Trial Outcomes & Findings for Clinical Characteristics, Anti-hyperglycaemic Treatment Pattern and Target Attainment of Type 2 Diabetes Mellitus Patients in Older Population With or Without Albuminuria in China (NCT NCT03064841)

NCT ID: NCT03064841

Last Updated: 2019-08-28

Results Overview

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.

• Recruitment status: COMPLETED
• Target enrollment: 1537 participants
• Primary outcome timeframe: At study visit (one day)
• Results posted on: 2019-08-28

Participant Flow

Patients were recruited into the study in the order of their clinical visits scheduled. First 7 consented and suitable patients were recruited for each site on each day, or fewer if without enough patients. One study visit was planned for each patient.The data was collected for this study from 09th March, 2017 to 30th December, 2017.

All subjects were screened for eligibility to participate in trial. Subjects attended specialist sites to ensure that they (the subjects) met all implemented inclusion/exclusion criteria. Subjects were not to be included in the study if any of specific entry criteria was violated.

Participant milestones

Measure	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.
Overall Study STARTED	1537
Overall Study COMPLETED	1520
Overall Study NOT COMPLETED	17

Reasons for withdrawal

Measure	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.
Overall Study Inclusion/exclusion criteria violation	4
Overall Study No glycated haemoglobinA1c measurement	11
Overall Study Screen failure	2

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Outpatients With Confirmed Type 2 Diabetes Mellitus (T2DM) n=1520 Participants 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.
Age, Continuous	67.7 Years STANDARD_DEVIATION 5.86 • n=1520 Participants
Sex: Female, Male Female	819 Participants n=1520 Participants
Sex: Female, Male Male	701 Participants n=1520 Participants

PRIMARY outcome

Timeframe: At study visit (one day)

Population: Full Analysis Set - Eligible (FAS - E): The FAS - E includes all eligible patients regarding to inclusion and exclusion criteria with an glycated haemoglobin A1c (HbA1c) measurement.

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.

Outcome measures

Measure	Outpatients With Confirmed Type 2 Diabetes Mellitus (T2DM) n=1520 Participants 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.
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.	43.4 Percentage of patients

SECONDARY outcome

Timeframe: At study visit (one day)

Population: FAS - E

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.

Outcome measures

Measure	Outpatients With Confirmed Type 2 Diabetes Mellitus (T2DM) n=1520 Participants 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.
Renal Function Level of Patients Measured by Albuminuria Normal	63.8 Percentage of patients
Renal Function Level of Patients Measured by Albuminuria Micro-albuminuria	27.6 Percentage of patients
Renal Function Level of Patients Measured by Albuminuria Macro-albuminuria	7.1 Percentage of patients
Renal Function Level of Patients Measured by Albuminuria Missing	1.5 Percentage of patients

SECONDARY outcome

Timeframe: At study visit (one day)

Population: FAS - E

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

Outcome measures

Measure	Outpatients With Confirmed Type 2 Diabetes Mellitus (T2DM) n=1520 Participants 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.
Renal Function Level of Patients Measured by Estimated Glomerular Filtration Rate (eGFR)	85.019 milliLitre/minute/1.73 meter ^ 2 Standard Deviation 18.204

SECONDARY outcome

Timeframe: At study visit (one day)

Population: FAS - E

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.

Outcome measures

Measure	Outpatients With Confirmed Type 2 Diabetes Mellitus (T2DM) n=1520 Participants 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.
Renal Function Level of Patients Measured by Chronic Kidney Disease (CKD) Stage eGFR >=60 mL/min/1.73m^2	51.1 Percentage of patients
Renal Function Level of Patients Measured by Chronic Kidney Disease (CKD) Stage eGFR < 60 mL/min/1.73m^2	5.4 Percentage of patients
Renal Function Level of Patients Measured by Chronic Kidney Disease (CKD) Stage Missing eGFR data	43.6 Percentage of patients

SECONDARY outcome

Timeframe: At study visit (one day)

Population: FAS - E

The treatment regimens for T2DM that patient are currently taking.

Outcome measures

Measure	Outpatients With Confirmed Type 2 Diabetes Mellitus (T2DM) n=1520 Participants 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.
Treatment Regimens for T2DM That Patient Are Currently Taking No treatment	2.6 Percentage of patients
Treatment Regimens for T2DM That Patient Are Currently Taking Only diet control and exercise	7.5 Percentage of patients
Treatment Regimens for T2DM That Patient Are Currently Taking Oral antidiabetic drug (OAD) - Mono therapy	16.8 Percentage of patients
Treatment Regimens for T2DM That Patient Are Currently Taking OAD - Combined therapy	28.7 Percentage of patients
Treatment Regimens for T2DM That Patient Are Currently Taking Insulin only	15.5 Percentage of patients
Treatment Regimens for T2DM That Patient Are Currently Taking OAD and Insulin	28.3 Percentage of patients
Treatment Regimens for T2DM That Patient Are Currently Taking Missing	0.6 Percentage of patients

SECONDARY outcome

Timeframe: At study visit (one day)

Population: FAS - E

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

Outcome measures

Measure	Outpatients With Confirmed Type 2 Diabetes Mellitus (T2DM) n=1520 Participants 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.
Percentage of Patients Macro-vascular and Micro-vascular Diabetic Complications Cardiovascular disease	14.9 Percentage of patients
Percentage of Patients Macro-vascular and Micro-vascular Diabetic Complications Cerebrovascular disease	11.2 Percentage of patients
Percentage of Patients Macro-vascular and Micro-vascular Diabetic Complications Peripheral vascular disease	8.8 Percentage of patients
Percentage of Patients Macro-vascular and Micro-vascular Diabetic Complications Kidney disease	8.6 Percentage of patients
Percentage of Patients Macro-vascular and Micro-vascular Diabetic Complications Retinopathy	14.4 Percentage of patients
Percentage of Patients Macro-vascular and Micro-vascular Diabetic Complications Neuropathy	13.6 Percentage of patients

SECONDARY outcome

Timeframe: At study visit (one day)

Population: FAS - E

The percentage of patients with hypoglycaemic occurrence.

Outcome measures

Measure	Outpatients With Confirmed Type 2 Diabetes Mellitus (T2DM) n=1520 Participants 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.
Percentage of Patients With Hypoglycaemic Occurrence	28.0 Percentage of patients

SECONDARY outcome

Timeframe: At study visit (one day)

Population: FAS - E

The percentage of patients with hypoglycaemia leading to therapy change.

Outcome measures

Measure	Outpatients With Confirmed Type 2 Diabetes Mellitus (T2DM) n=1520 Participants 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.
Percentage of Patients With Hypoglycaemia Leading to Therapy Change	7.2 Percentage of patients

SECONDARY outcome

Timeframe: At study visit (one day)

Population: FAS - E

The percentage of patients with anti-hypertension therapy usage.

Outcome measures

Measure	Outpatients With Confirmed Type 2 Diabetes Mellitus (T2DM) n=1520 Participants 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.
Percentage of Patients With Anti-hypertension Therapy Usage	49.0 Percentage of patients

SECONDARY outcome

Timeframe: At study visit (one day)

Population: FAS - E

The percentage of patients with lipid lowering therapy usage.

Outcome measures

Measure	Outpatients With Confirmed Type 2 Diabetes Mellitus (T2DM) n=1520 Participants 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.
Percentage of Patients With Lipid Lowering Therapy Usage	29.2 Percentage of patients

SECONDARY outcome

Timeframe: At study visit (one day)

Population: FAS - E

The percentage of patients with anti-platelet therapy usage.

Outcome measures

Measure	Outpatients With Confirmed Type 2 Diabetes Mellitus (T2DM) n=1520 Participants 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.
Percentage of Patients With Anti-platelet Therapy Usage	30.1 Percentage of patients

SECONDARY outcome

Timeframe: At study visit (one day)

Population: FAS - E

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.

Outcome measures

Measure	Outpatients With Confirmed Type 2 Diabetes Mellitus (T2DM) n=1520 Participants 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.
Follow up Duration of Type 2 Diabetes Related Risk Factors in Clinical Practice Follow-up duration - within 3 months	33.6 Percentage of patients
Follow up Duration of Type 2 Diabetes Related Risk Factors in Clinical Practice Follow-up duration - within 3 to 6 months	16.1 Percentage of patients
Follow up Duration of Type 2 Diabetes Related Risk Factors in Clinical Practice Follow-up duration - within 6 to 12 months	17.3 Percentage of patients
Follow up Duration of Type 2 Diabetes Related Risk Factors in Clinical Practice Follow-up duration - More than 12 months	27.8 Percentage of patients
Follow up Duration of Type 2 Diabetes Related Risk Factors in Clinical Practice Missing follow-up duration	5.3 Percentage of patients

Adverse Events

Outpatients With Confirmed Type 2 Diabetes Mellitus (T2DM)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Boehringer Ingelheim Call Centre

Boehringer Ingelheim

Phone: 1-800-243-0127

Email: clintriage.rdg@boehringer-ingelheim.com

Results disclosure agreements

• Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
• Publication restrictions are in place

Restriction type: OTHER