A Study on Safety and Tolerability of SAR425899 in Overweight to Obese Subjects and Type 2 Diabetes Mellitus Patients Not Requiring Anti-Diabetic Pharmacotherapy With an Optional 6-month Safety Extension Period

Type 2 Diabetes Mellitus Clinical Trial

Official title:

A Randomized, Comparative, Open Label Study to Assess the Safety and Tolerability of 3-arm, Parallel, Repeated Subcutaneous Dose Regimens of SAR425899 in Overweight to Obese Subjects and T2DM Patients Not Requiring Anti-diabetic Pharmacotherapy, With an Optional 6-month Safety Extension Period

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03414736
• Other study ID #: TDR15516
• Secondary ID: U1111-1205-1368
• Status: Completed
• Phase: Phase 1
• Start date: January 19, 2018
• Est. completion date: October 5, 2018

Study information

• Verified date: April 2022
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Primary Objectives:

• Main study: To assess in overweight to obese subjects and type 2 diabetes mellitus (T2DM) patients not requiring anti-diabetic pharmacotherapy the safety and tolerability of 3 different dose escalation regimens of SAR425899 in terms of the relative and absolute frequency and severity of gastrointestinal (GI) adverse events (AEs).

• Six-month safety extension period: To assess the safety and tolerability of SAR425899 after 6 months treatment at the maximum dose that was individually well tolerated during the main part of the study in terms of the relative and absolute frequency and severity of GI AEs.

Secondary Objectives:

Main study and 6-month study extension period:

To assess in overweight to obese subjects and T2DM patients not requiring anti-diabetic pharmacotherapy:

• The effect of once-daily dosing of SAR425899 on body weight (BW), fasting plasma glucose (FPG), and hemoglobin A1c (HbA1c).

• Safety and tolerability.

Description:

Main study: The maximum study duration is approximately 12 weeks per patient (up-to 3-week screening period, 8-week treatment period, 3-day post treatment follow-up period).

Six-month study extension period: The maximum study duration is approximately 9 months (up-to 3-week screening period, 8-month treatment period, 3-day post treatment follow-up period).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 5, 2018
• Est. primary completion date: October 5, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion criteria:

• Male or female overweight to obese subjects and type 2 diabetes mellitus (T2DM) patients not requiring anti-diabetic pharmacotherapy.

• Patients who are motivated to lose weight.

Exclusion criteria:

• Type 1 diabetes mellitus.

• Body mass index <27 kg/m2.

• Screening hemoglobin A1c (HbA1c; glycosylated hemoglobin) >7.0%.

• Previous treatment with glucose-lowering agent(s) (eg, insulin, thiazolidinediones, metformin, DPP-IV inhibitors (dipeptidylpeptidase 4), SGLT-2 (sodium dependent glucose transporter-2) inhibitors, etc) within the last 6 months.

• Previous treatment with glucagon-like peptide 1 (GLP-1) receptor agonists within the last 6 months.

• Uncontrolled hypertension.

• Laboratory findings at the time of screening: amylase and/or lipase >2 times the upper limit of the normal laboratory range (ULN), alanine aminotransferase >1.5 ULN, total bilirubin >1.5 ULN, serum creatinine levels =1.5 mg/dL [males]. =1.4 mg/dL [females], screening calcitonin =20 pmol/m, fasting serum triglycerides >400 mg/dL.

• Personal or immediate family history of medullary thyroid cancer (MTC) or genetic conditions that predispose to MTC.

• History of weight loss surgery.

• History of pancreatitis or pancreatectomy.

• Pregnant or lactating women.

• Women of childbearing potential (WOCBP) not protected by highly-effective method(s) of birth control and/or who are unwilling or unable to be tested for pregnancy.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Overweight
• Type 2 Diabetes Mellitus

Intervention

Drug:
• SAR425899
Pharmaceutical form: Solution Route of administration: Subcutaneous

Locations

Country	Name	City	State
United States	Investigational Site Number 8400001	Austin	Texas
United States	Investigational Site Number 8400003	Knoxville	Tennessee
United States	Investigational Site Number 8400002	Saint Paul	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of gastrointestinal (GI) adverse events (AEs)	Relative frequency of GI AEs	Main study: Up to week 8; Six-month study extension period: Up to month 8
Primary	Frequency of GI AEs	Absolute frequency of GI AEs	Main study: Up to week 8; Six-month study extension period: Up to month 8
Primary	Frequency of GI AEs	Severity of GI AEs	Main study: Up to week 8; Six-month study extension period: Up to month 8
Secondary	Change in body weight	Change in body weight from baseline to week 8 for the main study and from baseline to month 8 for the study extension period.	Main study: Baseline (D1) to week 8; Six-month study extension period: Baseline (D1) up to month 8
Secondary	Change in fasting plasma glucose (FPG)	Change in FPG from baseline to week 8 for the main study and from baseline to month 8 for the study extension period.	Main study: Baseline (D1) to week 8; Six-month study extension period: Baseline (D1) up to month 8
Secondary	Change in hemoglobin A1c (HbA1c)	Change in HbA1c from baseline to week 8 for the main study and from baseline to month 8 for the study extension period.	Main study: Baseline (D1) to week 8; Six-month study extension period: Baseline (D1) up to month 8
Secondary	Adverse events (AEs)	Number of AEs	Main study: up to week 8; Six-month extension period: up to month 8