Trial Outcomes & Findings for Observational Registry for Basal Insulin Treatment Study (ORBIT) (NCT NCT01859598)
NCT ID: NCT01859598
Last Updated: 2016-10-12
Results Overview
• Change of HbA1c from baseline to the end-point (6 month).
Recruitment status
COMPLETED
Target enrollment
19894 participants
Primary outcome timeframe
Baseline and 6 months
Results posted on
2016-10-12
Participant Flow
From December of 2011 to June 2013 in secondary and tertiary hospitals all over China, including in-patients and out-patients.
At the baseline stage: Patients registered to assess the eligibility(N=19894); Violate inclusion criteria (N=346); Excluded (N=553);
Participant milestones
| Measure |
6-month Follow-up for Basal Insulin Treatment Study (ORBIT)
At the baseline stage:
Patients registered to assess the eligibility(N=19894); Violate inclusion criteria (N=346); Excluded (N=553);
|
|---|---|
|
Visit 2 at 3 Months
STARTED
|
18995
|
|
Visit 2 at 3 Months
COMPLETED
|
17253
|
|
Visit 2 at 3 Months
NOT COMPLETED
|
1742
|
|
Visit 3 at 6 Months
STARTED
|
17253
|
|
Visit 3 at 6 Months
COMPLETED
|
16341
|
|
Visit 3 at 6 Months
NOT COMPLETED
|
912
|
Reasons for withdrawal
| Measure |
6-month Follow-up for Basal Insulin Treatment Study (ORBIT)
At the baseline stage:
Patients registered to assess the eligibility(N=19894); Violate inclusion criteria (N=346); Excluded (N=553);
|
|---|---|
|
Visit 2 at 3 Months
Lost to Follow-up
|
1742
|
Baseline Characteristics
Observational Registry for Basal Insulin Treatment Study (ORBIT)
Baseline characteristics by cohort
| Measure |
Follow up for 6 Months
n=18995 Participants
At the baseline stage:
Patients registered to assess the eligibility(N=19894); Violate inclusion criteria (N=346); Excluded (N=553);
|
|---|---|
|
Age, Continuous
|
55.4 year
STANDARD_DEVIATION 10.4 • n=99 Participants
|
|
Sex: Female, Male
Female
|
9027 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
9968 Participants
n=99 Participants
|
|
Region of Enrollment
China
|
18995 participants
n=99 Participants
|
|
HbA1c level
|
9.6 %
STANDARD_DEVIATION 2.0 • n=99 Participants
|
|
Fasting Plasma Glucose (FPG) level
|
11.7 mmol/L
STANDARD_DEVIATION 4.0 • n=99 Participants
|
|
Duration of Diabetes
|
6.4 years
STANDARD_DEVIATION 5.3 • n=99 Participants
|
|
Education
Primary school or illiterate
|
5154 participants
n=99 Participants
|
|
Education
High school
|
10583 participants
n=99 Participants
|
|
Education
College or higher
|
3258 participants
n=99 Participants
|
|
Complication
yes
|
6744 participants
n=99 Participants
|
|
Complication
no
|
12251 participants
n=99 Participants
|
|
Systolic Blood Pressure (SBP)
|
130.1 mmHg
STANDARD_DEVIATION 16.0 • n=99 Participants
|
|
Diastolic Blood Pressure (DBP)
|
79.5 mmHg
STANDARD_DEVIATION 9.5 • n=99 Participants
|
|
Body Mass Index (BMI)
|
24.7 kg/m2
STANDARD_DEVIATION 3.4 • n=99 Participants
|
|
Recruitment settings
Out-patient
|
8361 participants
n=99 Participants
|
|
Recruitment settings
In-patient
|
10634 participants
n=99 Participants
|
|
Hospital levels
Secondary hospitals
|
9443 participants
n=99 Participants
|
|
Hospital levels
Tertiary hospitals
|
9552 participants
n=99 Participants
|
|
Current residence of patients
Urban
|
13019 participants
n=99 Participants
|
|
Current residence of patients
Rural
|
5976 participants
n=99 Participants
|
|
Pre-insulin hypoglycemia
|
1.7 times/person/year
STANDARD_DEVIATION 10.4 • n=99 Participants
|
|
Physical activity
|
5.4 days
STANDARD_DEVIATION 2.5 • n=99 Participants
|
PRIMARY outcome
Timeframe: Baseline and 6 monthsPopulation: the patients who have the results of HbA1c
• Change of HbA1c from baseline to the end-point (6 month).
Outcome measures
| Measure |
Basal Insulin Treatment Study (ORBIT)
n=16271 Participants
|
|---|---|
|
To Assess the Change in HbA1c During the 6 Months Follow-up.
|
2.1 percent
Standard Deviation 2.1
|
PRIMARY outcome
Timeframe: baseline and 6 monthsPopulation: The population at visit 3 were used to analyze the hypoglycemia and weight change from visit 1 to visit 3
•The rate of hypoglycemia at baseline, 3 months (visit 2) and 6 months (visit 3)
Outcome measures
| Measure |
Basal Insulin Treatment Study (ORBIT)
n=16341 Participants
|
|---|---|
|
the Change of Hypoglycemia During Follow-up.
Visit 1
|
5.6 percentage of patients with hypoglycemia
|
|
the Change of Hypoglycemia During Follow-up.
visit 2
|
9.6 percentage of patients with hypoglycemia
|
|
the Change of Hypoglycemia During Follow-up.
visit 3
|
9.0 percentage of patients with hypoglycemia
|
SECONDARY outcome
Timeframe: baseline and 6 monthsPopulation: the population in the visit 3 were used for analysis
the FPG change = the FPG level at visit 1- the FPG level at visit 3
Outcome measures
| Measure |
Basal Insulin Treatment Study (ORBIT)
n=16341 Participants
|
|---|---|
|
the FPG Change From Visit 1 to Visit 3
|
3.8 mmol/L
Standard Deviation 4.2
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: At visit 3, the patients who self-reported their FPG level were used for analysis
the percentage of patients who had the FPG level \<7.0 mmol/L at visit 3
Outcome measures
| Measure |
Basal Insulin Treatment Study (ORBIT)
n=10416 Participants
|
|---|---|
|
the FPG Control Rate at Visit 3
|
42.5 percentage of patients with FPG<7.0
|
SECONDARY outcome
Timeframe: baseline and 6 monthsPopulation: Patients at visit 3 were used for analyzing the change of weight
the weight gain= the mean weight at visit1 - the mean weight at visit 3
Outcome measures
| Measure |
Basal Insulin Treatment Study (ORBIT)
n=16341 Participants
|
|---|---|
|
Overall Weight Gain From Visit 1 to Visit 3
|
0.1 Kg
Standard Deviation 2.94
|
Adverse Events
Follow up for 6 Months
Serious events: 635 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Follow up for 6 Months
n=18995 participants at risk
At the baseline stage:
Patients registered to assess the eligibility(N=19894); Violate inclusion criteria (N=346); Excluded (N=553);
At visit 1: Patients remained at baseline, N=18995; Loss to follow-up, N=1742 At visit 2, N=17253; Come back at visit 3, N=605 Loss to follow-up, N=1517 At visit 3, N=16341
|
|---|---|
|
Renal and urinary disorders
nephroma
|
0.34%
65/18995 • Number of events 65 • From baseline to 6 months
Led to death; Resulted in a life-threatening illness or injury; Required in-patient hospitalization or prolongation of existing hospitalization; Resulted in permanent impairment of a body structure or function; Led to congenital abnormality or birth defect. Resulted in important medical event or reaction
|
|
Cardiac disorders
Cardio-cerebrovascular disease
|
1.4%
258/18995 • Number of events 258 • From baseline to 6 months
Led to death; Resulted in a life-threatening illness or injury; Required in-patient hospitalization or prolongation of existing hospitalization; Resulted in permanent impairment of a body structure or function; Led to congenital abnormality or birth defect. Resulted in important medical event or reaction
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary disease
|
0.54%
103/18995 • Number of events 103 • From baseline to 6 months
Led to death; Resulted in a life-threatening illness or injury; Required in-patient hospitalization or prolongation of existing hospitalization; Resulted in permanent impairment of a body structure or function; Led to congenital abnormality or birth defect. Resulted in important medical event or reaction
|
|
Nervous system disorders
nerve system
|
0.26%
50/18995 • Number of events 50 • From baseline to 6 months
Led to death; Resulted in a life-threatening illness or injury; Required in-patient hospitalization or prolongation of existing hospitalization; Resulted in permanent impairment of a body structure or function; Led to congenital abnormality or birth defect. Resulted in important medical event or reaction
|
|
Eye disorders
eye disease
|
0.12%
23/18995 • Number of events 23 • From baseline to 6 months
Led to death; Resulted in a life-threatening illness or injury; Required in-patient hospitalization or prolongation of existing hospitalization; Resulted in permanent impairment of a body structure or function; Led to congenital abnormality or birth defect. Resulted in important medical event or reaction
|
|
Gastrointestinal disorders
Gastrointestinal disease
|
0.48%
91/18995 • Number of events 91 • From baseline to 6 months
Led to death; Resulted in a life-threatening illness or injury; Required in-patient hospitalization or prolongation of existing hospitalization; Resulted in permanent impairment of a body structure or function; Led to congenital abnormality or birth defect. Resulted in important medical event or reaction
|
|
Hepatobiliary disorders
Hepatobiliary disease
|
0.24%
45/18995 • Number of events 45 • From baseline to 6 months
Led to death; Resulted in a life-threatening illness or injury; Required in-patient hospitalization or prolongation of existing hospitalization; Resulted in permanent impairment of a body structure or function; Led to congenital abnormality or birth defect. Resulted in important medical event or reaction
|
Other adverse events
Adverse event data not reported
Additional Information
Pro. Linong Ji
The George Institute for Global Health at Peking University Health Science Center
Phone: 82800577
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place