A Phase III Study to Investigate the Efficacy and Safety of Elecoglipron Compared With Placebo in Adults With Type 2 Diabetes Mellitus on Background Insulin
About this study
The purpose of this study is to evaluate the efficacy, safety, and tolerability of elecoglipron compared with placebo in adults with Type 2 Diabetes Mellitus (T2DM), treated with a background insulin and other background glucose-lowering medication(s)
- Condition
- Type 2 Diabetes Mellitus
- Tested
- Elecoglipron, Placebo
- Sponsor
- AstraZeneca
Who can join
- Age
- 18 years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 7
- Minimum age: 18 years
- Study condition: Type 2 Diabetes Mellitus
- Diagnosed with T2DM for at least 90 days prior to screening
- Stable treatment with background insulin and other background glucose-lowering medication(s)
- HbA1c value of ≥ 7% to ≤ 10.5%
- Body mass index (BMI) of ≥ 23 kg/m2 at screening
- Stable body weight (self-reported or documented) for 90 days prior to screening
Exclusion 7
- T1DM, secondary forms of diabetes (including congenital forms), or history of ketoacidosis or hyperosmolar coma
- Currently receiving or anticipated to receive, therapeutic intervention for diabetic retinopathy and/or macular edema
- Have had more than one episode of severe hypoglycemia within 180 days prior to screening or has a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms
- Clinically significant condition affecting the upper GI tract or chronic use of any medication that affects gastric motility or gastric emptying
- History of acute or chronic pancreatitis.
- Severe congestive heart failure (NYHA IV)
- History/family history of medullary thyroid cancer or multiple endocrine neoplasia type 2
Where
132 sites, 121 recruiting
Research Site
East Toowoomba, Australia
Research Site
Toronto, Ontario, Canada
Research Site
Vancouver, British Columbia, Canada
Research Site
Miyazaki, Japan
Research Site
Naka, Japan
Research Site
Ocoee, Florida, United States
and 126 more sites on ClinicalTrials.gov
Contact
-
AstraZeneca Clinical Study Information Center
1-877-240-9479 information.center@astrazeneca.com
Potential match only. Final eligibility is determined by the study team.