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

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: NCT03353350
Recruitment Status : Completed
First Posted : November 27, 2017
Results First Posted : January 18, 2022
Last Update Posted : January 18, 2022
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Hanmi Pharmaceutical Company Limited

Study Description
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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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 406 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
Actual Primary Completion Date : January 29, 2020
Actual Study Completion Date : September 7, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Efpeglenatide 2mg
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 4 mg
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 6 mg
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


Outcome Measures
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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 at Week 30 [ Time Frame: Baseline to Week 30 ]
    Change from Baseline to Week 30 in body weight

  5. Change in Body Weight at Week 56 [ Time Frame: Baseline to Week 56 ]
    Change from Baseline to Week 56 in body weight

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

  7. Hypoglycemic Events [ Time Frame: Baseline to Week 56 ]
    Number of hypoglycemic events

  8. Treatment Emergent Adverse Events (TEAEs) [ Time Frame: Baseline to Week 56 ]
    Number of participants with TEAEs


Eligibility Criteria
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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.


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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.

Contacts and Locations
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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


Locations
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Sponsors and Collaborators
Hanmi Pharmaceutical Company Limited
Sanofi
Investigators
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Study Director: Clinical Sciences & Operations Sanofi
  Study Documents (Full-Text)

Documents provided by Hanmi Pharmaceutical Company Limited:
Study Protocol  [PDF] June 7, 2018
Statistical Analysis Plan  [PDF] August 19, 2020

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier: NCT03353350    
Other Study ID Numbers: EFC14822
2016-001857-42
U1111-1182-1806 ( Other Identifier: UTN )
First Posted: November 27, 2017    Key Record Dates
Results First Posted: January 18, 2022
Last Update Posted: January 18, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Efpeglenatide
Hypoglycemic Agents
Physiological Effects of Drugs