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
NCT07664553 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 600
Last updated 2026-08-04
Summary
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)
Conditions
Interventions
- DRUG
-
Elecoglipron
Elecoglipron is administered orally once daily.
- DRUG
-
Placebo is administered orally once daily.
Sponsors & Collaborators
- lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-07-08
- Primary Completion
- 2028-05-23
- Completion
- 2028-05-23
- FDA Drug
- Yes
Countries
- United States
- Australia
- Bulgaria
- Canada
- China
- Czechia
- Germany
- India
- Japan
- Malaysia
- Poland
- South Korea
- Thailand
Study Locations
More Related Trials
-
Efficacy and Safety of Efpeglenatide Versus Placebo in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Diet and Exercise
NCT03353350 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of Saxagliptin in Subjects With Type 2 Diabetes Who Have Inadequate Blood Sugar Control With Sulfonylureas
NCT00313313 ·Status: COMPLETED ·Phase: PHASE3
-
Phase III Study to Evaluate Safety and Efficacy of Added Exenatide Versus Placebo to Titrated Basal Insulin Glargine in Inadequately Controlled Patients With Type II Diabetes Mellitus
NCT02229383 ·Status: COMPLETED ·Phase: PHASE3
-
In-patient Study With GSK716155 In Patients With Type 2 Diabetes Mellitus
NCT00354536 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Investigate Efficacy and Safety of Teplizumab Compared With Placebo in Participants 1 to 25 Years of Age With Stage 3 Type 1 Diabetes
NCT07088068 ·Status: RECRUITING ·Phase: PHASE3
-
24-week Treatment With Lixisenatide in Type 2 Diabetes Insufficiently Controlled With Metformin and Insulin Glargine
NCT00975286 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of the Safety and Effectiveness of LY3053102 in Participants With Type 2 Diabetes
NCT02020616 ·Status: TERMINATED ·Phase: PHASE1/PHASE2
-
A Study of LY3192767 in Healthy Participants
NCT03025009 ·Status: COMPLETED ·Phase: PHASE1
-
Comparison of Technosphere® Insulin Versus Technosphere Powder (Placebo) in Insulin-Naive Subjects With Type 2 Diabetes Mellitus
NCT01451398 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of LY2922083 in Healthy Participants and Participants With Diabetes
NCT01748552 ·Status: COMPLETED ·Phase: PHASE1
-
Evaluation of the Effect on Glucose Control and the Safety and Tolerability of AC2993 in Patients With Type 2 Diabetes Mellitus
NCT00044694 ·Status: COMPLETED ·Phase: PHASE2
-
Evaluate Efficacy and Safety of Saxagliptin in Adult Patients With Type 2 Diabetes Inadequate Glycemic Control
NCT00698932 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of Insulin Peglispro (LY2605541) in Participants With Type 2 Diabetes Mellitus
NCT02106364 ·Status: WITHDRAWN ·Phase: PHASE3
-
Does Saxagliptin Reduce the Risk of Cardiovascular Events When Used Alone or Added to Other Diabetes Medications
NCT01107886 ·Status: COMPLETED ·Phase: PHASE4
-
Efficacy and Safety Study of Linagliptin (5 mg Administered Orally Once Daily) Over 24 Weeks, in Drug naïve or Previously Treated Type 2 Diabetic Patients With Insufficient Glycaemic Control
NCT01214239 ·Status: COMPLETED ·Phase: PHASE3
-
Japanese P III vs Voglibose and Placebo
NCT00654381 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of LY3325656 in Healthy Participants and Participants With Type 2 Diabetes
NCT03115099 ·Status: COMPLETED ·Phase: PHASE1
-
GALLANT 4 Tesaglitazar vs. Glibenclamide
NCT00255541 ·Status: TERMINATED ·Phase: PHASE3
-
Bridge Study to Evaluate the Efficacy and Safety of IN-B00009 Injection in Patients With T2DM Inadequately Controlled by Diet and Exercise Alone
NCT07308184 ·Status: NOT_YET_RECRUITING ·Phase: PHASE3
-
Linagliptin as Add on to Basal Insulin in the Elderly
NCT02240680 ·Status: COMPLETED ·Phase: PHASE4
-
Efficacy and Safety of Prandial Inhalation of Technosphere/Insulin in Combination With Metformin or Technosphere/Insulin Alone Versus 2 Oral Anti-Diabetic Agents in Subjects With Type 2 Diabetes
NCT00332488 ·Status: COMPLETED ·Phase: PHASE3
-
Safety and Efficacy of Saxagliptin Plus Insulin With or Without Metformin
NCT00757588 ·Status: COMPLETED ·Phase: PHASE3
-
Study to Assess Safety, Tolerability, PK, and PD of Multiple Doses of ZE63-0302 Administrated Orally in T2DM Patients.
NCT07234864 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1
-
Study to Evaluate the Efficacy and Safety of Exenatide Once-Weekly Injection Compared to Once-Daily Insulin in Type 2 Diabetes Mellitus
NCT00935532 ·Status: COMPLETED ·Phase: PHASE3
-
Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) Assessment of LIK066 in Healthy Subjects and in Patients With Type 2 Diabetes Mellitus (T2DM)
NCT01407003 ·Status: COMPLETED ·Phase: PHASE1/PHASE2