NCT01053728

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Feb 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 19, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 21, 2010

Completed
11 days until next milestone

Study Start

First participant enrolled

February 1, 2010

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

July 26, 2011

Status Verified

July 1, 2011

Enrollment Period

3 months

First QC Date

January 19, 2010

Last Update Submit

July 25, 2011

Conditions

Type 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

  • - Safety in terms of adverse and serious adverse events, vital signs, ECG, safety laboratory for each cohort

    up to 7 days after dose

  • - Pharmacodynamics (Glucose infusion rate) time-action profile

    up to 30 hours after dose

Secondary Outcomes (2)

  • - Pharmacokinetic parameters

    up to 168 hours after dose

  • - anti-insulin antibody production

    pre-dose and after 4th dose

Study Arms (3)

Cohort 1 : SAR161271 0.3 U/kg

EXPERIMENTAL

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

Drug: SAR161271Drug: Insulin glargine HOE901

Cohort 2 : SAR161271 0.6 U/kg

EXPERIMENTAL

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

Drug: SAR161271Drug: Insulin glargine HOE901

Cohort 3 : SAR161271 1.2 U/kg

EXPERIMENTAL

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

Drug: SAR161271Drug: Insulin glargine HOE901

Interventions

SAR161271DRUG

Pharmaceutical form:Solution for injection Route of administration: subcutaneous

Cohort 1 : SAR161271 0.3 U/kgCohort 2 : SAR161271 0.6 U/kgCohort 3 : SAR161271 1.2 U/kg
Insulin glargine HOE901DRUG

Pharmaceutical form:Solution for injection Route of administration: subcutaneous

Cohort 1 : SAR161271 0.3 U/kgCohort 2 : SAR161271 0.6 U/kgCohort 3 : SAR161271 1.2 U/kg

Eligibility Criteria

Age18 Years - 60 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanofi-Aventis Administrative Office

Berlin, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Clinical Sciences & Operations

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 19, 2010

First Posted

January 21, 2010

Study Start

February 1, 2010

Primary Completion

May 1, 2010

Study Completion

November 1, 2010

Last Updated

July 26, 2011

Record last verified: 2011-07

Locations

DE(1)