Elecoglipron for Type 2 Diabetes with Kidney Issues
A Phase III Study to Investigate the Efficacy and Safety of Elecoglipron Compared With Placebo in Adults With Type 2 Diabetes Mellitus and Impaired Renal Function on Background Dapagliflozin
Recruiting
Phase 3Interventional Study
Type 2 Diabetes MellitusType 2 Diabetes With Chronic Kidney Disease
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
900 (estimated)
Sponsor
AstraZeneca · Industry
Who this trial is looking for
This trial is looking for adults with type 2 diabetes and kidney problems. Participants will take either elecoglipron or a placebo while continuing their diabetes medications.
Are You a Good Fit for This Trial?
Must be takingDapagliflozin
You may be able to join if
I have been diagnosed with type 2 diabetes for at least 90 days
I have impaired renal function
I have a body mass index (BMI) of at least 23 kg/m2
I have been stable in my body weight for the last 90 days
I am taking sodium-glucose cotransporter 2 inhibitors (SGLT2i) or I have never taken them before
My HbA1c is between 7.0% and 10.5% if I am on SGLT2i, or between 7.5% and 10.5% if I have never taken SGLT2i
You may not be able to join if
I have type 1 diabetes or another form of diabetes
I have had severe low blood sugar more than once in the last 6 months
I have chronic pancreatitis
I currently have severe heart failure
I have a history of medullary thyroid cancer
I am receiving treatment for diabetic eye problems
I have had clinical issues affecting my upper gastrointestinal tract
I have a family history of multiple endocrine neoplasia type 2
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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) and impaired renal function, who are or will be on a background of sodium-glucose cotransporter 2 inhibitor (SGLT2i) dapagliflozin 10 mg as per guideline directed medical therapy (GDMT) for chronic kidney disease (CKD). Additionally, …
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) and impaired renal function, who are or will be on a background of sodium-glucose cotransporter 2 inhibitor (SGLT2i) dapagliflozin 10 mg as per guideline directed medical therapy (GDMT) for chronic kidney disease (CKD). Additionally, participants are on other glucose-lowering medication(s).
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Diagnosed with Type 2 Diabetes Mellitus for at least 90 days prior to screening
* On SGTL2i or SGLT2i-naïve and other glucose lowering medication(s)
* HbA1c value:
1. On stable dose of SGLT2i ≥ 7.0 % to ≤ 10.5% (53 to 91.3 mmol/mol)
2. SGLT2i-naive ≥ 7.5% to ≤ 10.5% (58 t…
Inclusion Criteria:
* Diagnosed with Type 2 Diabetes Mellitus for at least 90 days prior to screening
* On SGTL2i or SGLT2i-naïve and other glucose lowering medication(s)
* HbA1c value:
1. On stable dose of SGLT2i ≥ 7.0 % to ≤ 10.5% (53 to 91.3 mmol/mol)
2. SGLT2i-naive ≥ 7.5% to ≤ 10.5% (58 to 91.3 mmol/mol)
* Impaired renal function
* Body mass index (BMI) of ≥ 23 kg/m2 at screening
* Stable body weight (self-reported or documented) for 90 days prior to screening
Exclusion Criteria:
* Type 1 Diabetes, 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 (New York Heart Association IV)
* History/family history of medullary thyroid cancer or multiple endocrine neoplasia type 2
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