A Study to Assess the Safety and Efficacy of SAR425899 in Patients With Type 2 Diabetes Mellitus

Conditions

• Type 2 Diabetes Mellitus

Eligibility Criteria

Sex

ALL

Age

18 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• SAR425899 — DRUG
  Self-administered by SC injection using a solution for injection in cartridge.
• Placebo — DRUG
  Self-administered by SC injection using a solution for injection in cartridge.
• Liraglutide — DRUG
  Self-administered by SC injection using a pre-filled pen.
• Metformin — DRUG
  Orally administered at a stable dose , \>=1500 mg daily stable dose or maximal tolerated dose.

Study Details

Primary Objective: The primary objective of this study was to assess the dose-response relationship of SAR425899 versus placebo in terms of glycemic control as measured by the change in glycosylated hemoglobin (HbA1c). Secondary Objectives: * To assess the effect of SAR425899 on body weight. * To assess the safety and immunogenicity profile of SAR425899, including assessment of the heart rate (HR) change by electrocardiogram (ECG) and Holter monitor. * To assess the proportion of participants achieving predefined HbA1c targets of \<7% and \<6.5% as well as the proportion of participants achieving \>=5% and \>=10% body weight loss. * To assess the effect of once daily dosing of SAR425899 on additional parameters of glycemic control and lipid metabolism. * To assess the effect of once daily dosing of SAR425899 on additional pharmacodynamic (PD) biomarkers. * To assess the pharmacokinetic (PK) profile and parameters of SAR425899, inter-individual and inter-occasion variability in PK parameters using a population PK approach.

Key Dates

Start date

Dec 2, 2016

Status verified

Mar 2022

Primary completion

Dec 27, 2017

Completion

Dec 27, 2017

Study Design

Enrollment

296 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Placebo Comparator: Placebo
  Placebo (for SAR425899) subcutaneous (SC) injection once daily (QD) from Week 1 to Week 26, matching 3 SAR425899 dose levels of 0.12 mg, 0.16 mg and 0.20 mg.
• Experimental: SAR425899 0.12 mg
  SAR425899 SC injection QD at maintenance dose of 0.12 mg for 25 weeks (Week 2 to Week 26) following 1 week dose increase step (0.06 mg at Week 1).
• Experimental: SAR425899 0.16 mg
  SAR425899 SC injection QD at maintenance dose of 0.16 mg for 24 weeks (Week 3 to Week 26) following 2 weeks dose increase step (0.06 mg at Week 1 and 0.12 mg at Week 2).
• Experimental: SAR425899 0.20 mg
  SAR425899 SC injection QD at maintenance dose of 0.20 mg for 23 weeks (Week 4 to Week 26) following 3 weeks dose increase step (0.06 mg at Week 1, 0.12 mg at Week 2 and 0.16 mg at Week 3).
• Active Comparator: Liraglutide
  Liraglutide SC injection QD at maintenance dose of 1.8 mg for 24 weeks (Week 3 to Week 26) following 2 weeks dose increase steps (0.6 mg daily at Week 1 and by 1.2 mg daily at Week 2).

Primary Outcome Measure

Change From Baseline in HbA1c to Week 26 [ Time Frame: Baseline, Week 26 ]

Locations (23)

Find similar trials in Sheffield, AL

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