Type 2 Diabetes MellitusPhase 3AMPLITUDE-DNCT03684642

Efficacy and Safety of Efpeglenatide Versus Dulaglutide in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin

A Phase 3 study testing Efpeglenatide, Dulaglutide and Background therapy Metformin in people with Type 2 Diabetes Mellitus, run by Sanofi at 45 sites in 4 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

Primary Objective: To demonstrate the non-inferiority of once weekly injection of efpeglenatide in comparison to once weekly injection of dulaglutide on glycated hemoglobin (HbA1c) change in participants with Type 2 diabetes mellitus (T2DM) inadequately controlled with metformin. 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, Dulaglutide and Background therapy Metformin
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 908 participants
Where: 45 sitesin 4 countries
Study dates: 26 Sep 2018to 17 Nov 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

Participant must be greater than or equal to (>=) 18 years of age at the time of signing the informed consent.
Participants with T2DM.
Diabetes diagnosed at least 1 year before screening.
Participants on stable dose of at least 1500 milligram per day (mg/day) of metformin, or tolerated maximum dose, or as per country regulation if less, for at least 3 months prior to screening.
HbA1c between 7.0 percent (%) and 10.0% (inclusive) measured by the central laboratory at screening.

Who cannot join

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 (GI) 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 or history of surgery affecting gastric emptying.
History of pancreatitis (unless pancreatitis was related to gallstones and cholecystectomy had 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 predisposes to MTC (e.g., multiple endocrine neoplasia syndromes).
Body weight change of greater than or equal to (>=) 5 kilogram within the last 3 months prior to screening.
Systolic blood pressure greater than (>)180 millimeter of mercury (mmHg) and/or diastolic blood pressure >100 mmHg at randomization.

Show all 15Show fewer

Severe renal disease as defined by estimated glomerular filtration rate (eGFR), by Modification of Diet in Renal Disease (MDRD)] of less than (<)30 mL/min/1.73 m^2.
Laboratory findings at the screening visit:
Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 * upper limit of normal (ULN) or total bilirubin >1.5 * ULN (except in case of documented Gilbert's syndrome);
Amylase and/or lipase: >3 * ULN;
Calcitonin >=5.9 picomoles per liter (pmol/L) (20 picograms per milliliter).
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 was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Trial locations and contacts

45 sites in 4 countries.

Country

City, postcode or hospital

45 sites in 4 countries

United States30 sites

Investigational Site Number 8400038
Birmingham, Alabama, 35211
Investigational Site Number 8400061
Boston, Massachusetts, 02115
Investigational Site Number 8400001
Bridgeton, New Jersey, 08302
Investigational Site Number 8400028
Burlington, North Carolina, 27215
Investigational Site Number 8400035
Chandler, Arizona, 85224
Investigational Site Number 8400030
Dallas, Texas, 75230
Investigational Site Number 8400005
Glendale, Arizona, 85306
Investigational Site Number 8400014
Goose Creek, South Carolina, 29445
Investigational Site Number 8400057
Huntington Park, California, 90255
Investigational Site Number 8400025
Lawrenceville, Georgia, 30044
Investigational Site Number 8400037
Layton, Utah, 84041
Investigational Site Number 8400044
Lexington, Kentucky, 40503
Investigational Site Number 8400009
Los Angeles, California, 90057
Investigational Site Number 8400049
Manassas, Virginia, 20110
Investigational Site Number 8400013
Maumee, Ohio, 43537
Investigational Site Number 8400060
Meridian, Idaho, 83642
Investigational Site Number 8400036
Morehead City, North Carolina, 28557
Investigational Site Number 8400039
New Windsor, New York, 12553
Investigational Site Number 8400055
Orlando, Florida, 32825
Investigational Site Number 8400041
Pembroke Pines, Florida, 33026
Investigational Site Number 8400054
Peoria, Arizona, 85381
Investigational Site Number 8400020
San Antonio, Texas, 78218
Investigational Site Number 8400043
San Antonio, Texas, 78229
Investigational Site Number 8400053
San Antonio, Texas, 78258
Investigational Site Number 8400007
San Diego, California, 92120
Investigational Site Number 8400059
Skokie, Illinois, 60077
Investigational Site Number 8400045
Spring Valley, California, 91978
Investigational Site Number 8400040
Tustin, California, 92780
Investigational Site Number 8400026
Van Nuys, California, 91405
Investigational Site Number 8400050
Waterbury, Connecticut, 06708

Other trials in United States

Poland6 sites

Investigational Site Number 6160008
Gdansk, 80-382
Investigational Site Number 6160004
Gdynia, 81-537
Investigational Site Number 6160010
Katowice, 40-040
Investigational Site Number 6160009
Poznan, 60-702
Investigational Site Number 6160003
Warsaw, 01-192
Investigational Site Number 6160001
Wroclaw, 50-381

Other trials in Poland

Hungary5 sites

Investigational Site Number 3480004
Budapest, 1036
Investigational Site Number 3480003
Debrecen, 4025
Investigational Site Number 3480001
Gyula, 5700
Investigational Site Number 3480005
Hatvan, 3000
Investigational Site Number 3480002
Nyíregyháza, 4400

Other trials in Hungary

Ukraine4 sites

Investigational Site Number 8040003
Kyiv, 02002
Investigational Site Number 8040001
Kyiv, 03037
Investigational Site Number 8040002
Kyiv, 03049
Investigational Site Number 8040004
Vinnytsia, 21050

Other trials in Ukraine

About this study

Official title: A 56-week, Multicenter, Open-label, Active-controlled, Randomized Study to Evaluate the Efficacy and Safety of Efpeglenatide Once Weekly Compared to Dulaglutide Once Weekly in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin

Primary Objective:

To demonstrate the non-inferiority of once weekly injection of efpeglenatide in comparison to once weekly injection of dulaglutide on glycated hemoglobin (HbA1c) change in participants with Type 2 diabetes mellitus (T2DM) inadequately controlled with metformin.

Secondary Objectives:

To demonstrate the superiority of once weekly injection of efpeglenatide with once weekly injection of dulaglutide on glycemic control.
To demonstrate the superiority of once weekly injection of efpeglenatide with once weekly injection of dulaglutide on body weight.
To evaluate the safety of once weekly injection of efpeglenatide and once weekly injection of dulaglutide.

Read the detailed description

Study duration per participant was approximately 65 weeks including an up to 3-week Screening Period, a 56-week Treatment Period and a 6-week safety Follow-up Period.

Conditions: Type 2 Diabetes Mellitus
Being tested: Efpeglenatide, Dulaglutide, Background therapy Metformin
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.

EfpeglenatideDrug
Also called SAR439977
Pharmaceutical form: solution for injection; Route of administration: SC
DulaglutideDrug
Also called Trulicity™
Pharmaceutical form: solution for injection; Route of administration: SC
Background therapy MetforminDrug
Pharmaceutical form: tablet; Route of administration: oral; Dose to be kept stable throughout the study.

Study groups in NCT03684642
Study group	Role	What they receive
Efpeglenatide 4 mg	Experimental	Participants received Efpeglenatide subcutaneous (SC) injection once weekly up to Week 56 on top of metformin. Participants initiated dosing at 2 mg once weekly and increased every 2 weeks to the maximum of 4 mg once weekly for the treatment duration. Receives: Drug: Efpeglenatide; Drug: Background therapy Metformin
Efpeglenatide 6 mg	Experimental	Participants received Efpeglenatide SC injection once weekly up to Week 56 on top of metformin. Participants initiated dosing at 2 mg once weekly and increased every 2 weeks to the maximum of 6 mg once weekly for the treatment duration. Receives: Drug: Efpeglenatide; Drug: Background therapy Metformin
Dulaglutide 1.5 mg	Active comparator	Participants received Dulaglutide SC injection once weekly up to Week 56 on top of metformin. Participants initiated dosing at 0.75 mg once weekly and increased after 2 weeks to 1.5 mg once weekly for the treatment duration. Receives: Drug: Dulaglutide; Drug: Background therapy Metformin

What is being measured

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

Change From Baseline to Week 56 in HbA1c
Adjusted Least square (LS) means and Standard errors (SE) were obtained from analysis of covariance (ANCOVA) model to account for missing data. Missing values were imputed by baseline observation carried forward (BOCF)-like multiple imputation method.
Measured: Baseline to Week 56

Secondary outcomes (5)

Change From Baseline to Week 56 in Body Weight
Adjusted LS means and SE were obtained from ANCOVA model to account for missing data. Missing values were imputed by BOCF-like multiple imputation method.
Measured: Baseline to Week 56
Number of Participants With HbA1c < 7.0 %
Participants who had no available assessment for HbA1c at Week 56 were considered as non-responders.
Measured: Week 56
Change From Baseline to Week 56 in Fasting Plasma Glucose (FPG)
Adjusted LS means and SE were obtained from ANCOVA model to account for missing data. Missing values were imputed by BOCF-like multiple imputation method.
Measured: Baseline to Week 56
Number of Participants With At Least One Hypoglycemic Events (Documented Symptomatic Hypoglycemia <3.0 mmol/L [<54 mg/dL], Severe Hypoglycemia)
Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of <54 milligrams per deciliter (mg/dL) (<3.0 mmol/L). Severe hypoglycemia was an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.
Measured: Baseline up to Week 56
Number of Hypoglycemic Events (Documented Symptomatic Hypoglycemia <3.0 mmol/L [<54 mg/dL] and Severe Hypoglycemia) Per Participant-Year
Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of <54 mg/dL (<3.0 mmol/L). Severe hypoglycemia was an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.
Measured: Baseline up to Week 56

Timeline

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

26 Sep 201817 Nov 2020

First posted26 Sep 2018
Study start26 Sep 2018
Primary completion13 Oct 2020
Study completion17 Nov 2020

Why it stopped: Sponsor decision to cancel TRIAL, not related to safety concern.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
More trials run by SanofiThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: None (open label)
Enrolment: 908 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03684642
Sponsor's protocol ID: EFC14829
Other IDs: 2017-002956-10, U1111-1205-3150, 2017
Acronym: AMPLITUDE-D
Status last verified: Oct 2021
First submitted: 24 Sep 2018
Last updated: 1 Nov 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: No plan to share individual participant data (IPD) by SANOFI: Product rights transferred to Hanmi Pharmaceutical.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)

All Type 2 Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 56-week, Multicenter, Open-label, Active-controlled, Randomized Study to Evaluate the Efficacy and Safety of Efpeglenatide Once Weekly Compared to Dulaglutide Once Weekly in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin
ClinicalTrials.gov ID: NCT03684642
Acronym / sponsor ID: AMPLITUDE-D / EFC14829
Conditions: Type 2 Diabetes Mellitus
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: Sponsor decision to cancel TRIAL, not related to safety concern.
Enrolment: 908 participants (actual)
Lead sponsor: SanofiIndustry (pharma, biotech, devices)
Collaborators: Hanmi Pharmaceutical Company Limited
Study start: 26 Sep 2018 (actual)
Primary completion: 13 Oct 2020 (actual)
Study completion: 17 Nov 2020 (actual)
First posted: 26 Sep 2018 (actual)
Results: Posted 1 Nov 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Primary Objective:

Secondary Objectives:

To demonstrate the superiority of once weekly injection of efpeglenatide with once weekly injection of dulaglutide on glycemic control.
To demonstrate the superiority of once weekly injection of efpeglenatide with once weekly injection of dulaglutide on body weight.
To evaluate the safety of once weekly injection of efpeglenatide and once weekly injection of dulaglutide.

Detailed description

Study duration per participant was approximately 65 weeks including an up to 3-week Screening Period, a 56-week Treatment Period and a 6-week safety Follow-up Period.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Efpeglenatide 4 mg	Experimental	Drug: Efpeglenatide, Drug: Background therapy MetforminParticipants received Efpeglenatide subcutaneous (SC) injection once weekly up to Week 56 on top of metformin. Participants initiated dosing at 2 mg once weekly and increased every 2 weeks to the maximum of 4 mg once weekly for the treatment duration.
Efpeglenatide 6 mg	Experimental	Drug: Efpeglenatide, Drug: Background therapy MetforminParticipants received Efpeglenatide SC injection once weekly up to Week 56 on top of metformin. Participants initiated dosing at 2 mg once weekly and increased every 2 weeks to the maximum of 6 mg once weekly for the treatment duration.
Dulaglutide 1.5 mg	Active comparator	Drug: Dulaglutide, Drug: Background therapy MetforminParticipants received Dulaglutide SC injection once weekly up to Week 56 on top of metformin. Participants initiated dosing at 0.75 mg once weekly and increased after 2 weeks to 1.5 mg once weekly for the treatment duration.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Participant must be greater than or equal to (>=) 18 years of age at the time of signing the informed consent.
Participants with T2DM.
Diabetes diagnosed at least 1 year before screening.
Participants on stable dose of at least 1500 milligram per day (mg/day) of metformin, or tolerated maximum dose, or as per country regulation if less, for at least 3 months prior to screening.
HbA1c between 7.0 percent (%) and 10.0% (inclusive) measured by the central laboratory at screening.

Key exclusion criteria (15 listed)

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 (GI) 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 or history of surgery affecting gastric emptying.
History of pancreatitis (unless pancreatitis was related to gallstones and cholecystectomy had 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 predisposes to MTC (e.g., multiple endocrine neoplasia syndromes).
Body weight change of greater than or equal to (>=) 5 kilogram within the last 3 months prior to screening.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
EfpeglenatideAlso: SAR439977Pharmaceutical form: solution for injection; Route of administration: SC	Drug	Efpeglenatide 4 mg, Efpeglenatide 6 mg
DulaglutideAlso: Trulicity™Pharmaceutical form: solution for injection; Route of administration: SC	Drug	Dulaglutide 1.5 mg
Background therapy MetforminPharmaceutical form: tablet; Route of administration: oral; Dose to be kept stable throughout the study.	Drug	Dulaglutide 1.5 mg, Efpeglenatide 4 mg, Efpeglenatide 6 mg

Primary outcome

Change From Baseline to Week 56 in HbA1c
Time frame: Baseline to Week 56
Adjusted Least square (LS) means and Standard errors (SE) were obtained from analysis of covariance (ANCOVA) model to account for missing data. Missing values were imputed by baseline observation carried forward (BOCF)-like multiple imputation method.

5 secondary outcomes

Change From Baseline to Week 56 in Body Weight
Time frame: Baseline to Week 56
Number of Participants With HbA1c < 7.0 %
Time frame: Week 56
Change From Baseline to Week 56 in Fasting Plasma Glucose (FPG)
Time frame: Baseline to Week 56
Number of Participants With At Least One Hypoglycemic Events (Documented Symptomatic Hypoglycemia <3.0 mmol/L [<54 mg/dL], Severe Hypoglycemia)
Time frame: Baseline up to Week 56
Number of Hypoglycemic Events (Documented Symptomatic Hypoglycemia <3.0 mmol/L [<54 mg/dL] and Severe Hypoglycemia) Per Participant-Year
Time frame: Baseline up to Week 56

Results and safety

Results posted to the registry on 1 Nov 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Efpeglenatide 4 mg	303	200
Efpeglenatide 6 mg	302	169
Dulaglutide 1.5 mg	303	197

Primary outcome: Change From Baseline to Week 56 in HbA1c

Time frame: Baseline to Week 56. Least squares mean (Standard Error). Unit: percentage of HbA1c

Measure	Efpeglenatide 4 mg n = 257	Efpeglenatide 6 mg n = 254	Dulaglutide 1.5 mg n = 250
Value	-1.12 (0.06)	-1.17 (0.06)	-1.09 (0.06)

Efpeglenatide 4 mg vs Dulaglutide 1.5 mg: Least Square (LS) Mean difference: -0.03 (95% CI -0.20 to 0.14)
Efpeglenatide 6 mg vs Dulaglutide 1.5 mg: LS Mean Difference: -0.08 (95% CI -0.25 to 0.09)
Efpeglenatide 4 mg vs Dulaglutide 1.5 mg: p = 0.7064, ANCOVA

Population analysed: Analysis was performed on modified intent-to-treat (mITT) population which included participants who completed study treatment; or who discontinued study treatment and completed/discontinued study before early termination; or who discontinued treatment before early termination and discontinued study due to early termination; or who discontinued treatment due to early termination within 30 days of target Week 56 visit.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: All Adverse Events (AEs) were collected from signature of the informed consent up to end of study. Time frame for reporting of treatment emergent adverse events (TEAEs) was from first dose up to 30 days after the last injection of the Investigational Medicinal Product (IMP) (Week 60).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Efpeglenatide 4 mg	20 of 313 (6.4%)	202 of 313 (64.5%)	0 of 313
Efpeglenatide 6 mg	23 of 292 (7.9%)	180 of 292 (61.6%)	0 of 292
Dulaglutide 1.5 mg	20 of 302 (6.6%)	178 of 302 (58.9%)	1 of 302

Limitations and caveats (from the sponsor): The study was terminated early by the Sponsor on 09 September 2020. Due to early termination of the study, model-based efficacy analyses were performed in the mITT population instead of the ITT population originally planned and data was carefully considered given that the study was terminated early.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. No plan to share individual participant data (IPD) by SANOFI: Product rights transferred to Hanmi Pharmaceutical.

Related trials for Type 2 Diabetes Mellitus

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Clinical Sciences & Operations study director

Sanofi

45 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Efpeglenatide, Dulaglutide and Background therapy Metformin in people with Type 2 Diabetes Mellitus, run by Sanofi at 45 sites in 4 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 5 inclusion and 15 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: stopped early, as of the sponsor's last update on 1 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 45 sites in United States, Poland, Hungary, Ukraine. 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. 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 1 Nov 2021). 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 From Baseline to Week 56 in HbA1c (time frame: Baseline to Week 56). 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 NCT03684642.

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 1 Nov 2021.