Safety and Efficacy of SPIL1033 in Subjects With Type 2 D... | NCT01406717

Safety and Efficacy of SPIL1033 in Subjects With Type 2 D... | NCT01406717 | Trialant

Arms/Interventions Module

Label	Type	Description	Intervention Names
SPIL1033	Experimental		Drug: SPIL1033
Placebo	Placebo Comparator		Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SPIL1033	Drug	5 mcg twice daily for the first 4 weeks and 10 mcg twice daily for the remaining 20 weeks. To be self-administered twice daily.	SPIL1033

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change From Baseline to End of Study in Hemoglobin A1c (HbA1c)		24 weeks
Change From Baseline to End of Study in Fasting Plasma Glucose (FPG)		24 weeks
Count and Percentage of Subjects Positive for Anti-exenatide Antibodies		24 weeks
Count and Percentage of Subjects With Potentially Immune-related Treatment-emergent Adverse Events (TEAEs)		24 weeks

Secondary Outcomes

Measure	Description	Time Frame
Change From Baseline in 2hour Postprandial Glucose (2-h PPG)		24 weeks
Change From Baseline in Triglycerides		24 weeks
Change From Baseline in Low Density Lipoproteins

Facility	Status	City	State	ZIP	Country	Contacts
SPIL Site 22		Hyderabad	Andhra Pradesh		India
SPIL Site 25

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	SPIL1033	SPIL1033: 5 mcg twice daily for the first 4 weeks and 10 mcg twice daily for the remaining 20 weeks. To be self-administered twice daily.
FG001	Placebo	Placebo: 5 mcg twice daily for the first 4 weeks and 10 mcg twice daily for the remaining 20 weeks. To be self-administered twice daily.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Comment	Reasons
Subject non-compliance		FG0004 subjects FG0013 subjects
Protocol Violation		FG0005 subjects FG0011 subjects
Lost to Follow-up		FG00014 subjects FG0018 subjects
Withdrawal by Subject		FG00019 subjects FG00115 subjects
Adverse Event		FG0001 subjects FG0012 subjects
Lack of Efficacy		FG0000 subjects FG0011 subjects
Non-completion of visit activity		FG0000 subjects FG0011 subjects

Arm/Group Information

ID	Title	Description
BG000	SPIL1033	SPIL1033: 5 mcg twice daily for the first 4 weeks and 10 mcg twice daily for the remaining 20 weeks. To be self-administered twice daily. 168 are the number of subjects in mITT population
BG001	Placebo	Placebo: 5 mcg twice daily for the first 4 weeks and 10 mcg twice daily for the remaining 20 weeks. To be self-administered twice daily. 170 are the number of subjects in mTT population.
BG002	Total	Total of all reporting groups

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
	BG00052.9± 9.26 BG00151.9± 9.56 BG00252.4± 9.41

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00083 BG00186 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Change From Baseline to End of Study in Hemoglobin A1c (HbA1c)

Intent-to-treat

Posted

Least Squares Mean

Standard Error

percentage of hemoglobin A1c (HbA1c)

24 weeks

ID	Title	Description
OG000	SPIL1033	SPIL1033: 5 mcg twice daily for the first 4 weeks and 10 mcg twice daily for the remaining 20 weeks. To be self-administered twice daily. The number of subjects in evaluable population for efficacy (EPE) population are 112.
OG001	Placebo	Placebo: 5 mcg twice daily for the first 4 weeks and 10 mcg twice daily for the remaining 20 weeks. To be self-administered twice daily. The number of subjects in evaluable population for efficacy (EPE) population are 94.

Units	Counts
Participants	OG000112 OG00194

Title

Denominators

Categories

Title	Measurements
	OG000-0.227± 0.243 OG001-0.227± 0.254

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						ANCOVA	0.0002			2-Sided	95	-0.31377	0.31418					Other

Primary

Change From Baseline to End of Study in Fasting Plasma Glucose (FPG)

Posted

Least Squares Mean

Standard Error

mg/dL

24 weeks

ID	Title	Description
OG000	SPIL1033	SPIL1033, Placebo: 5 mcg twice daily for the first 4 weeks and 10 mcg twice daily for the remaining 20 weeks. To be self-administered twice daily. he number of subjects in the population for the analysis of FPG are 110.
OG001	Placebo	SPIL1033, Placebo: 5 mcg twice daily for the first 4 weeks and 10 mcg twice daily for the remaining 20 weeks. To be self-administered twice daily. he number of subjects in the population for the analysis of FPG are 94.

Units	Counts
Participants	OG000

Primary

Count and Percentage of Subjects Positive for Anti-exenatide Antibodies

modified intent to treat population

Posted

Count of Participants

Participants

24 weeks

ID	Title	Description
OG000	SPIL1033	SPIL1033: 5 mcg twice daily for the first 4 weeks and 10 mcg twice daily for the remaining 20 weeks. To be self-administered twice daily. The number of subjects in the evaluated anti-exenatide antibodies are 133.
OG001	Placebo	Placebo: 5 mcg twice daily for the first 4 weeks and 10 mcg twice daily for the remaining 20 weeks. To be self-administered twice daily. The number of subjects in evaluated anti-exenatide antibodies population are 143.

Units	Counts
Participants	OG000

Primary

Count and Percentage of Subjects With Potentially Immune-related Treatment-emergent Adverse Events (TEAEs)

Evaluable population for safety: subjects who were randomized and received at least one dose of a trial medication

Posted

Count of Participants

Participants

24 weeks

ID	Title	Description
OG000	SPIL1033	SPIL1033: 5 mcg twice daily for the first 4 weeks and 10 mcg twice daily for the remaining 20 weeks. To be self-administered twice daily. The number of subjects in the safety population are 179.
OG001	Placebo	Placebo: 5 mcg twice daily for the first 4 weeks and 10 mcg twice daily for the remaining 20 weeks. To be self-administered twice daily. The number of subjects in the safety population are 178.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in 2hour Postprandial Glucose (2-h PPG)

The evaluable population: all mITT subjects who received at least 80% of study medication over 24 weeks and completed treatment through week 24. (modified Intent-to-treat population: .subjects who were randomized and received at least one dose of the trial medication after visit 2 (baseline) and had at least one post-baseline visit.

Posted

Mean

Standard Deviation

mg/dl

24 weeks

ID	Title	Description
OG000	SPIL1033	SPIL1033: 5 mcg twice daily for the first 4 weeks and 10 mcg twice daily for the remaining 20 weeks. To be self-administered twice daily.
OG001	Placebo	Placebo: 5 mcg twice daily for the first 4 weeks and 10 mcg twice daily for the remaining 20 weeks. To be self-administered twice daily.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Triglycerides

Posted

Least Squares Mean

Standard Error

mg/dl

24 weeks

ID	Title	Description
OG000	SPIL1033	SPIL1033: 5 mcg twice daily for the first 4 weeks and 10 mcg twice daily for the remaining 20 weeks. To be self-administered twice daily.
OG001	Placebo	Placebo: 5 mcg twice daily for the first 4 weeks and 10 mcg twice daily for the remaining 20 weeks. To be self-administered twice daily.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Low Density Lipoproteins

Posted

Least Squares Mean

Standard Error

mg/dL

24 weeks

ID	Title	Description
OG000	SPIL1033	SPIL1033: 5 mcg twice daily for the first 4 weeks and 10 mcg twice daily for the remaining 20 weeks. To be self-administered twice daily.
OG001	Placebo	Placebo: 5 mcg twice daily for the first 4 weeks and 10 mcg twice daily for the remaining 20 weeks. To be self-administered twice daily.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in High Density Lipoproteins

Posted

Least Squares Mean

Standard Error

mg/dL

24 weeks

ID	Title	Description
OG000	SPIL1033	SPIL1033: 5 mcg twice daily for the first 4 weeks and 10 mcg twice daily for the remaining 20 weeks. To be self-administered twice daily.
OG001	Placebo	Placebo: 5 mcg twice daily for the first 4 weeks and 10 mcg twice daily for the remaining 20 weeks. To be self-administered twice daily.

Units	Counts
Participants	OG000

Secondary

Change in Body Weight

Posted

Least Squares Mean

Standard Error

kilograms

24 weeks

ID	Title	Description
OG000	SPIL1033	SPIL1033: 5 mcg twice daily for the first 4 weeks and 10 mcg twice daily for the remaining 20 weeks. To be self-administered twice daily.
OG001	Placebo	Placebo: 5 mcg twice daily for the first 4 weeks and 10 mcg twice daily for the remaining 20 weeks. To be self-administered twice daily.

Units	Counts
Participants	OG000

Secondary

Subjects Achieving Hemoglobin A1c (HbA1c) < 7%

Evaluable Population for Efficacy

Posted

Count of Participants

Participants

24 weeks

ID	Title	Description
OG000	SPIL1033	SPIL1033: 5 mcg twice daily for the first 4 weeks and 10 mcg twice daily for the remaining 20 weeks. To be self-administered twice daily. The number of subjects in the population for the analysis of HbA1c are 112.
OG001	Placebo	Placebo: 5 mcg twice daily for the first 4 weeks and 10 mcg twice daily for the remaining 20 weeks. To be self-administered twice daily. he number of subjects in the population for the analysis of HbA1c are 94.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Very Low Density Lipoproteins

Posted

Least Squares Mean

Standard Error

mg/dL

24 weeks

ID	Title	Description
OG000	SPIL1033	SPIL1033: 5 mcg twice daily for the first 4 weeks and 10 mcg twice daily for the remaining 20 weeks. To be self-administered twice daily.
OG001	Placebo	Placebo: 5 mcg twice daily for the first 4 weeks and 10 mcg twice daily for the remaining 20 weeks. To be self-administered twice daily.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Total Cholesterol

Posted

Least Squares Mean

Standard Error

mg/dL

24 weeks

ID	Title	Description
OG000	SPIL1033	SPIL1033: 5 mcg twice daily for the first 4 weeks and 10 mcg twice daily for the remaining 20 weeks. To be self-administered twice daily.
OG001	Placebo	Placebo: 5 mcg twice daily for the first 4 weeks and 10 mcg twice daily for the remaining 20 weeks. To be self-administered twice daily.

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	SPIL1033	SPIL1033: 5 mcg twice daily for the first 4 weeks and 10 mcg twice daily for the remaining 20 weeks. To be self-administered twice daily.	0	180	6	180	126	180
EG001	Placebo	Placebo: 5 mcg twice daily for the first 4 weeks and 10 mcg twice daily for the remaining 20 weeks. To be self-administered twice daily.	0	180	1	180	115	180

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Abscess limb	Infections and infestations	Systematic Assessment	EG0001 affected180 at risk EG0010 affected180 at risk
Gastroenteritis	Infections and infestations	Systematic Assessment	EG0001 affected180 at risk EG0010 affected180 at risk
Infected dermal cyst	Infections and infestations	Systematic Assessment	EG0001 affected180 at risk EG0010 affected180 at risk
Viral infection	Infections and infestations	Systematic Assessment	EG0001 affected180 at risk EG0010 affected180 at risk
joint injury	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 affected180 at risk EG0010 affected180 at risk
Rib fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 affected180 at risk EG0010 affected180 at risk
Road traffic accident	Infections and infestations	Systematic Assessment	EG0001 affected180 at risk EG0010 affected180 at risk
Upper limb fracture	Infections and infestations	Systematic Assessment	EG0001 affected180 at risk EG0010 affected180 at risk
Hemiparesis	Nervous system disorders	Systematic Assessment	EG0000 affected180 at risk EG0011 affected180 at risk
Lumbar radiculopathy	Nervous system disorders	Systematic Assessment	EG0001 affected180 at risk EG0010 affected180 at risk
Vertigo	Ear and labyrinth disorders	Systematic Assessment	EG0001 affected180 at risk EG0010 affected180 at risk
Gastroenteritis	Gastrointestinal disorders	Systematic Assessment	EG0001 affected180 at risk EG0010 affected180 at risk
Hyperglycaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0001 affected180 at risk EG0010 affected180 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 affected180 at risk EG0010 affected180 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 affected180 at risk EG0010 affected180 at risk

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Hyperglycemia	Metabolism and nutrition disorders	Systematic Assessment	EG00052 affected180 at risk EG00159 affected180 at risk
Hypoglycaemia	Metabolism and nutrition disorders	Systematic Assessment	EG00017 affected180 at risk EG00111 affected180 at risk
Dyslipidaemia	Metabolism and nutrition disorders	Systematic Assessment	EG00019 affected180 at risk EG00113 affected180 at risk
Decreased appetite	Metabolism and nutrition disorders	Systematic Assessment	EG00011 affected180 at risk EG0012 affected180 at risk
Nausea	Gastrointestinal disorders	Systematic Assessment	EG00026 affected180 at risk EG0019 affected180 at risk
Diarrhoea	Gastrointestinal disorders	Systematic Assessment	EG0005 affected180 at risk EG0019 affected180 at risk
Vomiting	Gastrointestinal disorders	Systematic Assessment	EG00010 affected180 at risk EG0013 affected180 at risk
Headache	Nervous system disorders	Systematic Assessment	EG00013 affected180 at risk EG0018 affected180 at risk
Dizziness	Nervous system disorders	Systematic Assessment	EG0008 affected180 at risk EG0016 affected180 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0005 affected180 at risk EG0013 affected180 at risk
Back Pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0003 affected180 at risk EG0014 affected180 at risk

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						ANCOVA	5.898			2-Sided	95	-6.7565	18.5535					Other

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		Mantel Haenszel		<0.0001														Other

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		ANCOVA		0.6318														Other

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		ANOVA		0.4887														Other

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		ANOVA		0.3813														Other

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		ANOVA		0.9900														Other

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		ANOVA		0.0017														Other

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		Mantel Haenszel		0.6098														Other

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		ANOVA		0.7324														Other

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		ANOVA		0.2984														Other

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases