NCT03550378

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

Completed Phase 2 Results posted Last updated 13 April 2020

What this trial tests

Phase 2 trial testing MEDI0382 in Type II Diabetes Mellitus in 41 participants. Completed in 4 February 2019.

Timeline

29 June 2018

Primary endpoint
4 February 2019

4 February 2019

Quick facts

Lead sponsor	MedImmune LLC
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	41
Start date	29 June 2018
Primary completion	4 February 2019
Estimated completion	4 February 2019
Sites	7 locations across United Kingdom, Germany

Drugs / interventions tested

• MEDI0382 — full drug profile →
• Placebo

Conditions studied

• Type II Diabetes Mellitus — all drugs for Type II Diabetes Mellitus →
• Renal Insufficiency — all drugs for Renal Insufficiency →

Sponsor

MedImmune LLC — full company profile →

Who can join

Adults 18 to 84, any sex, with Type II Diabetes Mellitus or Renal Insufficiency. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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 Primary · 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

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).

Group	Value	95% CI
Placebo	3.678	-3.793 – 11.149
MEDI0382	-26.706	-34.584 – -18.828

Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) Secondary · Day 1 through Day 60

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

TEAEs

Group	Value	95% CI
Placebo	13
MEDI0382	20

TESAEs

Group	Value	95% CI
Placebo	2
MEDI0382	2

Number of Participants With Abnormal Vital Signs Reported as TEAEs Secondary · Day 1 through Day 60

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).

Group	Value	95% CI
Placebo	0
MEDI0382	0

Change From Baseline in Postural Blood Pressure Secondary · Baseline (Day 1) through Day 32

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.

Systolic Blood Pressure

Group	Value	95% CI
Placebo	0.1	± 9.3
MEDI0382	8.9	± 14.2

Diastolic Blood Pressure

Group	Value	95% CI
Placebo	1.8	± 6.3
MEDI0382	0.8	± 5.2

Number of Participants With Abnormal Electrocardiograms (ECGs) Reported as TEAEs Secondary · Day 1 through Day 60

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.

Bradyarrhythmia

Group	Value	95% CI
Placebo	1
MEDI0382	0

Bundle branch block left

Group	Value	95% CI
Placebo	1
MEDI0382	0

Bundle branch block right

Group	Value	95% CI
Placebo	0
MEDI0382	1

Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs Secondary · Day 1 through Day 60

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.

Hypoglycaemia

Group	Value	95% CI
Placebo	1
MEDI0382	3

Alanine aminotransferase increased

Group	Value	95% CI
Placebo	1
MEDI0382	0

Aspartate aminotransferase increased

Group	Value	95% CI
Placebo	1
MEDI0382	0

Glomerular filtration rate decreased

Group	Value	95% CI
Placebo	0
MEDI0382	1

Number of Participants With Treatment-emergent Adverse Events of Special Interest (TEAESIs) Secondary · Day 1 through Day 60

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.

Group	Value	95% CI
Placebo	0
MEDI0382	0

Change From Baseline in Mean 24-hrs Pulse Rate to the End of Each Dosing Level Secondary · Day -5 (Baseline) and on Days 5, 12, 19, and 32

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.

Day 5

Group	Value	95% CI
Placebo	-0.73	± 4.13
MEDI0382	6.40	± 5.53

Day 12

Group	Value	95% CI
Placebo	1.04	± 5.07
MEDI0382	9.01	± 7.73

Day 19

Group	Value	95% CI
Placebo	1.32	± 5.28
MEDI0382	12.72	± 8.93

Day 32

Group	Value	95% CI
Placebo	-0.92	± 4.51
MEDI0382	11.85	± 8.82

Change From Baseline in Mean 24-hrs Systolic and Diastolic Blood Pressure to the End of Each Dosing Level Secondary · 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 levels: Day 5 for 50 μg, Day 12 for 100 μg, Day 19 for 200 μg, and Day 32 for 300 μg.

Day 5: Systolic Blood Pressure

Group	Value	95% CI
Placebo	-3.11	± 9.97
MEDI0382	-1.69	± 9.06

Day 12: Systolic Blood Pressure

Group	Value	95% CI
Placebo	-2.67	± 12.30
MEDI0382	-4.34	± 11.46

Day 19: Systolic Blood Pressure

Group	Value	95% CI
Placebo	-3.56	± 10.15
MEDI0382	-4.72	± 11.65

Day 32: Systolic Blood Pressure

Group	Value	95% CI
Placebo	2.21	± 7.24
MEDI0382	-1.15	± 18.43

Day 5: Diastolic Blood Pressure

Group	Value	95% CI
Placebo	-0.07	± 3.19
MEDI0382	1.15	± 3.64

Day 12: Diastolic Blood Pressure

Group	Value	95% CI
Placebo	-0.55	± 5.17
MEDI0382	1.28	± 5.22

Day 19: Diastolic Blood Pressure

Group	Value	95% CI
Placebo	-0.44	± 3.85
MEDI0382	0.76	± 3.75

Day 32: Diastolic Blood Pressure

Group	Value	95% CI
Placebo	1.84	± 1.79
MEDI0382	2.54	± 5.34

Change From Baseline in Haemoglobin A1c (HbA1c) to Day 32 Secondary · Day 1 (Baseline) and Day 32

Change from baseline in haemoglobin A1c (HbA1c) is reported.

Group	Value	95% CI
Placebo	0.01	-0.15 – 0.17
MEDI0382	-0.65	-0.82 – -0.49

Change From Baseline in Fasting Glucose to Day 32 Secondary · Day 1 (Baseline) and Day 32

Change from baseline in fasting glucose is reported.

Group	Value	95% CI
Placebo	0.60	-12.89 – 14.08
MEDI0382	-19.55	-33.39 – -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 Secondary · 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)

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).

Days 5 - 11

Group	Value	95% CI
Placebo	-10.49	-20.77 – -0.20
MEDI0382	12.25	2.52 – 21.98

Days 12 - 18

Group	Value	95% CI
Placebo	-5.34	-12.77 – 2.10
MEDI0382	15.62	8.39 – 22.86

Days 19 - 25

Group	Value	95% CI
Placebo	-16.05	-25.02 – -7.08
MEDI0382	19.18	10.21 – 28.15

Days 26 - 32

Group	Value	95% CI
Placebo	-21.23	-33.13 – -9.32
MEDI0382	14.79	2.54 – 27.04

Adverse events — posted to ClinicalTrials.gov

Time frame: Day 1 through Day 60. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Placebo

Serious: 2/20 (10%)

Deaths: 0/20

MEDI0382

Serious: 2/21 (10%)

Deaths: 1/21

Serious adverse events (4 terms)

Reaction	System	Placebo	MEDI0382
Diabetic ketoacidosis	Metabolism and nutrition disorders	—	—
Carotid artery stenosis	Nervous system disorders	—	—
Hypertensive crisis	Vascular disorders	—	—
Syncope	Nervous system disorders	—	—

Other adverse events (42 terms — click to expand)

Reaction	System	Placebo	MEDI0382
Nausea	Gastrointestinal disorders	—	—
Vomiting	Gastrointestinal disorders	—	—
Diarrhoea	Gastrointestinal disorders	—	—
Dyspepsia	Gastrointestinal disorders	—	—
Nasopharyngitis	Infections and infestations	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—
Hypoglycaemia	Metabolism and nutrition disorders	—	—
Flatulence	Gastrointestinal disorders	—	—
Rhinitis	Infections and infestations	—	—
Dizziness	Nervous system disorders	—	—
Headache	Nervous system disorders	—	—
Bradyarrhythmia	Cardiac disorders	—	—
Bundle branch block left	Cardiac disorders	—	—
Bundle branch block right	Cardiac disorders	—	—
Vertigo	Ear and labyrinth disorders	—	—
Vertigo positional	Ear and labyrinth disorders	—	—
Abdominal distension	Gastrointestinal disorders	—	—
Abdominal pain	Gastrointestinal disorders	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—
Eructation	Gastrointestinal disorders	—	—
Gastrooesophageal reflux disease	Gastrointestinal disorders	—	—
Complication associated with device	General disorders	—	—
Injection site erythema	General disorders	—	—
Injection site pruritus	General disorders	—	—
Influenza	Infections and infestations	—	—
Otitis media	Infections and infestations	—	—
Pyelonephritis	Infections and infestations	—	—
Urinary tract infection	Infections and infestations	—	—
Face injury	Injury, poisoning and procedural complications	—	—
Fall	Injury, poisoning and procedural complications	—	—
Alanine aminotransferase increased	Investigations	—	—
Aspartate aminotransferase increased	Investigations	—	—
Glomerular filtration rate decreased	Investigations	—	—
Hypoglycaemia unawareness	Metabolism and nutrition disorders	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—
Carotid artery stenosis	Nervous system disorders	—	—
Nervousness	Psychiatric disorders	—	—
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	—	—
Hyperhidrosis	Skin and subcutaneous tissue disorders	—	—
Night sweats	Skin and subcutaneous tissue disorders	—	—

Most-reported serious reactions: Diabetic ketoacidosis, Carotid artery stenosis, Hypertensive crisis, Syncope.

Data from ClinicalTrials.gov NCT03550378 adverse events section.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Efficacy and safety of cotadutide, a dual glucagon-like peptide-1 and glucagon receptor agonist, in a randomized phase 2a study of patients with type 2 diabetes and chronic kidney disease.
   Parker VER, Hoang T, Schlichthaar H, Gibb FW, et al · · 2022 · cited 58× · PMID 35403793 · DOI 10.1111/dom.14712
2. Impact of Cotadutide drug on patients with type 2 diabetes mellitus: a systematic review and meta-analysis.
   Ali MM, Hafez A, Abdelgalil MS, Hasan MT, et al · · 2022 · cited 19× · PMID 35488292 · DOI 10.1186/s12902-022-01031-5
3. Are we ready for an adipocentric approach in people living with type 2 diabetes and chronic kidney disease?
   Moreno-Pérez O, Reyes-García R, Modrego-Pardo I, López-Martínez M, et al · · 2024 · cited 8× · PMID 38572499 · DOI 10.1093/ckj/sfae039
4. Glycemic control, weight-loss effects, and safety of cotadutide in individuals with type 2 diabetes: A systematic review and meta-analysis.
   Kamrul-Hasan ABM, Dutta D, Nagendra L, Basavarajappa SD, et al · · 2025 · PMID 41480597 · DOI 10.4239/wjd.v16.i12.112830