Diabetes Mellitus, Type 2Phase 2NCT03235050

A Study to Evaluate the Efficacy and Safety of MEDI0382 in the Treatment of Overweight and Obese Subjects With Type 2 Diabetes

A Phase 2 study testing MEDI0382 low dose, MEDI0382 mid dose and MEDI0382 high dose in people with Diabetes Mellitus, Type 2, run by AstraZeneca at 119 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study is designed to evaluate the dose range for MEDI0382 with respect to blood glucose control and weight loss effects, as well as to further explore the safety profile of MEDI0382 Read more about this study

Who is it for?: Ages 18 to 130 years
Conditions the study is for: Diabetes Mellitus, Type 2
What is being tested?: MEDI0382 low dose, MEDI0382 mid dose and MEDI0382 high dose
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 834 participants
Where: 119 sitesin 8 countries
Study dates: 2 Aug 2017to 14 Jun 2019
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 130 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Provision of informed consent
Male and female subjects aged ≥ 18 years at screening
Body mass index ≥ 25 kg/m2 at screening
HbA1c range of 7.0% to 10.5% (inclusive) at screening
Diagnosed with type-2 diabetes mellitus (T2DM) and treated with metformin (stable dose of ≥1500 mg/day or maximal tolerated dose) for at least 2 months prior to screening. Use of another glucose-lowering medication for up to 2 weeks in the 2 months prior to screening is acceptable
Women of childbearing potential (WOCBP), not breastfeeding and using appropriate birth control to avoid pregnancy throughout the study and for up to 4 weeks after the last dose of investigational product (IP), with a negative pregnancy test within 72 hours prior to the start of IP

Who cannot join

History of, or any existing condition that, in the opinion of the Investigator, would interfere with evaluation of the IP, put the subject at risk, influence the subject's ability to participate or affect the interpretation of the results of the study and/or any subject unable or unwilling to follow study procedures
Any subject who has received another IP as part of a clinical study or a GLP-1 receptor agonist containing preparation within the last 30 days or 5 half lives of the drug (whichever is longer) at the time of screening
Severe allergy/hypersensitivity to any of the proposed study treatments or excipients
Symptoms of acutely decompensated blood glucose control, a history of type 1 diabetes mellitus or diabetic ketoacidosis, or if the subject has been treated with daily subcutaneous (SC) insulin for a period longer than 2 weeks within 90 days prior to screening
Acute or chronic pancreatitis. Subjects with serum triglyceride concentrations above 1000 mg/dL (11 mmol/L) at screening
Significant inflammatory bowel disease or other severe disease or surgery affecting the upper Gastrointestinal (GI) tract

Show all 11Show fewer

Significant hepatic disease
Impaired renal function defined as estimated glomerular filtration rate (eGFR) ≤30 mL/minute/1.73m2 at screening
Severely uncontrolled hypertension
Unstable angina pectoris, myocardial infarction (MI), transient ischaemic attack (TIA), or stroke within 3 months prior to screening
Severe congestive heart failure

Trial locations and contacts

119 sites in 8 countries.

Country

City, postcode or hospital

119 sites in 8 countries

United States22 sites

Research Site
Arlington, Virginia, 22206
Research Site
Baton Rouge, Louisiana, 70808
Research Site
Birmingham, Alabama, 35205
Research Site
Bridgeton, Missouri, 63044
Research Site
Brooklyn, New York, 11229
Research Site
Chandler, Arizona, 85224
Research Site
Elkridge, Maryland, 21075
Research Site
Evansville, Indiana, 47715
Research Site
Glendale, Arizona, 85306
Research Site
Glendale, Arizona, 85308
Research Site
Greer, South Carolina, 29651
Research Site
Houston, Texas, 77040
Research Site
Houston, Texas, 77074
Research Site
Las Vegas, Nevada, 89117
Research Site
Layton, Utah, 84014
Research Site
Manassas, Virginia, 20110
Research Site
Marietta, Georgia, 30067
Research Site
Mesa, Arizona, 85213
Research Site
Metairie, Louisiana, 70006
Research Site
Morehead City, North Carolina, 28557
Research Site
Philadelphia, Pennsylvania, 19104
Research Site
Plano, Texas, 75093

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Germany19 sites

Research Site
Aschaffenburg, 63739
Research Site
Berlin, 10437
Research Site
Berlin, 10787
Research Site
Eschweiler, 52249
Research Site
Essen, 45136
Research Site
Essen, 45359
Research Site
Gelnhausen, 63571
Research Site
Hamburg, 21109
Research Site
Hamburg, 22607
Research Site
Hof, 95030
Research Site
Löhne, 32584
Research Site
Lübeck, 23538
Research Site
Magdeburg, 39120
Research Site
Mannheim, 68163
Research Site
Münster, 48145
Research Site
Oldenburg, 23758
Research Site
Pirna, 01796
Research Site
Rhaunen, 55624
Research Site
Villingen-Schwenningen, 78048

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Slovakia17 sites

Research Site
Banská Bystrica, 974 01
Research Site
Bratislava, 831 01
Research Site
Dolný Kubín, 026 01
Research Site
Levice, 934 01
Research Site
Lučenec, 984 01
Research Site
Malacky, 901 01
Research Site
Námestovo, 029 01
Research Site
Nitra, 949 11
Research Site
Nové Mesto nad Váhom, 915 01
Research Site
Prievidza, 971 01
Research Site
Rimavská Sobota, 979 01
Research Site
Rožňava, 048 01
Research Site
Sabinov, 083 01
Research Site
Trebišov, 075 01
Research Site
Trenčín, 911 01
Research Site
Trnava, 917 01
Research Site
Žilina, 010 01

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Russia16 sites

Research Site
Chelyabinsk, 454091
Research Site
Izhevsk, 426035
Research Site
Kemerovo, 650066
Research Site
Moscow, 119034
Research Site
Moscow, 119435
Research Site
Moscow, 125367
Research Site
Novosibirsk, 630051
Research Site
Perm, 614000
Research Site
Perm, 614068
Research Site
Saint Petersburg, 196084
Research Site
Saint Petersburg, 196601
Research Site
Saint Petersburg, 198013
Research Site
Saint Petersburg, 199226
Research Site
Vladikavkaz, 362007
Research Site
Volgograd, 400131
Research Site
Yekaterinburg, 620039

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Canada15 sites

Research Site
Burlington, Ontario, L7M 4Y1
Research Site
Etobicoke, Ontario, M9W 4L6
Research Site
Guelph, Ontario, N1H 1B1
Research Site
Lévis, Quebec, G6W 0M5
Research Site
London, Ontario, N5W 6A2
Research Site
London, Ontario, N6G 5A9
Research Site
Montreal, Quebec, H4A 3T2
Research Site
Montreal, Quebec, H4N 2W2
Research Site
Newmarket, Ontario, L3Y 5G8
Research Site
Red Deer, Alberta, T4N 6V7
Research Site
Saint-Marc-des-Carrieres, Quebec, G0A 4B0
Research Site
Sarnia, Ontario, N7T 4X3
Research Site
Sherwood Park, Alberta, T8L 0N2
Research Site
Thornhill, Ontario, L4J 8L7
Research Site
Toronto, Ontario, M4G 3E8

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Bulgaria13 sites

Research Site
Botevgrad, 2140
Research Site
Kozloduy
Research Site
Kyustendil, 2500
Research Site
Lukovit
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Petrich, 2850
Research Site
Pleven, 5800
Research Site
Plovdiv, 4000
Research Site
Rousse, 7002
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Sofia, 1223
Research Site
Sofia, 1407
Research Site
Sofia, 1606
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Sofia, 1618
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Stara Zagora, 6000

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Czechia11 sites

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Beroun, 266 00
Research Site
Jílové u Prahy, 254 01
Research Site
Pardubice, 530 02
Research Site
Pilsen, 301 66
Research Site
Plzen - Severni Predmesti, 301 00
Research Site
Prague, 104 00
Research Site
Prague, 140 00
Research Site
Prague, 140 59
Research Site
Prague, 149 00
Research Site
Praha Klanovice, 190 14
Research Site
Uherské Hradiště, 686 01

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Mexico6 sites

Research Site
Guadalajara, 44670
Research Site
México, 03300
Research Site
México, 11650
Research Site
Monterrey, 66465
Research Site
Veracruz, 91900
Research Site
Veracruz, 91910

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About this study

Official title: A Phase IIb, Randomised, Parallel, Double-Blind Placebo-Controlled and Open-Label Active Comparator Study to Evaluate the Efficacy and Safety of MEDI0382 in the Treatment of Overweight and Obese Subjects With Type 2 Diabetes Mellitus

This study is designed to evaluate the dose range for MEDI0382 with respect to blood glucose control and weight loss effects, as well as to further explore the safety profile of MEDI0382

Conditions: Diabetes Mellitus, Type 2
Being tested: MEDI0382 low dose, MEDI0382 mid dose, MEDI0382 high dose, Placebo, Liraglutide
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MEDI0382 low doseDrug
Pharmaceutical form: solution Route of administration: subcutaneous
MEDI0382 mid doseDrug
Pharmaceutical form: solution Route of administration: subcutaneous
MEDI0382 high doseDrug
Pharmaceutical form: solution Route of administration: subcutaneous
PlaceboDrug
Pharmaceutical form: solution Route of administration: subcutaneous
LiraglutideDrug
Pharmaceutical form: solution Route of administration: subcutaneous

Study groups in NCT03235050
Study group	Role	What they receive
MEDI0382 low dose + Metformin	Experimental	Drug: MEDI0382 low dose Drug: Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose) Receives: Drug: MEDI0382 low dose
MEDI0382 mid dose + Metformin	Experimental	Drug: MEDI0382 mid dose Drug: Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose) Receives: Drug: MEDI0382 mid dose
MEDI0382 high dose + Metformin	Experimental	Drug: MEDI0382 high dose Drug: Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose) Receives: Drug: MEDI0382 high dose
Placebo + Metformin	Placebo comparator	Drug: Placebo Drug: Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose) Receives: Drug: Placebo
Liraglutide + Metformin	Active comparator	Drug: Liraglutide Drug: Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose) Receives: Drug: Liraglutide

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in HbA1c
To assess the effect of 100, 200, 300 μg of cotadutide on HbA1c versus placebo
Measured: From baseline to 14 weeks
Percent Change in Body Weight
To assess the effect of 100, 200, 300 μg of cotadutide on body weight versus placebo
Measured: From baseline to 14 weeks

Secondary outcomes (11)

Change in HbA1c
To assess the effect of 100, 200, 300 μg of cotadutide on HbA1c versus placebo
Measured: from baseline to 26 weeks and 54 weeks
Percentage of Participants Achieving an HbA1c Target < 7.0%
To assess the effect of 100, 200, and 300 μg of cotadutide on percentage of participants achieving an HbA1c target of <7% versus placebo
Measured: after 14, 26, and 54 weeks
Percent Change in Body Weight
To assess the effect of 100, 200, and 300 μg of cotadutide on body weight versus placebo
Measured: from baseline to 26 weeks and 54 weeks
Absolute Change in Body Weight
To assess the effect of 100, 200, 300 μg of cotadutide on body weight versus placebo
Measured: from baseline to 14 weeks, 26 weeks and 54 weeks
Percent Change in Body Weight Versus Active Comparator
To assess the effect of 100, 200, and 300 μg of cotadutide on body weight versus liraglutide 1.8 mg once daily
Measured: from baseline to 14 weeks, 26 weeks and 54 weeks
Absolute Change in Body Weight Versus Active Comparator
To assess the effect of 100, 200, and 300 μg of cotadutide on body weight versus liraglutide 1.8 mg once daily
Measured: from baseline to 14 weeks, 26 weeks and 54 weeks
Percentage of Participants Achieving Weight Loss of ≥5% and ≥10%
To assess the effect of 100, 200, and 300 μg of cotadutide on percentage of subjects achieving weight loss of ≥5% and ≥10% versus placebo
Measured: after 14 weeks, 26 weeks and 54 weeks
Percentage of Participants Rescued or Discontinued for Lack of Glycaemic Control
To assess the effect of 100, 200, and 300 μg of cotadutide on the requirement for additional blood glucose-lowering therapies versus placebo
Measured: at 14 weeks, 26 weeks and 54 weeks
Pharmacokinetic (PK) Endpoint: Trough Plasma Concentration (Cmin)
To characterise the PK profile of 100, 200, and 300 μg of cotadutide
Measured: Time points at which outcome measure were assessed for plasma concentration were Weeks 1,2,6,10,14,18,22,26, and 54
Immunogenicity Endpoint: Overall Antidrug Antibody (ADA) Incidence (Number and Percentage of Positive Partipants)
To characterise the immunogenicity of 100, 200, and 300 μg of cotadutide
Measured: Baseline through 54-week treatment period and 28-day follow-up
Immunogenicity Endpoint: Median Titer of the Anti-Drug Antibodies (ADA) to MEDI0382 in the Positive Participants
To characterise the immunogenicity of 100, 200, and 300 μg of cotadutide
Measured: Baseline through 54-week treatment period and 28-day follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Aug 201714 Jun 2019

First posted1 Aug 2017
Study start2 Aug 2017
Primary completion3 May 2018
Study completion14 Jun 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Randomised, parallel, double-blind, placebo-controlled study with an open-label active comparator.
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 834 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03235050
Sponsor's protocol ID: D5670C00004
Status last verified: Jul 2020
First submitted: 21 Jul 2017
Last updated: 17 Aug 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Nahra R, Wang T, Gadde KM, Oscarsson J, Stumvoll M, Jermutus L, Hirshberg B, Ambery P. Effects of Cotadutide on Metabolic and Hepatic Parameters in Adults With Overweight or Obesity and Type 2 Diabetes: A 54-Week Randomized Phase 2b Study. Diabetes Care. 2021 Jun;44(6):1433-1442. doi: 10.2337/dc20-2151. Epub 2021 May 20.
PubMed 34016612

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 17 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase IIb, Randomised, Parallel, Double-Blind Placebo-Controlled and Open-Label Active Comparator Study to Evaluate the Efficacy and Safety of MEDI0382 in the Treatment of Overweight and Obese Subjects With Type 2 Diabetes Mellitus
ClinicalTrials.gov ID: NCT03235050
Acronym / sponsor ID: D5670C00004
Conditions: Diabetes Mellitus, Type 2
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 834 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Collaborators: MedImmune LLC
Study start: 2 Aug 2017 (actual)
Primary completion: 3 May 2018 (actual)
Study completion: 14 Jun 2019 (actual)
First posted: 1 Aug 2017 (actual)
Results: Posted 20 Jul 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study is designed to evaluate the dose range for MEDI0382 with respect to blood glucose control and weight loss effects, as well as to further explore the safety profile of MEDI0382

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 5
Model description: Randomised, parallel, double-blind, placebo-controlled study with an open-label active comparator.

Arm	Type	Receives
MEDI0382 low dose + Metformin	Experimental	Drug: MEDI0382 low doseDrug: MEDI0382 low dose Drug: Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)
MEDI0382 mid dose + Metformin	Experimental	Drug: MEDI0382 mid doseDrug: MEDI0382 mid dose Drug: Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)
MEDI0382 high dose + Metformin	Experimental	Drug: MEDI0382 high doseDrug: MEDI0382 high dose Drug: Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)
Placebo + Metformin	Placebo comparator	Drug: PlaceboDrug: Placebo Drug: Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)
Liraglutide + Metformin	Active comparator	Drug: LiraglutideDrug: Liraglutide Drug: Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)

Who may qualify

Ages: 18 to 130 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Provision of informed consent
Male and female subjects aged ≥ 18 years at screening
Body mass index ≥ 25 kg/m2 at screening
HbA1c range of 7.0% to 10.5% (inclusive) at screening
Diagnosed with type-2 diabetes mellitus (T2DM) and treated with metformin (stable dose of ≥1500 mg/day or maximal tolerated dose) for at least 2 months prior to screening. Use of another glucose-lowering medication for up to 2 weeks in the 2 months prior to screening is acceptable

Key exclusion criteria (11 listed)

History of, or any existing condition that, in the opinion of the Investigator, would interfere with evaluation of the IP, put the subject at risk, influence the subject's ability to participate or affect the interpretation of the results of the study and/or any subject unable or unwilling to follow study procedures
Any subject who has received another IP as part of a clinical study or a GLP-1 receptor agonist containing preparation within the last 30 days or 5 half lives of the drug (whichever is longer) at the time of screening
Severe allergy/hypersensitivity to any of the proposed study treatments or excipients
Symptoms of acutely decompensated blood glucose control, a history of type 1 diabetes mellitus or diabetic ketoacidosis, or if the subject has been treated with daily subcutaneous (SC) insulin for a period longer than 2 weeks within 90 days prior to screening
Acute or chronic pancreatitis. Subjects with serum triglyceride concentrations above 1000 mg/dL (11 mmol/L) at screening

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MEDI0382 low dosePharmaceutical form: solution Route of administration: subcutaneous	Drug	MEDI0382 low dose + Metformin
MEDI0382 mid dosePharmaceutical form: solution Route of administration: subcutaneous	Drug	MEDI0382 mid dose + Metformin
MEDI0382 high dosePharmaceutical form: solution Route of administration: subcutaneous	Drug	MEDI0382 high dose + Metformin
PlaceboPharmaceutical form: solution Route of administration: subcutaneous	Drug	Placebo + Metformin
LiraglutidePharmaceutical form: solution Route of administration: subcutaneous	Drug	Liraglutide + Metformin

Primary outcome

Change in HbA1c
Time frame: From baseline to 14 weeks
To assess the effect of 100, 200, 300 μg of cotadutide on HbA1c versus placebo
Percent Change in Body Weight
Time frame: From baseline to 14 weeks
To assess the effect of 100, 200, 300 μg of cotadutide on body weight versus placebo

11 secondary outcomes

Change in HbA1c
Time frame: from baseline to 26 weeks and 54 weeks
Percentage of Participants Achieving an HbA1c Target < 7.0%
Time frame: after 14, 26, and 54 weeks
Percent Change in Body Weight
Time frame: from baseline to 26 weeks and 54 weeks
Absolute Change in Body Weight
Time frame: from baseline to 14 weeks, 26 weeks and 54 weeks
Percent Change in Body Weight Versus Active Comparator
Time frame: from baseline to 14 weeks, 26 weeks and 54 weeks
Absolute Change in Body Weight Versus Active Comparator
Time frame: from baseline to 14 weeks, 26 weeks and 54 weeks
Percentage of Participants Achieving Weight Loss of ≥5% and ≥10%
Time frame: after 14 weeks, 26 weeks and 54 weeks
Percentage of Participants Rescued or Discontinued for Lack of Glycaemic Control
Time frame: at 14 weeks, 26 weeks and 54 weeks
Pharmacokinetic (PK) Endpoint: Trough Plasma Concentration (Cmin)
Time frame: Time points at which outcome measure were assessed for plasma concentration were Weeks 1,2,6,10,14,18,22,26, and 54
Immunogenicity Endpoint: Overall Antidrug Antibody (ADA) Incidence (Number and Percentage of Positive Partipants)
Time frame: Baseline through 54-week treatment period and 28-day follow-up
Immunogenicity Endpoint: Median Titer of the Anti-Drug Antibodies (ADA) to MEDI0382 in the Positive Participants
Time frame: Baseline through 54-week treatment period and 28-day follow-up

Results and safety

Results posted to the registry on 20 Jul 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	112	108
Liraglutide	110	105
MEDI0382 100 mcg	100	96
MEDI0382 200 mcg	256	242
MEDI0382 300 mcg	256	245

Primary outcome: Change in HbA1c

Time frame: From baseline to 14 weeks. Least squares mean (95% Confidence Interval). Unit: percentage

Measure	Placebo n = 112	MEDI0382 100 mcg n = 100	MEDI0382 200 mcg n = 256	MEDI0382 300 mcg n = 256
Value	-0.18 (-0.34 to -0.02)	-1.01 (-1.18 to -0.84)	-1.22 (-1.33 to -1.11)	-1.09 (-1.20 to -0.98)

Placebo vs MEDI0382 100 mcg: LS Mean Difference: -0.83 (95% CI -1.06 to -0.59), p <0.001, ANCOVA
Placebo vs MEDI0382 200 mcg: LS Mean Difference: -1.04 (95% CI -1.23 to -0.85), p <0.001, ANCOVA
Placebo vs MEDI0382 300 mcg: LS Mean Difference: -0.91 (95% CI -1.11 to -0.72), p <0.001, ANCOVA

Population analysed: ITT population

Primary outcome: Percent Change in Body Weight

Time frame: From baseline to 14 weeks. Least squares mean (95% Confidence Interval). Unit: percentage

Measure	Placebo n = 112	MEDI0382 100 mcg n = 100	MEDI0382 200 mcg n = 256	MEDI0382 300 mcg n = 256
Value	-0.70 (-1.44 to 0.04)	-2.70 (-3.49 to -1.91)	-3.47 (-3.95 to -2.98)	-4.33 (-4.82 to -3.84)

Placebo vs MEDI0382 100 mcg: LS Mean Difference: -2.00 (95% CI -3.08 to -0.91), p <0.001, ANCOVA
Placebo vs MEDI0382 200 mcg: LS Mean Difference: -2.76 (95% CI -3.65 to -1.87), p <0.001, ANCOVA
Placebo vs MEDI0382 300 mcg: LS Mean Difference: -3.62 (95% CI -4.51 to -2.73), p <0.001, ANCOVA

Population analysed: ITT population

11 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected from time of first IP dose throughout the 54-week treatment period and including the 28-day follow-up period. Serious AEs were recorded from the time of signature of informed consent.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	12 of 112 (10.7%)	45 of 112 (40.2%)	0 of 112
Liraglutide	8 of 110 (7.3%)	36 of 110 (32.7%)	0 of 110
MEDI0382 100 mcg	12 of 100 (12%)	51 of 100 (51%)	0 of 100
MEDI0382 200 mcg	33 of 256 (12.9%)	159 of 256 (62.1%)	2 of 256
MEDI0382 300 mcg	20 of 256 (7.8%)	164 of 256 (64.1%)	1 of 256

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34016612Nahra R, Wang T, Gadde KM, Oscarsson J, Stumvoll M, Jermutus L, Hirshberg B, Ambery P. Effects of Cotadutide on Metabolic and Hepatic Parameters in Adults With Overweight or Obesity and Type 2 Diabetes: A 54-Week Randomized Phase 2b Study. Diabetes Care. 2021 Jun;44(6):1433-1442. doi: 10.2337/dc20-2151. Epub 2021 May 20.
D5670C00004 SAP redactedLink provided by the sponsor.
D5670C00004 CSP redactedLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

119 sites in 8 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MEDI0382 low dose, MEDI0382 mid dose and MEDI0382 high dose in people with Diabetes Mellitus, Type 2, run by AstraZeneca at 119 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 119 sites in United States, Germany, Slovakia, Russia, Canada and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in HbA1c (time frame: From baseline to 14 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03235050, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2020.