Diabetes Mellitus
Conditions
Keywords
Diabetes Mellitus, Drug Therapy, Diabetes Mellitus, Type II, Type 2 Diabetes Mellitus, Hyperinsulinism, Insulin Resistance
Brief summary
The purpose of this study is to determine the safety and efficacy of alogliptin, once daily (QD), compared to diet and exercise, sulfonylurea, metformin and a combination of sulfonylurea and metformin for treating subjects with type 2 diabetes.
Detailed description
Of the approximately 19 million people in the United States who have been diagnosed with diabetes mellitus, 90% to 95% have type 2 diabetes mellitus. The prevalence of type 2 diabetes mellitus varies among racial and ethnic populations and has been shown to increase with age, obesity, family history, history of gestational diabetes, and physical inactivity. Over the next decade, a disproportionate increase in the elderly population will result in a marked increase in diabetic patients, placing an ever-increasing burden on families and the health care system. In response to this problem, Takeda Global Research & Development Center, Inc. is developing SYR-322 (alogliptin), a selective, orally available inhibitor of the enzyme dipeptidyl peptidase IV. Dipeptidyl peptidase IV is thought to be primarily responsible for the in vivo degradation of 2 peptide hormones released in response to nutrient ingestion, namely glucagon-like peptide-1 and glucose-dependent insulinotropic peptide. Individuals who want to participate in this study will be required to provide written informed consent. Study participation is anticipated to be about 14 Weeks. Multiple procedures will occur at each visit which may include blood collection, urine collection, vital signs including sitting and standing blood pressure and pulse, body height and weight, physical examinations and electrocardiograms.
Interventions
DRUGAlogliptin
Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks
DRUGPlacebo
Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.
Sponsors
Takeda
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Has type 2 diabetes mellitus and were either receiving no current treatment or currently treated with a sulfonylurea, metformin, or a combination of a sulfonylurea and metformin but experiencing inadequate glycemic control. Subjects qualified as receiving no current treatment if 1 of the following conditions applied: * Subject was newly diagnosed (ie, had not received any treatment). * Subject was treated with diet and exercise alone for the 3 months prior to Screening * Subject had received \<7 continuous days of any antidiabetic therapy within the 3 months prior to Screening. * Subject had a diagnosis of type 2 diabetes mellitus based on current American Diabetes Association criteria: fasting plasma glucose ≥126 mg/dL, oral glucose tolerance test at 2 hours after administration of the glucose load must have been ≥200 mg/dL, or symptoms of diabetes plus casual plasma glucose ≥200 mg/dL. * Body mass index ≥23 kg/m2 and ≤40 kg/m2. * Fasting C-peptide concentration ≥0.8 ng/mL. * Glycosylated hemoglobin concentration between 6.8% and 11.0%. * Fasting plasma glucose \>126 mg/dL at Screening. * No treatment within the 3 months prior to Screening with any other agents known to have effects on glucose (other than as described above, a sulfonylurea, metformin, or a combination of a sulfonylurea and metformin in subjects on antidiabetics), including but not limited to the following: * Other antidiabetic agents * Investigational antidiabetic agents * Niacin * Regular use of systemic glucocorticoids. * No treatment within the 3 months prior to Screening with weight-loss drugs * If taking other non-excluded medications, must have been on a stable dose of medication for at least 4 weeks. * Diastolic blood pressure ≤110 mm Hg and a systolic pressure of ≤180 mm Hg. * Female subjects could neither be pregnant (confirmed by laboratory testing) nor lactating, and if of childbearing potential must have been practicing adequate contraception. * Able and willing to monitor their own blood glucose concentrations with a home glucose monitor. * No major illness or debility that in the investigator's opinion prohibited the subject from completing the study. * Hemoglobin ≥12 g/dL for males and ≥10 g/dL for females. * Hepatic transaminase ≤2 x upper limit of normal.
Exclusion criteria
* History of cancer, other than squamous cell or basal cell carcinoma of the skin, that had not been in full remission for at least 1 year prior to Screening. * History of proteinuria \>1000 mg/day on a 12- or 24-hour urine collection OR a urine albumin/creatinine ratio \>1000 μg/mg at Screening. If elevated, the subject was to be rescreened within 1 week. * Serum creatinine ≥2.0 mg/dL. * History of proliferative diabetic retinopathy OR any history of laser-treated retinopathy. * History of treated peripheral or autonomic neuropathy. * History of systolic dysfunction congestive heart failure. * History of myocardial infarction within 1 year prior to Screening. * History of ulcerative colitis or Crohn's disease. * History of infection with hepatitis B, hepatitis C, or human immunodeficiency virus. * History of a psychiatric disorder that would affect the subject's ability to participate in the study. * History of anaphylactic reaction(s) to any drug. * History of angioedema. * History of alcohol or substance abuse within the last 2 years. * History of any surgery that could potentially affect the absorption of the study drug. * Receipt of any investigational drug within the preceding 30 days or a history of receipt of an investigational antidiabetic drug within the preceding 90 days.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Day 85. | Baseline and Day 85. | The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at day 85 or final visit and glycosylated hemoglobin collected at baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Fasting Plasma Glucose (Day 43). | Baseline and Day 43 | The change between the value of fasting plasma glucose collected at day 43 and fasting plasma glucose collected at baseline. |
| Change From Baseline in Fasting Plasma Glucose (Day 85). | Baseline and Day 85. | The change between the value of fasting plasma glucose collected at day 85 or final visit and fasting plasma glucose collected at baseline. |
| Change From Baseline in Fasting Fructosamine (Day 43). | Baseline and Day 43. | The change between the value of fasting fructosamine collected at day 43 and fasting fructosamine collected at baseline. |
| Change From Baseline in Fasting Fructosamine (Day 85). | Baseline and Day 85. | The change between the value of fasting fructosamine collected at day 85 or final visit and fasting fructosamine collected at baseline. |
| Change From Baseline in Total Cholesterol (Day 43). | Baseline and Day 43 | The change between the value of cholesterol collected at day 43 and cholesterol collected at baseline. |
| Change From Baseline in Total Cholesterol (Day 85). | Baseline and Day 85. | The change between the value of cholesterol collected at day 85 or final visit and cholesterol collected at baseline. |
| Change From Baseline in Glycosylated Hemoglobin at Day 43. | Baseline and Day 43. | The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at day 43 and glycosylated hemoglobin collected at baseline. |
| Change From Baseline in High-Density Lipoprotein Cholesterol (Day 85). | Baseline and Day 85. | The change between high-density lipoprotein cholesterol collected at day 85 or final visit and high-density lipoprotein cholesterol collected at baseline. |
| Change From Baseline in Low-Density Lipoprotein Cholesterol (Day 43). | Baseline and Day 43. | The change between low-density lipoprotein cholesterol collected at day 43 and low-density lipoprotein cholesterol collected at baseline. |
| Change From Baseline in Low-Density Lipoprotein Cholesterol (Day 85). | Baseline and Day 85. | The change between low-density lipoprotein cholesterol collected at day 85 or final visit and low-density lipoprotein cholesterol collected at baseline. |
| Change From Baseline in Triglycerides (Day 43). | Baseline and Day 43. | The change between triglycerides collected at day 43 and triglycerides collected at baseline. |
| Change From Baseline in Triglycerides (Day 85). | Baseline and Day 85. | The change between triglycerides collected at day 85 or final visit and triglycerides collected at baseline. |
| Mean Percent Incidence of Marked Hyperglycemia (Fasting Plasma Glucose ≥ 200 mg/dL). | 85 Days. | The incidence of marked hyperglycemia occurring in participants with a fasting plasma glucose value greater than or equal to 200 mg per dL during study. Overall mean obtained by weighting the hyperglycemia percent incidence values at each time point by number of days in between visits. Mean percent incidence of marked hyperglycemia at each time point is the percent of self-monitored blood glucose measurements greater than or equal to 200 mg per dL, calculated per participant and then averaged across population. |
| Change From Baseline in High-Density Lipoprotein Cholesterol (Day 43). | Baseline and Day 43. | The change between high-density lipoprotein cholesterol collected at day 43 and high-density lipoprotein cholesterol collected at baseline. |
Participant flow
Recruitment details
Participants enrolled at 62 sites in Chile and the United States from 17 March 2005 to 10 June 2005.
Pre-assignment details
Participants with a historical diagnosis of type 2 diabetes mellitus who were either receiving no current treatment or currently treated with diet and exercise, a sulfonylurea, metformin, or a combination of a sulfonylurea and metformin enrolled in once daily (QD) groups.
Participants by arm
| Arm | Count |
|---|---|
| Placebo QD Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks. | 43 |
| Alogliptin 6.25 mg QD Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks | 44 |
| Alogliptin 12.5 mg QD Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks. | 44 |
| Alogliptin 25 mg QD Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks. | 45 |
| Alogliptin 50 mg QD Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks. | 44 |
| Alogliptin 100 mg QD Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks. | 45 |
| Total | 265 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Administrative Error | 0 | 1 | 0 | 0 | 0 | 0 |
| Overall Study | Adverse Event | 0 | 0 | 0 | 1 | 3 | 2 |
| Overall Study | Hyperglycemic Rescue | 21 | 7 | 5 | 8 | 8 | 7 |
| Overall Study | Lost to Follow-up | 0 | 2 | 1 | 0 | 4 | 2 |
| Overall Study | Participant Non-compliance | 0 | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Physician Decision | 1 | 3 | 0 | 1 | 0 | 1 |
| Overall Study | Protocol Violation | 1 | 1 | 1 | 1 | 1 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 3 | 5 | 2 | 0 | 1 |
Baseline characteristics
| Characteristic | Placebo QD | Alogliptin 6.25 mg QD | Alogliptin 12.5 mg QD | Alogliptin 25 mg QD | Alogliptin 50 mg QD | Alogliptin 100 mg QD | Total |
|---|---|---|---|---|---|---|---|
| Age, Customized <65 years | 33 participants | 38 participants | 33 participants | 36 participants | 31 participants | 34 participants | 205 participants |
| Age, Customized ≥65 years | 10 participants | 6 participants | 11 participants | 9 participants | 13 participants | 11 participants | 60 participants |
| Sex: Female, Male Female | 24 Participants | 25 Participants | 22 Participants | 17 Participants | 26 Participants | 25 Participants | 139 Participants |
| Sex: Female, Male Male | 19 Participants | 19 Participants | 22 Participants | 28 Participants | 18 Participants | 20 Participants | 126 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 14 / 41 | 12 / 42 | 18 / 44 | 19 / 45 | 15 / 43 | 22 / 44 |
| serious Total, serious adverse events | 2 / 41 | 1 / 42 | 0 / 44 | 1 / 45 | 0 / 43 | 0 / 44 |
Outcome results
Primary
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Day 85.
The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at day 85 or final visit and glycosylated hemoglobin collected at baseline.
Time frame: Baseline and Day 85.
Population: Randomized subjects who received at least 1 dose of study drug (Intent to Treat), and who had measurements at baseline and at Day 85. Missing data are imputed using last observation carried forward (LOCF).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo QD | Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Day 85. | -0.01 percentage of Glycosylated Hemoglobin | Standard Error 0.135 |
| Alogliptin 6.25 mg QD | Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Day 85. | -0.19 percentage of Glycosylated Hemoglobin | Standard Error 0.121 |
| Alogliptin 12.5 mg QD | Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Day 85. | -0.54 percentage of Glycosylated Hemoglobin | Standard Error 0.122 |
| Alogliptin 25 mg QD | Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Day 85. | -0.56 percentage of Glycosylated Hemoglobin | Standard Error 0.117 |
| Alogliptin 50 mg QD | Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Day 85. | -0.44 percentage of Glycosylated Hemoglobin | Standard Error 0.124 |
| Alogliptin 100 mg QD | Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Day 85. | -0.51 percentage of Glycosylated Hemoglobin | Standard Error 0.119 |
Comparison: The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c. With at least 234 patients, a two-group t-test with a 0.05 two-sided significance has at least 98% power to detect a treatment difference (all active versus placebo) in HbA1c change from baseline as small as 0.55%, assuming a common standard deviation of 0.7%.p-value: 0.001ANCOVA
Comparison: The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c. With at least 234 patients, a two-group t-test with a 0.05 two-sided significance level has 90% power to detect a treatment difference (each active dose versus placebo) in HbA1c change from baseline as small as 0.55%, assuming a common standard deviation of 0.7%.p-value: 0.004ANCOVA
Comparison: The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c. With at least 234 patients, a two-group t-test with a 0.05 two-sided significance level has 90% power to detect a treatment difference (each active dose versus placebo) in HbA1c change from baseline as small as 0.55%, assuming a common standard deviation of 0.7%.p-value: 0.017ANCOVA
Comparison: The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c. With at least 234 patients, a two-group t-test with a 0.05 two-sided significance level has 90% power to detect a treatment difference (each active dose versus placebo) in HbA1c change from baseline as small as 0.55%, assuming a common standard deviation of 0.7%.p-value: 0.001ANCOVA
Comparison: The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c. With at least 234 patients, a two-group t-test with a 0.05 two-sided significance level has 90% power to detect a treatment difference (each active dose versus placebo) in HbA1c change from baseline as small as 0.55%, assuming a common standard deviation of 0.7%.p-value: 0.003ANCOVA
Comparison: The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c. With at least 234 patients, a two-group t-test with a 0.05 two-sided significance level has 90% power to detect a treatment difference (each active dose versus placebo) in HbA1c change from baseline as small as 0.55%, assuming a common standard deviation of 0.7%.p-value: 0.307ANCOVA
Secondary
Change From Baseline in Fasting Fructosamine (Day 43).
The change between the value of fasting fructosamine collected at day 43 and fasting fructosamine collected at baseline.
Time frame: Baseline and Day 43.
Population: Randomized subjects who received at least 1 dose of study drug (Intent to Treat), and who had measurements at baseline and at Day 43. Missing data are imputed using last observation carried forward (LOCF).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo QD | Change From Baseline in Fasting Fructosamine (Day 43). | 7.6 mg/dL | Standard Error 5.35 |
| Alogliptin 6.25 mg QD | Change From Baseline in Fasting Fructosamine (Day 43). | -4.2 mg/dL | Standard Error 5.16 |
| Alogliptin 12.5 mg QD | Change From Baseline in Fasting Fructosamine (Day 43). | -13.1 mg/dL | Standard Error 5.12 |
| Alogliptin 25 mg QD | Change From Baseline in Fasting Fructosamine (Day 43). | -14.5 mg/dL | Standard Error 5.05 |
| Alogliptin 50 mg QD | Change From Baseline in Fasting Fructosamine (Day 43). | -16.3 mg/dL | Standard Error 5.47 |
| Alogliptin 100 mg QD | Change From Baseline in Fasting Fructosamine (Day 43). | -11.7 mg/dL | Standard Error 5.09 |
Comparison: The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in fasting fructosamine. The treatment effect will be evaluated as a contrast of all doses of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.p-value: <0.001ANCOVA
Comparison: The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in fasting fructosamine. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.p-value: 0.01ANCOVA
Comparison: The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in fasting fructosamine. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.p-value: 0.002ANCOVA
Comparison: The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in fasting fructosamine. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.p-value: 0.003ANCOVA
Comparison: The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in fasting fructosamine. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.p-value: 0.006ANCOVA
Comparison: The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in fasting fructosamine. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.p-value: 0.117ANCOVA
Secondary
Change From Baseline in Fasting Fructosamine (Day 85).
The change between the value of fasting fructosamine collected at day 85 or final visit and fasting fructosamine collected at baseline.
Time frame: Baseline and Day 85.
Population: Randomized subjects who received at least 1 dose of study drug (Intent to Treat), and who had measurements at baseline and at Day 85. Missing data are imputed using last observation carried forward (LOCF).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo QD | Change From Baseline in Fasting Fructosamine (Day 85). | 7.7 mg/dL | Standard Error 6.03 |
| Alogliptin 6.25 mg QD | Change From Baseline in Fasting Fructosamine (Day 85). | 0.2 mg/dL | Standard Error 5.91 |
| Alogliptin 12.5 mg QD | Change From Baseline in Fasting Fructosamine (Day 85). | -9.8 mg/dL | Standard Error 5.93 |
| Alogliptin 25 mg QD | Change From Baseline in Fasting Fructosamine (Day 85). | -16.4 mg/dL | Standard Error 5.71 |
| Alogliptin 50 mg QD | Change From Baseline in Fasting Fructosamine (Day 85). | -12.4 mg/dL | Standard Error 6.25 |
| Alogliptin 100 mg QD | Change From Baseline in Fasting Fructosamine (Day 85). | -4.8 mg/dL | Standard Error 5.82 |
Comparison: The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in fasting fructosamine. The treatment effect will be evaluated as a contrast of all doses of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.p-value: 0.014ANCOVA
Comparison: The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in fasting fructosamine. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.p-value: 0.136ANCOVA
Comparison: The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in fasting fructosamine. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.p-value: 0.022ANCOVA
Comparison: The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in fasting fructosamine. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.p-value: 0.004ANCOVA
Comparison: The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in fasting fructosamine. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.p-value: 0.04ANCOVA
Comparison: The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in fasting fructosamine. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.p-value: 0.378ANCOVA
Secondary
Change From Baseline in Fasting Plasma Glucose (Day 43).
The change between the value of fasting plasma glucose collected at day 43 and fasting plasma glucose collected at baseline.
Time frame: Baseline and Day 43
Population: Randomized subjects who received at least 1 dose of study drug (Intent to Treat), and who had measurements at baseline and at Day 43. Missing data are imputed using last observation carried forward (LOCF).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo QD | Change From Baseline in Fasting Plasma Glucose (Day 43). | 4.9 mg/dL | Standard Error 6.09 |
| Alogliptin 6.25 mg QD | Change From Baseline in Fasting Plasma Glucose (Day 43). | -7.3 mg/dL | Standard Error 6 |
| Alogliptin 12.5 mg QD | Change From Baseline in Fasting Plasma Glucose (Day 43). | -11.5 mg/dL | Standard Error 6.02 |
| Alogliptin 25 mg QD | Change From Baseline in Fasting Plasma Glucose (Day 43). | -24.5 mg/dL | Standard Error 5.8 |
| Alogliptin 50 mg QD | Change From Baseline in Fasting Plasma Glucose (Day 43). | -17.9 mg/dL | Standard Error 6.1 |
| Alogliptin 100 mg QD | Change From Baseline in Fasting Plasma Glucose (Day 43). | -25.6 mg/dL | Standard Error 5.88 |
Comparison: The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in fasting plasma glucose (FPG). The treatment effect was evaluated as a contrast of all doses of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.p-value: <0.001ANCOVA
Comparison: The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.p-value: <0.001ANCOVA
Comparison: The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.p-value: 0.009ANCOVA
Comparison: The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.p-value: <0.001ANCOVA
Comparison: The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.p-value: 0.057ANCOVA
Comparison: The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.p-value: 0.156ANCOVA
Secondary
Change From Baseline in Fasting Plasma Glucose (Day 85).
The change between the value of fasting plasma glucose collected at day 85 or final visit and fasting plasma glucose collected at baseline.
Time frame: Baseline and Day 85.
Population: Randomized subjects who received at least 1 dose of study drug (Intent to Treat), and who had measurements at baseline and at Day 85. Missing data are imputed using last observation carried forward (LOCF).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo QD | Change From Baseline in Fasting Plasma Glucose (Day 85). | 8.5 mg/dL | Standard Error 6.45 |
| Alogliptin 6.25 mg QD | Change From Baseline in Fasting Plasma Glucose (Day 85). | -7.8 mg/dL | Standard Error 6.36 |
| Alogliptin 12.5 mg QD | Change From Baseline in Fasting Plasma Glucose (Day 85). | -5.1 mg/dL | Standard Error 6.39 |
| Alogliptin 25 mg QD | Change From Baseline in Fasting Plasma Glucose (Day 85). | -27.0 mg/dL | Standard Error 6.14 |
| Alogliptin 50 mg QD | Change From Baseline in Fasting Plasma Glucose (Day 85). | -16.1 mg/dL | Standard Error 6.47 |
| Alogliptin 100 mg QD | Change From Baseline in Fasting Plasma Glucose (Day 85). | -20.9 mg/dL | Standard Error 6.23 |
Comparison: The null hypothesis that there is no difference between all doses of alogliptin and placebo arms in change from baseline in FPG. The treatment effect was evaluated as a contrast of all doses of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.p-value: <0.001ANCOVA
Comparison: The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.p-value: 0.001ANCOVA
Comparison: The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.p-value: 0.008ANCOVA
Comparison: The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.p-value: <0.001ANCOVA
Comparison: The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.p-value: 0.136ANCOVA
Comparison: The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.p-value: 0.073ANCOVA
Secondary
Change From Baseline in Glycosylated Hemoglobin at Day 43.
The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at day 43 and glycosylated hemoglobin collected at baseline.
Time frame: Baseline and Day 43.
Population: Randomized subjects who received at least 1 dose of study drug (Intent to treat), and who had measurements at baseline and at Day 43. Missing data are imputed using last observation carried forward (LOCF).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo QD | Change From Baseline in Glycosylated Hemoglobin at Day 43. | 0.02 percentage of Glycosylated Hemoglobin | Standard Error 0.097 |
| Alogliptin 6.25 mg QD | Change From Baseline in Glycosylated Hemoglobin at Day 43. | -0.12 percentage of Glycosylated Hemoglobin | Standard Error 0.095 |
| Alogliptin 12.5 mg QD | Change From Baseline in Glycosylated Hemoglobin at Day 43. | -0.35 percentage of Glycosylated Hemoglobin | Standard Error 0.096 |
| Alogliptin 25 mg QD | Change From Baseline in Glycosylated Hemoglobin at Day 43. | -0.36 percentage of Glycosylated Hemoglobin | Standard Error 0.093 |
| Alogliptin 50 mg QD | Change From Baseline in Glycosylated Hemoglobin at Day 43. | -0.32 percentage of Glycosylated Hemoglobin | Standard Error 0.097 |
| Alogliptin 100 mg QD | Change From Baseline in Glycosylated Hemoglobin at Day 43. | -0.31 percentage of Glycosylated Hemoglobin | Standard Error 0.094 |
Comparison: The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c. With at least 234 patients, a two-group t-test with a 0.05 two-sided significance level has at least 98% power to detect a treatment difference (all active versus placebo) in HbA1c change from baseline as small as 0.55%, assuming a common standard deviation of 0.7%.p-value: 0.004ANCOVA
Comparison: The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c. With at least 234 patients, a two-group t-test with a 0.05 two-sided significance level has 90% power to detect a treatment difference (each active dose versus placebo) in HbA1c change from baseline as small as 0.55%, assuming a common standard deviation of 0.7%.p-value: 0.017ANCOVA
Comparison: The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c. With at least 234 patients, a two-group t-test with a 0.05 two-sided significance level has 90% power to detect a treatment difference (each active dose versus placebo) in HbA1c change from baseline as small as 0.55%, assuming a common standard deviation of 0.7%.p-value: 0.016ANCOVA
Comparison: The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c. With at least 234 patients, a two-group t-test with a 0.05 two-sided significance level has 90% power to detect a treatment difference (each active dose versus placebo) in HbA1c change from baseline as small as 0.55%, assuming a common standard deviation of 0.7%.p-value: 0.005ANCOVA
Comparison: The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c. With at least 234 patients, a two-group t-test with a 0.05 two-sided significance level has 90% power to detect a treatment difference (each active dose versus placebo) in HbA1c change from baseline as small as 0.55%, assuming a common standard deviation of 0.7%.p-value: 0.008ANCOVA
Comparison: The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c. With at least 234 patients, a two-group t-test with a 0.05 two-sided significance level has 90% power to detect a treatment difference (each active dose versus placebo) in HbA1c change from baseline as small as 0.55%, assuming a common standard deviation of 0.7%.p-value: 0.321ANCOVA
Secondary
Change From Baseline in High-Density Lipoprotein Cholesterol (Day 43).
The change between high-density lipoprotein cholesterol collected at day 43 and high-density lipoprotein cholesterol collected at baseline.
Time frame: Baseline and Day 43.
Population: Randomized subjects who received at least 1 dose of study drug (Intent to Treat), and who had measurements at baseline and at Day 43. Missing data are imputed using last observation carried forward (LOCF).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo QD | Change From Baseline in High-Density Lipoprotein Cholesterol (Day 43). | -1.4 mg/dL | Standard Error 0.76 |
| Alogliptin 6.25 mg QD | Change From Baseline in High-Density Lipoprotein Cholesterol (Day 43). | -0.6 mg/dL | Standard Error 0.75 |
| Alogliptin 12.5 mg QD | Change From Baseline in High-Density Lipoprotein Cholesterol (Day 43). | -2.0 mg/dL | Standard Error 0.74 |
| Alogliptin 25 mg QD | Change From Baseline in High-Density Lipoprotein Cholesterol (Day 43). | -2.4 mg/dL | Standard Error 0.73 |
| Alogliptin 50 mg QD | Change From Baseline in High-Density Lipoprotein Cholesterol (Day 43). | -2.8 mg/dL | Standard Error 0.8 |
| Alogliptin 100 mg QD | Change From Baseline in High-Density Lipoprotein Cholesterol (Day 43). | -1.1 mg/dL | Standard Error 0.74 |
Comparison: The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HDL cholesterol. The treatment effect will be evaluated as a contrast of all doses of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.p-value: 0.689ANCOVA
Comparison: The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.p-value: 0.742ANCOVA
Comparison: The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.p-value: 0.22ANCOVA
Comparison: The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.p-value: 0.348ANCOVA
Comparison: The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.p-value: 0.627ANCOVA
Comparison: The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.p-value: 0.418ANCOVA
Secondary
Change From Baseline in High-Density Lipoprotein Cholesterol (Day 85).
The change between high-density lipoprotein cholesterol collected at day 85 or final visit and high-density lipoprotein cholesterol collected at baseline.
Time frame: Baseline and Day 85.
Population: Randomized subjects who received at least 1 dose of study drug (Intent to Treat), and who had measurements at baseline and at Day 85. Missing data are imputed using last observation carried forward (LOCF).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo QD | Change From Baseline in High-Density Lipoprotein Cholesterol (Day 85). | -1.9 mg/dL | Standard Error 0.87 |
| Alogliptin 6.25 mg QD | Change From Baseline in High-Density Lipoprotein Cholesterol (Day 85). | -0.7 mg/dL | Standard Error 0.86 |
| Alogliptin 12.5 mg QD | Change From Baseline in High-Density Lipoprotein Cholesterol (Day 85). | -2.3 mg/dL | Standard Error 0.85 |
| Alogliptin 25 mg QD | Change From Baseline in High-Density Lipoprotein Cholesterol (Day 85). | -2.5 mg/dL | Standard Error 0.83 |
| Alogliptin 50 mg QD | Change From Baseline in High-Density Lipoprotein Cholesterol (Day 85). | -2.0 mg/dL | Standard Error 0.92 |
| Alogliptin 100 mg QD | Change From Baseline in High-Density Lipoprotein Cholesterol (Day 85). | 0.4 mg/dL | Standard Error 0.84 |
Comparison: The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HDL cholesterol. The treatment effect will be evaluated as a contrast of all doses of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.p-value: 0.617ANCOVA
Comparison: The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.p-value: 0.052ANCOVA
Comparison: The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.p-value: 0.906ANCOVA
Comparison: The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.p-value: 0.628ANCOVA
Comparison: The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.p-value: 0.749ANCOVA
Comparison: The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.p-value: 0.34ANCOVA
Secondary
Change From Baseline in Low-Density Lipoprotein Cholesterol (Day 43).
The change between low-density lipoprotein cholesterol collected at day 43 and low-density lipoprotein cholesterol collected at baseline.
Time frame: Baseline and Day 43.
Population: Randomized subjects who received at least 1 dose of study drug (Intent to Treat), and who had measurements at baseline and at Day 43. Missing data are imputed using last observation carried forward (LOCF).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo QD | Change From Baseline in Low-Density Lipoprotein Cholesterol (Day 43). | -8.9 mg/dL | Standard Error 3.97 |
| Alogliptin 6.25 mg QD | Change From Baseline in Low-Density Lipoprotein Cholesterol (Day 43). | -3.8 mg/dL | Standard Error 3.79 |
| Alogliptin 12.5 mg QD | Change From Baseline in Low-Density Lipoprotein Cholesterol (Day 43). | -6.4 mg/dL | Standard Error 3.72 |
| Alogliptin 25 mg QD | Change From Baseline in Low-Density Lipoprotein Cholesterol (Day 43). | -1.5 mg/dL | Standard Error 3.69 |
| Alogliptin 50 mg QD | Change From Baseline in Low-Density Lipoprotein Cholesterol (Day 43). | -9.9 mg/dL | Standard Error 4.01 |
| Alogliptin 100 mg QD | Change From Baseline in Low-Density Lipoprotein Cholesterol (Day 43). | 0.8 mg/dL | Standard Error 3.84 |
Comparison: The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in LDL cholesterol. The treatment effect will be evaluated as a contrast of all doses of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.p-value: 0.269ANCOVA
Comparison: The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in LDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.p-value: 0.076ANCOVA
Comparison: The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in LDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.p-value: 0.867ANCOVA
Comparison: The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in LDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.p-value: 0.169ANCOVA
Comparison: The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in LDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.p-value: 0.645ANCOVA
Comparison: The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in LDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.p-value: 0.351ANCOVA
Secondary
Change From Baseline in Low-Density Lipoprotein Cholesterol (Day 85).
The change between low-density lipoprotein cholesterol collected at day 85 or final visit and low-density lipoprotein cholesterol collected at baseline.
Time frame: Baseline and Day 85.
Population: Randomized subjects who received at least 1 dose of study drug (Intent to Treat), and who had measurements at baseline and at Day 85. Missing data are imputed using last observation carried forward (LOCF).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo QD | Change From Baseline in Low-Density Lipoprotein Cholesterol (Day 85). | -13.6 mg/dL | Standard Error 3.72 |
| Alogliptin 6.25 mg QD | Change From Baseline in Low-Density Lipoprotein Cholesterol (Day 85). | -2.6 mg/dL | Standard Error 3.55 |
| Alogliptin 12.5 mg QD | Change From Baseline in Low-Density Lipoprotein Cholesterol (Day 85). | -2.7 mg/dL | Standard Error 3.54 |
| Alogliptin 25 mg QD | Change From Baseline in Low-Density Lipoprotein Cholesterol (Day 85). | -0.6 mg/dL | Standard Error 3.38 |
| Alogliptin 50 mg QD | Change From Baseline in Low-Density Lipoprotein Cholesterol (Day 85). | -5.0 mg/dL | Standard Error 3.7 |
| Alogliptin 100 mg QD | Change From Baseline in Low-Density Lipoprotein Cholesterol (Day 85). | 4.0 mg/dL | Standard Error 3.5 |
Comparison: The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in LDL cholesterol. The treatment effect will be evaluated as a contrast of all doses of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.p-value: 0.003ANCOVA
Comparison: The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in LDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.p-value: <0.001ANCOVA
Comparison: The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in LDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.p-value: 0.103ANCOVA
Comparison: The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in LDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.p-value: 0.009ANCOVA
Comparison: The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in LDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.p-value: 0.034ANCOVA
Comparison: The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in LDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.p-value: 0.033ANCOVA
Secondary
Change From Baseline in Total Cholesterol (Day 43).
The change between the value of cholesterol collected at day 43 and cholesterol collected at baseline.
Time frame: Baseline and Day 43
Population: Randomized subjects who received at least 1 dose of study drug (Intent to Treat), and who had measurements at baseline and at Day 43. Missing data are imputed using last observation carried forward (LOCF).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo QD | Change From Baseline in Total Cholesterol (Day 43). | -11.1 mg/dL | Standard Error 4.91 |
| Alogliptin 6.25 mg QD | Change From Baseline in Total Cholesterol (Day 43). | -9.7 mg/dL | Standard Error 4.85 |
| Alogliptin 12.5 mg QD | Change From Baseline in Total Cholesterol (Day 43). | -9.6 mg/dL | Standard Error 4.77 |
| Alogliptin 25 mg QD | Change From Baseline in Total Cholesterol (Day 43). | -9.8 mg/dL | Standard Error 4.71 |
| Alogliptin 50 mg QD | Change From Baseline in Total Cholesterol (Day 43). | -12.0 mg/dL | Standard Error 5.11 |
| Alogliptin 100 mg QD | Change From Baseline in Total Cholesterol (Day 43). | -4.7 mg/dL | Standard Error 4.8 |
Comparison: The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in total cholesterol. The treatment effect will be evaluated as a contrast of all doses of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.p-value: 0.718ANCOVA
Comparison: The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in total cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.p-value: 0.346ANCOVA
Comparison: The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in total cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.p-value: 0.901ANCOVA
Comparison: The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in total cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.p-value: 0.851ANCOVA
Comparison: The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in total cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.p-value: 0.825ANCOVA
Comparison: The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in total cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.p-value: 0.843ANCOVA
Secondary
Change From Baseline in Total Cholesterol (Day 85).
The change between the value of cholesterol collected at day 85 or final visit and cholesterol collected at baseline.
Time frame: Baseline and Day 85.
Population: Randomized subjects who received at least 1 dose of study drug (Intent to Treat), and who had measurements at baseline and at Day 85. Missing data are imputed using last observation carried forward (LOCF).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo QD | Change From Baseline in Total Cholesterol (Day 85). | -15.1 mg/dL | Standard Error 4.46 |
| Alogliptin 6.25 mg QD | Change From Baseline in Total Cholesterol (Day 85). | -9.0 mg/dL | Standard Error 4.41 |
| Alogliptin 12.5 mg QD | Change From Baseline in Total Cholesterol (Day 85). | -4.8 mg/dL | Standard Error 4.39 |
| Alogliptin 25 mg QD | Change From Baseline in Total Cholesterol (Day 85). | -8.7 mg/dL | Standard Error 4.24 |
| Alogliptin 50 mg QD | Change From Baseline in Total Cholesterol (Day 85). | -7.7 mg/dL | Standard Error 4.64 |
| Alogliptin 100 mg QD | Change From Baseline in Total Cholesterol (Day 85). | -0.4 mg/dL | Standard Error 4.31 |
Comparison: The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in total cholesterol. The treatment effect will be evaluated as a contrast of all doses of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.p-value: 0.069ANCOVA
Comparison: The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in total cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.p-value: 0.018ANCOVA
Comparison: The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in total cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.p-value: 0.258ANCOVA
Comparison: The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in total cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.p-value: 0.299ANCOVA
Comparison: The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in total cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.p-value: 0.103ANCOVA
Comparison: The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in total cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.p-value: 0.34ANCOVA
Secondary
Change From Baseline in Triglycerides (Day 43).
The change between triglycerides collected at day 43 and triglycerides collected at baseline.
Time frame: Baseline and Day 43.
Population: Randomized subjects who received at least 1 dose of study drug (Intent to Treat), and who had measurements at baseline and at Day 43. Missing data are imputed using last observation carried forward (LOCF).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo QD | Change From Baseline in Triglycerides (Day 43). | -18.7 mg/dL | Standard Error 15.69 |
| Alogliptin 6.25 mg QD | Change From Baseline in Triglycerides (Day 43). | -28.0 mg/dL | Standard Error 15.43 |
| Alogliptin 12.5 mg QD | Change From Baseline in Triglycerides (Day 43). | -10.1 mg/dL | Standard Error 15.28 |
| Alogliptin 25 mg QD | Change From Baseline in Triglycerides (Day 43). | -27.7 mg/dL | Standard Error 15.1 |
| Alogliptin 50 mg QD | Change From Baseline in Triglycerides (Day 43). | -7.2 mg/dL | Standard Error 16.33 |
| Alogliptin 100 mg QD | Change From Baseline in Triglycerides (Day 43). | -31.5 mg/dL | Standard Error 15.48 |
Comparison: The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in triglycerides. The treatment effect will be evaluated as a contrast of all doses of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.p-value: 0.897ANCOVA
Comparison: The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in triglycerides. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.p-value: 0.557ANCOVA
Comparison: The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in triglycerides. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.p-value: 0.616ANCOVA
Comparison: The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in triglycerides. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.p-value: 0.679ANCOVA
Comparison: The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in triglycerides. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.p-value: 0.697ANCOVA
Comparison: The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in triglycerides. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.p-value: 0.672ANCOVA
Secondary
Change From Baseline in Triglycerides (Day 85).
The change between triglycerides collected at day 85 or final visit and triglycerides collected at baseline.
Time frame: Baseline and Day 85.
Population: Randomized subjects who received at least 1 dose of study drug (Intent to Treat), and who had measurements at baseline and at Day 85. Missing data are imputed using last observation carried forward (LOCF).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo QD | Change From Baseline in Triglycerides (Day 85). | -13.9 mg/dL | Standard Error 14.98 |
| Alogliptin 6.25 mg QD | Change From Baseline in Triglycerides (Day 85). | -26.4 mg/dL | Standard Error 14.75 |
| Alogliptin 12.5 mg QD | Change From Baseline in Triglycerides (Day 85). | 9.2 mg/dL | Standard Error 14.77 |
| Alogliptin 25 mg QD | Change From Baseline in Triglycerides (Day 85). | -32.9 mg/dL | Standard Error 14.27 |
| Alogliptin 50 mg QD | Change From Baseline in Triglycerides (Day 85). | -14.4 mg/dL | Standard Error 15.58 |
| Alogliptin 100 mg QD | Change From Baseline in Triglycerides (Day 85). | -24.9 mg/dL | Standard Error 14.59 |
Comparison: The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in triglycerides. The treatment effect will be evaluated as a contrast of all doses of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.p-value: 0.809ANCOVA
Comparison: The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in triglycerides. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.p-value: 0.597ANCOVA
Comparison: The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in triglycerides. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.p-value: 0.982ANCOVA
Comparison: The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in triglycerides. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.p-value: 0.358ANCOVA
Comparison: The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in triglycerides. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.p-value: 0.274ANCOVA
Comparison: The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in triglycerides. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.p-value: 0.554ANCOVA
Secondary
Mean Percent Incidence of Marked Hyperglycemia (Fasting Plasma Glucose ≥ 200 mg/dL).
The incidence of marked hyperglycemia occurring in participants with a fasting plasma glucose value greater than or equal to 200 mg per dL during study. Overall mean obtained by weighting the hyperglycemia percent incidence values at each time point by number of days in between visits. Mean percent incidence of marked hyperglycemia at each time point is the percent of self-monitored blood glucose measurements greater than or equal to 200 mg per dL, calculated per participant and then averaged across population.
Time frame: 85 Days.
Population: Randomized participants who received at least 1 dose of study drug (Intent to Treat), and who had at least 1 fasting plasma glucose measurement after baseline.~Note: Mean percent incidence of marked hyperglycemia was only summarized by treatment group using descriptive statistics.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo QD | Mean Percent Incidence of Marked Hyperglycemia (Fasting Plasma Glucose ≥ 200 mg/dL). | 54.0 percent incidence | Standard Deviation 34.95 |
| Alogliptin 6.25 mg QD | Mean Percent Incidence of Marked Hyperglycemia (Fasting Plasma Glucose ≥ 200 mg/dL). | 34.7 percent incidence | Standard Deviation 33.43 |
| Alogliptin 12.5 mg QD | Mean Percent Incidence of Marked Hyperglycemia (Fasting Plasma Glucose ≥ 200 mg/dL). | 25.8 percent incidence | Standard Deviation 26.92 |
| Alogliptin 25 mg QD | Mean Percent Incidence of Marked Hyperglycemia (Fasting Plasma Glucose ≥ 200 mg/dL). | 28.1 percent incidence | Standard Deviation 25.94 |
| Alogliptin 50 mg QD | Mean Percent Incidence of Marked Hyperglycemia (Fasting Plasma Glucose ≥ 200 mg/dL). | 30.4 percent incidence | Standard Deviation 30.32 |
| Alogliptin 100 mg QD | Mean Percent Incidence of Marked Hyperglycemia (Fasting Plasma Glucose ≥ 200 mg/dL). | 30.6 percent incidence | Standard Deviation 29.92 |