| Trial ID: | L1879 |
| Source ID: | NCT03555994
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| Associated Drug: |
Medi0382
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| Title: |
A Study to Investigate the Effect of MEDI0382 on Hepatic Glycogen Metabolism in Overweight and Obese Subjects With Type 2 Diabetes Mellitus.
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| Acronym: |
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| Status: |
COMPLETED
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| Study Results: |
YES
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| Results: |
https://ClinicalTrials.gov/show/NCT03555994/results
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| Conditions: |
Type 2 Diabetes Mellitus
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| Interventions: |
DRUG: MEDI0382|DRUG: Placebo|DRUG: Liraglutide
|
| Outcome Measures: |
Primary: Change in Hepatic Glycogen Concentration Adjusted for Liver Volume as Measured by MRS at T = 4 Hours Post Standardised Morning Meal From Baseline (Day -1) to the End of 28 Days of Treatment (Part A Only), To assess the effect of MEDI0382 on hepatic glycogen levels postprandially versus placebo after 28 days of treatment, Day -1 to Day 28|Percentage Change in Fasting Hepatic Glycogen Concentration Adjusted for Liver Volume as Measured by MRS at T = 24 Hours Post Standardised Morning Meal From Baseline (Day -1) to the End of 35 Days of Treatment (Day 36) (Part B), To assess the effect of MEDI0382 on hepatic glycogen levels versus placebo after 35 days (Part B) of treatment, Day -1 to Day 36 | Secondary: Percentage Change in Fasting Hepatic Glycogen Concentration Adjusted for Liver Volume as Measured by MRS at T = 24 Hours Post Standardised Morning Meal From Baseline (Day 1) to the End of 35 Days of Treatment (Day 36, Part B Only), To assess the effect of MEDI0382 on hepatic glycogen levels versus liraglutide after 35 days of treatment (Part B only), Fom baseline (Day -1) to Day 35|Change of Hepatic Fat Fraction From Baseline as Measured by Magnetic Resonance Imaging (Day -1) to the End of 35 Days of Treatment (Part B Only), Day -1 to Day 36|Development of ADA, Baseline to (Follow-up Period) 28 days post last dose + (3-month poststudy)|Measures of Safety and Tolerability of Daily SC Doses of MEDI0382 Titrated up to a Dose Level of 300μg (Parts A and B) by Assessment of Number of Participants withTreatment Emergent Adverse Events (TEAEs) as Assessed by CTCAE V4.0, Safety and tolerability of daily SC doses of MEDI0382 by assessment of the following using CTCAE V4.0: The number of Treatment Emergent Adverse events (TEAEs), Post dosing (Day 1) to final follow-up (28 Days post last dose)|Measures of Safety and Tolerability of Daily SC Doses of MEDI0382 Titrated up to a Dose Level of 300μg (Parts A and B) by Assessment of Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs) as Assessed by CTCAE V4.0, Safety and tolerability of daily SC doses of MEDI0382 by assessment of the following using CTCAE V4.0: The number of Treatment-Emergent Serious Adverse Events (TESAEs), Post dosing (Day 1) to final follow-up (28 Days post last dose)|Measures of Safety and Tolerability of Daily SC Doses of MEDI0382 Titrated up to a Dose Level of 300μg (Parts A and B) by Assessment of Changes in Heart Rate and Blood Pressure, Number of subjects with clinically significant changes in heart rate (BPM) or systolic and diastolic blood pressure (mmHg), Post dosing (Day 1) to final follow-up (28 Days post last dose)|Measures of Safety and Tolerability of Daily SC Doses of MEDI0382 Titrated up to a Dose Level of 300μg (Parts A and B) by Assessment of Changes in ECG, Number of subjects with an ECG determined to be abnormal and clinically significant, Post dosing (Day 1) to final follow-up (28 Days post last dose)|Measures of Safety and Tolerability of Daily SC Doses of MEDI0382 Titrated up to a Dose Level of 300μg (Parts A and B) by Assessment of Changes in Haematology and Clinical Chemistry Parameters, Number of subjects with clinically significant changes in in haematology and or clinical chemistry parameters, Post dosing (Day 1) to final follow-up (28 Days post last dose)
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| Sponsor/Collaborators: |
Sponsor: MedImmune LLC
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| Gender: |
ALL
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| Age: |
ADULT, OLDER_ADULT
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| Phases: |
PHASE2
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| Enrollment: |
51
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| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
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| Start Date: |
2018-05-31
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| Completion Date: |
2021-04-14
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| Results First Posted: |
2024-11-12
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| Last Update Posted: |
2024-11-12
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| Locations: |
Research Site, Maastricht, 6229 ER, Netherlands|Research Site, Uppsala, 752 37, Sweden|Research Site, Nottingham, NG7 2UH, United Kingdom
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| URL: |
https://clinicaltrials.gov/show/NCT03555994
|
