Primary outcomeLeast squares mean· Baseline to Week 56
Change From Baseline to Week 56 in HbA1c
| Group | Value (percentage of HbA1c) | Spread |
|---|---|---|
| Efpeglenatide 4 mg | -1.12 | 0.06 |
| Efpeglenatide 6 mg | -1.17 | 0.06 |
| Dulaglutide 1.5 mg | -1.09 | 0.06 |
Trial · Interventional
TerminatedPhase 3Results postedRegistry dataEfficacy and Safety of Efpeglenatide Versus Dulaglutide in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin
Short name AMPLITUDE-D
NCTNCT03684642 (opens ClinicalTrials.gov in a new tab)Other idEFC14829Other id2017-002956-10Other idU1111-1205-3150Other id2017
This trial was stopped early.
Reason given at the registry: Sponsor decision to cancel TRIAL, not related to safety concern.
Results were posted for this trial.
Overview
- Status
- Terminated
- Phase
- Phase 3
- Enrollment
- 908 participants (actual)
- Sponsor
- Sanofi · Industry
- Design
- Randomized · Open label (no masking)
- Countries
4 countries
United States, Hungary, Poland, Ukraine
- Start
- 26 Sept 2018
- Primary completion
- 13 Oct 2020
- Completion
- 17 Nov 2020
- First posted
- 26 Sept 2018
- Last update posted
- 1 Nov 2021
- Conditions
- Type 2 Diabetes Mellitus
Timeline
1 trial · 1 stopped early · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
2018201920202021
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- EfpeglenatideDrug
- DulaglutideDrug
- Background therapy MetforminDrug
Arms3
Experimental
Efpeglenatide 4 mg
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.
Experimental
Efpeglenatide 6 mg
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.
Active comparator
Dulaglutide 1.5 mg
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.
Primary outcomes1
Outcomes the sponsor listed as primary.
Change From Baseline to Week 56 in HbA1c
Time frame · Baseline to Week 56
Registry description
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.
Secondary outcomes(5)
Change From Baseline to Week 56 in Body Weight
Time frame · Baseline to Week 56
Registry description
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.
Number of Participants With HbA1c < 7.0 %
Time frame · Week 56
Registry description
Participants who had no available assessment for HbA1c at Week 56 were considered as non-responders.
Change From Baseline to Week 56 in Fasting Plasma Glucose (FPG)
Time frame · Baseline to Week 56
Registry description
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.
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
Registry description
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.
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
Registry description
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.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(5)
Secondary outcomeLeast squares mean· Baseline to Week 56
Change From Baseline to Week 56 in Body Weight
| Group | Value (kilogram) | Spread |
|---|---|---|
| Efpeglenatide 4 mg | -2.87 | 0.64 |
| Efpeglenatide 6 mg | -3.04 | 0.67 |
| Dulaglutide 1.5 mg | -2.81 | 0.66 |
Secondary outcomeCount of participants· Week 56
Number of Participants With HbA1c < 7.0 %
| Group | Value (Participants) |
|---|---|
| Efpeglenatide 4 mg | 155 |
| Efpeglenatide 6 mg | 157 |
| Dulaglutide 1.5 mg | 150 |
Secondary outcomeLeast squares mean· Baseline to Week 56
Change From Baseline to Week 56 in Fasting Plasma Glucose (FPG)
| Group | Value (millimoles per liter (mmol/L)) | Spread |
|---|---|---|
| Efpeglenatide 4 mg | -1.81 | 0.15 |
| Efpeglenatide 6 mg | -1.57 | 0.15 |
| Dulaglutide 1.5 mg | -1.71 | 0.15 |
Secondary outcomeCount of participants· Baseline up to Week 56
Number of Participants With At Least One Hypoglycemic Events (Documented Symptomatic Hypoglycemia <3.0 mmol/L [<54 mg/dL], Severe Hypoglycemia)
| Group | Value (Participants) |
|---|---|
| Efpeglenatide 4 mg | 3 |
| Efpeglenatide 6 mg | 1 |
| Dulaglutide 1.5 mg | 0 |
Secondary outcomeNumber· 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
| Group | Value (events per participant-year) |
|---|---|
| Efpeglenatide 4 mg | 0.01 |
| Efpeglenatide 6 mg | 0.01 |
| Dulaglutide 1.5 mg | 0 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Efpeglenatide 4 mgParticipants 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 4 mg once weekly for the treatment duration. | 0 / 313 | 20 / 313 | 202 / 313 |
| Efpeglenatide 6 mgParticipants 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. | 0 / 292 | 23 / 292 | 180 / 292 |
| Dulaglutide 1.5 mgParticipants 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. | 1 / 302 | 20 / 302 | 178 / 302 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
Inclusion criteria:
* 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.
Exclusion criteria:
* 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.
* 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.
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