, vital signs, ECG, safety laboratory for each cohort
- Pharmacodynamics (Glucose infusion rate) time-action profile
Secondary Outcome Measures
- Pharmacokinetic parameters
- anti-insulin antibody production
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01053728
Brief Title
Study of How Single Rising Doses of SAR161271 Are Absorbed and Act in Patients With Type 1 Diabetes Mellitus (T1DM)
Official Title
Randomized, Double-blind, Euglycemic Glucose Clamp Study of Four Formulations of SAR161271, in Single Doses in Healthy Subjects and Single Ascending Doses in Patients With Type 1 Diabetes Mellitus
Study Type
Interventional
2. Study Status
Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
November 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sanofi
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Primary Objective:
- To establish initial safety/tolerability and pharmacodynamic and pharmacokinetic profiles of four formulations of SAR161271 in patients with T1DM.
Secondary Objective:
- To establish relative potency of SAR161271 compared with insulin glargine in patients with T1DM
Detailed Description
The total per patient is between 31 and 67 days; including post-study visit between 108 and 172 days. In case of an additional late post-study visit after last dosing, approximately 213 to 279 days, broken down as follows:
Screening: 3 to 27 days;
Treatment Periods each 1 day with institutionalisation from Day -1 to Day 3;
Wash-out between doses: 7 to 10 days;
End of Study visit: 7 to 10 days after last dose.
Post-study visit 84 to 112 days after last dosing. If necessary, additional post-study visit 6 to 7 months after last dosing.
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, Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cohort 1 : SAR161271 0.3 U/kg
Arm Type
Experimental
Arm Description
Cross-over design of four formulation of SAR161271 0.3U/kg or insulin glargine administered as a single dose in the morning between about 11h00 and about 12h00; fasting for about 12h before and for the duration of the clamp
Arm Title
Cohort 2 : SAR161271 0.6 U/kg
Arm Type
Experimental
Arm Description
Cross-over design of four formulation of SAR161271 0.6U/kg or insulin glargine administered as a single dose in the morning between about 11h00 and about 12h00; fasting for about 12h before and for the duration of the clamp
Arm Title
Cohort 3 : SAR161271 1.2 U/kg
Arm Type
Experimental
Arm Description
Cross-over design of four formulation of SAR161271 1.2 U/kg or insulin glargine administered as a single dose in the morning between about 11h00 and about 12h00; fasting for about 12h before and for the duration of the clamp
Intervention Type
Drug
Intervention Name(s)
SAR161271
Intervention Description
Pharmaceutical form:Solution for injection
Route of administration: subcutaneous
Intervention Type
Drug
Intervention Name(s)
Insulin glargine HOE901
Intervention Description
Pharmaceutical form:Solution for injection
Route of administration: subcutaneous
Primary Outcome Measure Information:
Title
- Safety in terms of adverse and serious adverse events, vital signs, ECG, safety laboratory for each cohort
Time Frame
up to 7 days after dose
Title
- Pharmacodynamics (Glucose infusion rate) time-action profile
Time Frame
up to 30 hours after dose
Secondary Outcome Measure Information:
Title
- Pharmacokinetic parameters
Time Frame
up to 168 hours after dose
Title
- anti-insulin antibody production
Time Frame
pre-dose and after 4th dose
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
Patients who have type 1 diabetes mellitus (T1DM) as defined by American Diabetes Association average total insulin dose of <1.2 U/kg/day
Fasting negative serum C-peptide (<0.3 nmol/L)
Glycated hemoglobin (HbA1c) < or = 9%
Stable insulin regimen for at least 2 months before the study
Body weight between 50-110 kg inclusive; body mass index between 18-30 kg/m2, inclusive
Certified as healthy for T1DM by a comprehensive clinical assessment
Exclusion criteria:
Any history or presence of clinically relevant (for T1DM) cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, psychiatric, systemic, ocular, or infectious disease, or signs of acute illness, or major diabetic complications such as diabetic retinopathy.
Blood donation, any volume, within 1 month before inclusion.
Presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician
Regular use of any medication other than insulins in the last month before study start with the exception of thyroid hormones, metformin, lipid-lowering and antihypertensive drugs
Positive reaction to any of the following tests: hepatitis B surface (HBs) antigen, anti-hepatitis C virus (anti-HCV) antibodies, anti-human immunodeficiency virus (HIV) 1 antibodies, anti-HIV2 antibodies.
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
Sanofi-Aventis Administrative Office
City
Berlin
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Study of How Single Rising Doses of SAR161271 Are Absorbed and Act in Patients With Type 1 Diabetes Mellitus (T1DM)
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