Lixisenatide for Restoration of Insulin Release in Subjects With Diabetes Mellitus Type 2 (RESTORE)

Sanofi

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Placebo; Drug: Lixisenatide (AVE0010)

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT00931372

PDY10433

EudraCT:2008-003242-28

Details and patient eligibility

About

The objective of this study is to test whether Lixisenatide (AVE0010) restores first phase and improves second phase insulin response in subjects with diabetes mellitus type 2.

Enrollment: 22 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Male and female subjects with type 2 diabetes mellitus on diet and exercise with/without metformin
• HbA1c>=6,0 % and <=8,5 % at screening
• BMI 25 to 35 kg/m²
• 155>=BP systolic >=90 mmHg
• 100>=BP diastolic>=45 mmHg

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: Quadruple Blind

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22 participants in 2 patient groups

Sequence 1: AVE0010/Placebo

Experimental group

Description:

Period 1: lixisenatide 20 µg in 200 µL, one single dose Period 2: placebo 200 µL, one single dose

Treatment:

Drug: Placebo

Drug: Lixisenatide (AVE0010)

Sequence 2: Placebo/AVE0010

Experimental group

Description:

Period 1: placebo 200 µL, one single dose Period 2: lixisenatide 20 µg in 200 µL, one single dose

Treatment:

Drug: Placebo

Drug: Lixisenatide (AVE0010)