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| Name | Class |
|---|---|
| Mackay Memorial Hospital | OTHER |
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This 24-weeks study will to compare the glycemic efficacy and safety of sitagliptin with pioglitazone in patients with type 2 diabetes who had inadequate glycemic control despite dual therapy with metformin and a sulfonylurea.
This is a prospective, open-label, randomized, parallel, 24-week study. Inclusion criteria: type 2 diabetes patients who were treated with stable doses of sulfonylurea and metformin to their half maximally dose (sulfonylureas > half maximal dose, and metformin > 1500 mg/d) for > 10 weeks. > 20 years old; A1C:> 7.0 % and < 11% Exclusion criteria: insulin use within 12 weeks of the screening visit, any contraindications for use of sitagliptin or pioglitazone, impaired renal function (serum creatinine > 1.4 mg/dl), alanine aminotransferase (ALT) or aspartate aminotransferase levels (AST) > 2.5 times the upper limit of normal (ULN), current or prepare to pregnancy and lactation.
Primary Purpose:
compare the change in hemoglobin A1c and the proportion of patients achieving A1C < 7% between the 2 groups
Secondary Purposes:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sitagliptin | Active Comparator | add sitagliptin100mg/d to pre-study OADs |
|
| pioglitazone | Active Comparator | add pioglitazone 30mg/d to pre-study OADs |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sitagliptin | Drug | add sitagliptin100mg/d to pre-study OADs |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Glycosylated Hemoglobin (A1C) | A1C change from baseline to 24 weeks | 24 weeks |
| Baseline A1C | baseline A1C | Baseline |
| The Percentages of Patient Achieving an A1C <7% | The percentages of patient achieving an A1C <7% at endpoint | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Fasting Plasma Glucose | fasting serum sugar change from baseline to 24 weeks | 24 weeks |
| Changes in High Sensitive C-reactive Protein | fasting high sensitive serum C-reactive protein change from baseline to 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sung-Chen Liu, MD | Division of Endocrinology and Metabolism, Department of Internal Medicine, Mackay Memorial Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Endocrinology and Metabolism, Department of Internal Medicine, Mackay Memorial Hospital | Taipei | Taipei | 10449 | Taiwan |
we screened 135 patients and 120 patients were randomized in a 1: 1 ratio to one of the treatment groups.
reson for excluded: 4 patients: ALT or AST >2.5x ULN 8 patiens : withdraw informed consent 3 patiens: baseline A1C>11%
The study was started from 01 OCT 2009 to 27 SEP 2011
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| ID | Title | Description |
|---|---|---|
| FG000 | Sitagliptin | add sitagliptin100mg/d to pre-study OADs |
| FG001 | Pioglitazone | add pioglitazone 30mg/d to pre-study OADs |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sitagliptin | add sitagliptin100mg/d to pre-study OADs |
| BG001 | Pioglitazone | add pioglitazone 30mg/d to pre-study OADs |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Mean Change in Glycosylated Hemoglobin (A1C) | A1C change from baseline to 24 weeks | An intent-to-treat analysis with last observation carried forward was used to assess efficacy. | Posted | Least Squares Mean | Standard Error | percentage of Hb | 24 weeks |
|
adverse event was recorded after 12 weeks and 24 weeks treatment or was recorded if adverse event was noted at any time during the study period.
All adverse events was recorded after treatment. Symptomatic hypoglycemia was defined as an event with clinical symptoms consistent with hypoglycemia and severe hypoglycemia was defined as an event with symptoms consistent with hypoglycemia in which the patient required the assistance of another person.
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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 | Sitagliptin | add sitagliptin100mg/d to pre-study OADs |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| edema | General disorders | Systematic Assessment | 12 patients in the pioglitazone group had peripheral edema after treamtnet for 12 weeks and 16 patients had edema after treatment for 24 weeks. No edema in the sitagliptin group was noted. |
The reasons for withdrawal:
lost to follow-up:2 in pioglitazone and 2 in sitagliptin protocol violation:4 in pioglitazone and 3 in sitagliptin edema:1 in pioglitazone, ALT >3 times ULN:1 in pioglitazone gastrointestinal events:1 in sitagliptin
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sung-Chen Liu | Department of Internal Medicine, Mackay Memorial Hospital | 886-2-2543-3535 | 2174 | pine3.tw@yahoo.com.tw |
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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 |
|---|---|
| D000068900 | Sitagliptin Phosphate |
| D000077205 | Pioglitazone |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| pioglitazone | Drug | add pioglitazone 30mg/d to pre-study OADs |
|
|
| 24 weeks |
| Changes in Homoeostasis Model Assessment of Insulin Resistance (HOMA-IR) | HOMA-IR change from baseline to 24 weeks | 24 weeks |
| Body Weight Change | body weight change from baseline to 24 weeks | 24 weeks |
| Percentages of Patients With Total Adverse Events (AE) | percentages of total adverse events | 24 weeks |
| Change in Fasting Total-cholesterol | Total-cholesterol change from baseline to 24 weeks | 24 weeks |
| Change in Fasting Low-density Lipoprotein Cholesterol (LDL-C) | LDL-C change from baseline to 24 weeks | 24 weeks |
| Change in Fasting Triglycerides(TG) | TG change from baseline to 24 weeks | 24 weeks |
| Change in Fasting High-density Lipoprotein Cholesterol(HDL-C) | HDL-C change from baseline to 24 weeks | 24 weeks |
| Change in Fasting Plasma Alanine-aminotransferase (ALT) | ALT change from baseline to 24 weeks | 24 weeks |
| Percentages of Patients With Mild to Moderate Hypoglycemia | Incidence of mild to moderate hypoglycemia after treatment | 24 weeks |
| Percentages of Patients With Edema | proportion of edema after treatment | 24 weeks |
| Percentages of Patients With Gastrointestinal Adverse Events | Proportion of Gastrointestinal adverse events after treatment | 24 weeks |
| Percentages of Patients With Nasopharyngitis | Proportion of Nasopharyngitis after treatment | 24 weeks |
| Percentages of Patients With Severe Hypoglycemia | Proportion of severe hypoglycemia after treatment | 24 weeks |
| Baseline Fasting Plasma Glucose | Baseline fasting plasma glucose | baseline |
| Baseline High Sensitive C-reactive Protein | Baseline high sensitive C-reactive Protein | baseline |
| Baseline Homoeostasis Model Assessment of Insulin Resistance (HOMA-IR) | Baseline HOMA-IR | Baseline HOMA-IR |
| Baseline Alanine-aminotransferase (ALT) | Baseline alanine-aminotransferase | Baseline |
| Baseline Body Weight | Baseline body weight | Baseline |
| Baseline Total Cholesterol | Baseline Total cholesterol | Baseline |
| Baseline Triglyceride (TG) | Baseline TG | Baseline |
| Baseline Low-density Lipoprotein Cholesterol (LDL-C) | Baseline LDL-C | Baseline |
| Baseline High-density Lipoprotein Cholesterol (HDL-C) | Baseline HDL-C | Baseline |
| Protocol Violation |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
| Secondary | Changes in Fasting Plasma Glucose | fasting serum sugar change from baseline to 24 weeks | An intent-to-treat (ITT) analysis with last observation carried forward was used to assess efficacy. | Posted | Least Squares Mean | Standard Error | mg/dl | 24 weeks |
|
|
|
| Secondary | Changes in High Sensitive C-reactive Protein | fasting high sensitive serum C-reactive protein change from baseline to 24 weeks | An intent-to-treat analysis with last observation carried forward was used to assess efficacy | Posted | Least Squares Mean | Standard Error | mg/dl | 24 weeks |
|
|
|
| Secondary | Changes in Homoeostasis Model Assessment of Insulin Resistance (HOMA-IR) | HOMA-IR change from baseline to 24 weeks | An intent-to-treat analysis with last observation carried forward was used to assess efficacy | Posted | Least Squares Mean | Standard Error | HOMA-IR score | 24 weeks |
|
|
|
| Secondary | Body Weight Change | body weight change from baseline to 24 weeks | An intent-to-treat analysis with last observation carried forward was used to assess efficacy | Posted | Least Squares Mean | Standard Error | kg | 24 weeks |
|
|
|
| Secondary | Percentages of Patients With Total Adverse Events (AE) | percentages of total adverse events | All patients who had taken at least one dose of study medication were included in the safety analysis | Posted | Number | percentage | 24 weeks |
|
|
|
| Secondary | Change in Fasting Total-cholesterol | Total-cholesterol change from baseline to 24 weeks | An intent-to-treat analysis with last observation carried forward was used to assess efficacy. | Posted | Least Squares Mean | Standard Error | mg/dl | 24 weeks |
|
|
|
| Secondary | Change in Fasting Low-density Lipoprotein Cholesterol (LDL-C) | LDL-C change from baseline to 24 weeks | An intent-to-treat analysis with last observation carried forward was used to assess efficacy | Posted | Least Squares Mean | Standard Error | mg/dl | 24 weeks |
|
|
|
| Secondary | Change in Fasting Triglycerides(TG) | TG change from baseline to 24 weeks | An intent-to-treat analysis with last observation carried forward was used to assess efficacy. | Posted | Least Squares Mean | Standard Error | mg/dl | 24 weeks |
|
|
|
| Secondary | Change in Fasting High-density Lipoprotein Cholesterol(HDL-C) | HDL-C change from baseline to 24 weeks | An intent-to-treat analysis with last observation carried forward was used to assess efficacy. | Posted | Least Squares Mean | Standard Error | mg/dl | 24 weeks |
|
|
|
| Secondary | Change in Fasting Plasma Alanine-aminotransferase (ALT) | ALT change from baseline to 24 weeks | An intent-to-treat analysis with last observation carried forward was used to assess efficacy | Posted | Least Squares Mean | Standard Error | IU/L | 24 weeks |
|
|
|
| Secondary | Percentages of Patients With Mild to Moderate Hypoglycemia | Incidence of mild to moderate hypoglycemia after treatment | All patients who had taken at least one dose of study medication were included in the safety analysis | Posted | Number | percentage | 24 weeks |
|
|
|
| Secondary | Percentages of Patients With Edema | proportion of edema after treatment | All patients who had taken at least one dose of study medication were included in the safety analysis | Posted | Number | percentage | 24 weeks |
|
|
|
| Secondary | Percentages of Patients With Gastrointestinal Adverse Events | Proportion of Gastrointestinal adverse events after treatment | All patients who had taken at least one dose of study medication were included in the safety analysis | Posted | Number | percentge | 24 weeks |
|
|
|
| Secondary | Percentages of Patients With Nasopharyngitis | Proportion of Nasopharyngitis after treatment | All patients who had taken at least one dose of study medication were included in the safety analysis | Posted | Number | percentage | 24 weeks |
|
|
|
| Primary | Baseline A1C | baseline A1C | baseline Laboratory measurements | Posted | Mean | Standard Deviation | percentage of Hb | Baseline |
|
|
|
| Primary | The Percentages of Patient Achieving an A1C <7% | The percentages of patient achieving an A1C <7% at endpoint | The percentages of patient achieving an A1C <7% at endpoint | Posted | Number | percentage | 24 weeks |
|
|
|
|
| Secondary | Percentages of Patients With Severe Hypoglycemia | Proportion of severe hypoglycemia after treatment | Proportion of severe ypoglycemia after treatment | Posted | Number | percentage | 24 weeks |
|
|
|
| Secondary | Baseline Fasting Plasma Glucose | Baseline fasting plasma glucose | Baseline fasting plasma glucose | Posted | Mean | Standard Deviation | mg/dl | baseline |
|
|
|
| Secondary | Baseline High Sensitive C-reactive Protein | Baseline high sensitive C-reactive Protein | Baseline high sensitive C-reactive Protein | Posted | Mean | Standard Deviation | mg/dl | baseline |
|
|
|
| Secondary | Baseline Homoeostasis Model Assessment of Insulin Resistance (HOMA-IR) | Baseline HOMA-IR | Baseline HOMA-IR | Posted | Mean | Standard Deviation | HOMA-IR score | Baseline HOMA-IR |
|
|
|
| Secondary | Baseline Alanine-aminotransferase (ALT) | Baseline alanine-aminotransferase | Baseline alanine-aminotransferase | Posted | Mean | Standard Deviation | IU/L | Baseline |
|
|
|
| Secondary | Baseline Body Weight | Baseline body weight | Baseline body weight | Posted | Mean | Standard Deviation | kg | Baseline |
|
|
|
| Secondary | Baseline Total Cholesterol | Baseline Total cholesterol | Baseline Total cholesterol | Posted | Mean | Standard Deviation | mg/dl | Baseline |
|
|
|
| Secondary | Baseline Triglyceride (TG) | Baseline TG | Baseline TG | Posted | Mean | Standard Deviation | mg/dl | Baseline |
|
|
|
| Secondary | Baseline Low-density Lipoprotein Cholesterol (LDL-C) | Baseline LDL-C | Baseline LDL-C | Posted | Mean | Standard Deviation | mg/dl | Baseline |
|
|
|
| Secondary | Baseline High-density Lipoprotein Cholesterol (HDL-C) | Baseline HDL-C | Baseline HDL-C | Posted | Mean | Standard Deviation | mg/dl | Baseline |
|
|
|
| 0 |
| 60 |
| 26 |
| 60 |
| EG001 | Pioglitazone | add pioglitazone 30mg/d to pre-study OADs | 0 | 60 | 31 | 60 |
|
| Hypoglycemia | General disorders | Systematic Assessment | Hypoglycemic events occurred in 5 patients in the pioglitazone group and in 6 patients in the sitagliptin group. All the adverse events were mild to moderate. |
|
| Gastrointestinal adverse event | Gastrointestinal disorders | Systematic Assessment | Gastrointestinal adverse event was recorded at any visit after treatment |
|
| Nasopharyngitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Nasopharyngitis was recorded at every visit |
|
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| D004700 | Endocrine System Diseases |
| D011719 |
| Pyrazines |
| D045162 | Thiazolidinediones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |