Type 2 Diabetes
Conditions
Keywords
Obese, Overweight, T2DM
Brief summary
This is a Phase 1, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and tolerability, pharmacodynamics (PD) and pharmacokinetics (PK) of ALT-801 and its effects on glucose control in overweight and obese subjects with type 2 diabetes mellitus (T2DM).
Interventions
DRUGALT-801
Injected subcutaneously (SC)
OTHERPlacebo
Injected subcutaneously (SC)
Sponsors
Altimmune, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Written informed consent signed prior to the performance of any study procedures * Male or female volunteers, age 18 to 65 years, inclusive * Overweight to obese (BMI \>/=28.0 kg/m2) * Type 2 diabetes mellitus (T2DM), on stable regimen, for at least 3 months prior to screening, of any combination of (1) diet and exercise, (2) metformin with absent or mild gastrointestinal symptoms (nausea, vomiting or diarrhea), and/or (3) sodium glucose cotransporter-2 (SGLT-2) therapy * Female subjects of childbearing potential who are not pregnant or breastfeeding, do not plan to become pregnant during the study, and agree to use effective birth control
Exclusion criteria
* Type 1 diabetes mellitus (DM) and/or insulin-dependent T2DM, or uncontrolled T2DM defined as hemoglobin A1c (HbA1c) ≥ 9.5% or C-peptide ≤ 8 ng/mL * History of acute or chronic pancreatitis or hypersensitivity reaction to GLP-1 analogues
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes from baseline in fasting serum glucose and insulin as measured by Homeostasis Model Assessment for Insulin Resistance 2 (HOMA-IR2) | Baseline to Day 85 |
| The Number of Participants with One or More Treatment-Emergent Adverse Events (TEAEs) | Up to Day 110 |
| Changes from baseline in area under the curve of serum glucose, C-peptide, and insulin | Baseline to Day 85 |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in hemoglobin A1c (HbA1c) | Baseline to Day 85 |
| Change from baseline in fasting serum glucose | Baseline to Day 85 |
Other
| Measure | Time frame |
|---|---|
| Changes in quality of life questionnaires compared to baseline | Baseline to Day 85 |
| Change from baseline metformin concentrations | Baseline to Day 85 |
| ALT-801 concentrations | Baseline to Day 110 |
Countries
United States
Outcome results
None listed