A Phase 2 interventional study of MEDI0382 and Placebo in Type II Diabetes Mellitus and Renal Insufficiency, sponsored by MedImmune LLC. Completed at 7 sites in 2 countries. Open to participants aged 18 Years to 84 Years. Per ClinicalTrials.gov, last updated 2020-04-13.
Sponsored by MedImmune LLC · Phase 2, Interventional, and Treatment
A study to look at the effect MEDI0382 has on blood sugar in people with type 2 diabetes and kidney problems and also to check that MEDI0382 is well tolerated.
1,995 studies on the registry are indexed under Renal Insufficiency; 173 are open to participants now.
This study's enrollment of 41 is close to the median of 43 across 1,504 interventional studies indexed under Renal Insufficiency.
Browse Renal Insufficiency studies →MedImmune LLC is the lead sponsor of 265 studies on the registry; none are open to participants now.
Of its 50 completed or terminated interventional studies of FDA-regulated products, 28 (56%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Any participant who has received any of the following medications within the specified timeframe prior to the start of the study (Visit 2)
Significant hepatic disease (except for non-alcoholic steatohepatitis or nonalcoholic fatty liver disease without portal hypertension or cirrhosis) and/or participants with any of the following results:
Poorly controlled hypertension defined as:
Participants will receive subcutaneous (SC) dose of MEDI0382 titrated from 50 μg upto 300 μg (50 μg once daily for 4 days, followed by 100 μg daily for 7 days, 200 μg daily for 7 days, and 300 μg daily for 14 days) for 32 days.
Drug: MEDI0382
Participants will receive SC dose of placebo matched to MEDI0382 once daily for 32 days.
Drug: Placebo
Participants will receive subcutaneous MEDI0382 titrated from 50 μg upto 300 μg (50 μg once daily for 4 days, followed by 100 μg daily for 7 days, 200 μg daily for 7 days, and 300 μg daily for 14 days) for 32 days.
Participants will receive SC placebo matched to MEDI0382 once daily for 32 days.
Percent Change From Baseline in Plasma Glucose Area Under the Concentration Time-curve From Time 0 to 4 Hours (AUC0-4 Hrs) as Measured by Mixed-meal Tolerance Test (MMTT) to Day 32
The MMTT involved the consumption of a standardised liquid meal (a nutritional supplement containing the components of fat, carbohydrate, and protein, which make up a standard MMTT) within 15 minutes, and timed serial blood samples obtained for measurement of glucose and parameters related to glucose metabolism through 240 minutes after consumption of the standardized meal (with no additional food intake during this time).
Time frame: Zero minutes before and 15, 30, 45, 60, 90, 120, 180, and 240 minutes after consumption of the standardised meal on Day -5 (Baseline) and Day 32
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.
Time frame: Day 1 through Day 60
Number of Participants With Abnormal Vital Signs Reported as TEAEs
Number of participants with abnormal vital signs reported as TEAEs is reported. Vital sign measurements were obtained after the participant had rested in the supine position for at least 10 minutes at the recording time. Abnormal vital signs is defined as any abnormal finding in the vital sign parameters (blood pressure, pulse rate, body temperature, and respiratory rate).
Time frame: Day 1 through Day 60
Change From Baseline in Postural Blood Pressure
The change difference is the change from Day 1 to Day 32 in the difference between systolic blood pressure (SBP) or diastolic blood pressure (DBP) values in standing and supine positions. For this outcome measure, participants with difference (standing-supine) in DBP or SBP on Day 1 and Day 32 were analyzed. For few participants either DBP or SBP was recorded eg, standing DBP was not recorded on Day 1 for 2 participants in Placebo arm and 1 participant in MEDI0382 arm; standing SBP was not recorded on Day 32 for a participant in the Placebo arm.
Time frame: Baseline (Day 1) through Day 32
Number of Participants With Abnormal Electrocardiograms (ECGs) Reported as TEAEs
Number of participants with abnormal ECGs reported as TEAEs is reported. Abnormal ECGs is defined as any abnormal findings in heart rate, RR interval, PR interval, QRS, axis, ST-T morphology, and QT intervals from the primary lead of the digital 12-lead ECG.
Time frame: Day 1 through Day 60
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs
Number of participants with abnormal clinical laboratory parameters reported as TEAEs is reported. Abnormal clinical laboratory parameters defined as any abnormal finding during analysis of serum chemistry, hematology, and urine.
Time frame: Day 1 through Day 60
Number of Participants With Treatment-emergent Adverse Events of Special Interest (TEAESIs)
An adverse event of special interest (AESI) was one of scientific and medical interest specific to understanding of the study drug and may require close monitoring and rapid communication by the investigator to the sponsor.
Time frame: Day 1 through Day 60
Change From Baseline in Mean 24-hrs Pulse Rate to the End of Each Dosing Level
Change from baseline in mean 24-hrs pulse rate to the end of each dosing levels: Day 5 for 50 μg; Day 12 for 100 μg, Day 19 for 200 μg, and Day 32 for 300 μg.
Time frame: Day -5 (Baseline) and on Days 5, 12, 19, and 32
Change From Baseline in Mean 24-hrs Systolic and Diastolic Blood Pressure to the End of Each Dosing Level
Change from baseline in mean 24-hrs systolic and diastolic blood pressure to the end of each dosing levels: Day 5 for 50 μg, Day 12 for 100 μg, Day 19 for 200 μg, and Day 32 for 300 μg.
Time frame: Day -5 (Baseline) and on Days 5, 12, 19, and 32
Change From Baseline in Haemoglobin A1c (HbA1c) to Day 32
Change from baseline in haemoglobin A1c (HbA1c) is reported.
Time frame: Day 1 (Baseline) and Day 32
Change From Baseline in Fasting Glucose to Day 32
Change from baseline in fasting glucose is reported.
Time frame: Day 1 (Baseline) and Day 32
Change From Baseline in Percentage of Time Spent Within a Target Glucose Range Over a 7-day Period to the Final Week of Treatment
Change from baseline in percentage of time spent within a target glucose range over a 7-day period to the final week of treatment is reported. Target glucose range was considered as 70 mg/dL (3.9 mmol/L) to 180 mg/dL (10 mmol/L).
Time frame: Baseline (Days -8 to -2), Days 5 to 11, Days 12 to 18, Days 19 to 25, and Days 26 to 32 (final week of treatment)
Percent Change Frome Baseline in Body Weight to Day 33
Percent change from baseline in body weight is reported.
Time frame: Day 1 (Baseline) and Day 33
Change From Baseline in Absolute Body Weight to Day 33
Change from baseline in absolute body weight is reported.
Time frame: Day 1 (Baseline) and Day 33
Area Under the Plasma Concentration Time Curve Over a Dosing Duration (AUCτ) of MEDI0382 at 300 μg
Area under the plasma concentration time curve over a dosing duration (AUCτ) of MEDI0382 at 300 μg is reported.
Time frame: Predose and at 0.5, 1, 2, 4, 6, 8, and 24 hrs postdose on Day 32
Maximum Observed Serum Concentration (Cmax) of MEDI0382 at 300 μg
Maximum observed serum concentration (Cmax) of MEDI0382 at 300 μg is reported.
Time frame: Predose and at 0.5, 1, 2, 4, 6, 8, and 24 hrs postdose on Day 32
Time to Observed Maximum Serum Concentration (Tmax) of MEDI0382 at 300 μg
Time to observed maximum serum concentration (Tmax) of MEDI0382 at 300 μg is reported.
Time frame: Predose and at 0.5, 1, 2, 4, 6, 8, and 24 hrs postdose on Day 32
Trough Plasma Concentration (Ctrough) of MEDI0382
Trough concentration is the lowest concentration reached by a drug before the next dose is administered. Trough plasma concentration of MEDI0382 is reported.
Time frame: Days 1, 5, 12, and 19: Predose; and Day 32: Predose and at 0.5, 1, 2, 4, 6, 8, and 24 hrs postdose (Day 33)
Number of Participants With Positive Anti-drug Antibodies (ADA) Titre to MEDI0382
Number of participants with positive Anti-drug antibodies (ADA) Titre to MEDI0382 is reported.
Time frame: Pre-dose on Days 1, 12, and 32 and on Day 60
The study was conducted in the United Kingdom and Germany between 29Jun2018 and 04Feb2019.
| Milestone | Placebo | MEDI0382 |
|---|---|---|
| Started | 20 | 21 |
| Completed | 20 | 20 |
| Not completed | 0 | 1 |
| Withdrew: Death | 0 | 1 |
The MMTT involved the consumption of a standardised liquid meal (a nutritional supplement containing the components of fat, carbohydrate, and protein, which make up a standard MMTT) within 15 minutes, and timed serial blood samples obtained for measurement of glucose and parameters related to glucose metabolism through 240 minutes after consumption of the standardized meal (with no additional food intake during this time).
| Percent change in plasma glucose | Placebo | MEDI0382 |
|---|---|---|
| Percent Change From Baseline in Plasma Glucose Area Under the Concentration Time-curve From Time 0 to 4 Hours (AUC0-4 Hrs) as Measured by Mixed-meal Tolerance Test (MMTT) to Day 32 | 3.678 (-3.793 to 11.149) | -26.706 (-34.584 to -18.828) |
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.
| Participants | Placebo | MEDI0382 |
|---|---|---|
| TEAEs | 13 | 20 |
| TESAEs | 2 | 2 |
Number of participants with abnormal vital signs reported as TEAEs is reported. Vital sign measurements were obtained after the participant had rested in the supine position for at least 10 minutes at the recording time. Abnormal vital signs is defined as any abnormal finding in the vital sign parameters (blood pressure, pulse rate, body temperature, and respiratory rate).
| Participants | Placebo | MEDI0382 |
|---|---|---|
| Number of Participants With Abnormal Vital Signs Reported as TEAEs | 0 | 0 |
The change difference is the change from Day 1 to Day 32 in the difference between systolic blood pressure (SBP) or diastolic blood pressure (DBP) values in standing and supine positions. For this outcome measure, participants with difference (standing-supine) in DBP or SBP on Day 1 and Day 32 were analyzed. For few participants either DBP or SBP was recorded eg, standing DBP was not recorded on Day 1 for 2 participants in Placebo arm and 1 participant in MEDI0382 arm; standing SBP was not recorded on Day 32 for a participant in the Placebo arm.
| mmHg | Placebo | MEDI0382 |
|---|---|---|
| Systolic Blood Pressure | 0.1 ± 9.3 | 8.9 ± 14.2 |
| Diastolic Blood Pressure | 1.8 ± 6.3 | 0.8 ± 5.2 |
Number of participants with abnormal ECGs reported as TEAEs is reported. Abnormal ECGs is defined as any abnormal findings in heart rate, RR interval, PR interval, QRS, axis, ST-T morphology, and QT intervals from the primary lead of the digital 12-lead ECG.
| Participants | Placebo | MEDI0382 |
|---|---|---|
| Bradyarrhythmia | 1 | 0 |
| Bundle branch block left | 1 | 0 |
| Bundle branch block right | 0 | 1 |
Number of participants with abnormal clinical laboratory parameters reported as TEAEs is reported. Abnormal clinical laboratory parameters defined as any abnormal finding during analysis of serum chemistry, hematology, and urine.
| Participants | Placebo | MEDI0382 |
|---|---|---|
| Hypoglycaemia | 1 | 3 |
| Alanine aminotransferase increased | 1 | 0 |
| Aspartate aminotransferase increased | 1 | 0 |
| Glomerular filtration rate decreased | 0 | 1 |
An adverse event of special interest (AESI) was one of scientific and medical interest specific to understanding of the study drug and may require close monitoring and rapid communication by the investigator to the sponsor.
| Participants | Placebo | MEDI0382 |
|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events of Special Interest (TEAESIs) | 0 | 0 |
Change from baseline in mean 24-hrs pulse rate to the end of each dosing levels: Day 5 for 50 μg; Day 12 for 100 μg, Day 19 for 200 μg, and Day 32 for 300 μg.
| Beats/min | Placebo | MEDI0382 |
|---|---|---|
| Day 5 | -0.73 ± 4.13 | 6.40 ± 5.53 |
| Day 12 | 1.04 ± 5.07 | 9.01 ± 7.73 |
| Day 19 | 1.32 ± 5.28 | 12.72 ± 8.93 |
| Day 32 | -0.92 ± 4.51 | 11.85 ± 8.82 |
Change from baseline in mean 24-hrs systolic and diastolic blood pressure to the end of each dosing levels: Day 5 for 50 μg, Day 12 for 100 μg, Day 19 for 200 μg, and Day 32 for 300 μg.
| mmHg | Placebo | MEDI0382 |
|---|---|---|
| Day 5: Systolic Blood Pressure | -3.11 ± 9.97 | -1.69 ± 9.06 |
| Day 12: Systolic Blood Pressure | -2.67 ± 12.30 | -4.34 ± 11.46 |
| Day 19: Systolic Blood Pressure | -3.56 ± 10.15 | -4.72 ± 11.65 |
| Day 32: Systolic Blood Pressure | 2.21 ± 7.24 | -1.15 ± 18.43 |
| Day 5: Diastolic Blood Pressure | -0.07 ± 3.19 | 1.15 ± 3.64 |
| Day 12: Diastolic Blood Pressure | -0.55 ± 5.17 | 1.28 ± 5.22 |
| Day 19: Diastolic Blood Pressure | -0.44 ± 3.85 | 0.76 ± 3.75 |
| Day 32: Diastolic Blood Pressure | 1.84 ± 1.79 | 2.54 ± 5.34 |
Change from baseline in haemoglobin A1c (HbA1c) is reported.
| Percent | Placebo | MEDI0382 |
|---|---|---|
| Change From Baseline in Haemoglobin A1c (HbA1c) to Day 32 | 0.01 (-0.15 to 0.17) | -0.65 (-0.82 to -0.49) |
Change from baseline in fasting glucose is reported.
| mg/dL | Placebo | MEDI0382 |
|---|---|---|
| Change From Baseline in Fasting Glucose to Day 32 | 0.60 (-12.89 to 14.08) | -19.55 (-33.39 to -5.71) |
Change from baseline in percentage of time spent within a target glucose range over a 7-day period to the final week of treatment is reported. Target glucose range was considered as 70 mg/dL (3.9 mmol/L) to 180 mg/dL (10 mmol/L).
| Percentage of time | Placebo | MEDI0382 |
|---|---|---|
| Days 5 - 11 | -10.49 (-20.77 to -0.20) | 12.25 (2.52 to 21.98) |
| Days 12 - 18 | -5.34 (-12.77 to 2.10) | 15.62 (8.39 to 22.86) |
| Days 19 - 25 | -16.05 (-25.02 to -7.08) | 19.18 (10.21 to 28.15) |
| Days 26 - 32 | -21.23 (-33.13 to -9.32) | 14.79 (2.54 to 27.04) |
Percent change from baseline in body weight is reported.
| Percent change in body weight | Placebo | MEDI0382 |
|---|---|---|
| Percent Change Frome Baseline in Body Weight to Day 33 | -0.21 (-1.05 to 0.62) | -3.69 (-4.55 to -2.83) |
Change from baseline in absolute body weight is reported.
| Kg | Placebo | MEDI0382 |
|---|---|---|
| Change From Baseline in Absolute Body Weight to Day 33 | -0.15 ± 1.84 | -3.39 ± 2.16 |
Area under the plasma concentration time curve over a dosing duration (AUCτ) of MEDI0382 at 300 μg is reported.
| ng.hr/mL | MEDI0382 |
|---|---|
| Area Under the Plasma Concentration Time Curve Over a Dosing Duration (AUCτ) of MEDI0382 at 300 μg | 285.93 (124.08 to 669.17) |
Maximum observed serum concentration (Cmax) of MEDI0382 at 300 μg is reported.
| ng/mL | MEDI0382 |
|---|---|
| Maximum Observed Serum Concentration (Cmax) of MEDI0382 at 300 μg | 16.93 (5.17 to 35.4) |
Time to observed maximum serum concentration (Tmax) of MEDI0382 at 300 μg is reported.
| Hours | MEDI0382 |
|---|---|
| Time to Observed Maximum Serum Concentration (Tmax) of MEDI0382 at 300 μg | 5.6 (4 to 24) |
Trough concentration is the lowest concentration reached by a drug before the next dose is administered. Trough plasma concentration of MEDI0382 is reported.
| ng/mL | MEDI0382 |
|---|---|
| Day 5 | 1.44 (0.48 to 2.58) |
| Day 12 | 2.03 (0.63 to 3.75) |
| Day 19 | 3.68 (0.59 to 8.86) |
| Day 32 | 5.86 (1.3 to 19.4) |
| Day 33 | 5.96 (2.43 to 19.2) |
Number of participants with positive Anti-drug antibodies (ADA) Titre to MEDI0382 is reported.
| Participants | Placebo | MEDI0382 |
|---|---|---|
| Positive at baseline | 0 | 0 |
| Positive post-baseline | 0 | 2 |
| Positive at baseline and post-baseline | 0 | 0 |
| Not detected at baseline; positive post-baseline | 0 | 2 |
| Positive at baseline; not detected post-baseline | 0 | 0 |
Collected over Day 1 through Day 60. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 0/20 (0%) | 2/20 (10%) | 13/20 (65%) |
| MEDI0382 | 1/21 (4.8%) | 2/21 (9.5%) | 19/21 (90.5%) |
| Event | Placebo | MEDI0382 |
|---|---|---|
| Carotid artery stenosisNervous system disorders | 1/20 | 0/21 |
| SyncopeNervous system disorders | 1/20 | 0/21 |
| Diabetic ketoacidosisMetabolism and nutrition disorders | 0/20 | 1/21 |
| Hypertensive crisisVascular disorders | 0/20 | 1/21 |
| Event | Placebo | MEDI0382 |
|---|---|---|
| NauseaGastrointestinal disorders | 4/20 | 9/21 |
| VomitingGastrointestinal disorders | 1/20 | 6/21 |
| DiarrhoeaGastrointestinal disorders | 0/20 | 5/21 |
| DyspepsiaGastrointestinal disorders | 1/20 | 5/21 |
| NasopharyngitisInfections and infestations | 2/20 | 3/21 |
| Decreased appetiteMetabolism and nutrition disorders | 0/20 | 3/21 |
| HypoglycaemiaMetabolism and nutrition disorders | 1/20 | 3/21 |
| RhinitisInfections and infestations | 2/20 | 1/21 |
| HeadacheNervous system disorders | 2/20 | 2/21 |
| FlatulenceGastrointestinal disorders | 0/20 | 2/21 |
As-treated population included all participants who received any dose of study drug and analyzed according to the treatment they actually received.
| Age, Continuous(Years) | Placebo | MEDI0382 | Total |
|---|---|---|---|
| Mean | 70.9 ± 4.7 | 71.1 ± 7.4 | 71.0 ± 6.1 |
| Sex: Female, Male(Participants) | Placebo | MEDI0382 | Total |
|---|---|---|---|
| Female | 11 | 9 | 20 |
| Male | 9 | 12 | 21 |
| Ethnicity (NIH/OMB)(Participants) | Placebo | MEDI0382 | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 20 | 21 | 41 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Placebo | MEDI0382 | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 1 |
| Black or African American | 0 | 0 | 0 |
| White | 20 | 20 | 40 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
Supporting information: Study protocol, Sap
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