NCT02548585

Brief Summary

A Phase 1/2, multiple dose study with 6 cohorts of ascending doses designed to evaluate the efficacy, safety and pharmacokinetics (PK) of MEDI0382 in participants with Type 2 Diabetes Mellitus (T2DM).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
113

participants targeted

Target at P75+ for phase_1 type-2-diabetes-mellitus

Timeline
Completed

Started Dec 2015

Longer than P75 for phase_1 type-2-diabetes-mellitus

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 4, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 14, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

December 9, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 24, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 24, 2017

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

April 5, 2019

Completed
Last Updated

April 5, 2019

Status Verified

January 1, 2019

Enrollment Period

1.2 years

First QC Date

September 4, 2015

Results QC Date

May 24, 2018

Last Update Submit

January 8, 2019

Conditions

Type 2 Diabetes Mellitus

Keywords

MEDI0382, diabetes

Outcome Measures

Primary Outcomes (2)

  • Percent Change From Baseline in Mixed-meal Test (MMT) Glucose Area Under the Concentration-time Curve From Time 0 to 4 Hours to the End of Treatment (EOT) (Cohort 4)

    Mixed-meal test involved consumption of a standardized meal (nutritional supplement containing the components of fat, carbohydrate and protein, which make up a standard MMT) within 5 minutes, and timed serial blood samples were obtained for measurement of glucose and parameters related to glucose metabolism just before and 4 hours (hrs) after consumption of the standardized meal (with no additional food intake during this time).

    0 minutes before; and 15, 30, 45, 60, 90, 120, 180, and 240 minutes post standardized meal intake (SMI) on Baseline (Day -1) and EOT (Day 41)

  • Change From Baseline in Body Weight to the EOT (Cohort 4)

    Baseline (Day 1) and EOT (Day 42)

Secondary Outcomes (24)

  • Percent Change From Baseline in MMT Glucose AUC0-4h to the EOT (Cohorts 1, 2, 3, 5, and 6)

    0 minutes before; and 15, 30, 45, 60, 90, 120, 180, and 240 minutes post SMI on Baseline (Day -1) and EOT (Day 7 for Cohort 1; Day 11 for Cohort 2; Day 15 for Cohort 3; Day 22 for Cohort 5; and Day 17 for Cohort 6)

  • Change From Baseline in Body Weight to the EOT (Cohorts 1, 2, 3, 5, and 6)

    Cohort 1: Baseline (Day 1) to EOT (Day 8); Cohort 2: Baseline (Day 1) to EOT (Day 12); Cohort 3: Baseline (Day 1) to EOT (Day 16); Cohort 5: Baseline (Day 1) to EOT (Day 22); Cohort 6: Baseline (Day 1) to EOT (Day 17)

  • Percent Change From Baseline in Hemoglobin A1c (HbA1c) to the EOT (Cohorts 4, 5, and 6)

    Cohort 4: Baseline (Day -2) to EOT (Day 42); Cohort 5: Baseline (Day -2) to EOT (Day 22); Cohort 6: Baseline (Day -2) to EOT (Day 17)

  • Change From Baseline in Fructosamine to the EOT (Cohorts 4, 5, and 6)

    Cohort 4: Baseline (Day -2) to EOT (Day 41); Cohort 5: Baseline (Day -2) to EOT (Day 22); Cohort 6: Baseline (Day -2) to EOT (Day 17)

  • Change From Baseline in Fasting Glucose Prior to MMT to the EOT (Cohorts 1, 2, 3, 4, 5, and 6)

    Cohort 1: Baseline (Day-1) to EOT (Day7); Cohort 2: Baseline (Day-1) to EOT (Day11); Cohort 3: Baseline (Day-1) to EOT (Day15); Cohort 4: Baseline (Day-1) to EOT (Day41); Cohort 5: Baseline (Day-1) to EOT (Day22); Cohort 6: Baseline (Day-1) to EOT (Day17)

  • +19 more secondary outcomes

Study Arms (7)

Placebo

PLACEBO COMPARATOR

Participants will receive placebo (matched to either 100 micrograms \[mcg\], or 150 mcg or 200 mcg or 300 mcg of MEDI0382) subcutaneously (SC) once daily from Day 1 to Day 7 (Cohort 1); or Day 1 to Day 11 (Cohort 2); or Day 1 to Day 15 (Cohort 3); or Day 1 to Day 41 (Cohort 4); or Day 1 to Day 22 (Cohort 5); or Day 1 to Day 17 (Cohort 6).

Drug: Placebo

Cohort 1: MEDI0382 100 mcg

EXPERIMENTAL

Participants will receive MEDI0382 100 mcg SC once daily from Day 1 to Day 7.

Drug: MEDI0382

Cohort 2: MEDI0382 150 mcg

EXPERIMENTAL

Participants will receive MEDI0382 100 mcg SC once daily for at least 4 days (Day 1 to Day 4) and thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 7 days (Day 5 to Day 11).

Drug: MEDI0382

Cohort 3: MEDI0382 200 mcg

EXPERIMENTAL

Participants will receive MEDI0382 100 mcg SC once daily for at least 4 days (Day 1 to Day 4); thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 4 days (Day 5 to Day 8); followed by second up titrated dose of MEDI0382 200 mcg SC once daily for 7 days (Day 9 to Day 15).

Drug: MEDI0382

Cohort 4: MEDI0382 200 mcg

EXPERIMENTAL

Participants will receive MEDI0382 100 mcg SC once daily for at least 4 days (Day 1 to Day 4); thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 4 days (Day 5 to Day 8); followed by second up titrated dose of MEDI0382 200 mcg SC once daily for 4 days (Day 9 to Day 12), then a further MEDI0382 200 mcg SC once daily for 28 days (Day 13 to Day 40) at home-dosing; followed by MEDI0382 200 mcg SC once daily for 1 day in hospital (Day 41).

Drug: MEDI0382

Cohort 5: MEDI0382 300 mcg

EXPERIMENTAL

Participants will receive MEDI0382 100 mcg SC once daily for at least 5 days (Day 1 to Day 5); thereafter, an up titrated dose of MEDI0382 150 mcg SC once daily for 5 days (Day 6 to Day 10); then a second up titrated dose of MEDI0382 200 mcg SC once daily for 5 days (Day 11 to Day 15); followed by third up titrated dose of MEDI0382 300 mcg SC once daily for 7 days (Day 16 to Day 22).

Drug: MEDI0382

Cohort 6: MEDI0382 300 mcg

EXPERIMENTAL

Participants will receive MEDI0382 100 mcg SC once daily for at least 5 days (Day 1 to Day 5); thereafter, an up titrated dose of MEDI0382 200 mcg SC once daily for 5 days (Day 6 to Day 10); followed by a second up titrated dose of MEDI0382 300 mcg SC once daily for 7 days (Day 11 to Day 17).

Drug: MEDI0382

Interventions

MEDI0382DRUG

MEDI0382 administered subcutaneously.

Cohort 1: MEDI0382 100 mcgCohort 2: MEDI0382 150 mcgCohort 3: MEDI0382 200 mcgCohort 4: MEDI0382 200 mcgCohort 5: MEDI0382 300 mcgCohort 6: MEDI0382 300 mcg
PlaceboDRUG

Placebo administered subcutaneously.

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of T2DM
  • Must provide written informed consent
  • Body mass index greater than (\>) 27 and less than (\<) 40 kg/m\^2, inclusive
  • Venous access suitable for multiple cannulations
  • Vital signs within normal specified ranges
  • Females must be non-lactating and non-childbearing potential
  • Males must practice 2 effective contraceptive measures if sexually active

You may not qualify if:

  • Any concurrent condition that in the opinion of the investigator would interfere with the evaluation of the investigational product
  • History or presence of gastrointestinal, renal, or hepatic disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs
  • History of cancer within the last 10 years, with the exception of non-melanoma skin cancer
  • Any clinically important illness (except for T2DM), medical/surgical procedure, or trauma within 4 weeks prior to dosing
  • Fasting glucose greater than or equal to (\>=) 200 mg/dL
  • Positive Hepatitis B, Hepatitis C or human immunodeficiency virus test or use of antiretroviral medications at screening.
  • Concurrent or previous use of a glucagon-like peptide 1 receptor agonist
  • Current or previous use of systemic corticosteroids within the past 28 days prior to screening
  • Use of any medicinal products or herbal preparations licensed for control of body weight or appetite is prohibited.
  • Known or suspected history of alcohol or drug abuse within the past 3 years.
  • Positive drug screen

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Research Site

Berlin, 10117, Germany

Location

Research Site

Erfurt, 99084, Germany

Location

Research Site

Kiel, 24105, Germany

Location

Research Site

Leipzig, 04103, Germany

Location

Research Site

Lübeck, 23538, Germany

Location

Research Site

Magdeburg, 39120, Germany

Location

Research Site

Mainz, 55116, Germany

Location

Research Site

Mannheim, 68167, Germany

Location

Research Site

München, 81241, Germany

Location

Research Site

Neu-Ulm, 89231, Germany

Location

Research Site

Neuss, 41460, Germany

Location

Related Publications (2)

  • Bosch R, Petrone M, Arends R, Vicini P, Sijbrands EJG, Hoefman S, Snelder N. Characterisation of cotadutide's dual GLP-1/glucagon receptor agonistic effects on glycaemic control using an in vivo human glucose regulation quantitative systems pharmacology model. Br J Pharmacol. 2024 Jun;181(12):1874-1885. doi: 10.1111/bph.16336. Epub 2024 Feb 25.

    PMID: 38403793DERIVED

  • Ambery P, Parker VE, Stumvoll M, Posch MG, Heise T, Plum-Moerschel L, Tsai LF, Robertson D, Jain M, Petrone M, Rondinone C, Hirshberg B, Jermutus L. MEDI0382, a GLP-1 and glucagon receptor dual agonist, in obese or overweight patients with type 2 diabetes: a randomised, controlled, double-blind, ascending dose and phase 2a study. Lancet. 2018 Jun 30;391(10140):2607-2618. doi: 10.1016/S0140-6736(18)30726-8. Epub 2018 Jun 23.

    PMID: 29945727DERIVED

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Interventions

cotadutide

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Results Point of Contact

Title
Philip Ambery
Organization
MedImmune, LLC
information.center@astrazeneca.com
+44 (0) 1223 895997

Study Officials

  • Michael Stumvoll

    Universitätsklinikum Leipzig

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 4, 2015

First Posted

September 14, 2015

Study Start

December 9, 2015

Primary Completion

February 24, 2017

Study Completion

February 24, 2017

Last Updated

April 5, 2019

Results First Posted

April 5, 2019

Record last verified: 2019-01

Locations

DE(11)