Study identifier:D5670C00002
ClinicalTrials.gov identifier:NCT02548585
EudraCT identifier:N/A
CTIS identifier:N/A
A Phase 1/2, Randomized, Double-blind, Placebo-controlled, Multiple-ascending-dose Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of MEDI0382 in Overweight and Obese Subjects with a History of Type 2 Diabetes Mellitus
Type 2 Diabetes Mellitus
Phase 1/2
No
MEDI0382, Placebo
All
113
Interventional
18 Years - 65 Years
Allocation: Randomized
Endpoint Classification: Safety/Efficacy
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verified 01 Jan 2019 by MedImmune, LLC
MedImmune, LLC
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A Phase 1/2, multiple dose study with 6 cohorts of ascending doses designed to evaluate the efficacy, safety and pharmacokinetics (PK) of MEDI0382 in participants with Type 2 Diabetes Mellitus (T2DM).
This is a randomized, double-blind, placebo controlled study designed to evaluate the efficacy, safety, and PK of MEDI0382 administered as multiple daily SC doses to participants with T2DM. Approximately one hundred and seven participants will be enrolled across 6 cohorts. In cohorts 1-3 the participants will be randomized to MEDI0382 or placebo (2:1). In Cohort 4, participants will be randomized to MEDI0382 or placebo (1:1). In cohort 5 and 6 participants will be randomized to MEDI0382 or placebo (3:1).
Location
Location
Berlin, Germany, 10117
Location
Leipzig, Germany, 04103
Location
Neuss, Germany, 41460
Location
München, Germany, 81241
Location
Mainz, Germany, 55116
Location
Mannheim, Germany, 68167
Location
Kiel, Germany, 24105
Location
Neu-Ulm, Germany, 89231
Arms | Assigned Interventions |
---|---|
Placebo Comparator: Placebo Participants will receive placebo (matched to either 100 micrograms [mcg], or 150 mcg or 200 mcg or 300 mcg of MEDI0382) subcutaneously (SC) once daily from Day 1 to Day 7 (Cohort 1); or Day 1 to Day 11 (Cohort 2); or Day 1 to Day 15 (Cohort 3); or Day 1 to Day 41 (Cohort 4); or Day 1 to Day 22 (Cohort 5); or Day 1 to Day 17 (Cohort 6). | Drug: Placebo Placebo administered subcutaneously. |
Experimental: Cohort 1: MEDI0382 100 mcg Participants will receive MEDI0382 100 mcg SC once daily from Day 1 to Day 7. | Drug: MEDI0382 MEDI0382 administered subcutaneously. |
Experimental: Cohort 2: MEDI0382 150 mcg Participants will receive MEDI0382 100 mcg SC once daily for at least 4 days (Day 1 to Day 4) and thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 7 days (Day 5 to Day 11). | Drug: MEDI0382 MEDI0382 administered subcutaneously. |
Experimental: Cohort 3: MEDI0382 200 mcg Participants will receive MEDI0382 100 mcg SC once daily for at least 4 days (Day 1 to Day 4); thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 4 days (Day 5 to Day 8); followed by second up titrated dose of MEDI0382 200 mcg SC once daily for 7 days (Day 9 to Day 15). | Drug: MEDI0382 MEDI0382 administered subcutaneously. |
Experimental: Cohort 4: MEDI0382 200 mcg Participants will receive MEDI0382 100 mcg SC once daily for at least 4 days (Day 1 to Day 4); thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 4 days (Day 5 to Day 8); followed by second up titrated dose of MEDI0382 200 mcg SC once daily for 4 days (Day 9 to Day 12), then a further MEDI0382 200 mcg SC once daily for 28 days (Day 13 to Day 40) at home-dosing; followed by MEDI0382 200 mcg SC once daily for 1 day in hospital (Day 41). | Drug: MEDI0382 MEDI0382 administered subcutaneously. |
Experimental: Cohort 5: MEDI0382 300 mcg Participants will receive MEDI0382 100 mcg SC once daily for at least 5 days (Day 1 to Day 5); thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 5 days (Day 6 to Day 10); then a second up titrated dose of MEDI0382 200 mcg SC once daily for 5 days (Day 11 to Day 15); followed by third up titrated dose of MEDI0382 300 mcg SC once daily for 7 days (Day 16 to Day 22). | Drug: MEDI0382 MEDI0382 administered subcutaneously. |
Experimental: Cohort 6: MEDI0382 300 mcg Participants will receive MEDI0382 100 mcg SC once daily for at least 5 days (Day 1 to Day 5); thereafter, an up titrated dose of MEDI0382 200 mcg SC once daily for 5 days (Day 6 to Day 10); followed by a second up titrated dose of MEDI0382 300 mcg SC once daily for 7 days (Day 11 to Day 17). | Drug: MEDI0382 MEDI0382 administered subcutaneously. |
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