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Trial record 99 of 10795 for:    Placebo AND once

Efficacy and Safety of Efpeglenatide Versus Placebo in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Diet and Exercise (AMPLITUDE-M)

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ClinicalTrials.gov Identifier: NCT03353350
Recruitment Status : Recruiting
First Posted : November 27, 2017
Last Update Posted : June 25, 2019
Sponsor:
Information provided by (Responsible Party):
Sanofi

Brief Summary:

Primary Objective:

To demonstrate the superiority of once weekly injection of efpeglenatide in comparison to placebo in glycated hemoglobin (HbA1c) change in participants with T2DM (Type 2 Diabetes Mellitus) inadequately controlled with diet and exercise.

Secondary Objectives:

  • To demonstrate the superiority of once-weekly injection of efpeglenatide in comparison to placebo on glycemic control
  • To demonstrate the superiority of once-weekly injection of efpeglenatide in comparison to placebo on body weight
  • To evaluate the safety of once-weekly injection of efpeglenatide

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: efpeglenatide (SAR439977) Drug: placebo Phase 3

Detailed Description:
Study duration per participant is approximately 65 weeks, including a 3-week screening period, 30 weeks core treatment period, 26 weeks extension treatment period, and 6 weeks safety follow up.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A 56-week, Multicenter, Double-blind, Placebo-controlled, Randomized Study to Evaluate the Efficacy and Safety of Efpeglenatide Once Weekly in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Diet and Exercise
Actual Study Start Date : December 5, 2017
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Efpeglenatide low dose
Efpeglenatide low dose (Prefilled syringe) administered once weekly for 56 weeks
Drug: efpeglenatide (SAR439977)

Pharmaceutical form: solution for injection

Route of administration: subcutaneous


Experimental: Efpeglenatide middle dose
Efpeglenatide middle dose (Prefilled syringe) administered once weekly for 56 weeks (including titration period)
Drug: efpeglenatide (SAR439977)

Pharmaceutical form: solution for injection

Route of administration: subcutaneous


Experimental: Efpeglenatide high dose
Efpeglenatide high dose (Prefilled syringe) administered once weekly for 56 weeks (including titration period)
Drug: efpeglenatide (SAR439977)

Pharmaceutical form: solution for injection

Route of administration: subcutaneous


Placebo Comparator: Placebo
Matching placebo (Prefilled syringe) administered once weekly for 56 weeks
Drug: placebo

Pharmaceutical form: solution for injection

Route of administration: subcutaneous





Primary Outcome Measures :
  1. Change in glycated hemoglobin (HbA1c) (%) [ Time Frame: Baseline to Week 30 ]
    Change from Baseline to Week 30 in HbA1c


Secondary Outcome Measures :
  1. Change in HbA1c (%) [ Time Frame: Baseline to Week 56 ]
    Change from Baseline to Week 56 in HbA1c

  2. Change in fasting plasma glucose (FPG) [ Time Frame: Baseline to Week 30 ]
    Change from Baseline to Week 30 in FPG

  3. HbA1c <7% [ Time Frame: Week 30 ]
    Number of participants with HbA1c <7.0% at Week 30

  4. Change in body weight [ Time Frame: Baseline to Week 30, Baseline to Week 56 ]
    Change from Baseline to Week 30 and to Week 56 in body weight

  5. Hypoglycemic participants [ Time Frame: Baseline to Week 56 ]
    Number of participants with at least 1 hypoglycemic event during treatment period

  6. Hypoglycemic events [ Time Frame: Baseline to Week 56 ]
    Number of hypoglycemic events per participant-year during treatment period

  7. Adverse Events (AEs) [ Time Frame: Baseline to Week 56 ]
    Number of participants with AEs



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Participants must be at least 18 years of age at the time of signing the informed consent.
  • Participants with T2DM, and treated with diet and exercise.
  • Hemoglobin A1c between 7.0% and 10.0% (inclusive) measured by the central laboratory at Screening.

Exclusion criteria:

  • Clinically relevant history of gastrointestinal disease associated with prolonged nausea and vomiting, including (but not limited to) gastroparesis, unstable and not controlled gastroesophageal reflux disease within 6 months prior to Screening or history of surgery affecting gastric emptying.
  • History of pancreatitis (unless pancreatitis was related to gallstone and cholecystectomy has been performed) and pancreatitis during previous treatment with incretin therapies, chronic pancreatitis, and pancreatectomy.
  • Personal or family history of Medullary Thyroidian Cancer (MTC) or genetic conditions that predisposes to MTC (eg multiple endocrine neoplasia syndromes).
  • Retinopathy or maculopathy with one of the following treatments, either recent (within 3 months of screening) or planned: intravitreal injections or laser or vitrectomy surgery.
  • Body weight change of ≥5 kg within the last 3 months prior to Screening.
  • Systolic blood pressure >180 mmHg and/or diastolic blood pressure >100 mmHg at Randomization.
  • End-stage renal disease as defined by estimated glomerular filtration rate (eGFR , by Modification of Diet in Renal Disease [MDRD]) of <15 mL/min/1.73 m2.
  • Laboratory findings at the Screening Visit:
  • Alanine aminotransferase (ALT ) or aspartate aminotransferase (AST ) >3 times the upper limit of the normal (ULN ) or total bilirubin >1.5 times the ULN (except in case of documented Gilbert's syndrome).
  • Amylase and/or lipase: >3 times the ULN laboratory range.
  • Calcitonin ≥5.9 pmol/L (20 pg/mL).
  • Gastric surgery or other gastric procedures intended for weight loss within 2 years prior to Screening, or planned during study period.
  • History of drug or alcohol abuse within 6 months prior to the time of Screening.
  • Pregnant (demonstrated by serum pregnancy test at Screening) or breast-feeding women.
  • Women of childbearing potential not willing to use highly effective method(s) of birth control during the study period and for at least 5 weeks after the last dose of study intervention.

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): NCT03353350


Contacts
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Contact: Trial Transparency email recommended (Toll free number for US & Canada) 800-633-1610 ext 1 then # Contact-Us@sanofi.com

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Sponsors and Collaborators
Sanofi
Investigators
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Study Director: Clinical Sciences & Operations Sanofi

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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT03353350     History of Changes
Other Study ID Numbers: EFC14822
2016-001857-42
U1111-1182-1806 ( Other Identifier: UTN )
First Posted: November 27, 2017    Key Record Dates
Last Update Posted: June 25, 2019
Last Verified: June 2019
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/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases