Study of How Single Rising Doses of SAR161271 Are Absorbed and Act in Patients With Type 1 Diabetes Mellitus (T1DM)

NCT ID: NCT01053728

Last Updated: 2011-07-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2010-11-30

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.

Conditions

Type 1 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Cohort 1 : SAR161271 0.3 U/kg

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

Group Type: EXPERIMENTAL

SAR161271

Intervention Type: DRUG

Pharmaceutical form:Solution for injection

Route of administration: subcutaneous

Insulin glargine HOE901

Intervention Type: DRUG

Pharmaceutical form:Solution for injection

Route of administration: subcutaneous

Cohort 2 : SAR161271 0.6 U/kg

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

Group Type: EXPERIMENTAL

SAR161271

Intervention Type: DRUG

Pharmaceutical form:Solution for injection

Route of administration: subcutaneous

Insulin glargine HOE901

Intervention Type: DRUG

Pharmaceutical form:Solution for injection

Route of administration: subcutaneous

Cohort 3 : SAR161271 1.2 U/kg

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

Group Type: EXPERIMENTAL

SAR161271

Intervention Type: DRUG

Pharmaceutical form:Solution for injection

Route of administration: subcutaneous

Insulin glargine HOE901

Intervention Type: DRUG

Pharmaceutical form:Solution for injection

Route of administration: subcutaneous

Interventions

SAR161271

Pharmaceutical form:Solution for injection

Route of administration: subcutaneous

Intervention Type: DRUG

Insulin glargine HOE901

Pharmaceutical form:Solution for injection

Route of administration: subcutaneous

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

sanofi-aventis

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

Sanofi-Aventis Administrative Office

Berlin, , Germany

Countries

Germany

Other Identifiers

TDU10948

Identifier Type: -

Identifier Source: secondary_id

TDU10987

Identifier Type: -

Identifier Source: org_study_id