Clinical Characteristics, Anti-hyperglycaemic Treatment P... | NCT03064841

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

Label	Type	Description	Intervention Names
Outpatient with confirmed T2DM		subjects with confirmed T2DM	Drug: No Treatment

Name	Type	Description	Arm Group Labels	Other Names
No Treatment	Drug	No treatment	Outpatient with confirmed T2DM

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Patients Attained Blood Glucose Control Target Defined as Glycated Haemoglobin A1c (HbA1c)<7%, According to 2015 American Diabetes Association (ADA) and 2013 Chinese Diabetes Society (CDS) Guidelines.	The percentage of patients attaining blood glucose control target defined as HbA1c<7%, according to 2015 American Diabetes Association (ADA) and 2013 Chinese Diabetes Society (CDS) guidelines.	At study visit (one day)

Secondary Outcomes

Measure	Description	Time Frame
Renal Function Level of Patients Measured by Albuminuria	The renal function level of patients was measured by albuminuria into following categories - normal, micro-albuminuria, macro-albuminuria and missing data. Albuminuria was measured using either as a random spot urine sample, a 24-h urine sample, or a timed urine sample. Normal was defined as < 30 mg/g, <30 mg/24h, and < 20 μg/min with the random spot urine sample, the 24-h urine sample, and the timed urine sample, respectively. Micro-albuminuria was defined as 30 - 300 mg/g, 30 - 300 mg/24h, and 20 - 200 μg/min with the random spot urine sample, the 24-h urine sample, and the timed urine sample, respectively. Macro-albuminuria was defined as >300 mg/g, >300 mg/24h, and >200 μg/min with the random spot urine sample, the 24-h urine sample, and the timed urine sample, respectively.

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Boehringer Ingelheim	Boehringer Ingelheim	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Peking University Shougang Hospital		Beijing		100043	China
Beijing Hospital

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Outpatients With Confirmed Type 2 Diabetes Mellitus (T2DM)	Outpatients with confirmed type 2 diabetes mellitus (T2DM), whose treatments patterns included only diet control and exercise; oral antidiabetic drug (OAD)-mono therapy; OAD-combined therapy; insulin only; OAD and insulin both.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Dec 20, 2016	Dec 19, 2018

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

No data available

No data is available for this block.

Arm/Group Information

ID	Title	Description
BG000	Outpatients With Confirmed Type 2 Diabetes Mellitus (T2DM)	Outpatients with confirmed type 2 diabetes mellitus (T2DM), whose treatments patterns included only diet control and exercise; oral antidiabetic drug (OAD)-mono therapy; OAD-combined therapy; insulin only; OAD and insulin both.

Units	Counts
Participants	BG0001520

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
	OG00043.4

Secondary

Renal Function Level of Patients Measured by Albuminuria

The renal function level of patients was measured by albuminuria into following categories - normal, micro-albuminuria, macro-albuminuria and missing data.

Albuminuria was measured using either as a random spot urine sample, a 24-h urine sample, or a timed urine sample. Normal was defined as < 30 mg/g, <30 mg/24h, and < 20 μg/min with the random spot urine sample, the 24-h urine sample, and the timed urine sample, respectively. Micro-albuminuria was defined as 30 - 300 mg/g, 30 - 300 mg/24h, and 20 - 200 μg/min with the random spot urine sample, the 24-h urine sample, and the timed urine sample, respectively. Macro-albuminuria was defined as >300 mg/g, >300 mg/24h, and >200 μg/min with the random spot urine sample, the 24-h urine sample, and the timed urine sample, respectively.

FAS - E

Posted

Number

Percentage of patients

At study visit (one day)

ID	Title	Description
OG000	Outpatients With Confirmed Type 2 Diabetes Mellitus (T2DM)	Outpatients with confirmed type 2 diabetes mellitus (T2DM), whose treatments patterns included only diet control and exercise; oral antidiabetic drug (OAD)-mono therapy; OAD-combined therapy; insulin only; OAD and insulin both.

Units	Counts
Participants

Secondary

Renal Function Level of Patients Measured by Estimated Glomerular Filtration Rate (eGFR)

The renal function level of patients was measured by estimated glomerular filtration rate (eGFR).

FAS - E

Posted

Mean

Standard Deviation

milliLitre/minute/1.73 meter ^ 2

At study visit (one day)

ID	Title	Description
OG000	Outpatients With Confirmed Type 2 Diabetes Mellitus (T2DM)	Outpatients with confirmed type 2 diabetes mellitus (T2DM), whose treatments patterns included only diet control and exercise; oral antidiabetic drug (OAD)-mono therapy; OAD-combined therapy; insulin only; OAD and insulin both.

Units	Counts
Participants	OG000

Secondary

Renal Function Level of Patients Measured by Chronic Kidney Disease (CKD) Stage

The renal function level of patients was measured by CKD into following categories - eGFR ≥ 60 milliLitre/minute/1.73 meter ^ 2 (mL/min/1.73m^2), eGFR < 60 mL/min/1.73m^2 and missing data.

FAS - E

Posted

Number

Percentage of patients

At study visit (one day)

ID	Title	Description
OG000	Outpatients With Confirmed Type 2 Diabetes Mellitus (T2DM)	Outpatients with confirmed type 2 diabetes mellitus (T2DM), whose treatments patterns included only diet control and exercise; oral antidiabetic drug (OAD)-mono therapy; OAD-combined therapy; insulin only; OAD and insulin both.

Units	Counts
Participants	OG000

Secondary

Treatment Regimens for T2DM That Patient Are Currently Taking

The treatment regimens for T2DM that patient are currently taking.

FAS - E

Posted

Number

Percentage of patients

At study visit (one day)

ID	Title	Description
OG000	Outpatients With Confirmed Type 2 Diabetes Mellitus (T2DM)	Outpatients with confirmed type 2 diabetes mellitus (T2DM), whose treatments patterns included only diet control and exercise; oral antidiabetic drug (OAD)-mono therapy; OAD-combined therapy; insulin only; OAD and insulin both.

Units	Counts
Participants	OG000

Secondary

Percentage of Patients Macro-vascular and Micro-vascular Diabetic Complications

The percentage of patients macro-vascular and micro-vascular diabetic complications.

FAS - E

Posted

Number

Percentage of patients

At study visit (one day)

ID	Title	Description
OG000	Outpatients With Confirmed Type 2 Diabetes Mellitus (T2DM)	Outpatients with confirmed type 2 diabetes mellitus (T2DM), whose treatments patterns included only diet control and exercise; oral antidiabetic drug (OAD)-mono therapy; OAD-combined therapy; insulin only; OAD and insulin both.

Units	Counts
Participants	OG000

Secondary

Percentage of Patients With Hypoglycaemic Occurrence

The percentage of patients with hypoglycaemic occurrence.

FAS - E

Posted

Number

Percentage of patients

At study visit (one day)

ID	Title	Description
OG000	Outpatients With Confirmed Type 2 Diabetes Mellitus (T2DM)	Outpatients with confirmed type 2 diabetes mellitus (T2DM), whose treatments patterns included only diet control and exercise; oral antidiabetic drug (OAD)-mono therapy; OAD-combined therapy; insulin only; OAD and insulin both.

Units	Counts
Participants	OG0001520

Secondary

Percentage of Patients With Hypoglycaemia Leading to Therapy Change

The percentage of patients with hypoglycaemia leading to therapy change.

FAS - E

Posted

Number

Percentage of patients

At study visit (one day)

ID	Title	Description
OG000	Outpatients With Confirmed Type 2 Diabetes Mellitus (T2DM)	Outpatients with confirmed type 2 diabetes mellitus (T2DM), whose treatments patterns included only diet control and exercise; oral antidiabetic drug (OAD)-mono therapy; OAD-combined therapy; insulin only; OAD and insulin both.

Units	Counts
Participants	OG000

Secondary

Percentage of Patients With Anti-hypertension Therapy Usage

The percentage of patients with anti-hypertension therapy usage.

FAS - E

Posted

Number

Percentage of patients

At study visit (one day)

ID	Title	Description
OG000	Outpatients With Confirmed Type 2 Diabetes Mellitus (T2DM)	Outpatients with confirmed type 2 diabetes mellitus (T2DM), whose treatments patterns included only diet control and exercise; oral antidiabetic drug (OAD)-mono therapy; OAD-combined therapy; insulin only; OAD and insulin both.

Units	Counts
Participants	OG0001520

Secondary

Percentage of Patients With Lipid Lowering Therapy Usage

The percentage of patients with lipid lowering therapy usage.

FAS - E

Posted

Number

Percentage of patients

At study visit (one day)

ID	Title	Description
OG000	Outpatients With Confirmed Type 2 Diabetes Mellitus (T2DM)	Outpatients with confirmed type 2 diabetes mellitus (T2DM), whose treatments patterns included only diet control and exercise; oral antidiabetic drug (OAD)-mono therapy; OAD-combined therapy; insulin only; OAD and insulin both.

Units	Counts
Participants	OG0001520

Secondary

Percentage of Patients With Anti-platelet Therapy Usage

The percentage of patients with anti-platelet therapy usage.

FAS - E

Posted

Number

Percentage of patients

At study visit (one day)

ID	Title	Description
OG000	Outpatients With Confirmed Type 2 Diabetes Mellitus (T2DM)	Outpatients with confirmed type 2 diabetes mellitus (T2DM), whose treatments patterns included only diet control and exercise; oral antidiabetic drug (OAD)-mono therapy; OAD-combined therapy; insulin only; OAD and insulin both.

Units	Counts
Participants	OG0001520

Secondary

Follow up Duration of Type 2 Diabetes Related Risk Factors in Clinical Practice

The follow up duration of type 2 diabetes related risk factors was summarized using the situation of lab test including serum creatinine, uric acid, high density lipoprotein cholesterol, low density lipoprotein cholesterol, triglyceride and total cholesterol.

FAS - E

Posted

Number

Percentage of patients

At study visit (one day)

ID	Title	Description
OG000	Outpatients With Confirmed Type 2 Diabetes Mellitus (T2DM)	Outpatients with confirmed type 2 diabetes mellitus (T2DM), whose treatments patterns included only diet control and exercise; oral antidiabetic drug (OAD)-mono therapy; OAD-combined therapy; insulin only; OAD and insulin both.

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	Outpatients With Confirmed Type 2 Diabetes Mellitus (T2DM)	Outpatients with confirmed type 2 diabetes mellitus (T2DM), whose treatments patterns included only diet control and exercise; oral antidiabetic drug (OAD)-mono therapy; OAD-combined therapy; insulin only; OAD and insulin both.	0	1,520	0	1,520	0	1,520

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