Diabetes
Conditions
Keywords
diabetes, basal insulin, effectiveness and safety, oral antidiabetic drugs, real world clinical practice
Brief summary
The scientific use of basal insulin is of great help to individuals and the government. However, there are few studies to investigate the real world use, effect, safety and influence factors of basal insulin in China. This study is to evaluate the use of first basal insulin in China patients with type 2 diabetes with inadequate glycemic control on oral antidiabetic agents (OADs) from the naturalistic clinical practice.
Detailed description
This is a 6-month multicentre, observational, prospective, registry study. About 200 hospitals from different parts of China will take part in this study, and about 20,000 patients with type 2 diabetes mellitus (T2DM) who are inadequately controlled with OADs and willing to accept basal insulin (BI) treatment will be consecutively enrolled during a 12 months period. The study participants will include at baseline (0 month), 3 month and end point (6 month) to collect the study information. The project will probably last for about 18 months.
Interventions
None listed
Sponsors
Chinese Diabetes Society
The George Institute for Global Health, China
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 18-80 years old * Type 2 diabetic patients * Taking OADs before inclusion * Recently tested HbA1c \>=7% at the same site within 3 months * Being suggested by physician to start basal insulin (BI) treatment * Willing to start and having been prescribed BI treatment * Willing to join the registry study and sign the informed consent
Exclusion criteria
* Diagnosed with type 1 diabetes * Received any type of insulin in the last 2 years (except for the intermittent use of insulin of less than 1 month each time) * With any severe health problem, or any other situation judged by the investigator, that is difficult for the 6 months follow-up * Current or planned pregnant, lactating women * Involved in other clinical trial simultaneously or at most 1 month before
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To Assess the Change in HbA1c During the 6 Months Follow-up. | Baseline and 6 months | • Change of HbA1c from baseline to the end-point (6 month). |
| the Change of Hypoglycemia During Follow-up. | baseline and 6 months | •The rate of hypoglycemia at baseline, 3 months (visit 2) and 6 months (visit 3) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the FPG Change From Visit 1 to Visit 3 | baseline and 6 months | the FPG change = the FPG level at visit 1- the FPG level at visit 3 |
| the FPG Control Rate at Visit 3 | 6 months | the percentage of patients who had the FPG level \<7.0 mmol/L at visit 3 |
| Overall Weight Gain From Visit 1 to Visit 3 | baseline and 6 months | the weight gain= the mean weight at visit1 - the mean weight at visit 3 |
Countries
China
Participant flow
Recruitment details
From December of 2011 to June 2013 in secondary and tertiary hospitals all over China, including in-patients and out-patients.
Pre-assignment details
At the baseline stage: Patients registered to assess the eligibility(N=19894); Violate inclusion criteria (N=346); Excluded (N=553);
Participants by arm
| Arm | Count |
|---|---|
| Follow up for 6 Months At the baseline stage:
Patients registered to assess the eligibility(N=19894); Violate inclusion criteria (N=346); Excluded (N=553); | 18,995 |
| Total | 18,995 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Visit 2 at 3 Months | Lost to Follow-up | 1,742 |
Baseline characteristics
| Characteristic | Follow up for 6 Months |
|---|---|
| Age, Continuous | 55.4 year STANDARD_DEVIATION 10.4 |
| Body Mass Index (BMI) | 24.7 kg/m2 STANDARD_DEVIATION 3.4 |
| Complication no | 12251 participants |
| Complication yes | 6744 participants |
| Current residence of patients Rural | 5976 participants |
| Current residence of patients Urban | 13019 participants |
| Diastolic Blood Pressure (DBP) | 79.5 mmHg STANDARD_DEVIATION 9.5 |
| Duration of Diabetes | 6.4 years STANDARD_DEVIATION 5.3 |
| Education College or higher | 3258 participants |
| Education High school | 10583 participants |
| Education Primary school or illiterate | 5154 participants |
| Fasting Plasma Glucose (FPG) level | 11.7 mmol/L STANDARD_DEVIATION 4 |
| HbA1c level | 9.6 % STANDARD_DEVIATION 2 |
| Hospital levels Secondary hospitals | 9443 participants |
| Hospital levels Tertiary hospitals | 9552 participants |
| Physical activity | 5.4 days STANDARD_DEVIATION 2.5 |
| Pre-insulin hypoglycemia | 1.7 times/person/year STANDARD_DEVIATION 10.4 |
| Recruitment settings In-patient | 10634 participants |
| Recruitment settings Out-patient | 8361 participants |
| Region of Enrollment China | 18995 participants |
| Sex: Female, Male Female | 9027 Participants |
| Sex: Female, Male Male | 9968 Participants |
| Systolic Blood Pressure (SBP) | 130.1 mmHg STANDARD_DEVIATION 16 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 18,995 |
| serious Total, serious adverse events | 635 / 18,995 |
Outcome results
Primary
the Change of Hypoglycemia During Follow-up.
•The rate of hypoglycemia at baseline, 3 months (visit 2) and 6 months (visit 3)
Time frame: baseline and 6 months
Population: The population at visit 3 were used to analyze the hypoglycemia and weight change from visit 1 to visit 3
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Basal Insulin Treatment Study (ORBIT) | the Change of Hypoglycemia During Follow-up. | Visit 1 | 5.6 percentage of patients with hypoglycemia |
| Basal Insulin Treatment Study (ORBIT) | the Change of Hypoglycemia During Follow-up. | visit 2 | 9.6 percentage of patients with hypoglycemia |
| Basal Insulin Treatment Study (ORBIT) | the Change of Hypoglycemia During Follow-up. | visit 3 | 9.0 percentage of patients with hypoglycemia |
Primary
To Assess the Change in HbA1c During the 6 Months Follow-up.
• Change of HbA1c from baseline to the end-point (6 month).
Time frame: Baseline and 6 months
Population: the patients who have the results of HbA1c
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Basal Insulin Treatment Study (ORBIT) | To Assess the Change in HbA1c During the 6 Months Follow-up. | 2.1 percent | Standard Deviation 2.1 |
Secondary
Overall Weight Gain From Visit 1 to Visit 3
the weight gain= the mean weight at visit1 - the mean weight at visit 3
Time frame: baseline and 6 months
Population: Patients at visit 3 were used for analyzing the change of weight
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Basal Insulin Treatment Study (ORBIT) | Overall Weight Gain From Visit 1 to Visit 3 | 0.1 Kg | Standard Deviation 2.94 |
Secondary
the FPG Change From Visit 1 to Visit 3
the FPG change = the FPG level at visit 1- the FPG level at visit 3
Time frame: baseline and 6 months
Population: the population in the visit 3 were used for analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Basal Insulin Treatment Study (ORBIT) | the FPG Change From Visit 1 to Visit 3 | 3.8 mmol/L | Standard Deviation 4.2 |
Secondary
the FPG Control Rate at Visit 3
the percentage of patients who had the FPG level \<7.0 mmol/L at visit 3
Time frame: 6 months
Population: At visit 3, the patients who self-reported their FPG level were used for analysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Basal Insulin Treatment Study (ORBIT) | the FPG Control Rate at Visit 3 | 42.5 percentage of patients with FPG<7.0 |