Type 2 Diabetes Mellitus
Conditions
Brief summary
The purpose of this study is to measure the effect of retatrutide versus placebo, administered every week, on time to recovery from hypoglycemia during hypoglycemic clamp in participants with Type 2 Diabetes Mellitus (T2DM) following 16 weeks of treatment.
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)
Masking description
Sponsor-blind
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Have been diagnosed with T2DM for at least 6 months prior to screening. * Treated with diet and exercise and stable treatment with metformin with or without 1 additional allowed oral antihyperglycemic medications (OAM), 3 months prior to screening. * Treatment with metformin will be considered stable if all prescribed total daily doses for this period were ±850 mg from the original prescription for the same participant. * Allowed OAMs include dipeptidyl peptidase-4 (DPP-IV) inhibitors, sodium-glucose co-transporter-2 (SGLT2) inhibitors, glinides, or sulfonylureas. * Have a hemoglobin A1c value at screening of * ≥6.0% (≥ 42 millimole per liter(mmol/L)) and ≤9.5% (≤80 mmol/L) if on metformin only or * ≥6.0% (≥42 mmol/L) and ≤8.5% (≤69 mmol/L) if on metformin in combination with 1 additional allowed OAM. * Have a BMI within the range 25.0 kg/m2 and 45.0 kg/m2 kg/m2 (both inclusive). * Have had a stable body weight that is less than 5% change in body weight for more than 3 months prior to screening.
Exclusion criteria
* Have Type 1 diabetes mellitus. * Have had more than 1 episode of severe hypoglycemia, as defined by the American Diabetes Association criteria, within 6 months before screening or has a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms. * Have had 1 or more episodes of ketoacidosis or hyperosmolar state/coma requiring hospitalization within the 6 months prior to screening. * Have impaired renal estimated glomerular filtration rate \<60 mL/min/1.73 m2 calculated by Chronic Kidney Disease-Epidemiology. * Have acute or chronic pancreatitis or a history of acute idiopathic pancreatitis. * Have elevations in * serum aspartate aminotransferase (AST) \>2.5× upper limit normal (ULN) * serum alanine aminotransferase (ALT) \>2.5×ULN * total bilirubin level (TBL) \>1.5×ULN, or * alkaline phosphatase (ALP) level ≥1.5× ULN. * Have a known clinically significant gastric emptying abnormality.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time-to-Event of Recovery of Plasma Glucose (PG) Concentration from 48 Milligram per Deciliter (48 mg/dL) to 70 mg/dL (tPG_nadir-70 mg/dL) | Within 60 minutes after nadir | Time-to-event of recovery of PG concentration from 48 mg/dL to 70 mg/dL. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Reach Recovery of Plasma Glucose (PG) Concentration from 48 mg/dL to 70 mg/dL (tPG_nadir-70 mg/dL) Including Recovery Beyond 60 Minutes. | Beyond 60 minutes after nadir | Time-to-event of recovery of PG concentration from 48 mg/dL to 70 mg/dL including recovery beyond 60 minutes. |
| Percentage of Participants Who Require Rescue Glucose Infusion to Attain Recovery PG Concentration of 70 mg/dL | Up to 60 minutes after nadir | Percentage of participants who require rescue glucose infusion to attain recovery PG concentration of 70 mg/dL. |
| Hypoglycemic Symptoms Score at set PG Concentration Points | Day 114 during hypoglycemic clamp | Hypoglycemia symptoms were measured with the Edinburgh Hypoglycemia Symptom Scale (EHSS) where lower scores indicate fewer symptoms. |
| Percentage of Participants Who Experienced Hypoglycemic Awareness at Set PG Points | Day 114 during hypoglycemic clamp | Percentage of participants who experienced hypoglycemic awareness at set PG points. |
Countries
Austria
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