Type 2 Diabetes Mellitus (T2DM)
Conditions
Keywords
siRNA, RNAi
Brief summary
The purpose of this study is to evaluate the effect of a single dose of ALN-4324 on whole-body insulin sensitivity in participants with T2DM
Interventions
DRUGALN-4324
ALN-4324 will be administered subcutaneously (SC).
DRUGPlacebo
Placebo will be administered SC.
Sponsors
Alnylam Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Is an adult patient with a confirmed diagnosis of T2DM * Has a body mass index (BMI) of ≥23 kg/m\^2 to ≤39.9 kg/m\^2 * Has a hemoglobin A1c (HbA1c) ≥6.5% to \<10.5% * Is on a stable dose of metformin, sodium-glucose cotransporter 2 inhibitor (SGLT2i), or dipeptidyl peptidase-4 inhibitor (DPP4i)
Exclusion criteria
* Has any clinically significant concomitant disease, medical condition, or abnormal laboratory finding that could compromise participant safety or confound interpretation of study results * Receiving therapies known to interfere with glucose or insulin metabolism other than current treatment for T2DM or birth control methods Note: other protocol defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in M-value | Baseline up to Month 3 | M-value is measured as the glucose infusion rate at steady state |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of Adverse Events (AEs) | Up to Month 9 | — |
| Change from Baseline in M/I | Baseline up to Month 6 | M/I is measured as the ratio of M-value to insulin concentration \[I\] at steady state |
| Change from Baseline in M-value | Baseline up to Month 6 | M-value is measured as the glucose infusion rate at steady state |
| Change from Baseline in Endogenous Glucose Production (EGP) | Baseline up to Month 6 | Both in the basal state and during steady state during the hyperinsulinemic euglycemic clamp (HEC) procedure |
| Change from Baseline in Hemoglobin A1c (HbA1c) | Baseline up to Month 6 | — |
Countries
United States
Contacts
CONTACTAlnylam Clinical Trial Information Line
STUDY_DIRECTORMedical Director
Alnylam Pharmaceuticals
Outcome results
None listed