An Efficacy, Safety, and Tolerability Study of Canagliflo... | NCT00642278

ID	Type	Description	Link
28431754DIA2001	Other Identifier	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

An Efficacy, Safety, and Tolerability Study of Canagliflo... | NCT00642278 | Trialant

Description Module

Detailed Description

Type 2 diabetes mellitus is a metabolic disorder that is characterized by decreased secretion of insulin by the pancreas and resistance to the action of insulin in various tissues (muscle, liver, and adipose), which results in impaired glucose uptake. Chronic hyperglycemia leads to progressive impairment of insulin secretion and to insulin resistance of peripheral tissues in diabetes (so-called glucose toxicity), which further worsens control of blood glucose. In addition, chronic hyperglycemia is a major risk factor for complications, including heart disease, retinopathy, nephropathy, and neuropathy. Although numerous treatments have been developed for the treatment of diabetes and individual agents may be highly effective for some patients, it is still difficult to maintain optimal glycemic control in most patients with diabetes. This is a randomized, double-blind, placebo-controlled, parallel group, multicenter, dose-ranging study to determine the efficacy, safety and tolerability of JNJ-28431754 taken orally over 12 weeks, compared with placebo, in the treatment of Type 2 diabetes mellitus. The primary clinical hypothesis is that JNJ-28431754 is superior to placebo as measured by the change in hemoglobin A1c from baseline through Week 12 in the treatment of type 2 diabetes mellitus. Subject safety will be monitored throughout the study using spontaneous adverse event reporting, clinical laboratory tests (hematology, serum chemistry, urinalysis); severe and serious hypoglycemic episodes, assessment of urinary albumin excretion and markers of proximal renal tubular function; pregnancy tests; electrocardiograms (ECGs); vital sign measurements; physical examinations, assessment of calcium and phosphate homeostasis, bone formation and resorption markers, and hormones regulating calcium and phosphorus homeostasis; and vaginal and urine sample collection for fungal and bacterial culture in subjects with symptoms consistent with vulvovaginal candidiasis (VVC) or urinary tract infection (UTI).

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Canagliflozin 50 mg daily	Experimental	Each patient will receive 50 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).	Drug: Canagliflozin (JNJ-28431754) Drug: Placebo
Canagliflozin 100 mg daily	Experimental	Each patient will receive 100 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).	Drug: Canagliflozin (JNJ-28431754) Drug: Placebo
Canagliflozin 200 mg daily	Experimental	Each patient will receive 200 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).	Drug: Canagliflozin (JNJ-28431754) Drug: Placebo
Canagliflozin 300 mg daily	Experimental	Each patient will receive 300 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo capsule once daily (in the evening).	Drug: Canagliflozin (JNJ-28431754) Drug: Placebo
Canagliflozin 300 mg twice daily	Experimental

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Canagliflozin (JNJ-28431754)	Drug	One 50 mg, 100 mg, 200 mg, or 300 mg over-encapsulated tablet orally (by mouth) once daily for 12 weeks or one 300 mg over-encapsulated tablet orally twice daily for 12 weeks.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in HbA1c From Baseline to Week 12	The table below shows the mean change in HbA1c from Baseline to Week 12 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin or sitagliptin group minus placebo) in the least-squares mean change.	Day 1 (Baseline) and Week 12

Secondary Outcomes

Measure	Description	Time Frame
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 12	The table below shows the mean change in FPG from Baseline to Week 12 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin or sitagliptin group minus placebo) in the least-squares mean change.	Day 1 (Baseline) and Week 12

Contacts/Locations Module

Name	Affiliation	Role
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22632452	Derived	Nyirjesy P, Zhao Y, Ways K, Usiskin K. Evaluation of vulvovaginal symptoms and Candida colonization in women with type 2 diabetes mellitus treated with canagliflozin, a sodium glucose co-transporter 2 inhibitor. Curr Med Res Opin. 2012 Jul;28(7):1173-8. doi: 10.1185/03007995.2012.697053. Epub 2012 Jun 14.
22548646	Derived

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Placebo	Each patient received matching placebo twice daily for 12 weeks.
FG001	Canagliflozin 50 mg Daily	Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Comment	Reasons
Adverse Event		FG0002 subjects FG0011 subjects FG0023 subjects FG0031 subjects FG0042 subjects FG0052 subjects FG0060 subjects
Lack of Efficacy		FG0000 subjects FG0011 subjects FG0020 subjects FG0030 subjects FG004
Lost to Follow-up		FG0005 subjects FG0011 subjects FG0020 subjects FG0031 subjects FG004
Physician Decision		FG0000 subjects FG0010 subjects FG0020 subjects FG0031 subjects FG004
Protocol Violation		FG0000 subjects FG0010 subjects FG0021 subjects FG0031 subjects FG004
Withdrawal by Subject		FG0001 subjects FG0011 subjects FG0021 subjects FG0033 subjects FG004
Noncompliance with study drug regimen		FG0000 subjects FG0010 subjects FG0020 subjects FG0031 subjects FG004
Other		FG0002 subjects FG0011 subjects FG0020 subjects FG0031 subjects FG004

Arm/Group Information

ID	Title	Description
BG000	Placebo	Each patient received matching placebo twice daily for 12 weeks.
BG001	Canagliflozin 50 mg Daily	Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
BG002	Canagliflozin 100 mg Daily	Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
BG003	Canagliflozin 200 mg Daily	Each patient received 200 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
BG004	Canagliflozin 300 mg Daily	Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
BG005	Canagliflozin 300 mg Twice Daily	Each patient received 300 mg of canagliflozin (JNJ-28431754) twice daily for 12 weeks.
BG006	Sitagliptin 100 mg Daily	Each patient received 100 mg of sitagliptin once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
BG007	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, Categorical

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
<=18 years	BG0000 BG0010 BG0020 BG003

Age Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00053.3± 7.82 BG00153.3± 8.48 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00034 BG00130 BG002

Region Enroll

Number

participants

Title

Denominators

Categories

ARGENTINA

Title	Measurements
	BG0001 BG0011 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 in HbA1c From Baseline to Week 12

The table below shows the mean change in HbA1c from Baseline to Week 12 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin or sitagliptin group minus placebo) in the least-squares mean change.

This analysis was conducted using the intent-to-treat analysis set, which included all patients who were randomly assigned to a treatment group. The last-observation-carried-forward method was applied when Week 12 values were missing. The table includes only patients with both baseline and post baseline values.

Posted

Mean

Standard Deviation

Percent

Day 1 (Baseline) and Week 12

ID	Title	Description
OG000	Placebo	Each patient received matching placebo twice daily for 12 weeks.
OG001	Canagliflozin 50 mg Daily	Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
OG002	Canagliflozin 100 mg Daily	Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
OG003	Canagliflozin 200 mg Daily	Each patient received 200 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
OG004	Canagliflozin 300 mg Daily	Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
OG005	Canagliflozin 300 mg Twice Daily	Each patient received 300 mg of canagliflozin (JNJ-28431754) twice daily for 12 weeks.
OG006	Sitagliptin 100 mg Daily	Each patient received 100 mg of sitagliptin once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).

Units	Counts
Participants	OG00061 OG00162 OG00262 OG003

Title

Denominators

Categories

Title	Measurements
	OG000-0.22± 0.702 OG001-0.79± 0.749 OG002-0.76± 0.992 OG003

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	ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).	<0.001	Adjusted using Dunnett's procedure.	Least-Squares Mean Difference	-0.45	Standard Error of the Mean	0.116	2-Sided	95	-0.747	-0.148				No	Superiority or Other

Secondary

Change in Fasting Plasma Glucose (FPG) From Baseline to Week 12

The table below shows the mean change in FPG from Baseline to Week 12 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin or sitagliptin group minus placebo) in the least-squares mean change.

Posted

Mean

Standard Deviation

mmol/L

Day 1 (Baseline) and Week 12

ID	Title	Description
OG000	Placebo	Each patient received matching placebo twice daily for 12 weeks.
OG001	Canagliflozin 50 mg Daily	Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
OG002	Canagliflozin 100 mg Daily	Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).

Secondary

Percentage of Patients With Symptoms of Hypoglycemia

The table below shows the percentage of patients who experienced symptomatic hypoglycemic events between Baseline and Week 12.

This analysis was conducted using the intent-to-treat analysis set, which included all patients who were randomiy assigned to a treatment group.

Posted

Number

Percentage of patients

Up to Week 12

ID	Title	Description
OG000	Placebo	Each patient received matching placebo twice daily for 12 weeks.
OG001	Canagliflozin 50 mg Daily	Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
OG002	Canagliflozin 100 mg Daily	Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
OG003	Canagliflozin 200 mg Daily	Each patient received 200 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).

Secondary

Change in Overnight Urine Glucose/Creatinine Ratio From Baseline to Week 12

The table below shows the mean change in overnight urine glucose/creatinine ratio from Baseline to Week 12 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin or sitagliptin group minus placebo) in the least-squares mean change.

Posted

Mean

Standard Deviation

mg/mg

Day 1 (Baseline) and Week 12

ID	Title	Description
OG000	Placebo	Each patient received matching placebo twice daily for 12 weeks.
OG001	Canagliflozin 50 mg Daily	Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
OG002	Canagliflozin 100 mg Daily	Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).

Secondary

Absolute Change in Body Weight From Baseline to Week 12

The table below shows the mean absolute change in body weight from Baseline to Week 12 for each treatment group.

Posted

Mean

Standard Deviation

Day 1 (Baseline) and Week 12

ID	Title	Description
OG000	Placebo	Each patient received matching placebo twice daily for 12 weeks.
OG001	Canagliflozin 50 mg Daily	Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
OG002	Canagliflozin 100 mg Daily	Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
OG003	Canagliflozin 200 mg Daily

Secondary

Percent Change in Body Weight From Baseline to Week 12

The table below shows the mean percent change in body weight from Baseline to Week 12 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin or sitagliptin group minus placebo) in the least-squares mean change.

Posted

Mean

Standard Deviation

Percent change

Day 1 (Baseline) and Week 12

ID	Title	Description
OG000	Placebo	Each patient received matching placebo twice daily for 12 weeks.
OG001	Canagliflozin 50 mg Daily	Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
OG002	Canagliflozin 100 mg Daily	Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	Each patient received matching placebo twice daily for 12 weeks.	1	65	9	65
EG001	Canagliflozin 50 mg Daily	Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).	1	64	13	64
EG002	Canagliflozin 100 mg Daily	Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).	1	64	10	64
EG003	Canagliflozin 200 mg Daily	Each patient received 200 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).	1	65	10	65
EG004	Canagliflozin 300 mg Daily	Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).	1	64	10	64
EG005	Canagliflozin 300 mg Twice Daily	Each patient received 300 mg of canagliflozin (JNJ-28431754) twice daily for 12 weeks.	1	64	12	64
EG006	Sitagliptin 100 mg Daily	Each patient received 100 mg of sitagliptin once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).	0	65	7	65

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Atrial fibrillation	Cardiac disorders	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected65 at risk EG0010 affected64 at risk EG0020 affected64 at risk EG0030 affected65 at risk EG0041 affected64 at risk EG0050 affected64 at risk EG0060 affected65 at risk
Cardiac failure congestive	Cardiac disorders	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected65 at risk EG0010 affected64 at risk EG0020 affected64 at risk EG003
Gastroenteritis	Infections and infestations	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected65 at risk EG0010 affected64 at risk EG0020 affected64 at risk EG003
Otitis externa	Infections and infestations	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected65 at risk EG0011 affected64 at risk EG0020 affected64 at risk EG003
Pneumonia	Infections and infestations	MEDDRA 11.1	Non-systematic Assessment	EG0001 affected65 at risk EG0010 affected64 at risk EG0020 affected64 at risk EG003
Blood creatine phosphokinase increased	Investigations	MEDDRA 11.1	Non-systematic Assessment	EG0001 affected65 at risk EG0010 affected64 at risk EG0020 affected64 at risk EG003
Gestational diabetes	Metabolism and nutrition disorders	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected65 at risk EG0010 affected64 at risk EG0020 affected64 at risk EG003
Spondylolisthesis	Musculoskeletal and connective tissue disorders	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected65 at risk EG0010 affected64 at risk EG0021 affected64 at risk EG003
Hypoxia	Respiratory, thoracic and mediastinal disorders	MEDDRA 11.1	Non-systematic Assessment	EG0001 affected65 at risk EG0010 affected64 at risk EG0020 affected64 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal pain upper	Gastrointestinal disorders	MEDDRA 11.1	Non-systematic Assessment	EG0001 affected65 at risk EG0010 affected64 at risk EG0020 affected64 at risk EG0030 affected65 at risk EG0042 affected64 at risk EG0054 affected64 at risk EG0060 affected65 at risk
Nausea	Gastrointestinal disorders	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected65 at risk EG0013 affected64 at risk EG0021 affected64 at risk EG003
Nasopharyngitis	Infections and infestations	MEDDRA 11.1	Non-systematic Assessment	EG0002 affected65 at risk EG0015 affected64 at risk EG0020 affected64 at risk EG003
Urinary tract infection	Infections and infestations	MEDDRA 11.1	Non-systematic Assessment	EG0004 affected65 at risk EG0013 affected64 at risk EG0022 affected64 at risk EG003
Vulvovaginal mycotic infection	Infections and infestations	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected65 at risk EG0014 affected64 at risk EG0022 affected64 at risk EG003
Headache	Nervous system disorders	MEDDRA 11.1	Non-systematic Assessment	EG0002 affected65 at risk EG0011 affected64 at risk EG0025 affected64 at risk EG003

Ancestor Terms

ID	Term
D013876	Thiophenes
D013457	Sulfur Compounds
D009930	Organic Chemicals
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D005960	Glucosides
D006027	Glycosides
D002241	Carbohydrates
D014230	Triazoles
D001393	Azoles
D011719	Pyrazines

Group IDs	Statistical Method	Statistical Comment	P-Value	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Tested Non-Inferiority	Non-Inferiority Type
OG000 OG001	ANCOVA	ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).	0.001	Least-Squares Mean Difference	-0.9	Standard Error of the Mean	0.27	2-Sided	95	-1.39	-0.34	No	Superiority or Other
OG000 OG002	ANCOVA	ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).	<0.001	Least-Squares Mean Difference	-1.4	Standard Error of the Mean	0.27	2-Sided	95	-1.98	-0.92	No	Superiority or Other
OG000 OG003	ANCOVA	ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).	<0.001	Least-Squares Mean Difference	-1.8	Standard Error of the Mean	0.27	2-Sided	95	-2.33	-1.27	No	Superiority or Other
OG000 OG004	ANCOVA	ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).	<0.001	Least-Squares Mean Difference	-1.8	Standard Error of the Mean	0.27	2-Sided	95	-2.32	-1.26	No	Superiority or Other
OG000 OG005	ANCOVA	ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).	<0.001	Least-Squares Mean Difference	-1.7	Standard Error of the Mean	0.27	2-Sided	95	-2.25	-1.19	No	Superiority or Other
OG000 OG006	ANCOVA	ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).	<0.001	Least-Squares Mean Difference	-1.0	Standard Error of the Mean	0.27	2-Sided	95	-1.51	-0.46	No	Superiority or Other

Group IDs	Statistical Method	Statistical Comment	P-Value	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Tested Non-Inferiority	Non-Inferiority Type
OG000 OG001	ANCOVA	ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).	<0.001	Least-Sqaures Mean Difference	36.1	Standard Error of the Mean	5.10	2-Sided	95	26.07	46.13	No	Superiority or Other
OG000 OG002	ANCOVA	ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).	<0.001	Least-Sqaures Mean Difference	49.3	Standard Error of the Mean	5.13	2-Sided	95	39.17	59.34	No	Superiority or Other
OG000 OG003	ANCOVA	ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).	<0.001	Least-Sqaures Mean Difference	48.2	Standard Error of the Mean	5.2	2-Sided	95	37.98	58.42	No	Superiority or Other
OG000 OG004	ANCOVA	ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).	<0.001	Least-Squares Mean Difference	49.0	Standard Error of the Mean	5.11	2-Sided	95	38.91	59.01	No	Superiority or Other
OG000 OG005	ANCOVA	ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).	<0.001	Least-Sqaures Mean Difference	60.3	Standard Error of the Mean	5.13	2-Sided	95	50.17	70.35	No	Superiority or Other
OG000 OG006	ANCOVA	ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).	0.513	Least-Squares Mean Difference	-3.3	Standard Error of the Mean	5.09	2-Sided	95	-13.33	6.67	No	Superiority or Other

Group IDs	Statistical Method	Statistical Comment	P-Value	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Tested Non-Inferiority	Non-Inferiority Type
OG000 OG001	ANCOVA	ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).	0.009	Least-Sqaures Mean Difference	-1.3	Standard Error of the Mean	0.5	2-Sided	95	-2.2	-0.3	No	Superiority or Other
OG000 OG002	ANCOVA	ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).	0.002	Least-Sqaures Mean Difference	-1.5	Standard Error of the Mean	0.5	2-Sided	95	-2.5	-0.6	No	Superiority or Other
OG000 OG003	ANCOVA	ANCOVA model included terms for treatment, baseline value, and mixed meal tolerance test.	<0.001	Least-Sqaures Mean Difference	-1.6	Standard Error of the Mean	0.5	2-Sided	95	-2.6	-0.7	No	Superiority or Other
OG000 OG004	ANCOVA	ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).	<0.001	Least-Sqaures Mean Difference	-2.3	Standard Error of the Mean	0.5	2-Sided	95	-3.3	-1.4	No	Superiority or Other
OG000 OG005	ANCOVA	ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).	<0.001	Least-Sqaures Mean Difference	-2.3	Standard Error of the Mean	0.5	2-Sided	95	-3.3	-1.4	No	Superiority or Other
OG000 OG006	ANCOVA	ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).	0.371	Least-Sqaures Mean Difference	0.4	Standard Error of the Mean	0.5	2-Sided	95	-0.5	1.4	No	Superiority or Other

Facility	Status	City	State	ZIP	Country	Contacts
		Birmingham	Alabama		United States

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