Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    TDR15516
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03414736
Recruitment Status : Completed
First Posted : January 30, 2018
Last Update Posted : November 26, 2018
Sponsor:
Information provided by (Responsible Party):
Sanofi

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: SAR425899 Phase 1

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).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : January 19, 2018
Actual Primary Completion Date : October 5, 2018
Actual Study Completion Date : October 5, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cohort 1
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.
Drug: SAR425899

Pharmaceutical form: Solution

Route of administration: Subcutaneous


Experimental: Cohort 2
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.
Drug: SAR425899

Pharmaceutical form: Solution

Route of administration: Subcutaneous


Experimental: Cohort 3
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.
Drug: SAR425899

Pharmaceutical form: Solution

Route of administration: Subcutaneous





Primary Outcome Measures :
  1. Frequency of gastrointestinal (GI) adverse events (AEs) [ Time Frame: Main study: Up to week 8; Six-month study extension period: Up to month 8 ]
    Relative frequency of GI AEs

  2. Frequency of GI AEs [ Time Frame: Main study: Up to week 8; Six-month study extension period: Up to month 8 ]
    Absolute frequency of GI AEs

  3. Frequency of GI AEs [ Time Frame: Main study: Up to week 8; Six-month study extension period: Up to month 8 ]
    Severity of GI AEs


Secondary Outcome Measures :
  1. Change in body weight [ Time Frame: Main study: Baseline (D1) to week 8; Six-month study extension period: Baseline (D1) up to month 8 ]
    Change in body weight from baseline to week 8 for the main study and from baseline to month 8 for the study extension period.

  2. Change in fasting plasma glucose (FPG) [ Time Frame: Main study: Baseline (D1) to week 8; Six-month study extension period: Baseline (D1) up to month 8 ]
    Change in FPG from baseline to week 8 for the main study and from baseline to month 8 for the study extension period.

  3. Change in hemoglobin A1c (HbA1c) [ Time Frame: Main study: Baseline (D1) to week 8; Six-month study extension period: Baseline (D1) up to month 8 ]
    Change in HbA1c from baseline to week 8 for the main study and from baseline to month 8 for the study extension period.

  4. Adverse events (AEs) [ Time Frame: Main study: up to week 8; Six-month extension period: up to month 8 ]
    Number of AEs



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03414736


Locations
Layout table for location information
United States, Minnesota
Investigational Site Number 8400002
Saint Paul, Minnesota, United States, 55144
United States, Tennessee
Investigational Site Number 8400003
Knoxville, Tennessee, United States, 37920
United States, Texas
Investigational Site Number 8400001
Austin, Texas, United States, 78744
Sponsors and Collaborators
Sanofi
Investigators
Layout table for investigator information
Study Director: Clinical Sciences & Operations Sanofi
Layout table for additonal information
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT03414736    
Other Study ID Numbers: TDR15516
U1111-1205-1368 ( Other Identifier: UTN )
First Posted: January 30, 2018    Key Record Dates
Last Update Posted: November 26, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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://www.clinicalstudydatarequest.com/

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Diabetes Mellitus, Type 2
Overweight
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Body Weight
Signs and Symptoms