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

Sanofi

Status and phase: Completed; Phase 2; Phase 1

Conditions: Type 1 Diabetes Mellitus

Treatments: Drug: SAR161271; Drug: Insulin glargine HOE901

Study type: Interventional

Funder types: Industry

Identifiers

NCT01053728

TDU10948

TDU10987

Details and patient eligibility

About

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

Full 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.

Enrollment: 46 patients

Sex: Male

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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46 participants in 3 patient groups

Cohort 1 : SAR161271 0.3 U/kg

Experimental group

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

Treatment:

Drug: Insulin glargine HOE901

Drug: SAR161271

Cohort 2 : SAR161271 0.6 U/kg

Experimental group

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

Treatment:

Drug: Insulin glargine HOE901

Drug: SAR161271

Cohort 3 : SAR161271 1.2 U/kg

Experimental group

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

Treatment:

Drug: Insulin glargine HOE901

Drug: SAR161271