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Type 2 Diabetes MellitusPhase 3AMPLITUDE-MNCT03353350

Efficacy and Safety of Efpeglenatide Versus Placebo in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Diet and Exercise

A Phase 3 study testing efpeglenatide (SAR439977) in people with Type 2 Diabetes Mellitus, run by Hanmi Pharmaceutical Company Limited at 54 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
efpeglenatide (SAR439977)
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
406 participants
Where
54 sitesin 5 countries
Study dates
5 Dec 2017to 7 Sep 2020
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 16Show fewer
  • 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.

Trial locations and contacts

54 sites in 5 countries.

54 sites in 5 countries

United States32 sites

  • Investigational Site Number 8400004

    Birmingham, Alabama, 35205

  • Investigational Site Number 8400001

    Bridgeton, New Jersey, 08302

  • Investigational Site Number 8400028

    Burlington, North Carolina, 27215

  • Investigational Site Number 8400003

    Canoga Park, California, 91303

  • Investigational Site Number 8400017

    Carrollton, Texas, 75010

  • Investigational Site Number 8400034

    Chicago, Illinois, 60612

  • Investigational Site Number 8400007

    Chula Vista, California, 91911

  • Investigational Site Number 8400030

    Dallas, Texas, 75230

  • Investigational Site Number 8400010

    DeLand, Florida, 32720

  • Investigational Site Number 8400005

    Glendale, Arizona, 85306

  • Investigational Site Number 8400008

    Hatboro, Pennsylvania, 19040

  • Investigational Site Number 8400006

    Hialeah, Florida, 33012

  • Investigational Site Number 8400002

    Holladay, Utah, 84117-7054

  • Investigational Site Number 8400015

    Houston, Texas, 77074

  • Investigational Site Number 8400033

    Kansas City, Missouri, 64128

  • Investigational Site Number 8400011

    La Mesa, California, 91942

  • Investigational Site Number 8400062

    Las Vegas, Nevada, 89106

  • Investigational Site Number 8400021

    Las Vegas, Nevada, 89109

  • Investigational Site Number 8400025

    Lawrenceville, Georgia, 30044

  • Investigational Site Number 8400018

    Lincoln, Nebraska, 68503

  • Investigational Site Number 8400009

    Los Angeles, California, 90057

  • Investigational Site Number 8400013

    Maumee, Ohio, 43537

  • Investigational Site Number 8400019

    Plano, Texas, 75024

  • Investigational Site Number 8400029

    Pomona, California, 91767

  • Investigational Site Number 8400020

    San Antonio, Texas, 78218

  • Investigational Site Number 8400016

    San Antonio, Texas, 78229

  • Investigational Site Number 8400027

    San Antonio, Texas, 78229

  • Investigational Site Number 8400023

    Schertz, Texas, 78154

  • Investigational Site Number 8400024

    Tarzana, California, 91356

  • Investigational Site Number 8400026

    Van Nuys, California, 91405

  • Investigational Site Number 8400032

    West Palm Beach, Florida, 33409

  • Investigational Site Number 8400031

    Wilmington, North Carolina, 28401

Other trials in United States

United Kingdom8 sites

  • Investigational Site Number 8260005

    Birmingham, B15 2SQ

  • Investigational Site Number 8260004

    Cardiff, CF15 9SS

  • Investigational Site Number 8260007

    Chorley, PR7 7NA

  • Investigational Site Number 8260008

    Glasgow, G20 0SP

  • Investigational Site Number 8260001

    Hexham, NE46 1QJ

  • Investigational Site Number 8260003

    Liverpool, L22 0LG

  • Investigational Site Number 8260006

    Manchester, M15 6SX

  • Investigational Site Number 8260002

    Reading, RG2 0TG

Other trials in United Kingdom

Poland7 sites

  • Investigational Site Number 6160005

    Gdansk, 80-382

  • Investigational Site Number 6160004

    Gdynia, 81-537

  • Investigational Site Number 6160007

    Katowice, 40-040

  • Investigational Site Number 6160002

    Krakow, 31-501

  • Investigational Site Number 6160006

    Poznan, 60-702

  • Investigational Site Number 6160003

    Warsaw, 01-192

  • Investigational Site Number 6160001

    Wroclaw, 50-381

Other trials in Poland

Ukraine4 sites

  • Investigational Site Number 8040003

    Kyiv, 02002

  • Investigational Site Number 8040001

    Kyiv, 03037

  • Investigational Site Number 8040002

    Kyiv, 03049

  • Investigational Site Number 8040004

    Vinnitsa, 21009

Other trials in Ukraine

Germany3 sites

  • Investigational Site Number 2760005

    Berlin, 12627

  • Investigational Site Number 2760003

    Frankfurt am Main, 60313

  • Investigational Site Number 2760001

    Leipzig, 04103

Other trials in Germany

About this study

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

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
Read the 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.

Being tested
efpeglenatide (SAR439977), placebo
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • efpeglenatide (SAR439977)Drug

    Pharmaceutical form: solution for injection

    Route of administration: subcutaneous

  • placeboDrug

    Pharmaceutical form: solution for injection

    Route of administration: subcutaneous

Study groups in NCT03353350
Study groupRoleWhat they receive
Efpeglenatide 2mgExperimentalEfpeglenatide low dose (Prefilled syringe) administered once weekly for 56 weeks
Receives: Drug: efpeglenatide (SAR439977)
Efpeglenatide 4 mgExperimentalEfpeglenatide middle dose (Prefilled syringe) administered once weekly for 56 weeks (including titration period)
Receives: Drug: efpeglenatide (SAR439977)
Efpeglenatide 6 mgExperimentalEfpeglenatide high dose (Prefilled syringe) administered once weekly for 56 weeks (including titration period)
Receives: Drug: efpeglenatide (SAR439977)
PlaceboPlacebo comparatorMatching placebo (Prefilled syringe) administered once weekly for 56 weeks
Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Glycated Hemoglobin (HbA1c) (%)

    Change from Baseline to Week 30 in HbA1c

    Measured: Baseline to Week 30

Secondary outcomes (8)

  1. Change in HbA1c (%)

    Change from Baseline to Week 56 in HbA1c

    Measured: Baseline to Week 56

  2. Change in Fasting Plasma Glucose (FPG)

    Change from Baseline to Week 30 in FPG

    Measured: Baseline to Week 30

  3. HbA1c <7%

    Number of participants with HbA1c <7.0% at Week 30

    Measured: Week 30

  4. Change in Body Weight at Week 30

    Change from Baseline to Week 30 in body weight

    Measured: Baseline to Week 30

  5. Change in Body Weight at Week 56

    Change from Baseline to Week 56 in body weight

    Measured: Baseline to Week 56

  6. Hypoglycemic Participants

    Number of participants with at least 1 hypoglycemic event during treatment period

    Measured: Baseline to Week 56

  7. Hypoglycemic Events

    Number of hypoglycemic events

    Measured: Baseline to Week 56

  8. Treatment Emergent Adverse Events (TEAEs)

    Number of participants with TEAEs

    Measured: Baseline to Week 56

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Nov 2017
  2. Study start5 Dec 2017
  3. Primary completion29 Jan 2020
  4. Study completion7 Sep 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
406 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03353350
Sponsor's protocol ID
EFC14822
Other IDs
2016-001857-42, U1111-1182-1806, 2016
Acronym
AMPLITUDE-M
Status last verified
Jan 2022
First submitted
21 Nov 2017
Last updated
18 Jan 2022
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Frias JP, Choi J, Rosenstock J, Popescu L, Niemoeller E, Muehlen-Bartmer I, Baek S. Efficacy and Safety of Once-Weekly Efpeglenatide Monotherapy Versus Placebo in Type 2 Diabetes: The AMPLITUDE-M Randomized Controlled Trial. Diabetes Care. 2022 Jul 7;45(7):1592-1600. doi: 10.2337/dc21-2656.

    PubMed 35671039

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing efpeglenatide (SAR439977) in people with Type 2 Diabetes Mellitus, run by Hanmi Pharmaceutical Company Limited at 54 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 54 sites in United States, United Kingdom, Poland, Ukraine, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Jan 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Glycated Hemoglobin (HbA1c) (%) (time frame: Baseline to Week 30). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03353350, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2022.

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