Phase 2
Completed N=41
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
Type II Diabetes Mellitus · Renal insufficiency
Source: ClinicalTrials.gov NCT03550378 ↗
Enrolled (actual)
41
Serious AEs
9.8%
Results posted
Apr 2020
Primary outcomePrimary: 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; -26.706 Percent change in plasma glucose — p=<0.001
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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; -26.706 | <0.001 sig |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) |
13; 20; 2; 2 | — |
| SECONDARY Number of Participants With Abnormal Vital Signs Reported as TEAEs |
0; 0 | — |
| SECONDARY Change From Baseline in Postural Blood Pressure |
0.1; 8.9; 1.8; 0.8 | — |
| SECONDARY Number of Participants With Abnormal Electrocardiograms (ECGs) Reported as TEAEs |
1; 0; 1; 0; 0; 1 | — |
| SECONDARY Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs |
1; 3; 1; 0; 1; 0 | — |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events of Special Interest (TEAESIs) |
0; 0 | — |
| SECONDARY Change From Baseline in Mean 24-hrs Pulse Rate to the End of Each Dosing Level |
-0.73; 6.40; 1.04; 9.01; 1.32; 12.72 | — |
| SECONDARY Change From Baseline in Mean 24-hrs Systolic and Diastolic Blood Pressure to the End of Each Dosing Level |
-3.11; -1.69; -2.67; -4.34; -3.56; -4.72 | — |
| SECONDARY Change From Baseline in Haemoglobin A1c (HbA1c) to Day 32 |
0.01; -0.65 | — |
| SECONDARY Change From Baseline in Fasting Glucose to Day 32 |
0.60; -19.55 | — |
| SECONDARY Change From Baseline in Percentage of Time Spent Within a Target Glucose Range Over a 7-day Period to the Final Week of Treatment |
-10.49; 12.25; -5.34; 15.62; -16.05; 19.18 | — |
| SECONDARY Percent Change Frome Baseline in Body Weight to Day 33 |
-0.21; -3.69 | — |
| SECONDARY Change From Baseline in Absolute Body Weight to Day 33 |
-0.15; -3.39 | — |
| SECONDARY Area Under the Plasma Concentration Time Curve Over a Dosing Duration (AUCτ) of MEDI0382 at 300 μg |
285.93 | — |
| SECONDARY Maximum Observed Serum Concentration (Cmax) of MEDI0382 at 300 μg |
16.93 | — |
| SECONDARY Time to Observed Maximum Serum Concentration (Tmax) of MEDI0382 at 300 μg |
5.6 | — |
| SECONDARY Trough Plasma Concentration (Ctrough) of MEDI0382 |
1.44; 2.03; 3.68; 5.86; 5.96 | — |
| SECONDARY Number of Participants With Positive Anti-drug Antibodies (ADA) Titre to MEDI0382 |
0; 0; 0; 2; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Age ≥ 18 and 180 mm Hg
- Diastolic BP ≥ 100 mm Hg Participants who fail BP screening criteria may be considered for 24-hour ambulatory blood pressure monitoring (ABPM) at the discretion of the investigator. Participants who maintain a mean 24-hour systolic BP ≤ 180 or diastolic BP 15% will be considered eligible
- Unstable angina pectoris, myocardial infarction, transient ischemic attack or stroke within 3 months prior to screening, or participants who have undergone percutaneous coronary intervention or a coronary artery bypass graft within the past 6 months or who are due to undergo these procedures at the time of screening
- Severe congestive heart failure (New York Heart Association Class III or IV)
- Basal calcitonin level > 50 ng/L at screening or history/family history of medullary thyroid carcinoma or multiple endocrine neoplasia
- History of neoplastic disease within 5 years prior to screening, except for adequately treated basal cell skin cancer, squamous cell skin cancer, or in situ cervical cancer
- Any positive results for serum hepatitis B surface antigen (HBsAg), hepatitis C antibody, and human immunodeficiency virus (HIV) antibody
- Nephrotic range proteinuria defined as spot urine albumin creatinine ratio (ACR) > 250 mg/mmol at screening
- History of substance dependence, alcohol abuse, or excessive alcohol intake (defined as an average weekly intake of > 21 alcoholic drinks for men or > 10 alcoholic drinks for women) within 3 years prior to screening, and/or a positive screen for drugs of abuse or alcohol at screening or on Day -5. Participants who use tricyclic antidepressants or benzodiazepines for an established clinical indication may be permitted to enter the study based upon the judgement of the investigator
Data sourced from ClinicalTrials.gov (NCT03550378). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.