Addition Of Januvia (Sitagliptin) Improves Glycemic Contr... | NCT00545584

ID	Type	Description	Link
2007_023

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sitagliptin with Standard of Care	Experimental	Subjects received sitagliptin 100 mg once daily for 26 Weeks, and: No specific intervention (standard recommendation) on physical exercise and diet.	Drug: sitagliptin phosphate
Sitagliptin with Diet Advice	Experimental	Subjects received sitagliptin 100 mg once daily for 26 Weeks, and: Intervention on diet which includes advice on diet with a leaflet and a diary	Drug: sitagliptin phosphate Behavioral: Comparator: Diet
Sitagliptin with Diet and Physical Activity Advice	Experimental	Subjects received sitagliptin 100 mg once daily for 26 Weeks, and: Intervention on diet + physical activity which includes advice on diet and physical activity with leaflets and diaries PLUS advice on physical activity with the utilization of a pedometer: subjects were asked to walk 10,000 steps per day 5 or more days per week.	Drug: sitagliptin phosphate Behavioral: Comparator: Diet Behavioral: Comparator: Physical Activity

Interventions

Name	Type	Description	Arm Group Labels	Other Names
sitagliptin phosphate	Drug	sitagliptin 100 mg once daily. Duration of treatment: 26 Weeks	Sitagliptin with Diet Advice Sitagliptin with Diet and Physical Activity Advice

Measure	Description	Time Frame
Hemoglobin A1c Measurement	Hemoglobin A1c (HbA1c) is a measure of glycated hemoglobin in the blood. HbA1c greater than 6.5% was considered inadequately controlled.	Baseline and Week 24

Measure	Description	Time Frame
Fasting Plasma Glucose (FPG) Measurement	Generally FPG values of ~5.0-7.2 mmol/L would be considered goal (American Diabetes Association).	Baseline and Week 24

Eligibility Module

Name	Affiliation	Role
Medical Monitor	Merck Sharp & Dohme LLC	Study Director

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Sitagliptin With Standard of Care	Subjects received sitagliptin 100 mg once daily for 26 Weeks, and: No specific intervention (standard recommendation) on physical exercise and diet.
FG001	Sitagliptin With Diet Advice

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Sitagliptin With Standard of Care	Subjects received sitagliptin 100 mg once daily for 26 Weeks, and: No specific intervention (standard recommendation) on physical exercise and diet.
BG001	Sitagliptin With Diet Advice	Subjects received sitagliptin 100 mg once daily for 26 Weeks, and: Intervention on diet which includes advice on diet with a leaflet and a diary
BG002	Sitagliptin With Diet and Physical Activity Advice	Subjects received sitagliptin 100 mg once daily for 26 Weeks, and: Intervention on diet + physical activity which includes advice on diet and physical activity with leaflets and diaries PLUS advice on physical activity with the utilization of a pedometer: subjects were asked to walk 10,000 steps per day 5 or more days per week.
BG003	Total	Total of all reporting groups

Units	Counts
Participants	BG000362 BG001358 BG002265 BG003985

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

The Full Analysis Set (FAS) population included all selected patients with at least one measured HbA1c value after Visit 2 and having received at least one dose of sitagliptin.

Mean

Standard Deviation

years

Title

Denominators

Categories

Baseline (n=360, 358, and 265, respectively)

Title	Measurements
	OG0007.37± 0.61 OG0017.50± 0.66 OG0027.49± 0.60

Week 24 (n=362, 358, and 265, respectively)

Secondary

Fasting Plasma Glucose (FPG) Measurement

Generally FPG values of ~5.0-7.2 mmol/L would be considered goal (American Diabetes Association).

FAS population. Furthermore, only 350, 252, and 350 subjects had FPG evaluations in the Diet advice, Diet & physical activity advice, and Standard groups, respectively, at Baseline; and 303, 224, and 310 subjects had FPG evaluations in the Diet advice, Diet & physical activity advice, and Standard groups, respectively, at Week 24.

Posted

Mean

Standard Deviation

mmol/L glucose

Baseline and Week 24

ID	Title	Description
OG000	Sitagliptin With Standard of Care	Subjects received sitagliptin 100 mg once daily for 26 Weeks, and: No specific intervention (standard recommendation) on physical exercise and diet.
OG001	Sitagliptin With Diet Advice	Subjects received sitagliptin 100 mg once daily for 26 Weeks, and: Intervention on diet which includes advice on diet with a leaflet and a diary
OG002	Sitagliptin With Diet and Physical Activity Advice	Subjects received sitagliptin 100 mg once daily for 26 Weeks, and: Intervention on diet + physical activity which includes advice on diet and physical activity with leaflets and diaries PLUS advice on physical activity with the utilization of a pedometer: subjects were asked to walk 10,000 steps per day 5 or more days per week.

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (At Risk)
EG000	Sitagliptin With Standard of Care	Subjects received sitagliptin 100 mg once daily for 26 Weeks, and: No specific intervention (standard recommendation) on physical exercise and diet.	8	412	412
EG001	Sitagliptin With Diet Advice	Subjects received sitagliptin 100 mg once daily for 26 Weeks, and: Intervention on diet which includes advice on diet with a leaflet and a diary	18	414	414
EG002	Sitagliptin With Diet and Physical Activity Advice	Subjects received sitagliptin 100 mg once daily for 26 Weeks, and: Intervention on diet + physical activity which includes advice on diet and physical activity with leaflets and diaries PLUS advice on physical activity with the utilization of a pedometer: subjects were asked to walk 10,000 steps per day 5 or more days per week.	7	305	305

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
IDIOPATHIC THROMBOCYTOPENIC PURPURA	Blood and lymphatic system disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected412 at risk EG0010 events0 affected414 at risk EG0020 events0 affected305 at risk
ACUTE CORONARY SYNDROME	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected412 at risk EG0011 events1 affected414 at risk EG0020 events0 affected305 at risk
ADAMS-STOKES SYNDROME	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected412 at risk EG0010 events0 affected414 at risk EG0020 events0 affected305 at risk
ANGINA UNSTABLE	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected412 at risk EG0011 events1 affected414 at risk EG0020 events0 affected305 at risk
MYOCARDIAL INFARCTION	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected412 at risk EG0011 events1 affected414 at risk EG0020 events0 affected305 at risk
MACULAR OPACITY	Eye disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected412 at risk EG0011 events1 affected414 at risk EG0020 events0 affected305 at risk
INGUINAL HERNIA	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected412 at risk EG0010 events0 affected414 at risk EG0020 events0 affected305 at risk
CARDIAC DEATH	General disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected412 at risk EG0011 events1 affected414 at risk EG0020 events0 affected305 at risk
SUDDEN DEATH	General disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected412 at risk EG0010 events0 affected414 at risk EG0020 events0 affected305 at risk
CHOLECYSTITIS	Hepatobiliary disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected412 at risk EG0011 events1 affected414 at risk EG0020 events0 affected305 at risk
ABDOMINAL WALL ABSCESS	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected412 at risk EG0011 events1 affected414 at risk EG0020 events0 affected305 at risk
EAR INFECTION	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected412 at risk EG0011 events1 affected414 at risk EG0020 events0 affected305 at risk
LARYNGITIS	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected412 at risk EG0010 events0 affected414 at risk EG0020 events0 affected305 at risk
PNEUMONIA	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected412 at risk EG0011 events1 affected414 at risk EG0020 events0 affected305 at risk
DRUG EXPOSURE DURING PREGNANCY	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected412 at risk EG0011 events1 affected414 at risk EG0020 events0 affected305 at risk
FRACTURE	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected412 at risk EG0010 events0 affected414 at risk EG0021 events1 affected305 at risk
LIMB TRAUMATIC AMPUTATION	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected412 at risk EG0011 events1 affected414 at risk EG0020 events0 affected305 at risk
LUMBAR VERTEBRAL FRACTURE	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected412 at risk EG0011 events1 affected414 at risk EG0020 events0 affected305 at risk
TENDON RUPTURE	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected412 at risk EG0011 events1 affected414 at risk EG0020 events0 affected305 at risk
DIABETES MELLITUS	Metabolism and nutrition disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected412 at risk EG0010 events0 affected414 at risk EG0020 events0 affected305 at risk
OSTEOARTHRITIS	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected412 at risk EG0010 events0 affected414 at risk EG0021 events1 affected305 at risk
BREAST CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected412 at risk EG0011 events1 affected414 at risk EG0020 events0 affected305 at risk
FIBROMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected412 at risk EG0011 events1 affected414 at risk EG0020 events0 affected305 at risk
LUNG NEOPLASM MALIGNANT	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected412 at risk EG0010 events0 affected414 at risk EG0021 events1 affected305 at risk
PROSTATE CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected412 at risk EG0010 events0 affected414 at risk EG0022 events2 affected305 at risk
CERVICAL ROOT PAIN	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected412 at risk EG0010 events0 affected414 at risk EG0021 events1 affected305 at risk
ENCEPHALITIS	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected412 at risk EG0011 events1 affected414 at risk EG0020 events0 affected305 at risk
SCIATICA	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected412 at risk EG0010 events0 affected414 at risk EG0021 events1 affected305 at risk
SYNCOPE	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected412 at risk EG0011 events1 affected414 at risk EG0020 events0 affected305 at risk
DEPRESSION	Psychiatric disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected412 at risk EG0011 events1 affected414 at risk EG0020 events0 affected305 at risk
SUICIDE ATTEMPT	Psychiatric disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected412 at risk EG0010 events0 affected414 at risk EG0020 events0 affected305 at risk
RENAL NECROSIS	Renal and urinary disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected412 at risk EG0011 events1 affected414 at risk EG0020 events0 affected305 at risk
GENITAL PROLAPSE	Reproductive system and breast disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected412 at risk EG0011 events1 affected414 at risk EG0020 events0 affected305 at risk
PULMONARY EMBOLISM	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected412 at risk EG0010 events0 affected414 at risk EG0020 events0 affected305 at risk
RASH	Skin and subcutaneous tissue disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected412 at risk EG0011 events1 affected414 at risk EG0020 events0 affected305 at risk

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

ID	Term
D014230	Triazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D011719	Pyrazines