Type 2 Diabetes
Conditions
Keywords
MEDI-4166, diabetes
Brief summary
A Phase 1, combined Single Ascending Dose (SAD) and Multiple-ascending Dose (MAD) study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of MEDI4166 in Subjects with Type 2 Diabetes Mellitus (T2D).
Detailed description
This study is a first time in human (FTIH), Phase 1, randomized, double-blind study to evaluate the safety, tolerability, PK, and PD of MEDI4166 administered as both single and multiple ascending doses to subjects with T2D.
Interventions
BIOLOGICALMEDI-4166
MEDI-4166 administered subcutaneously
BIOLOGICALPlacebo
Placebo administered subcutaneously
Sponsors
MedImmune LLC
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
* Type 2 Diabetes, ages 18-65 * Must provide written informed consent * BMI\>=25 and =\<42 * Venous access suitable for multiple cannulations * Vital signs within normal specified ranges * Females must be non-lactating and non-childbearing potential * Males must practice 2 effective contraceptive measures if sexually active
Exclusion criteria
* Any concurrent condition that in the opinion of the investigator would interfere with the evaluation of the investigational product * History or presence of gastrointestinal, renal, or hepatic disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs * History of cancer, with the exception of basal cell carcinoma or carcinoma of the cervix * Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks prior to dosing * Positive Hepatitis B, Hepatitis C or HIV test or use of antiretroviral medications at screening * Current or previous use of systemic corticosteroids within the past 28 days prior to screening * Use of any medicinal products or herbal preparations licensed for weight loss is prohibited. * Positive drug screen * Type 1 diabetes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part A: Number of subjects with adverse events as a measure of safety and tolerability of MEDI4166 | 43 days post dosing | Treatment emergent adverse events (TEAEs) and serious adverse events (TESAEs) |
| Part B: Change in glucose AUC measured up to 240 minutes after mixed meal tolerance test (MMTT) from baseline to Day 36 | 36 days post dosing | Part B: Change in glucose AUC measured up to 240 minutes after mixed meal tolerance test (MMTT) from baseline to Day 36 |
| Part B: Change in LDL-C from baseline to Day 36 | 36 days post dosing | Part B: Change in LDL-C from baseline to Day 36 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Part A: Proportion of subjects with Anti-drug Antibodies (ADA) to MEDI4166 | 43 days post dosing | Part A: Proportion of subjects with ADA to MEDI4166 |
| Part B: Number of subjects with adverse events as a measure of safety and tolerability of MEDI4166 | 71 days post dosing | Treatment emergent adverse events (TEAEs) and serious adverse events (TESAEs) |
| Part B: Pharmacokinetics of MEDI4166, maximum plasma concentration (Cmax) | 71 days post dosing | Part B: Pharmacokinetics of MEDI4166, maximum plasma concentration (Cmax) |
| Part B: Pharmacokinetics of MEDI4166, area under the curve concentration (AUC) | 71 days post dosing | Part B: Pharmacokinetics of MEDI4166, area under the curve concentration (AUC) |
| Part A: Pharmacokinetics of MEDI4166, maximum plasma concentration (Cmax) | 43 days post dosing | Part A: Pharmacokinetics of MEDI4166, maximum plasma concentration (Cmax) |
| Part B: Proportion of subjects with ADA to MEDI4166 | 71 days post dosing | Part B: Proportion of subjects with ADA to MEDI4166 |
| Part A: Pharmacokinetics of MEDI4166, time to maximum observed plasma drug concentration (Tmax) | 43 days post dosing | Part A: Pharmacokinetics of MEDI4166, time to maximum observed plasma drug concentration (Tmax) |
| Part A: Change from baseline in glucose AUC up to 240 minutes | 43 days post dosing | Part A: Change from baseline in glucose AUC up to 240 minutes |
| Part B: Pharmacokinetics of MEDI4166, time to maximum observed plasma drug concentration (Tmax) | 71 days post dosing | Part B: Pharmacokinetics of MEDI4166, time to maximum observed plasma drug concentration (Tmax) |
| Part B: Change from baseline in fructosamine levels | 36 days post dosing | Part B: Change from baseline in fructosamine levels |
| Part A: Pharmacokinetics of MEDI4166, area under the curve concentration (AUC) | 43 days post dosing | Part A: Pharmacokinetics of MEDI4166, area under the curve concentration (AUC) |
| Part A: Change from baseline in LDL-C | 43 days post dosing | Part A: Change from baseline in LDL-C |
Countries
United States
Outcome results
None listed