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Efficacy and Safety of Efpeglenatide Versus Placebo in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Basal Insulin Alone or in Combination With Oral Antidiabetic Drug(s) (AMPLITUDE-L)

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ClinicalTrials.gov Identifier: NCT03713684
Recruitment Status : Recruiting
First Posted : October 22, 2018
Last Update Posted : August 22, 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 type 2 diabetes mellitus (T2DM) inadequately controlled with basal insulin alone or in combination with oral antidiabetic drugs (OADs).

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 Drug: Insulin glargine Phase 3

Detailed Description:
Study duration per participant is approximately 64 weeks including an up to 2-week Screening Period, a 30-week Core Treatment Period, a 26-week Safety Extension Period, and a 6-week safety Follow-up Period.

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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 Basal Insulin Alone or in Combination With Oral Antidiabetic Drug(s)
Actual Study Start Date : August 20, 2019
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : August 2021

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

Drug: Insulin glargine
Pharmaceutical form: solution for injection Route of administration: subcutaneous

Experimental: Efpeglenatide middle dose
Efpeglenatide middle dose (prefilled syringe) administered once weekly for 56 weeks
Drug: Efpeglenatide SAR439977
Pharmaceutical form: solution for injection Route of administration: subcutaneous

Drug: Insulin glargine
Pharmaceutical form: solution for injection Route of administration: subcutaneous

Experimental: Efpeglenatide high dose
Efpeglenatide high dose (prefilled syringe) administered once weekly for 56 weeks
Drug: Efpeglenatide SAR439977
Pharmaceutical form: solution for injection Route of administration: subcutaneous

Drug: Insulin glargine
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

Drug: Insulin glargine
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. Participants with HbA1c <7.0% [ Time Frame: Baseline to Week 30 ]
    Number of participants with HbA1c < 7.0% at Week 30

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

  5. Hypoglycemic participants [ Time Frame: Baseline to Week 56 ]
    Number of participants with at least one 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 30 and 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:

  • Participant must be ≥18 years of age at the time of signing the informed consent.
  • Participants with type 2 diabetes mellitus (T2DM).
  • Diabetes diagnosed at least 1 year before screening.
  • Participants on basal insulin regimen alone or in combination with oral antidiabetic drugs (OADs) for at least 6 months prior to screening.
  • Glycated hemoglobin (HbA1c) between 7.0% and 10.0% (inclusive) measured by the central laboratory at screening.

Exclusion criteria:

  • History of severe hypoglycemia requiring emergency room admission or hospitalization within 3 months prior to screening.
  • Retinopathy or maculopathy with one of the following treatments, either recent (within 3 months prior to screening) or planned: intravitreal injections or laser or vitrectomy surgery.
  • 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 requiring medical treatment within 6 months prior to screening.
  • History of pancreatitis (unless pancreatitis was related to gallstones and cholecystectomy has been performed), pancreatitis during previous treatment with incretin therapies, chronic pancreatitis, pancreatectomy.
  • Personal or family history of medullary thyroid cancer (MTC) or genetic conditions that predispose to MTC (e.g., multiple endocrine neoplasia syndromes).
  • 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 x upper limit of normal (ULN) or total bilirubin >1.5 x ULN (except in case of documented Gilbert's syndrome);
    • Amylase and/or lipase: >3 x ULN;
    • 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.
  • Pregnant (confirmed by serum pregnancy test at screening) or breast-feeding women.
  • Women of childbearing potential (WOCBP) not willing to use highly effective method(s) of birth control or who are unwilling to be tested for pregnancy 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): NCT03713684


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

Locations
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United States, Florida
investigational site number United States Recruiting
Orlando, Florida, United States, 32825
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: NCT03713684     History of Changes
Other Study ID Numbers: EFC14893
U1111-1189-5009 ( Other Identifier: UTN )
First Posted: October 22, 2018    Key Record Dates
Last Update Posted: August 22, 2019
Last Verified: August 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

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Insulin, Globin Zinc
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs