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)
Type 2 Diabetes Mellitus
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus
Eligibility 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.
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.
Sites / Locations
- Investigational Site Number 8400038
- Investigational Site Number 8400035
- Investigational Site Number 8400005
- Investigational Site Number 8400057
- Investigational Site Number 8400058
- Investigational Site Number 8400009
- Investigational Site Number 8400045
- Investigational Site Number 8400040
- Investigational Site Number 8400026
- Investigational Site Number 8400055
- Investigational Site Number 8400041
- Investigational Site Number 8400025
- Investigational Site Number 8400052
- Investigational Site Number 8400044
- Investigational Site Number 8400001
- Investigational Site Number 8400039
- Investigational Site Number 8400036
- Investigational Site Number 8400013
- Investigational Site Number 8400030
- Investigational Site Number 8400063
- Investigational Site Number 8400043
- Investigational Site Number 8400037
- Investigational Site Number 1560005
- Investigational Site Number 1560017
- Investigational Site Number 1560006
- Investigational Site Number 1560001
- Investigational Site Number 1560004
- Investigational Site Number 1560036
- Investigational Site Number 1560012
- Investigational Site Number 1560013
- Investigational Site Number 1560003
- Investigational Site Number 4100009
- Investigational Site Number 4100001
- Investigational Site Number 4100016
- Investigational Site Number 4100010
- Investigational Site Number 4100013
- Investigational Site Number 4100015
- Investigational Site Number 4100014
- Investigational Site Number 4100007
- Investigational Site Number 4100008
- Investigational Site Number 4100002
- Investigational Site Number 4100005
- Investigational Site Number 4100004
- Investigational Site Number 4100003
- Investigational Site Number 4100011
- Investigational Site Number 4100006
- Investigational Site Number 4100012
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Placebo Comparator
Experimental
Experimental
Experimental
Placebo
Efpeglenatide 2 mg
Efpeglenatide 4 mg
Efpeglenatide 6 mg
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).
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.
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.
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.