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 |
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Recruitment Status :
Terminated
(Sponsor decision to cancel TRIAL, not related to safety concern)
First Posted : October 22, 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 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: Background therapy | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 370 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 : | November 9, 2018 |
| Actual Primary Completion Date : | November 20, 2020 |
| Actual Study Completion Date : | January 4, 2021 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Type 2 diabetes
MedlinePlus related topics:
Medicines
| Arm | Intervention/treatment |
|---|---|
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Placebo Comparator: Placebo
Participants received placebo (matched to efpeglenatide) subcutaneous (SC) injection once weekly up to Week 56 on top of basal insulin alone or in combination with oral antidiabetic drugs (OADs).
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Drug: Placebo
Pharmaceutical form: solution for injection Route of administration: subcutaneous Drug: Background therapy Lantus (Insulin Glargine), SC, once daily; OADs, administered as per investigator prescription 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 56 on top of basal insulin alone or in combination with OADs.
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Drug: Efpeglenatide SAR439977
Pharmaceutical form: solution for injection Route of administration: subcutaneous Drug: Background therapy Lantus (Insulin Glargine), SC, once daily; OADs, administered as per investigator prescription 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 56 on top of basal insulin alone or in combination with OADs. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg and maintained at the 4 mg dose through-out the treatment duration up to Week 56.
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Drug: Efpeglenatide SAR439977
Pharmaceutical form: solution for injection Route of administration: subcutaneous Drug: Background therapy Lantus (Insulin Glargine), SC, once daily; OADs, administered as per investigator prescription 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 56 on top of basal insulin alone or in combination with OADs. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg until Week 4 and later up-titrated to 6 mg and maintained at the 6 mg dose through-out the treatment duration up to Week 56.
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Drug: Efpeglenatide SAR439977
Pharmaceutical form: solution for injection Route of administration: subcutaneous Drug: Background therapy Lantus (Insulin Glargine), SC, once daily; OADs, administered as per investigator prescription and in accordance with local labeling. |
Primary Outcome Measures :
- Change From Baseline to Week 30 in HbA1c [ Time Frame: Baseline to Week 30 ]
Secondary Outcome Measures :
- Number of Participants With HbA1c <7.0% at Week 30 [ Time Frame: Week 30 ]Participants who had no available assessment for HbA1c at Week 30 were considered as non-responders.
- Change From Baseline to Week 56 in HbA1c [ Time Frame: Baseline to Week 56 ]This analysis included Week 56 assessment performed per protocol as well as premature end of treatment/study visit recorded as Week 56 due to early termination.
- Change From Baseline to Week 30 in Fasting Plasma Glucose (FPG) [ Time Frame: Baseline to Week 30 ]
- Change From Baseline to Week 30 and Week 56 in Body Weight [ Time Frame: Baseline to Week 30 and Week 56 ]This analysis included Week 56 assessment performed per protocol as well as premature end of treatment/study visit recorded as Week 56 due to early termination.
- Number of Participants With At Least One Hypoglycemic Events (Documented Symptomatic Hypoglycemia <3.0 mmol/L [<54 mg/dL], and Severe Hypoglycemia) [ Time Frame: Baseline up to Week 56 ]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.
- 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 ]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 basal insulin regimen alone or in combination with OADs for at least 6 months prior to screening.
- HbA1c between 7.0 percent (%) 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 kilograms within the last 3 months prior to screening.
- Systolic blood pressure greater than (>)180 millimetres of mercury (mmHg) and/or diastolic blood pressure >100 mmHg at randomization.
- End-stage renal disease as defined by estimated glomerular filtration rate (by Modification of Diet in Renal Disease) of less than 15 mL/min/1.73 m^2.
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Laboratory findings at the screening Visit:
- Alanine aminotransferase or aspartate aminotransferase >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 [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 not willing to use highly effective method(s) of birth control or who were 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): NCT03713684
Locations
Show 47 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] September 30, 2019
Statistical Analysis Plan [PDF] November 11, 2020
| Responsible Party: | Sanofi |
| ClinicalTrials.gov Identifier: | NCT03713684 |
| Other Study ID Numbers: |
EFC14893 U1111-1189-5009 ( Other Identifier: UTN ) |
| First Posted: | October 22, 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 |
Additional relevant MeSH terms:
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Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases |
Endocrine System Diseases Efpeglenatide Hypoglycemic Agents Physiological Effects of Drugs |