A Study to Look at the Effect MEDI0382 Has on Blood Sugar in People With Type 2 Diabetes and Kidn… (NCT03550378) | Clinical Trial Compass
CompletedPhase 2
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
Germany, United Kingdom41 participantsStarted 2018-06-29
Plain-language 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.
Who can participate
Age range18 Years – 84 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Age ≥ 18 and \< 85 years at screening.
✓. Signed and dated written informed consent (with the exception of consent for genetic and nongenetic research) prior to performing any protocol-related procedures, including screening evaluations.
✓. Diagnosed with type 2 diabetes mellitus (T2DM) with glucose control managed with any insulin and/or oral therapy combination where no significant dose changes of oral therapy of more than 50% have occurred in the 3 months prior to screening
✓. Body mass index (BMI) between 25 and 45 kg/m\^2 (inclusive) at screening
✓. Haemoglobin A1c (HbA1c) range of 6.5 % to 10.5% (inclusive) at screening
✓. Renal impairment with estimated glomerular filtration rate (eGFR) ≥ 30 and \< 60 mL/min/1.73 m\^2 at screening. Approximately 16 participants (40%) are required to have a screening eGFR ≥30 and \< 45 mL/min/1.73 m\^2 and at least 16 participants (40%) are required to have screening eGFR ≥45 and \< 60 mL/min/1.73 m\^2.
✓. Females of childbearing potential must have a negative pregnancy test at screening and randomisation, and must not be lactating. Women of childbearing potential who are sexually active with a non-sterilized male partner must be using at least one highly effective method of contraception from screening and up to 4 weeks after the last dose study drug.
Exclusion criteria
✕. History or presence of significant medical or psychological conditions, including substance dependence/abuse, or significant abnormalities in laboratory parameters or vital signs including electrocardiogram (ECG), which in the opinion of the investigator, would compromise the participant's safety or successful participation in the study. As an example, severe anaemia (haemoglobin \< 7.0 g/dL) could be exclusionary due to blood sampling required by the protocol, at the discretion of investigator.
What they're measuring
1
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
Timeframe: 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
✕. Concurrent participation in another interventional study of any kind and repeat randomisation in this study is prohibited.
✕. Any participant who has received another study drug as part of a clinical study or a glucagon-like peptide-1 (GLP-1) analogue-containing preparation within the last 30 days or 5 half-lives of the drug (if known; whichever is longer) at the time of Visit 2.
✕. Any participant who has received any of the following medications within the specified timeframe prior to the start of the study (Visit 2)
✕. Severe allergy/hypersensitivity to any of the proposed study treatments or excipients
✕. Symptoms of acutely decompensated blood glucose control (eg, thirst, polyuria, weight loss), a history of type 1 diabetes mellitus or diabetic ketoacidosis
✕. Participants who have undergone a renal transplant
✕. Participants with suspicion of acute or subacute renal function deterioration (eg, participants with large fluctuations of creatinine values documented within the 6 months prior to screening)