A multiple-ascending-dose study to evaluate the efficacy, safety, and pharmacokinetics (PK) of MEDI0382 in overweight and obese participants with Type 2 Diabetes Mellitus
Study identifier:D5670C00002
ClinicalTrials.gov identifier:NCT02548585
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
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
Medical condition
Type 2 Diabetes Mellitus
Phase
Phase 1/2
Healthy volunteers
No
Study drug
MEDI0382, Placebo
Sex
All
Actual Enrollment
113
Study type
Interventional
Age
18 Years - 65 Years
Date
Study Start Date: 09 Dec 2015
Primary Completion Date: 24 Feb 2017
Study Completion Date: 24 Feb 2017
Study design
Allocation: Randomized
Endpoint Classification: Safety/Efficacy
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Jan 2019 by MedImmune, LLC
Sponsors
MedImmune, LLC
Collaborators
-
Inclusion and exclusion criteria
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| 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. |
Contacts
Investigators
Principal Investigator
Michael Stumvoll
Universitätsklinikum Leipzig
