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Sodium-Glucose Cotransporter 2 (SGLT2) Inhibitor

Orforglipron Dose 2 for Type 2 Diabetes (ACHIEVE-2 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
No Placebo-Only Group
Pivotal Trial

ACHIEVE-2 Trial 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.

ACHIEVE-2 Trial 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.

ACHIEVE-2 Trial 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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

ACHIEVE-2 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.

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
2,597 Previous Clinical Trials
3,185,291 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,331 Previous Clinical Trials
401,952 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

At how many distinct sites is the management of this study taking place?

"In addition to CenterMed Lublin NZOZ in Lublin, Nuevo León and Cardiolink Clin Trials in Monterrey, Illinois, Accellacare - DuPage located in Lombard, South carolina is also enrolling patients for this clinical trial. Furthermore, there are 49 other locations participating as well."

Answered by AI

What are the potential risks associated with Orforglipron Dose 1 when administered to individuals?

"Based on the fact that this trial is in Phase 3, indicating a significant amount of safety data and evidence supporting efficacy, our team at Power rates the safety of Orforglipron Dose 1 as a level 3."

Answered by AI

Are participants currently being recruited for this trial?

"Based on the information from clinicaltrials.gov, this specific trial is not currently seeking participants. The trial was initially posted on February 12th, 2024 and was last modified on December 21st, 2023. However, it's worth noting that there are currently 1359 other ongoing studies actively accepting patients at present."

Answered by AI

Who else is applying?

What site did they apply to?
Accellacare, US Inc., d/b/a Accellacare of Knoxville
Collaborative Neuroscience Research, LLC
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

Always looking for better ways to control my diabetes.
PatientReceived 1 prior treatment
~592 spots leftby Oct 2025