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

NCT03550378 | Completed Phase 2 Results

• 2 other identifiers: D5670C000132018-000019-26
• Study Type: interventional
• Target: 41
• Locations: 2 countries
• Sites: 7

Brief 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.

Conditions

Type II Diabetes Mellitus; Renal Insufficiency

Keywords

Type 2 Diabetes Mellitus; MEDI0382; Renal Impairment; Glucose concentration; Hemoglobin A1c

Outcome Measures

Primary Outcomes (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

  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).

  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

Secondary Outcomes (18)

• Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)

  Day 1 through Day 60

• Number of Participants With Abnormal Vital Signs Reported as TEAEs

  Day 1 through Day 60

• Change From Baseline in Postural Blood Pressure

  Baseline (Day 1) through Day 32

• Number of Participants With Abnormal Electrocardiograms (ECGs) Reported as TEAEs

  Day 1 through Day 60

• Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs

  Day 1 through Day 60

Study Arms (2)

MEDI0382

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

Participants will receive SC dose of placebo matched to MEDI0382 once daily for 32 days.

Drug: Placebo

Interventions

MEDI0382 DRUG

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.

MEDI0382

Placebo DRUG

Participants will receive SC placebo matched to MEDI0382 once daily for 32 days.

Placebo

Eligibility Criteria

• Age: 18 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)
• Herbal preparations within 1 week prior to the start of dosing (Visit 4) or drugs licensed for control of body weight or appetite (eg, orlistat, bupropion-naltrexone, phentermine-topiramate, phentermine, lorcaserin) within 30 days (or 5 half-lives of the drug) prior to the start of dosing (Visit 4)
• Aspirin (acetylsalicylic acid) at a dose greater than 150 mg once daily and within the last 3 days prior to the start of the run-in period (Visit 2)
• Paracetamol (acetaminophen) or paracetamol-containing preparations at a total daily dose of greater than 3000 mg and within the last 3 days prior to the start of the run-in period (Visit 2)
• Ascorbic acid (vitamin C) supplements at a total daily dose of greater than 1000 mg and within the last 3 days prior to the start of the run-in period (Visit 2)
• Opiates, domperidone, metoclopramide, or other drugs known to alter gastric emptying and within 2 weeks prior to the start of dosing (Visit 4)
• 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)
• Significant inflammatory bowel disease, gastroparesis, or other severe disease or surgery affecting the upper gastrointestinal (GI) tract including weight-reducing surgery and procedures) which may affect gastric emptying or could affect the interpretation of safety and tolerability data
• History of acute or chronic pancreatitis
• 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:

Sponsors & Collaborators

• MedImmune LLC: lead

Study Sites (7)

Research Site

Berlin, 10117, Germany

Location

Research Site

Magdeburg, 39120, Germany

Location

Research Site

München, 81241, Germany

Location

Research Site

Münster, 48145, Germany

Location

Research Site

Dundee, DD1 9SY, United Kingdom

Location

Research Site

Edinburgh, EH16 4SA, United Kingdom

Location

Research Site

Edinburgh, EH4 2XU, United Kingdom

Location

Related Publications (2)

• Natale P, Green SC, Tunnicliffe DJ, Pellegrino G, Toyama T, Strippoli GF. Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2025 Feb 18;2(2):CD015849. doi: 10.1002/14651858.CD015849.pub2.

  PMID: 39963952 DERIVED

• Parker VER, Hoang T, Schlichthaar H, Gibb FW, Wenzel B, Posch MG, Rose L, Chang YT, Petrone M, Hansen L, Ambery P, Jermutus L, Heerspink HJL, McCrimmon RJ. 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. Diabetes Obes Metab. 2022 Jul;24(7):1360-1369. doi: 10.1111/dom.14712. Epub 2022 Apr 25.

  PMID: 35403793 DERIVED

Related Links

• D5670C00013 CSP redacted
• D5670C00013 - SAP\_Redacted

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Renal Insufficiency

Interventions

cotadutide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Lars Hansen
• Organization: MedImmune, LLC

information.center@astrazeneca.com

+1 301 398 4563

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomised, Double-Blind, Placebo-Controlled

Study Record Dates

• First Submitted: April 27, 2018
• First Posted: June 8, 2018
• Study Start: June 29, 2018
• Primary Completion: February 4, 2019
• Study Completion: February 4, 2019
• Last Updated: April 13, 2020
• Results First Posted: April 13, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
• Access Criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

Locations

GB (3); DE (4)