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Sodium-Glucose Cotransporter 2 (SGLT2) Inhibitor

Orforglipron vs Dapagliflozin for Type 2 Diabetes (ACHIEVE-2 Trial)

Verified Trial
Phase 3
Recruiting
Research Sponsored by Eli Lilly and Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have a clinical diagnosis of T2D based on the World Health Organization classification or other locally applicable diagnostic standards
Have been on stable diabetes treatment with metformin ≥1500 milligram per day (mg/day) during the 90 days prior to screening and maintained through randomization
Timeline
Screening 3 weeks
Treatment 40 weeks
Follow Up week 40
Awards & highlights

Summary

This trial will compare the safety and effectiveness of orforglipron and dapagliflozin in helping people with type 2 diabetes control their blood sugar levels. The trial will last for about

Who is the study for?
This trial is for adults with Type 2 Diabetes who haven't been able to control their blood sugar levels using metformin alone. Participants should be stable on their current metformin dose.Check my eligibility
What is being tested?
The study compares the safety and effectiveness of a new diabetes medication, Orforglipron, with an existing one, Dapagliflozin. It aims to see which is better at controlling blood sugar over about 46 weeks.See study design
What are the potential side effects?
Possible side effects may include urinary tract infections, dehydration, low blood pressure, kidney problems, increased cholesterol levels and hypersensitivity reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with Type 2 Diabetes.
Select...
I have been taking at least 1500 mg of metformin daily for the last 90 days.

Timeline

Screening ~ 3 weeks
Treatment ~ 40 weeks
Follow Up ~week 40
This trial's timeline: 3 weeks for screening, 40 weeks for treatment, and week 40 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from Baseline in Hemoglobin A1c: (HbA1c)
Secondary outcome measures
Change from Baseline in Body Weight
Change from Baseline in Diabetes Treatment Satisfaction Questionnaire-Change (DTSQc) Scores
Change from Baseline in Diastolic Blood Pressure (DBP)
+13 more

Side effects data

From 2018 Phase 4 trial • 30 Patients • NCT03006471
20%
Cervicovaginal infection
13%
Urinary tract infections
100%
80%
60%
40%
20%
0%
Study treatment Arm
Dapagliflozin
Placebo

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Orforglipron Dose 3Experimental Treatment1 Intervention
Participants will receive orforglipron orally.
Group II: Orforglipron Dose 2Experimental Treatment1 Intervention
Participants will receive orforglipron orally.
Group III: Orforglipron Dose 1Experimental Treatment1 Intervention
Participants will receive orforglipron orally.
Group IV: DapagliflozinActive Control1 Intervention
Participants will receive dapagliflozin orally.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
GLP-1 receptor agonists, such as Orforglipron, mimic the incretin hormone GLP-1 to enhance insulin secretion, reduce glucagon release, slow gastric emptying, and increase satiety, thereby improving blood sugar control and aiding in weight loss. This multifaceted approach is vital for Type 2 Diabetes patients as it targets key issues like insulin resistance and beta-cell dysfunction. Other treatments, like metformin and SGLT2 inhibitors, work by decreasing hepatic glucose production and increasing insulin sensitivity or reducing glucose reabsorption in the kidneys, respectively. These mechanisms collectively help manage blood glucose levels and mitigate the risk of complications.
Cardiovascular effects of GLP-1 receptor agonism.Incretin therapies: highlighting common features and differences in the modes of action of glucagon-like peptide-1 receptor agonists and dipeptidyl peptidase-4 inhibitors.

Find a Location

Logistics

Other reimbursement is provided

Other forms of reimbursement are provided for this trial.

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,629 Previous Clinical Trials
3,217,222 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,351 Previous Clinical Trials
415,588 Total Patients Enrolled
~592 spots leftby Oct 2025
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