Type 2 Diabetes
Conditions
Keywords
Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases, Diabetes Mellitus, Diabetes Mellitus, Type 2, Kidney Disease, Renal Insufficiency Chronic
Brief summary
The purpose of this study is to investigate the efficacy and safety of retatrutide compared with placebo in participants with Type 2 Diabetes and renal impairment, with inadequate glycemic control on basal insulin alone or a combination of basal insulin with or without metformin and/or sodium-glucose cotransporter-2 (SGLT2) inhibitor. The study will last about 14 months and may include up to 22 visits.
Interventions
DRUGRetatrutide
Administered SC
DRUGPlacebo
Administered SC
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have Type 2 Diabetes (T2D) * Have HbA1c ≥7.0% (53 millimoles per mole (mmol/mol)) to ≤10.5% (91 mmol/mol) * Have moderate or severe renal impairment * Have been on the following stable diabetes treatment during 90 days prior to screening * basal insulin (≥20 International Units (IU)/day) with or without * metformin and/or SGLT2 inhibitor * Are of stable weight for at least 90 days prior to screening * Have a Body Mass Index (BMI) ≥23.0 kilograms per meter squared (kg/m2)
Exclusion criteria
* Have Type 1 Diabetes (T1D) * Have a history of ketoacidosis or hyperosmolar state or coma within the last 6 months prior to screening * Have a history of severe hypoglycemia or hypoglycemia unawareness within the last 6 months prior to screening * Are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema * Have a history of unstable or rapidly progressing renal disease * Have a prior or planned surgical treatment for obesity * Have New York Heart Association Functional Classification III or IV congestive heart failure * Have had acute myocardial infarction, stroke, or were hospitalized for congestive heart failure within 90 days prior to screening * Have a known clinically significant gastric emptying abnormality * Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy for less than 5 years * Have a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia (MEN) syndrome Type 2. * Have any lifetime history of a suicide attempt * Had chronic or acute pancreatitis * Have taken prescribed or over-the-counter medication, or alternative remedies, intended to promote body weight reduction within 90 days prior to screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from Baseline in Hemoglobin A1c (HbA1c) (%) | Baseline, Week 52 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving HbA1c <7.0% | Week 52 | — |
| Percentage of Participants Achieving HbA1c ≤6.5% | Week 52 | — |
| Change from Baseline in Fasting Serum Glucose | Baseline, Week 52 | — |
| Percentage of Time Continuous Glucose Monitoring (CGM) Glucose Values are Between 70 and 180 mg/dL | Week 52 | Measured during the CGM session that occurs during 30 days prior to Week 52 |
| Percent Change from Baseline in Body Weight | Baseline, Week 52 | — |
| Change from Baseline in Body Weight | Baseline, Week 52 | — |
| Percentage of Participants Achieving Weight Reduction of ≥5% | Week 52 | — |
| Percentage of Participants Achieving Weight Reduction of ≥10% | Week 52 | — |
| Percentage of Participants Achieving Weight Reduction of ≥15% | Week 52 | — |
| Percentage of Participants Achieving HbA1c ≤6.5% and ≥10% Weight Reduction | Week 52 | — |
| Percent Change from Baseline in Non-HDL Cholesterol | Baseline, Week 52 | — |
| Percent Change from Baseline in Triglycerides | Baseline, Week 52 | — |
| Change from Baseline in Systolic Blood Pressure (SBP) | Baseline, Week 52 | — |
Countries
Argentina, Brazil, Israel, Mexico, Puerto Rico, United Kingdom, United States
Contacts
STUDY_DIRECTORCall 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Outcome results
None listed