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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

Primary Purpose

Type 2 Diabetes Mellitus

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

SAR425899

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Investigational Site Number 8400002
Investigational Site Number 8400003
Investigational Site Number 8400001

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Cohort 1

Cohort 2

Cohort 3

Arm Description

Daily dose escalation (click-by-click): Starting at dose 1 in the morning with daily increments to dose 2. During the escalation phase, the dose will only be increased if the patient is feeling fine.

Weekly dose escalation in 6 escalation steps (7 dose levels): Starting at dose 1 injected in the morning with weekly increments to dose 2. In case a dose level is not well tolerated by a patient, the treatment should continue at the same dose level for another 7 days before the next dose escalation.

Weekly dose escalation in 4 escalation steps (5 dose levels): Starting at dose 3 with weekly increments to dose 2. In case a dose level is not well tolerated by a patient, the treatment should continue at the same dose level for another 7 days before the next dose escalation.

Outcomes

Primary Outcome Measures

Frequency of gastrointestinal (GI) adverse events (AEs)

Relative frequency of GI AEs

Frequency of GI AEs

Absolute frequency of GI AEs

Frequency of GI AEs

Severity of GI AEs

Secondary Outcome Measures

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.

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.

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.

Adverse events (AEs)

Number of AEs

Full Information

NCT ID

NCT03414736

First Posted

January 17, 2018

Last Updated

April 22, 2022

Sponsor

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT03414736

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Completed

Study Start Date

January 19, 2018 (Actual)

Primary Completion Date

October 5, 2018 (Actual)

Study Completion Date

October 5, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sanofi

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

Detailed 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes Mellitus

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cohort 1

Arm Type

Experimental

Arm Description

Daily dose escalation (click-by-click): Starting at dose 1 in the morning with daily increments to dose 2. During the escalation phase, the dose will only be increased if the patient is feeling fine.

Arm Title

Cohort 2

Arm Type

Experimental

Arm Description

Arm Title

Cohort 3

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

SAR425899

Intervention Description

Pharmaceutical form: Solution Route of administration: Subcutaneous

Primary Outcome Measure Information:

Title

Frequency of gastrointestinal (GI) adverse events (AEs)

Description

Relative frequency of GI AEs

Time Frame

Main study: Up to week 8; Six-month study extension period: Up to month 8

Title

Frequency of GI AEs

Description

Absolute frequency of GI AEs

Time Frame

Main study: Up to week 8; Six-month study extension period: Up to month 8

Title

Frequency of GI AEs

Description

Severity of GI AEs

Time Frame

Main study: Up to week 8; Six-month study extension period: Up to month 8

Secondary Outcome Measure Information:

Title

Change in body weight

Description

Change in body weight from baseline to week 8 for the main study and from baseline to month 8 for the study extension period.

Time Frame

Main study: Baseline (D1) to week 8; Six-month study extension period: Baseline (D1) up to month 8

Title

Change in fasting plasma glucose (FPG)

Description

Change in FPG from baseline to week 8 for the main study and from baseline to month 8 for the study extension period.

Time Frame

Main study: Baseline (D1) to week 8; Six-month study extension period: Baseline (D1) up to month 8

Title

Change in hemoglobin A1c (HbA1c)

Description

Change in HbA1c from baseline to week 8 for the main study and from baseline to month 8 for the study extension period.

Time Frame

Main study: Baseline (D1) to week 8; Six-month study extension period: Baseline (D1) up to month 8

Title

Adverse events (AEs)

Description

Number of AEs

Time Frame

Main study: up to week 8; Six-month extension period: up to month 8

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Sciences & Operations

Organizational Affiliation

Sanofi

Official's Role

Study Director

Facility Information:

Facility Name

Investigational Site Number 8400002

City

Saint Paul

State/Province

Minnesota

ZIP/Postal Code

55144

Country

United States

Facility Name

Investigational Site Number 8400003

City

Knoxville

State/Province

Tennessee

ZIP/Postal Code

37920

Country

United States

Facility Name

Investigational Site Number 8400001

City

Austin

State/Province

Texas

ZIP/Postal Code

78744

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

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