Efficacy and Safety of Efpeglenatide Versus Placebo in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin Alone or in Combination With Sulfonylurea (AMPLITUDE-S)
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| ClinicalTrials.gov Identifier: NCT03770728 |
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Recruitment Status :
Terminated
(Sponsor decision to cancel TRIAL, not related to safety concern)
First Posted : December 10, 2018
Results First Posted : December 2, 2021
Last Update Posted : December 2, 2021
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Sponsor:
Sanofi
Collaborator:
Hanmi Pharmaceutical Company Limited
Information provided by (Responsible Party):
Sanofi
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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 type 2 diabetes mellitus (T2DM) inadequately controlled with metformin alone or in combination with sulfonylurea (SU).
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: Background therapy: Metformin alone or in combination with SU | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 312 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A 30-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 Metformin Alone or in Combination With Sulfonylurea |
| Actual Study Start Date : | August 1, 2019 |
| Actual Primary Completion Date : | November 28, 2020 |
| Actual Study Completion Date : | December 27, 2020 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Type 2 diabetes
| Arm | Intervention/treatment |
|---|---|
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Placebo Comparator: Placebo
Participants received placebo (matched to Efpeglenatide) subcutaneous (SC) injection once weekly up to Week 30 on top of metformin alone or in combination with SU.
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Drug: Placebo
Pharmaceutical form: solution for injection Route of administration: subcutaneous Drug: Background therapy: Metformin alone or in combination with SU Pharmaceutical form: tablet Route of administration: oral, administered as per investigator and in accordance with local labeling. |
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Experimental: Efpeglenatide 2 mg
Participants received Efpeglenatide 2 milligrams (mg) SC injection once weekly up to Week 30 on top of metformin alone or in combination with SU.
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Drug: Efpeglenatide SAR439977
Pharmaceutical form: solution for injection Route of administration: subcutaneous Drug: Background therapy: Metformin alone or in combination with SU Pharmaceutical form: tablet Route of administration: oral, administered as per investigator and in accordance with local labeling. |
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Experimental: Efpeglenatide 4 mg
Participants received Efpeglenatide 4 mg SC injection once weekly up to Week 30 on top of metformin alone or in combination with SU. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg and was maintained at the 4 mg dose through-out the treatment duration, up to Week 30.
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Drug: Efpeglenatide SAR439977
Pharmaceutical form: solution for injection Route of administration: subcutaneous Drug: Background therapy: Metformin alone or in combination with SU Pharmaceutical form: tablet Route of administration: oral, administered as per investigator and in accordance with local labeling. |
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Experimental: Efpeglenatide 6 mg
Participants received Efpeglenatide 6 mg SC injection once weekly up to Week 30 on top of metformin alone or in combination with SU. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg until Week 3 and later up-titrated to 6 mg and was maintained at the 6 mg dose through-out the treatment duration, up to Week 30.
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Drug: Efpeglenatide SAR439977
Pharmaceutical form: solution for injection Route of administration: subcutaneous Drug: Background therapy: Metformin alone or in combination with SU Pharmaceutical form: tablet Route of administration: oral, administered as per investigator and in accordance with local labeling. |
Primary Outcome Measures :
- Change From Baseline to Week 30 in HbA1c [ Time Frame: Baseline to Week 30 ]This analysis included all Week 30 assessment values available.
Secondary Outcome Measures :
- Number of Participants With HbA1c <7.0% [ Time Frame: Week 30 ]Participants who had no available assessment for HbA1c <7% at Week 30 were considered as non-responders.
- Change From Baseline to Week 30 in Fasting Plasma Glucose (FPG) [ Time Frame: Baseline to Week 30 ]This analysis included all Week 30 assessment values available.
- Change From Baseline to Week 30 in Body Weight [ Time Frame: Baseline to Week 30 ]This analysis included all Week 30 assessment values available.
- 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 30 ]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 30 ]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.
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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 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 metformin alone or in combination with SU, for at least 3 months prior to screening.
- Glycated hemoglobin 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 or history of surgery affecting gastric emptying.
- 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 kilograms within the last 3 months prior to screening.
- Systolic blood pressure greater than (>)180 millimeters of mercury (mmHg) and/or diastolic blood pressure >100 mmHg at randomization.
- Severe renal disease as defined by estimated glomerular filtration rate (eGFR) of <30 milliliters per minute per 1.73 square meter.
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Laboratory findings at the screening visit:
- Alanine aminotransferase or aspartate aminotransferase >3*upper limit of the normal (ULN) or total bilirubin >1.5*ULN (except in case of documented Gilbert's syndrome);
- Amylase and/or lipase: >3*ULN laboratory range;
- Calcitonin >=5.9 picomoles per liter (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 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.
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): NCT03770728
Locations
Show 48 study locations
Sponsors and Collaborators
Sanofi
Hanmi Pharmaceutical Company Limited
Investigators
| Study Director: | Clinical Sciences & Operations | Sanofi |
Study Documents (Full-Text)
Documents provided by Sanofi:
Documents provided by Sanofi:
Study Protocol [PDF] June 20, 2018
Statistical Analysis Plan [PDF] October 28, 2020
| Responsible Party: | Sanofi |
| ClinicalTrials.gov Identifier: | NCT03770728 |
| Other Study ID Numbers: |
EFC15337 U1111-1205-1291 ( Other Identifier: UTN ) |
| First Posted: | December 10, 2018 Key Record Dates |
| Results First Posted: | December 2, 2021 |
| Last Update Posted: | December 2, 2021 |
| Last Verified: | November 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Plan Description: | No plan to share individual participant data (IPD) by SANOFI: Product rights transferred to Hanmi Pharmaceutical. |
| 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 |
Metformin Efpeglenatide Hypoglycemic Agents Physiological Effects of Drugs |