Evaluation of Evolocumab (AMG 145) Efficacy in Diabetic A... | NCT02739984

ID	Type	Description	Link
2015-004711-21	EudraCT Number

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	Participants received placebo subcutaneous injection once every month (QM) for 12 weeks.	Drug: Placebo to Evolocumab
Evolocumab	Experimental	Participants received 420 mg evolocumab subcutaneous injection once every month (QM) for 12 weeks.	Biological: Evolocumab

Name	Type	Description	Arm Group Labels	Other Names
Evolocumab	Biological	Administered by subcutaneous injection with an automated mini doser	Evolocumab

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12		Baseline and Weeks 10 and 12
Percent Change From Baseline in LDL-C at Week 12		Baseline and week 12

Secondary Outcomes

Measure	Description	Time Frame
Change From Baseline in LDL-C at the Mean of Weeks 10 and 12		Baseline and weeks 10 and 12
Change From Baseline in LDL-C at Week 12		Baseline and week 12
Percent Change From Baseline in Non-HDL-C at the Mean of Weeks 10 and 12

Eligibility Module

Name	Affiliation	Role
MD	Amgen	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Tuscumbia	Alabama	35674	United States
Research Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36435949	Derived	Rosenson RS, Lopez JAG, Monsalvo ML, Wu Y, Wang H, Marcovina SM. Quantification of LDL-Cholesterol Corrected for Molar Concentration of Lipoprotein(a). Cardiovasc Drugs Ther. 2024 Feb;38(1):191-197. doi: 10.1007/s10557-022-07407-y. Epub 2022 Nov 26.
30953107	Derived	Rosenson RS, Daviglus ML, Handelsman Y, Pozzilli P, Bays H, Monsalvo ML, Elliott-Davey M, Somaratne R, Reaven P. Efficacy and safety of evolocumab in individuals with type 2 diabetes mellitus: primary results of the randomised controlled BANTING study. Diabetologia. 2019 Jun;62(6):948-958. doi: 10.1007/s00125-019-4856-7. Epub 2019 Apr 5.

Label	URL
AmgenTrials clinical trials website	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Placebo	Participants received placebo subcutaneous injection once every month (QM) for 12 weeks.
FG001	Evolocumab	Participants received 420 mg evolocumab subcutaneous injection once every month (QM) for 12 weeks.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jan 6, 2016	Aug 2, 2018

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	OG000-0.84± 1.76 OG001-64.98± 1.31

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Repeated measures linear effects model	Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.	<0.0001		LS Mean Treatment Difference	-64.14	Standard Error of the Mean	2.05	2-Sided	95	-68.16	-60.12			Evolocumab - Placebo		Superiority	Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.

Primary

Percent Change From Baseline in LDL-C at Week 12

Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab).

Posted

Least Squares Mean

Standard Error

percent change

Baseline and week 12

ID	Title	Description
OG000	Placebo	Participants received placebo subcutaneous injection once every month (QM) for 12 weeks.
OG001	Evolocumab	Participants received 420 mg evolocumab subcutaneous injection once every month (QM) for 12 weeks.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in LDL-C at the Mean of Weeks 10 and 12

Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab).

Posted

Least Squares Mean

Standard Error

mg/dL

Baseline and weeks 10 and 12

ID	Title	Description
OG000	Placebo	Participants received placebo subcutaneous injection once every month (QM) for 12 weeks.
OG001	Evolocumab	Participants received 420 mg evolocumab subcutaneous injection once every month (QM) for 12 weeks.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in LDL-C at Week 12

Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab).

Posted

Least Squares Mean

Standard Error

mg/dL

Baseline and week 12

ID	Title	Description
OG000	Placebo	Participants received placebo subcutaneous injection once every month (QM) for 12 weeks.
OG001	Evolocumab	Participants received 420 mg evolocumab subcutaneous injection once every month (QM) for 12 weeks.

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in Non-HDL-C at the Mean of Weeks 10 and 12

Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab).

Posted

Least Squares Mean

Standard Error

percent change

Baseline and weeks 10 and 12

ID	Title	Description
OG000	Placebo	Participants received placebo subcutaneous injection once every month (QM) for 12 weeks.
OG001	Evolocumab	Participants received 420 mg evolocumab subcutaneous injection once every month (QM) for 12 weeks.

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in Non-HDL-C at Week 12

Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab).

Posted

Least Squares Mean

Standard Error

percent change

Baseline and week 12

ID	Title	Description
OG000	Placebo	Participants received placebo subcutaneous injection once every month (QM) for 12 weeks.
OG001	Evolocumab	Participants received 420 mg evolocumab subcutaneous injection once every month (QM) for 12 weeks.

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12

Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab).

Posted

Least Squares Mean

Standard Error

percent change

Baseline and weeks 10 and 12

ID	Title	Description
OG000	Placebo	Participants received placebo subcutaneous injection once every month (QM) for 12 weeks.
OG001	Evolocumab	Participants received 420 mg evolocumab subcutaneous injection once every month (QM) for 12 weeks.

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in Apolipoprotein B at Week 12

Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab).

Posted

Least Squares Mean

Standard Error

percent change

Baseline and week 12

ID	Title	Description
OG000	Placebo	Participants received placebo subcutaneous injection once every month (QM) for 12 weeks.
OG001	Evolocumab	Participants received 420 mg evolocumab subcutaneous injection once every month (QM) for 12 weeks.

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in Total Cholesterol at the Mean of Weeks 10 and 12

Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab).

Posted

Least Squares Mean

Standard Error

percent change

Baseline and weeks 10 and 12

ID	Title	Description
OG000	Placebo	Participants received placebo subcutaneous injection once every month (QM) for 12 weeks.
OG001	Evolocumab	Participants received 420 mg evolocumab subcutaneous injection once every month (QM) for 12 weeks.

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in Total Cholesterol at Week 12

Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab).

Posted

Least Squares Mean

Standard Error

percent change

Baseline and week 12

ID	Title	Description
OG000	Placebo	Participants received placebo subcutaneous injection once every month (QM) for 12 weeks.
OG001	Evolocumab	Participants received 420 mg evolocumab subcutaneous injection once every month (QM) for 12 weeks.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With Mean LDL-C at Weeks 10 and 12 Less Than 70 mg/dL (1.8 mmol/L)

Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab).

Posted

Number

95% Confidence Interval

percentage of participants

Weeks 10 and 12

ID	Title	Description
OG000	Placebo	Participants received placebo subcutaneous injection once every month (QM) for 12 weeks.
OG001	Evolocumab	Participants received 420 mg evolocumab subcutaneous injection once every month (QM) for 12 weeks.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With LDL-C at Week 12 Less Than 70 mg/dL (1.8 mmol/L)

Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab).

Posted

Number

95% Confidence Interval

percentage of participants

Week 12

ID	Title	Description
OG000	Placebo	Participants received placebo subcutaneous injection once every month (QM) for 12 weeks.
OG001	Evolocumab	Participants received 420 mg evolocumab subcutaneous injection once every month (QM) for 12 weeks.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With at Least a 50% Reduction From Baseline in Mean LDL-C at Weeks 10 and 12

Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab).

Posted

Number

95% Confidence Interval

percentage of participants

Baseline and weeks 10 and 12

ID	Title	Description
OG000	Placebo	Participants received placebo subcutaneous injection once every month (QM) for 12 weeks.
OG001	Evolocumab	Participants received 420 mg evolocumab subcutaneous injection once every month (QM) for 12 weeks.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With at Least a 50% Reduction From Baseline in LDL-C at Week 12

Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab).

Posted

Number

95% Confidence Interval

percentage of participants

Baseline and Week 12

ID	Title	Description
OG000	Placebo	Participants received placebo subcutaneous injection once every month (QM) for 12 weeks.
OG001	Evolocumab	Participants received 420 mg evolocumab subcutaneous injection once every month (QM) for 12 weeks.

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in Lipoprotein(a) at the Mean of Weeks 10 and 12

Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab).

Posted

Least Squares Mean

Standard Error

percent change

Baseline and weeks 10 and 12

ID	Title	Description
OG000	Placebo	Participants received placebo subcutaneous injection once every month (QM) for 12 weeks.
OG001	Evolocumab	Participants received 420 mg evolocumab subcutaneous injection once every month (QM) for 12 weeks.

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in Lipoprotein(a) at Week 12

Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab).

Posted

Least Squares Mean

Standard Error

percent change

Baseline and week 12

ID	Title	Description
OG000	Placebo	Participants received placebo subcutaneous injection once every month (QM) for 12 weeks.
OG001	Evolocumab	Participants received 420 mg evolocumab subcutaneous injection once every month (QM) for 12 weeks.

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12

Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab).

Posted

Least Squares Mean

Standard Error

percent change

Baseline and weeks 10 and 12

ID	Title	Description
OG000	Placebo	Participants received placebo subcutaneous injection once every month (QM) for 12 weeks.
OG001	Evolocumab	Participants received 420 mg evolocumab subcutaneous injection once every month (QM) for 12 weeks.

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in Triglycerides at Week 12

Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab).

Posted

Least Squares Mean

Standard Error

percent change

Baseline and week 12

ID	Title	Description
OG000	Placebo	Participants received placebo subcutaneous injection once every month (QM) for 12 weeks.
OG001	Evolocumab	Participants received 420 mg evolocumab subcutaneous injection once every month (QM) for 12 weeks.

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in HDL-C at the Mean of Weeks 10 and 12

Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab).

Posted

Least Squares Mean

Standard Error

percent change

Baseline and weeks 10 and 12

ID	Title	Description
OG000	Placebo	Participants received placebo subcutaneous injection once every month (QM) for 12 weeks.
OG001	Evolocumab	Participants received 420 mg evolocumab subcutaneous injection once every month (QM) for 12 weeks.

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in HDL-C at Week 12

Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab).

Posted

Least Squares Mean

Standard Error

percent change

Baseline and week 12

ID	Title	Description
OG000	Placebo	Participants received placebo subcutaneous injection once every month (QM) for 12 weeks.
OG001	Evolocumab	Participants received 420 mg evolocumab subcutaneous injection once every month (QM) for 12 weeks.

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in VLDL-C at the Mean of Weeks 10 and 12

Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab).

Posted

Least Squares Mean

Standard Error

percent change

Baseline and weeks 10 and 12

ID	Title	Description
OG000	Placebo	Participants received placebo subcutaneous injection once every month (QM) for 12 weeks.
OG001	Evolocumab	Participants received 420 mg evolocumab subcutaneous injection once every month (QM) for 12 weeks.

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in VLDL-C at Week 12

Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab).

Posted

Least Squares Mean

Standard Error

percent change

Baseline and week 12

ID	Title	Description
OG000	Placebo	Participants received placebo subcutaneous injection once every month (QM) for 12 weeks.
OG001	Evolocumab	Participants received 420 mg evolocumab subcutaneous injection once every month (QM) for 12 weeks.

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	Participants received placebo subcutaneous injection once every month (QM) for 12 weeks.	0	141	2	141	19	141
EG001	Evolocumab	Participants received 420 mg evolocumab subcutaneous injection once every month (QM) for 12 weeks.	1	280	14	280	37	280

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Atrial fibrillation	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected141 at risk EG0011 affected280 at risk
Coronary artery disease	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected141 at risk EG0012 affected280 at risk
Peptic ulcer	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected141 at risk EG0010 affected280 at risk
Sudden cardiac death	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected141 at risk EG0011 affected280 at risk
Cellulitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected141 at risk EG0011 affected280 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected141 at risk EG0011 affected280 at risk
Osteomyelitis chronic	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected141 at risk EG0010 affected280 at risk
Pneumonia	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected141 at risk EG0011 affected280 at risk
Pneumonia bacterial	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected141 at risk EG0011 affected280 at risk
Sepsis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected141 at risk EG0011 affected280 at risk
Fracture displacement	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected141 at risk EG0011 affected280 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected141 at risk EG0011 affected280 at risk
B-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected141 at risk EG0011 affected280 at risk
Haemorrhagic stroke	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected141 at risk EG0011 affected280 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected141 at risk EG0014 affected280 at risk
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected141 at risk EG0011 affected280 at risk
Hypertension	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected141 at risk EG0011 affected280 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diarrhoea	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0004 affected141 at risk EG0016 affected280 at risk
Pharyngitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0003 affected141 at risk EG0010 affected280 at risk
Urinary tract infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0002 affected141 at risk EG0016 affected280 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0004 affected141 at risk EG0015 affected280 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0005 affected141 at risk EG0018 affected280 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0003 affected141 at risk EG0012 affected280 at risk
Headache	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0003 affected141 at risk EG0016 affected280 at risk
Hypertension	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected141 at risk EG00111 affected280 at risk

ID	Term
D006937	Hypercholesterolemia
D003924	Diabetes Mellitus, Type 2
D003920	Diabetes Mellitus

ID	Term
D006949	Hyperlipidemias
D050171	Dyslipidemias
D052439	Lipid Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D044882	Glucose Metabolism Disorders
D004700	Endocrine System Diseases

ID	Title	Description
BG000	Placebo	Participants received placebo subcutaneous injection once every month (QM) for 12 weeks.
BG001	Evolocumab	Participants received 420 mg evolocumab subcutaneous injection once every month (QM) for 12 weeks.
BG002	Total	Total of all reporting groups