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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1111-9453 | Other Identifier | WHO |
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This trial is conducted in Asia. The aim of this clinical trial is to investigate the blood glucose lowering effect and the safety profile of repaglinide given alone compared to gliclazide given alone in Chinese subjects with type 2 diabetes who never have been treated with oral anti-diabetic drugs (OADs). This study also investigates the augment effect of repaglinide on the phases of insulin secretion as a subgroup study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| repaglinide | Active Comparator | 1 mg repaglinide twice daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 4 mg three times daily |
|
| gliclazide | Active Comparator | 80 mg gliclazide once daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 160 mg twice daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| repaglinide | Drug | Individually adjusted dose for 16 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Glycosylated Haemoglobin (HbA1c) | Week 0, week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Fasting Plasma Glucose | Week 0, week 16 | |
| Change in 2-hour Postprandial Plasma Glucose (PPG) Over a Standard Meal | A standard meal contains 100g carbohydrate | Week 0, week 16 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai | Shanghai Municipality | 200025 | China |
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| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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Between screening and treatment with trial drug the participants were assessed for eligibility and were randomised to one of two treatment arms. A sub-group of 69 participants was recruited for intravenous glucose tolerance test and randomised into the repaglinide treatment group (35 participants) and gliclazide treatment group (34 participants)
The trial was conducted at 23 sites in China.
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| ID | Title | Description |
|---|---|---|
| FG000 | Repaglinide | 1 mg repaglinide twice daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 4 mg three times daily |
| FG001 | Gliclazide | 80 mg gliclazide once daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 160 mg twice daily |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Repaglinide | 1 mg repaglinide twice daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 4 mg three times daily |
| BG001 | Gliclazide |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Glycosylated Haemoglobin (HbA1c) | Full analysis set (FAS) is randomised participants exposed to at least one dose of trial product after randomisation. Missing values were replaced with the last post-baseline data based on LOCF (last observation carried forward). | Posted | Least Squares Mean | Standard Error | percentage (%) of total haemoglobin | Week 0, week 16 |
|
The adverse events were collected in a timespan of 16 weeks.
Safety analysis set contains all randomised participants exposed to at least one dose of trial drug(s).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Repaglinide | 1 mg repaglinide twice daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 4 mg three times daily |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Public Access to Clinical Trials | Novo Nordisk A/S | clinicaltrials@novonordisk.com |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C072379 | repaglinide |
| D005907 | Gliclazide |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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| gliclazide |
| Drug |
Individually adjusted dose for 16 weeks |
|
| Percentage of Participants Achieving the Treatment Target of HbA1c Below or Equal to 6.5% | Week 16 |
| Change in Fasting Serum Free Fatty Acid (FFA) From Baseline | Week 0, week 16 |
| Change in 2-hour Postprandial Serum Free Fatty Acid (FFA) Over a Standard Meal | Week 0, week 16 |
| Change in AUC0-180 of Serum Insulin Concentration of IVGTT (Intravenous Glucose Tolerance Test) | Over the course of three hours at Week 0 and Week 16 |
| Change in AUC0-180 of Plasma Glucose Concentration of IVGTT | Over the course of three hours at Week 0 and Week 16 |
| Number of All Treatment Emergent Hypoglycaemic Episodes | A hypoglycaemic episode was defined as treatment emergent if the onset of the episode was on or after the first day of trial product and no later than the last day of the trial product. | Weeks 0-16 |
| Cholesterol | The number of participants having a change in cholesterol from "normal" to "abnormal". "Abnormal" means a value of blood cholesterol is out of the normal range. | Week 0, week 16 |
| Change in Body Weight | Week 0, week 16 |
| Protocol Violation |
|
| Unclassified |
|
80 mg gliclazide once daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 160 mg twice daily
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Height | Mean | Standard Deviation | cm |
|
| Weight | Mean | Standard Deviation | kg |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| Duration of diagnosed diabetes | Mean | Standard Deviation | years |
|
|
|
|
| Secondary | Change in Fasting Plasma Glucose | Full analysis set (FAS) is randomised participants exposed to at least one dose of trial product after randomisation. Missing values were replaced with the last post-baseline data based on LOCF (last observation carried forward). | Posted | Least Squares Mean | Standard Error | mmol/L | Week 0, week 16 |
|
|
|
| Secondary | Change in 2-hour Postprandial Plasma Glucose (PPG) Over a Standard Meal | A standard meal contains 100g carbohydrate | Full analysis set (FAS) is randomised participants exposed to at least one dose of trial product after randomisation. Missing values were replaced with the last post-baseline data based on LOCF (last observation carried forward). | Posted | Least Squares Mean | Standard Error | mmol/L | Week 0, week 16 |
|
|
|
| Secondary | Percentage of Participants Achieving the Treatment Target of HbA1c Below or Equal to 6.5% | Full analysis set (FAS) is randomised participants exposed to at least one dose of trial product after randomisation. Missing values were replaced with the last post-baseline data based on LOCF (last observation carried forward). | Posted | Number | percentage of participants | Week 16 |
|
|
|
| Secondary | Change in Fasting Serum Free Fatty Acid (FFA) From Baseline | Full analysis set (FAS) is randomised participants exposed to at least one dose of trial product after randomisation. Missing values were replaced with the last post-baseline data based on LOCF (last observation carried forward). | Posted | Least Squares Mean | Standard Error | mmol/L | Week 0, week 16 |
|
|
|
| Secondary | Change in 2-hour Postprandial Serum Free Fatty Acid (FFA) Over a Standard Meal | Full analysis set (FAS) is randomised participants exposed to at least one dose of trial product after randomisation. Missing values were replaced with the last post-baseline data based on LOCF (last observation carried forward). | Posted | Least Squares Mean | Standard Error | mmol/L | Week 0, week 16 |
|
|
|
| Secondary | Change in AUC0-180 of Serum Insulin Concentration of IVGTT (Intravenous Glucose Tolerance Test) | A total of 69 participants were recruited into IVGTT, and were randomised into repaglinide treatment group (35 participants) and gliclazide treatment group (34 participants). Participants with eligible IVGTT profiles were included in IVGTT analysis set. | Posted | Mean | Standard Deviation | min*pmol/L | Over the course of three hours at Week 0 and Week 16 |
|
|
|
| Secondary | Change in AUC0-180 of Plasma Glucose Concentration of IVGTT | A total of 69 participants were recruited into IVGTT, and were randomised into repaglinide treatment group (35 participants) and gliclazide treatment group (34 participants). Participants with eligible IVGTT profiles were included in IVGTT analysis set. | Posted | Mean | Standard Deviation | min*mmol/L | Over the course of three hours at Week 0 and Week 16 |
|
|
|
| Secondary | Number of All Treatment Emergent Hypoglycaemic Episodes | A hypoglycaemic episode was defined as treatment emergent if the onset of the episode was on or after the first day of trial product and no later than the last day of the trial product. | Safety analysis set contains all randomised participants exposed to at least one dose of trial drug(s). One participant was randomised into repaglinide group, but was dispensed gliclazide from the very beginning of the study due to the investigator's negligence. This participant continued the gliclazide treatment until the end of the study. | Posted | Number | episodes | Weeks 0-16 |
|
|
|
| Secondary | Cholesterol | The number of participants having a change in cholesterol from "normal" to "abnormal". "Abnormal" means a value of blood cholesterol is out of the normal range. | Safety analysis set contains all randomised participants exposed to at least one dose of trial drug(s) | Posted | Number | participants | Week 0, week 16 |
|
|
|
| Secondary | Change in Body Weight | Full analysis set (FAS) is randomised participants exposed to at least one dose of trial product after randomisation | Posted | Least Squares Mean | Standard Error | kg | Week 0, week 16 |
|
|
|
| 3 |
| 216 |
| 0 |
| 216 |
| EG001 | Gliclazide | 80 mg gliclazide once daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 160 mg twice daily | 0 | 219 | 0 | 219 |
| Intervertebral Disc Protrusion | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Gall bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
|
Novo Nordisk reserves the right to not release data until specified milestones, e.g. when the clinical trial report is available. This includes the right to not release interim results of clinical trials. At the end of the trial, one or more manuscripts for publication will be prepared collaboratively between Investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for less than 60 days to protect intellectual property.
| D013453 |
| Sulfonylurea Compounds |
| D014508 | Urea |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |