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

Type 1 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01053728
• Other study ID #: TDU10987
• Secondary ID: TDU10948
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: January 19, 2010
• Last updated: July 25, 2011
• Start date: February 2010
• Est. completion date: November 2010

Study information

• Verified date: July 2011
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ministry of Health
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: November 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Drug:
• SAR161271
Pharmaceutical form:Solution for injection Route of administration: subcutaneous
• Insulin glargine HOE901
Pharmaceutical form:Solution for injection Route of administration: subcutaneous

Locations

Country	Name	City	State
Germany	Sanofi-Aventis Administrative Office	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	- Safety in terms of adverse and serious adverse events, vital signs, ECG, safety laboratory for each cohort		up to 7 days after dose	Yes
Primary	- Pharmacodynamics (Glucose infusion rate) time-action profile		up to 30 hours after dose	No
Secondary	- Pharmacokinetic parameters		up to 168 hours after dose	No
Secondary	- anti-insulin antibody production		pre-dose and after 4th dose	Yes