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| Name | Class |
|---|---|
| Bayer | INDUSTRY |
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Primary objective To evaluate the efficacy of Acarbose add-on therapy on glucose control in subjects with type 2 diabetes inadequately controlled with Metformin and Sitagliptin combination therapy.
The effect of acarbose, an alpha glucosidase inhibitor as a third-line therapeutic medication in subject who are inadequately controlled with metformin and DPP4 inhibitor will be evaluated with multicenter, randomized, 24-week, double blinded, placebo-controlled study in Korea.
Eligible subjects will be assigned among 3 groups randomly at a ration of 2:2:1 to the following groups and primary efficacy variable analyzed at week 16.
group 1 : acarbose placebo + metformin + sitagliptin (with switching placebo to acarbose qt week 16) group 2 : acarbose + metformin + sitagliptin group 3 : acarbose + metformin placebo + sitagliptin (with switching placebo to metformin at week 16)
After 16 week of treatment, all subjects in 3 groups will be treated as triple combination of acarbose + metformin + sitagliptin, and diabetes related variables be collected and analyzed.
for exploratory purpose, following data will be collected and analyzed
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acarbose placebo, Metformin, Sitagliptin | Placebo Comparator | The Acarbose placebo should be changed into real Acarbose from the 16th week. |
|
| Sitagliptin, Metformin, Acarbose | Experimental | Metformin, Sitagliptin, Acarbose group |
|
| Metformin placebo, Sitagliptin, Acarbose | Other | The Metformin placebo should be changed into real Metformin from the 16th week. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acarbose | Drug | Acarbose 50mg b.i.d at first, at the 2nd week 50mg t.i.d and the 4th week, 100mg tid. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Change of Glycated Hemoglogin(HbA1c) From Baseline to 16 Weeks of Treatment | The change of glycated hemoglogin(HbA1c) from baseline to 16 weeks of treatment between Placebo + Metformin+Sitagliptin and Metformin + Sitagliptin + Acarbose group | baseline, 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The Change of HbA1c From Baseline to 24 Weeks of Treatment | The change of glycated hemoglogin(HbA1c) from baseline to 24 weeks of treatment between 3 groups | baseline, 24 weeks |
| The Change of PPG2hr From Baseline to 24 Weeks of Treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Mean Glucose During CGMS Between 3 Group | Change of mean glucose of CGMS(continuous glucose monitoring system) data at 16 week from baseline between 3 groups | Visit 2(baseline) and Visit 5(16W) |
| Changes in Variation of Glucose During CGMS Between 3 Group |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kun-HO Yoon, professor | Seoul St. Mary's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MedicalExcellence | Seoul | 137-701 | South Korea |
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| ID | Title | Description |
|---|---|---|
| FG000 | Acarbose Placebo, Metformin, Sitagliptin | Metformin and sitagliptin and placebo treatment for 16 weeks. Placebo was changed to acarbose at 16 week and maintained for another 8 weeks. |
| FG001 | Sitagliptin, Metformin, Acarbose | Metformin and sitagliptin and acarbose treatment for 24 weeks. |
| FG002 | Metformin Placebo, Sitagliptin, Acarbose | Placebo and sitagliptin and acarbose treatment for 16 weeks. Placebo was changed to acarbose at 16 week and maintained for another 8 weeks. The Metformin placebo should be changed into real Metformin from the 16th week. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Acarbose Placebo, Metformin, Sitagliptin | The dose of Acarbose should be 50mg b.i.d, 50mg t.i.d and 100mg t.i.d at the 18th week, the 20th week and the 24th week respectively. The Acarbose placebo should be changed into real Acarbose from the 16th week. Acarbose: The dose of Acarbose or its placebo should be 50mg b.i.d at first. At the 2nd week and the 4th week, it should be 50mg t.i.d and 100mg t.i.d respectively |
| 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 | The Change of Glycated Hemoglogin(HbA1c) From Baseline to 16 Weeks of Treatment | The change of glycated hemoglogin(HbA1c) from baseline to 16 weeks of treatment between Placebo + Metformin+Sitagliptin and Metformin + Sitagliptin + Acarbose group | ITT: intention to treatment, All subject randomized to each treatment group | Posted | Mean | Standard Error | % of HbA1c | baseline, 16 weeks |
|
24 weeks
total number afffected by any other adverse event : included SAEs
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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 | Acarbose Placebo, Metformin, Sitagliptin | The dose of Acarbose should be 50mg b.i.d, 50mg t.i.d and 100mg t.i.d at the 18th week, the 20th week and the 24th week respectively. The Acarbose placebo should be changed into real Acarbose from the 16th week. Acarbose: The dose of Acarbose or its placebo should be 50mg b.i.d at first. At the 2nd week and the 4th week, it should be 50mg t.i.d and 100mg t.i.d respectively |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| chest pain | General disorders | MedDRA (17.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| cataract | Eye disorders | MedDRA (17.1) | Non-systematic Assessment |
Evaluation of GIP and oxidative stress markers (8-OHdG, Nitrotyrosin) were not analyzed due to limited number of sample and technical problems leading to uninterpretable data.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Yoon Hee Choi | The Catholic University of Korea, Seoul St Mary's Hospital | 82-2-2258-8288 | choiyh@catholic.ac.kr |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D020909 | Acarbose |
| D000068899 | Sitagliptin Phosphate, Metformin Hydrochloride Drug Combination |
| D000068900 | Sitagliptin Phosphate |
| ID | Term |
|---|---|
| D014312 | Trisaccharides |
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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placebo medication
| Placebo acarbose | Drug | acarbose placebo |
|
|
| placebo metformin | Drug | metformin placebo |
|
|
The change of PPG2hr (post prandia blood glucose 2hr from baseline to 24 weeks of treatment between 3 groups
| baseline, 24 weeks |
| Changes in Glucose During Meal Tolerance Test Between 2 Group(Group 1 vs Group 2), | Change of AUC(area under the curve) of glucose at 16 week from baseline between 2 groups (placebo+metformin + sitagliptin vs acarbose + metformin + sitagliptin) | Visit 2(baseline) and Visit 5(16W) |
| Changes in Insulin During Mixed Meal Tolerance Test Between 2 Group(Group 1 vs Group 2), | Change of AUC(area under the curve) of insulin at 16 week from baseline between 2 groups (placebo+metformin + sitagliptin vs acarbose + metformin + sitagliptin) | Visit 2(baseline) and Visit 5(16W) |
| Change in Active GLP-1 at 0 Minute During Mixed Meal Test Between 2 Groups (Group 1, group2) | Change of active GLP-1 at 0 minute during mixed meal test at 16 week from baseline between 2 groups(group1, group2) | baseline, 16 week |
| Change in Active GLP-1 at 120 Minute During Mixed Meal Test Between 2 Groups (Group 1, group2) | Change of active GLP-1 at 120 minute during mixed meal test at 16 week from baseline between 2 groups(group1, group2) | baseline, 16 week |
| Changes in Glucagon During Meal Tolerance Test Between 2 Group(Group 1 vs Group 2), | Change of AUC(area under the curve) of glucagon at 16 week from baseline between 2 groups (placebo+metformin + sitagliptin vs acarbose + metformin + sitagliptin) | Visit 2(baseline) and Visit 5(16W) |
Change of standard deviation of CGMS(continuous glucose monitoring system) data at 16 week from baseline between 3 groups (placebo+metformin + sitagliptin vs acarbose + metformin + sitagliptin vs placebo + acarbose + sitagliptin) |
| Visit 2(baseline) and Visit 5(16W) |
| Changes in MAGE of Glucose During CGMS Between 2 Group(Group 1 vs Group 2), | Change of mean amplitude of glycemic excursion of CGMS(continuous glucose monitoring system) data at 16 week from baseline between 2 groups (placebo+metformin + sitagliptin vs acarbose + metformin + sitagliptin) | Visit 2(baseline) and Visit 5(16W) |
| Adverse Event |
|
| other cause |
|
| BG001 | Sitagliptin, Metformin, Acarbose | The group's drugs not include placebo. (Metformin, Sitagliptin, Acarbose) Acarbose: The dose of Acarbose or its placebo should be 50mg b.i.d at first. At the 2nd week and the 4th week, it should be 50mg t.i.d and 100mg t.i.d respectively |
| BG002 | Metformin Placebo, Sitagliptin, Acarbose | The Metformin placebo should be changed into real Metformin from the 16th week. Acarbose: The dose of Acarbose or its placebo should be 50mg b.i.d at first. At the 2nd week and the 4th week, it should be 50mg t.i.d and 100mg t.i.d respectively |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Metformin and sitagliptin and acarbose treatment for 24 weeks.
| OG002 | Placebo+Sitagliptin+Acarbose | Placebo and sitagliptin and acarbose treatment for 16 weeks. The placebo will be changed to Metformin from the 16th week and maintained another 8 week for triple combination of metformin + sitagliptin + acarbose. |
|
|
|
| Secondary | The Change of HbA1c From Baseline to 24 Weeks of Treatment | The change of glycated hemoglogin(HbA1c) from baseline to 24 weeks of treatment between 3 groups | ITT: intention to treatment, All subject randomized to each treatment group | Posted | Mean | Standard Deviation | % of HbA1c | baseline, 24 weeks |
|
|
|
|
| Secondary | The Change of PPG2hr From Baseline to 24 Weeks of Treatment | The change of PPG2hr (post prandia blood glucose 2hr from baseline to 24 weeks of treatment between 3 groups | ITT: intention to treatment, All subject randomized to each treatment group | Posted | Mean | Standard Deviation | mmol/L | baseline, 24 weeks |
|
|
|
|
| Secondary | Changes in Glucose During Meal Tolerance Test Between 2 Group(Group 1 vs Group 2), | Change of AUC(area under the curve) of glucose at 16 week from baseline between 2 groups (placebo+metformin + sitagliptin vs acarbose + metformin + sitagliptin) | Posted | Mean | Standard Deviation | mg min/dL | Visit 2(baseline) and Visit 5(16W) |
|
|
|
|
| Secondary | Changes in Insulin During Mixed Meal Tolerance Test Between 2 Group(Group 1 vs Group 2), | Change of AUC(area under the curve) of insulin at 16 week from baseline between 2 groups (placebo+metformin + sitagliptin vs acarbose + metformin + sitagliptin) | Posted | Mean | Standard Deviation | pg min/mL | Visit 2(baseline) and Visit 5(16W) |
|
|
|
|
| Secondary | Change in Active GLP-1 at 0 Minute During Mixed Meal Test Between 2 Groups (Group 1, group2) | Change of active GLP-1 at 0 minute during mixed meal test at 16 week from baseline between 2 groups(group1, group2) | Posted | Mean | Standard Deviation | pg/ml | baseline, 16 week |
|
|
|
|
| Secondary | Change in Active GLP-1 at 120 Minute During Mixed Meal Test Between 2 Groups (Group 1, group2) | Change of active GLP-1 at 120 minute during mixed meal test at 16 week from baseline between 2 groups(group1, group2) | Posted | Mean | Standard Deviation | pg/ml | baseline, 16 week |
|
|
|
|
| Secondary | Changes in Glucagon During Meal Tolerance Test Between 2 Group(Group 1 vs Group 2), | Change of AUC(area under the curve) of glucagon at 16 week from baseline between 2 groups (placebo+metformin + sitagliptin vs acarbose + metformin + sitagliptin) | Posted | Mean | Standard Deviation | min pg/mL | Visit 2(baseline) and Visit 5(16W) |
|
|
|
|
| Other Pre-specified | Changes in Mean Glucose During CGMS Between 3 Group | Change of mean glucose of CGMS(continuous glucose monitoring system) data at 16 week from baseline between 3 groups | Posted | Mean | Standard Deviation | mmol/L | Visit 2(baseline) and Visit 5(16W) |
|
|
|
|
| Other Pre-specified | Changes in Variation of Glucose During CGMS Between 3 Group | Change of standard deviation of CGMS(continuous glucose monitoring system) data at 16 week from baseline between 3 groups (placebo+metformin + sitagliptin vs acarbose + metformin + sitagliptin vs placebo + acarbose + sitagliptin) | Posted | Mean | Standard Deviation | mmol/L | Visit 2(baseline) and Visit 5(16W) |
|
|
|
|
| Other Pre-specified | Changes in MAGE of Glucose During CGMS Between 2 Group(Group 1 vs Group 2), | Change of mean amplitude of glycemic excursion of CGMS(continuous glucose monitoring system) data at 16 week from baseline between 2 groups (placebo+metformin + sitagliptin vs acarbose + metformin + sitagliptin) | Posted | Mean | Standard Deviation | mg/dL | Visit 2(baseline) and Visit 5(16W) |
|
|
|
|
| 0 |
| 65 |
| 2 |
| 65 |
| 14 |
| 65 |
| EG001 | Sitagliptin, Metformin, Acarbose | The group's drugs not include placebo. (Metformin, Sitagliptin, Acarbose) Acarbose: The dose of Acarbose or its placebo should be 50mg b.i.d at first. At the 2nd week and the 4th week, it should be 50mg t.i.d and 100mg t.i.d respectively | 0 | 66 | 1 | 66 | 19 | 66 |
| EG002 | Metformin Placebo, Sitagliptin, Acarbose | The Metformin placebo should be changed into real Metformin from the 16th week. Acarbose: The dose of Acarbose or its placebo should be 50mg b.i.d at first. At the 2nd week and the 4th week, it should be 50mg t.i.d and 100mg t.i.d respectively | 0 | 34 | 0 | 34 | 11 | 34 |
| lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
|
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
|
| visual acuity reduced | Eye disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| abdominal discomfort | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| abdominal distension | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| abdominal pain | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| chronic gastritis | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| constipation | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| dental caries | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| diarrhea | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| dyspepsia | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| flatulence | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| large intestinal polyp | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| nausea | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| toothcache | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| vomiting | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| chest pain | General disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| hordeolum | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
|
| nasopharyngitis | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
|
| urinary tract infection | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
|
| laceration | Injury, poisoning and procedural complications | MedDRA (17.1) | Non-systematic Assessment |
|
| tooth fracture | Injury, poisoning and procedural complications | MedDRA (17.1) | Non-systematic Assessment |
|
| wrist fracture | Injury, poisoning and procedural complications | MedDRA (17.1) | Non-systematic Assessment |
|
| ALT increased | Investigations | MedDRA (17.1) | Systematic Assessment |
|
| AST increased | Investigations | MedDRA (17.1) | Systematic Assessment |
|
| liver function test abnormal | Investigations | MedDRA (17.1) | Systematic Assessment |
|
| diabetes mellitus inadequate controll | Metabolism and nutrition disorders | MedDRA (17.1) | Systematic Assessment |
|
| hyperglycemia | Metabolism and nutrition disorders | MedDRA (17.1) | Systematic Assessment |
|
| hypoglycemia | Metabolism and nutrition disorders | MedDRA (17.1) | Systematic Assessment |
|
| lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| uterine leimyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.1) | Non-systematic Assessment |
|
| dizziness | Nervous system disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| paresthesia | Nervous system disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| tremor | Nervous system disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| prorteinuria | Renal and urinary disorders | MedDRA (17.1) | Systematic Assessment |
|
| pelvic pain | Reproductive system and breast disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| pruritus | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| vitiligo | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Non-systematic Assessment |
|
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| D004700 | Endocrine System Diseases |
| D008687 |
| Metformin |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011719 | Pyrazines |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |