A Study on Safety and Tolerability of SAR425899 in Overweight to Obese Subjects and Type 2 Diabetes Mellitus Patients Not Requiring Anti-Diabetic Pharmacotherapy

ID: NCT03414736
Status: Recruiting
Phase: Phase 1
Start Date: January 19, 2018
First Submitted: January 17, 2018
Last Updated: February 22, 2018
Results: N/A
Organization: Sanofi
Sponsors & Collaborators: Sanofi
Location: United States
Conditions: Type 2 Diabetes Mellitus
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Study Description

Brief Summary

Primary Objective:

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.

Secondary Objectives:

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

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).
Condition or disease Intervention/treatment Phase

Type 2 Diabetes Mellitus

Drug: SAR425899
Other Names
Phase 1

Tracking Information

First Submitted DateJanuary 17, 2018
Last Update Posted DateFebruary 22, 2018
Actual Start DateJanuary 19, 2018
Anticipated Completion DateMay 01, 2018
Actual Primary Completion DateMay 01, 2018
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • Frequency of gastrointestinal (GI) adverse events (AEs) [Time Frame: Up to week 8]

    Severity of GI AEs

  • Frequency of gastrointestinal (GI) adverse events (AEs) [Time Frame: Up to week 8]

    Absolute frequency of GI AEs

  • Frequency of gastrointestinal (GI) adverse events (AEs) [Time Frame: Up to week 8]

    Relative frequency of GI AEs

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

  • Change in body weight [Time Frame: Baseline (D1) to week 8]

    Change in body weight from baseline to Week 8

  • Change in fasting plasma glucose (FPG) [Time Frame: Baseline (D1) to week 8]

    Change in FPG from baseline to Week 8

  • Change in hemoglobin A1c (HbA1c) [Time Frame: Baseline (D1) to week 8]

    Change in HbA1c from baseline to Week 8

  • Adverse events (AEs) [Time Frame: Up to week 12]

    Number of AEs

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleA Study on Safety and Tolerability of SAR425899 in Overweight to Obese Subjects and Type 2 Diabetes Mellitus Patients Not Requiring Anti-Diabetic Pharmacotherapy
Official TitleA 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
Brief Summary

Primary Objective:

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.

Secondary Objectives:

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

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).

Study TypeInterventional
Study PhasePhase 1
Estimated Enrollment
60
Allocation
Randomized
Interventional Model
Parallel Assignment
Masking
None (Open Label)
Primary Purpose
Treatment
Conditions
Type 2 Diabetes Mellitus
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
Drug: SAR425899

Pharmaceutical form: Solution Route of administration: Subcutaneous

Other Names
Study Groups/Cohorts
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.

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.

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.

Study Arms
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

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
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
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

Recruitment Information

Recruitment Status:Recruiting
Enrollment60
Completion DateMay 01, 2018
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.
GenderAll
Age18 Years to 75 Years
Accepts Healthy VolunteersNo
Contacts
Listed Location Countries
United States

Administrative Information

NCT Number:NCT03414736
Other Study ID Numbers
TDR15516
U1111-1205-1368
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible Party,
Study Sponsor
Sanofi
Collaborators
Not Available
Investigators
Study Director
Clinical Sciences & Operations
Sanofi