Clinical Trials List
Protocol NumberNN1250-3586
2010-03-03 - 2010-12-31
Phase III
Terminated8
ICD-10E11.9
Type 2 diabetes mellitus without complications
ICD-10E13.9
Other specified diabetes mellitus without complications
ICD-9250.00
Diabetes mellitus without mention of complication, Type II [non-insulin dependent type][NIDDM type] [ adult-onset type] or unspecified type, not stated as uncontrolled
A pan-Asian clinical trial comparing the efficacy and safety of insulin NN1250 and insulin glargin in patients with type 2 diabetes who are currently using oral hypoglycemic drugs. A 26-week, randomized, confirmatory, controlled, open-ended, multi-center, multi-country, clinical trial that achieves the treatment goals, comparing SIBA and insulin glargine injected once a day with oral hypoglycemic drugs for type 2 diabetes The efficacy and safety of patients.
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Trial Applicant
NOVO NORDISK PHARMA (TAIWAN) LTD.
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Sponsor
Novonordisk
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 楊宜瑱 Division of Endocrinology
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 李明蒼 Division of Endocrinology
- CHIH-YUAN WANG CHIH-YUAN WANG Division of Endocrinology
- 陳華芬 Division of Endocrinology
- CHIH-YUAN WANG Division of Endocrinology
- 陳美秀 Division of Endocrinology
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Kun Der Lin Division of Endocrinology
- 何俊緯 Division of Endocrinology
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
Condition/Disease
Diabetes
Objectives
Confirm the blood glucose control effect of SIBA administered once a day and oral hypoglycemic drugs after 26 weeks of treatment. The blood sugar control effect is expressed by the change of glycated blood color quality from entering the test to 26 weeks of treatment. Compare the effect of giving SIBA+OAD(s) and giving insulin glargine+OAD(s) on the control effect of glycosylated hemoglobin.
Secondary purpose: To confirm whether the efficacy and safety of SIBA+OAD(s) after 26 weeks of treatment is better than insulin glargin+OAD(s) through the following indicators. a. The occurrence of a hypoglycemia event (severe or mild) b. The occurrence of a night hypoglycemia (severe or mild) c. The fasting blood glucose level measured by the central laboratory d. The subject self-measures the blood glucose level before breakfast Change e. Subjects who have responded to an glycated hemoglobin value of less than 7% but have not experienced any severe or alleviated hypoglycemia events.
Test Drug
Insulin 454 (SIBA) 100 U/ml, 3 mL prefilled pen, solution for injection
Active Ingredient
insulin 454
Dosage Form
Solution for injection
Dosage
100
Endpoints
1. Main evaluation indicators:
Changes of glycosylated hemoglobin before treatment and after 26 weeks of treatment
2. Secondary evaluation indicators:
•Confirmative secondary efficacy evaluation index
1. The number of severe or minor hypoglycemia events requiring emergency treatment
2. Changes in fasting blood glucose before treatment and after 26 weeks of treatment (analyzed by the central laboratory)
3. The coefficient of variation of the blood glucose level before breakfast measured by the subjects themselves
4. Those who did not have a hypoglycemic event and reached the treatment target response (defined as glycosylated hemoglobin <7% at the end of the trial), and in the last 12 of the treatment period
There were no serious or minor hypoglycemia events within a week, which also included subjects who received at least 12 weeks of treatment
• Auxiliary secondary efficacy evaluation indicators
1. Respondents who reach the target of glycosylated hemoglobin
2.9 point self blood glucose measurement
3. Self blood glucose measurement for dose adjustment during the test
4. Central laboratory evaluation, including glycosylated hemoglobin, fasting blood glucose value and pharmacokinetic test value
•Safety assessment indicators
1. Adverse events
2. The number of occurrences of hypoglycemia, according to the definition of the American Diabetes Association, and Novo Nordisk's additional definition of mild hypoglycemia
3. Clinical evaluation (physical examination, fundoscopy, 12-lead ECG and vital signs)
4. Central laboratory evaluation (hematology examination, biochemical examination, blood fat examination, blood pregnancy test for women who may be pregnant,
Evaluate the ratio of albumin/creatinine in urine with a single urine, and detect urine and antibodies with urine test paper)
5. Weight
6. Insulin dosage
•Patient reports results
The following questionnaires will be used to compare the reported results of patients in different treatment groups with related hypoglycemic events:
1. Diabetic medication satisfaction (DiabMedSat)
2. Diabetic Productivity Measurement (DPM)
3. Health-related quality of life questionnaire (SF-36)
4. Treatment Satisfaction Questionnaire (TRIM-D)
5. Interviews on the expense of dealing with hypoglycemia events
Changes of glycosylated hemoglobin before treatment and after 26 weeks of treatment
2. Secondary evaluation indicators:
•Confirmative secondary efficacy evaluation index
1. The number of severe or minor hypoglycemia events requiring emergency treatment
2. Changes in fasting blood glucose before treatment and after 26 weeks of treatment (analyzed by the central laboratory)
3. The coefficient of variation of the blood glucose level before breakfast measured by the subjects themselves
4. Those who did not have a hypoglycemic event and reached the treatment target response (defined as glycosylated hemoglobin <7% at the end of the trial), and in the last 12 of the treatment period
There were no serious or minor hypoglycemia events within a week, which also included subjects who received at least 12 weeks of treatment
• Auxiliary secondary efficacy evaluation indicators
1. Respondents who reach the target of glycosylated hemoglobin
2.9 point self blood glucose measurement
3. Self blood glucose measurement for dose adjustment during the test
4. Central laboratory evaluation, including glycosylated hemoglobin, fasting blood glucose value and pharmacokinetic test value
•Safety assessment indicators
1. Adverse events
2. The number of occurrences of hypoglycemia, according to the definition of the American Diabetes Association, and Novo Nordisk's additional definition of mild hypoglycemia
3. Clinical evaluation (physical examination, fundoscopy, 12-lead ECG and vital signs)
4. Central laboratory evaluation (hematology examination, biochemical examination, blood fat examination, blood pregnancy test for women who may be pregnant,
Evaluate the ratio of albumin/creatinine in urine with a single urine, and detect urine and antibodies with urine test paper)
5. Weight
6. Insulin dosage
•Patient reports results
The following questionnaires will be used to compare the reported results of patients in different treatment groups with related hypoglycemic events:
1. Diabetic medication satisfaction (DiabMedSat)
2. Diabetic Productivity Measurement (DPM)
3. Health-related quality of life questionnaire (SF-36)
4. Treatment Satisfaction Questionnaire (TRIM-D)
5. Interviews on the expense of dealing with hypoglycemia events
Inclution Criteria
1. Obtain the consent of the subject before performing any test-related steps (test-related steps mean that the subject will not do it in normal care
A step of)
2. Men or women over 18 years old
3. Clinically diagnosed as a type 2 diabetes patient for more than 6 months
4. Diabetes patients who have not received insulin treatment (including short-term insulin treatment for up to 14 days; if they are hospitalized or have gestational diabetes
Patients can receive insulin therapy for more than 14 days)
5. Current treatment methods: alone or in combination with an insulin enhancer (Sulphonylurea or glinide drugs) and metformin, no
Whether it is used in combination with glucosidase inhibitor or DPP-4 inhibitor, the dosage should not be changed at least three months before the first outpatient visit.
The minimum dose is as follows:
a. Insulin enhancer (sulfonylurea or glinide): Reach half of the maximum daily dose approved by the Department of Health
b.Metformin: used alone or in combination (including fixed-dose compound): maximum tolerable dose
c. alpha-glucosidase inhibitor: at least half the maximum daily dose approved by the Department of Health or the highest tolerable dose
d. DPP-4 inhibitor: According to the approved dose of the Department of Health
6. According to the analysis of the central laboratory, the glycosylated hemoglobin is 7.0-10.0% (including 7% and 10%)
7. The body mass index BMI value is above 35.0 kg/m2
8. Able and willing to follow the instructions of the plan, including self-measurement of blood glucose according to the plan.
A step of)
2. Men or women over 18 years old
3. Clinically diagnosed as a type 2 diabetes patient for more than 6 months
4. Diabetes patients who have not received insulin treatment (including short-term insulin treatment for up to 14 days; if they are hospitalized or have gestational diabetes
Patients can receive insulin therapy for more than 14 days)
5. Current treatment methods: alone or in combination with an insulin enhancer (Sulphonylurea or glinide drugs) and metformin, no
Whether it is used in combination with glucosidase inhibitor or DPP-4 inhibitor, the dosage should not be changed at least three months before the first outpatient visit.
The minimum dose is as follows:
a. Insulin enhancer (sulfonylurea or glinide): Reach half of the maximum daily dose approved by the Department of Health
b.Metformin: used alone or in combination (including fixed-dose compound): maximum tolerable dose
c. alpha-glucosidase inhibitor: at least half the maximum daily dose approved by the Department of Health or the highest tolerable dose
d. DPP-4 inhibitor: According to the approved dose of the Department of Health
6. According to the analysis of the central laboratory, the glycosylated hemoglobin is 7.0-10.0% (including 7% and 10%)
7. The body mass index BMI value is above 35.0 kg/m2
8. Able and willing to follow the instructions of the plan, including self-measurement of blood glucose according to the plan.
Exclusion Criteria
1. Those who have received TZDs (exenatide or liraglutide) treatment within three months before the first outpatient clinic
2. Anticipate changes to concomitant drugs that are known to have a significant effect on glucose metabolism, such as systemic steroids, beta-blockers (beta-blockers)
blockers), monoamine oxidase inhibitors (MAO inhibitors)
3. Those who have had cardiovascular disease in the past six months before the first outpatient visit are defined as follows: Stroke, as defined by the New York Heart Association (NYHA)
Class III or IV non-compensated heart failure, myocardial infarction, unstable angina, undergoing coronary artery bypass surgery or balloon dilation
Zhang Shu's patient
4. Uncontrolled/untreated severe hypertension (defined as systolic blood pressure above 180 mmHg and/or diastolic blood pressure above 100 mmHg)
5. Liver function impairment, defined as ALAT above 2.5 times the upper limit of normal
New test, analyzed by the central laboratory to confirm the result)
6. Impaired renal function, defined as male serum creatinine greater than 125 µmol/L (1.4 mg/dL or greater), female serum creatinine 110
µmol/L or more (1.3 mg/dL or more), or according to the local approved renal function regulations for the use of metformin (available after receiving the screening report
Within one week of the results, a re-test will be performed, and the results will be confirmed by the central laboratory analysis)
7. Repeated occurrence of severe hypoglycemia events (defined as severe hypoglycemia events that occurred more than once in the past 12 months) or the test host
Those who are judged to be involuntary hypoglycemia or have been hospitalized due to diabetic ketoacidemia in the past 6 months
8. The proliferative retinopathy or macular degeneration that needs to be treated according to the trial host
9. Those who are pregnant, breast-feeding, planning to become pregnant, or who have not used appropriate contraceptive methods according to local regulations
10. People with a history of cancer or cancer (but excluding basal cell skin cancer and squamous cell skin cancer)
11. According to the judgment of the test host, any clinically significant disease or abnormality that may affect the results of this test, but excludes type 2 diabetes
Disease-related conditions
12. Subjects who are incapacitated, have mental disorders, are unwilling or have language barriers and are unable to understand or cooperate enough, this also includes
Subjects who read or write
13. Have participated in this trial, and participation is defined as entering random allocation. Subjects who fail to be screened can be screened again during the admission period
14. Those who are known or suspected of being allergic to test drugs or related products
15. Those who have been treated with other experimental drugs one month before the first outpatient clinic
16. Those who have donated blood one month before the first clinic
17. Those who have participated in other clinical trials one month before the first outpatient visit
18. Known or suspected of abusing alcohol, drugs or illegal drugs
19. Those who are expected to significantly change their lifestyles during the trial period, such as: work changes (including night shift workers) and those with large changes in eating habits.
2. Anticipate changes to concomitant drugs that are known to have a significant effect on glucose metabolism, such as systemic steroids, beta-blockers (beta-blockers)
blockers), monoamine oxidase inhibitors (MAO inhibitors)
3. Those who have had cardiovascular disease in the past six months before the first outpatient visit are defined as follows: Stroke, as defined by the New York Heart Association (NYHA)
Class III or IV non-compensated heart failure, myocardial infarction, unstable angina, undergoing coronary artery bypass surgery or balloon dilation
Zhang Shu's patient
4. Uncontrolled/untreated severe hypertension (defined as systolic blood pressure above 180 mmHg and/or diastolic blood pressure above 100 mmHg)
5. Liver function impairment, defined as ALAT above 2.5 times the upper limit of normal
New test, analyzed by the central laboratory to confirm the result)
6. Impaired renal function, defined as male serum creatinine greater than 125 µmol/L (1.4 mg/dL or greater), female serum creatinine 110
µmol/L or more (1.3 mg/dL or more), or according to the local approved renal function regulations for the use of metformin (available after receiving the screening report
Within one week of the results, a re-test will be performed, and the results will be confirmed by the central laboratory analysis)
7. Repeated occurrence of severe hypoglycemia events (defined as severe hypoglycemia events that occurred more than once in the past 12 months) or the test host
Those who are judged to be involuntary hypoglycemia or have been hospitalized due to diabetic ketoacidemia in the past 6 months
8. The proliferative retinopathy or macular degeneration that needs to be treated according to the trial host
9. Those who are pregnant, breast-feeding, planning to become pregnant, or who have not used appropriate contraceptive methods according to local regulations
10. People with a history of cancer or cancer (but excluding basal cell skin cancer and squamous cell skin cancer)
11. According to the judgment of the test host, any clinically significant disease or abnormality that may affect the results of this test, but excludes type 2 diabetes
Disease-related conditions
12. Subjects who are incapacitated, have mental disorders, are unwilling or have language barriers and are unable to understand or cooperate enough, this also includes
Subjects who read or write
13. Have participated in this trial, and participation is defined as entering random allocation. Subjects who fail to be screened can be screened again during the admission period
14. Those who are known or suspected of being allergic to test drugs or related products
15. Those who have been treated with other experimental drugs one month before the first outpatient clinic
16. Those who have donated blood one month before the first clinic
17. Those who have participated in other clinical trials one month before the first outpatient visit
18. Known or suspected of abusing alcohol, drugs or illegal drugs
19. Those who are expected to significantly change their lifestyles during the trial period, such as: work changes (including night shift workers) and those with large changes in eating habits.
The Estimated Number of Participants
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Taiwan
60 participants
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Global
609 participants
