Diabetes Mellitus
Conditions
Keywords
Glucose Metabolism Disorder, Dysmetabolic Syndrome, Type II Diabetes, Diabetes Mellitus, Lipoatrophic; Dyslipidemia, Drug Therapy
Brief summary
The purpose of this study is to compare the efficacy of Alogliptin, once daily (QD), taken by itself and with pioglitazone on postprandial lipid measures in type 2 diabetes.
Detailed description
SYR-322 (alogliptin) is a selective, orally available inhibitor of dipeptidyl peptidase IV being developed as a treatment for type 2 diabetes mellitus. Dipeptidyl peptidase IV is the primary enzyme involved in the in vivo degradation of at least 2 peptide hormones released in response to nutrient ingestion, namely glucagon-like peptide-1 and glucose-dependent insulinotropic peptide. Pioglitazone HCl (ACTOS®) is a thiazolidinedione developed by Takeda Chemical Industries, Ltd. (Osaka, Japan). Pioglitazone HCl depends on the presence of insulin for its mechanism of action. This study will assess the effects of alogliptin and alogliptin coadministered with pioglitazone HCl on postprandial lipid and lipoprotein metabolism in participants with type 2 diabetes. Individuals who participate in this study will be required to commit to a screening visit and up to 6 additional visits at the study center. Study participation is anticipated to be about 20 weeks (or approximately 5 months). Multiple procedures will occur at each visit which may include fasting, blood collection, urine collection, physical examinations and electrocardiograms. At 3 of the visits a meal will be served that must be eaten within 10 minutes.
Interventions
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.
DRUGAlogliptin
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
DRUGPlacebo
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 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 70 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of type 2 diabetes * Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study. * Either failed treatment with diet and exercise for 3 months prior to Screening or has been receiving a stable dose of metformin, sulfonylurea, nateglinide, or repaglinide for more than 3 months prior to Screening. * Inadequate glycemic control as defined by glycosylated hemoglobin concentration between 6.5 and 9.0%, inclusive. * Fasting plasma glucose less than 13.3 mmol per L. * Fasting serum triglyceride level of 1.7 to 5.0 mmol per L, inclusive. * Has not been receiving any lipid-lowering therapy within 3 months prior to Screening or on a stable statin and/or ezetimibe therapy (same drug and dose) for at least 3 months. * Body mass index greater than 23 kg/m2 and less than 45 kg/m2. * If has regular use of other, non-excluded medications, must be on a stable dose for at least 4 weeks prior to Screening. Use of as needed prescription medications and over-the-counter medications is allowed at the discretion of the investigator. * Is to be Apolipoprotein E 3/3 or Apolipoprotein E 3/4 phenotype positive prior to baseline.
Exclusion criteria
* History of type 1 diabetes. * History of drug abuse (defined as illicit drug use) or a history of alcohol abuse (defined as regular or daily consumption of more than 4 alcoholic drinks per day) within the past 2 years. * Diastolic blood pressure greater than 100 mm Hg or a systolic blood pressure of greater than 160 mm Hg. * History of cancer, other than basal cell carcinoma, that has not been in remission for at least 5 years prior to the first dose of study medication. * Hemoglobin less than 120 g per L for males and less than100 g per L for females. * Alanine transaminase level greater than 2.5 times the upper limit of normal, active liver disease, or jaundice. * Serum creatinine level greater than 133 μmol per L. * Fasting total cholesterol greater than 6.5 mmol per L. * New York Heart Association heart failure of any Class (I-IV) regardless of therapy. * History of coronary angioplasty, coronary stent placement, coronary bypass surgery, or myocardial infarction within 6 months prior to Screening. * History of acute metabolic diabetic complications. * History of any hemoglobinopathy that may affect determination of glycosylated hemoglobin. * History of infection with human immunodeficiency virus. * History of diabetic gastro paresis. * History of gastric bypass surgery.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Postprandial Incremental Area Under the Curve for Total Triglycerides at Week 16. | Baseline and Week 16. | The change in postprandial (after eating a meal) incremental area under the plasma concentration-time curve from 0 to 8 hours (AUC (0-8h)) postdose at week 16 relative to baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Postprandial Incremental Area Under the Curve for Total Triglycerides at Week 4. | Baseline and Week 4. | The change in postprandial incremental area under the plasma concentration-time curve from 0 to 8 hours (AUC(0-8h)) postdose at week 4 relative to baseline. |
| Change From Baseline in Postprandial Incremental Area Under the Curve Changes for Lipid Parameters. | Baseline, Week 4 and Week 16. | The change in postprandial incremental area under the plasma concentration-time curve for very-low-density lipoprotein (VLDL) cholesterol, VLDL triglycerides, VLDL2 cholesterol, VLDL2 triglycerides, chylomicron cholesterol, chylomicron triglycerides, intermediate-density lipoprotein (IDL) cholesterol, and IDL triglycerides from 0 to 8 hours postdose at week 4 and week 16 relative to baseline. |
| Change From Baseline in Postprandial Incremental Area Under the Curve for Lipoprotein Parameters. | Baseline, Week 4 and Week 16. | Postprandial incremental area under the curve changes for very-low-density lipoprotein (VLDL) Apo B-48, VLDL Apo B 100, VLDL2 Apo B-48, VLDL2 Apo B 100, chylomicron Apo B-48, chylomicron Apo B 100, and intermediate density lipoprotein (IDL) Apo B-48, IDL Apo B 100, and triglyceride-rich remnant (TRR) lipoproteins from 0 to 8 hours postdose at week 4 and week 16 relative to baseline. |
| Postprandial Changes Over Time From Baseline for Glucagon-like Peptide-1 (GLP-1) | Baseline, Week 4 and Week 16. | Postprandial changes over time at each week indicated relative to baseline. |
| Postprandial Changes Over Time From Baseline for Glucose | Baseline, Week 4 and Week 16. | Postprandial changes over time at each week indicated relative to baseline. |
| Postprandial Changes Over Time From Baseline for Glucagon | Baseline, Week 4 and Week 16. | Postprandial changes over time at each week indicated relative to baseline. |
| Change From Baseline in Glycosylated Hemoglobin | Baseline, Week 8 and Week 16. | 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 each week indicated relative to baseline. |
| Change From Baseline in Fasting Plasma Glucose | Baseline, Week 4, Week 8 and Week 16. | The change in fasting plasma glucose collected at each week indicated relative to baseline. |
| Postprandial Changes Over Time From Baseline for Insulin | Baseline, Week 4 and Week 16. | Postprandial changes over time at each week indicated relative to baseline. |
| Change From Baseline in Postprandial Proinsulin | Baseline, Week 4 and Week 16. | The change in postprandial proinsulin collected at each week indicated relative to baseline. |
| Change From Baseline in High-sensitive C-reactive Protein (Hs-CRP) | Baseline, Week 4 and Week 16. | The change in hs-CRP collected at each week indicated relative to baseline. |
| Change From Baseline in Adiponectin | Baseline, Week 4 and Week 16. | The change in adiponectin collected at each week indicated relative to baseline. |
| Change From Baseline in Anti-Vascular Cell Adhesion Molecule (VCAM) | Baseline, Week 4 and Week 16. | The change in VCAM collected at each week indicated relative to baseline. |
| Change From Baseline in Anti-Intercellular Adhesion Molecule (ICAM) | Baseline, Week 4 and Week 16. | The change in ICAM collected at each week indicated relative to baseline. |
| Change From Baseline in e-Selectin | Baseline, Week 4 and Week 16. | The change in e-Selectin collected at each week indicated relative to baseline. |
| Change From Baseline in Endothelial Function Through Pulse Wave Tonometry | Baseline and Week 16. | Pulse wave tonometry performed before the meal and 2 hours postmeal using one recording consisting of 15 to 20 sequentially recorded radial artery waveforms collected at each assessment. |
| Change From Baseline in Postprandial C-Peptide | Baseline, Week 4 and Week 16. | The change in postprandial C-peptide collected at each week indicated relative to baseline. |
Countries
Netherlands, Sweden
Participant flow
Recruitment details
Participants enrolled at 2 investigative sites in The Netherlands and Sweden from 16 July 2007 to 17 December 2009.
Pre-assignment details
Participants with a historical diagnosis of type 2 diabetes mellitus were enrolled in one of three, once-daily (QD) treatment groups.
Participants by arm
| Arm | Count |
|---|---|
| Placebo QD Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks. | 24 |
| Alogliptin 25 mg QD Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks. | 25 |
| Alogliptin 25 mg QD + Pioglitazone 30 mg QD Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks. | 22 |
| Total | 71 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Placebo QD | Alogliptin 25 mg QD | Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Total |
|---|---|---|---|---|
| Age Continuous | 59.1 years STANDARD_DEVIATION 6.23 | 58.7 years STANDARD_DEVIATION 6.47 | 59.1 years STANDARD_DEVIATION 6.94 | 59.0 years STANDARD_DEVIATION 6.45 |
| Body Mass Index (BMI) | 32.12 kg/m2 STANDARD_DEVIATION 3.997 | 31.09 kg/m2 STANDARD_DEVIATION 4.196 | 31.15 kg/m2 STANDARD_DEVIATION 3.503 | 31.46 kg/m2 STANDARD_DEVIATION 3.898 |
| Diabetes duration | 5.55 years STANDARD_DEVIATION 3.243 | 6.40 years STANDARD_DEVIATION 3.622 | 5.03 years STANDARD_DEVIATION 3.791 | 5.69 years STANDARD_DEVIATION 3.548 |
| Height | 178.3 cm STANDARD_DEVIATION 6.74 | 173.9 cm STANDARD_DEVIATION 8.17 | 172.8 cm STANDARD_DEVIATION 10.97 | 175.0 cm STANDARD_DEVIATION 8.91 |
| Race (NIH/OMB) | 24 Participants | 25 Participants | 22 Participants | 71 Participants |
| Region of Enrollment Netherlands | 9 participants | 10 participants | 9 participants | 28 participants |
| Region of Enrollment Sweden | 15 participants | 15 participants | 13 participants | 43 participants |
| Sex: Female, Male Female | 4 Participants | 10 Participants | 7 Participants | 21 Participants |
| Sex: Female, Male Male | 20 Participants | 15 Participants | 15 Participants | 50 Participants |
| Weight | 101.83 kg STANDARD_DEVIATION 11.989 | 93.68 kg STANDARD_DEVIATION 10.816 | 93.05 kg STANDARD_DEVIATION 13.16 | 96.24 kg STANDARD_DEVIATION 12.471 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 15 / 24 | 19 / 25 | 13 / 22 |
| serious Total, serious adverse events | 0 / 24 | 2 / 25 | 3 / 22 |
Outcome results
Primary
Change From Baseline in Postprandial Incremental Area Under the Curve for Total Triglycerides at Week 16.
The change in postprandial (after eating a meal) incremental area under the plasma concentration-time curve from 0 to 8 hours (AUC (0-8h)) postdose at week 16 relative to baseline.
Time frame: Baseline and Week 16.
Population: The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo QD | Change From Baseline in Postprandial Incremental Area Under the Curve for Total Triglycerides at Week 16. | -39.728 mg.h/dL | Standard Error 48.2481 |
| Alogliptin 25 mg QD | Change From Baseline in Postprandial Incremental Area Under the Curve for Total Triglycerides at Week 16. | -346.957 mg.h/dL | Standard Error 47.2251 |
| Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Change From Baseline in Postprandial Incremental Area Under the Curve for Total Triglycerides at Week 16. | -293.439 mg.h/dL | Standard Error 51.1271 |
Comparison: The null hypothesis that there was no difference between Alogliptin 25 mg QD and placebo groups was tested at a 2-sided 0.05 significance level. The ANCOVA model used for the change in postprandial incremental area the curver for total triglycerides includes treatment and statin use as fixed effects and baseline AUC(0-8h) for total triglycerides as a covariate.p-value: <0.00195% CI: [-443.168, -171.29]ANCOVA
Comparison: The null hypothesis that there was no difference between Alogliptin 25 mg QD + Pioglitazone 30 mg QD and placebo QD groups was tested at a 2-sided 0.05 significance level. The ANCOVA model used for the change in postprandial incremental area the curve for total triglycerides includes treatment and statin use as fixed effects and baseline AUC(0-8h) for total triglycerides as a covariate.p-value: <0.00195% CI: [-394.161, -113.262]ANCOVA
Secondary
Change From Baseline in Adiponectin
The change in adiponectin collected at each week indicated relative to baseline.
Time frame: Baseline, Week 4 and Week 16.
Population: The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo QD | Change From Baseline in Adiponectin | Week 4: 5 minutes prior to meal (n=24;n=21; n=19) | 0.001 µg/mL | Standard Error 0.0004 |
| Placebo QD | Change From Baseline in Adiponectin | Week 16: 5 minutes prior to meal (n=24;n=25;n=21) | 0.000 µg/mL | Standard Error 0.0005 |
| Alogliptin 25 mg QD | Change From Baseline in Adiponectin | Week 4: 5 minutes prior to meal (n=24;n=21; n=19) | 0.000 µg/mL | Standard Error 0.0005 |
| Alogliptin 25 mg QD | Change From Baseline in Adiponectin | Week 16: 5 minutes prior to meal (n=24;n=25;n=21) | 0.000 µg/mL | Standard Error 0.0005 |
| Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Change From Baseline in Adiponectin | Week 4: 5 minutes prior to meal (n=24;n=21; n=19) | 0.006 µg/mL | Standard Error 0.0005 |
| Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Change From Baseline in Adiponectin | Week 16: 5 minutes prior to meal (n=24;n=25;n=21) | 0.007 µg/mL | Standard Error 0.0005 |
Secondary
Change From Baseline in Anti-Intercellular Adhesion Molecule (ICAM)
The change in ICAM collected at each week indicated relative to baseline.
Time frame: Baseline, Week 4 and Week 16.
Population: The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo QD | Change From Baseline in Anti-Intercellular Adhesion Molecule (ICAM) | Week 4: 5 minutes prior to meal (n=24;n=21; n=19) | -1.154 ng/mL | Standard Error 6.7415 |
| Placebo QD | Change From Baseline in Anti-Intercellular Adhesion Molecule (ICAM) | Week 16: 5 minutes prior to meal (n=24; n=25;n=21) | -2.495 ng/mL | Standard Error 8.6653 |
| Alogliptin 25 mg QD | Change From Baseline in Anti-Intercellular Adhesion Molecule (ICAM) | Week 4: 5 minutes prior to meal (n=24;n=21; n=19) | -0.294 ng/mL | Standard Error 7.1785 |
| Alogliptin 25 mg QD | Change From Baseline in Anti-Intercellular Adhesion Molecule (ICAM) | Week 16: 5 minutes prior to meal (n=24; n=25;n=21) | -4.140 ng/mL | Standard Error 8.4752 |
| Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Change From Baseline in Anti-Intercellular Adhesion Molecule (ICAM) | Week 4: 5 minutes prior to meal (n=24;n=21; n=19) | -23.810 ng/mL | Standard Error 7.638 |
| Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Change From Baseline in Anti-Intercellular Adhesion Molecule (ICAM) | Week 16: 5 minutes prior to meal (n=24; n=25;n=21) | -16.556 ng/mL | Standard Error 9.3414 |
Secondary
Change From Baseline in Anti-Vascular Cell Adhesion Molecule (VCAM)
The change in VCAM collected at each week indicated relative to baseline.
Time frame: Baseline, Week 4 and Week 16.
Population: The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo QD | Change From Baseline in Anti-Vascular Cell Adhesion Molecule (VCAM) | Week 4: 5 minutes prior to meal (n=24;n=21; n=19) | -37.351 ng/mL | Standard Error 17.6828 |
| Placebo QD | Change From Baseline in Anti-Vascular Cell Adhesion Molecule (VCAM) | Week 16: 5 minutes prior to meal (n=24;n=25;n=21) | 5.067 ng/mL | Standard Error 16.6654 |
| Alogliptin 25 mg QD | Change From Baseline in Anti-Vascular Cell Adhesion Molecule (VCAM) | Week 4: 5 minutes prior to meal (n=24;n=21; n=19) | 2.392 ng/mL | Standard Error 18.8767 |
| Alogliptin 25 mg QD | Change From Baseline in Anti-Vascular Cell Adhesion Molecule (VCAM) | Week 16: 5 minutes prior to meal (n=24;n=25;n=21) | -1.441 ng/mL | Standard Error 16.3094 |
| Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Change From Baseline in Anti-Vascular Cell Adhesion Molecule (VCAM) | Week 4: 5 minutes prior to meal (n=24;n=21; n=19) | 4.849 ng/mL | Standard Error 19.8297 |
| Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Change From Baseline in Anti-Vascular Cell Adhesion Molecule (VCAM) | Week 16: 5 minutes prior to meal (n=24;n=25;n=21) | 13.665 ng/mL | Standard Error 17.758 |
Secondary
Change From Baseline in Endothelial Function Through Pulse Wave Tonometry
Pulse wave tonometry performed before the meal and 2 hours postmeal using one recording consisting of 15 to 20 sequentially recorded radial artery waveforms collected at each assessment.
Time frame: Baseline and Week 16.
Population: The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo QD | Change From Baseline in Endothelial Function Through Pulse Wave Tonometry | Week 16: pre-meal (n=23;n=23;n=20) | -3.6 mmHg | Standard Error 2.51 |
| Placebo QD | Change From Baseline in Endothelial Function Through Pulse Wave Tonometry | Week 16: 2 hours postmeal (n=24;n=24;n=20) | -1.6 mmHg | Standard Error 3.16 |
| Alogliptin 25 mg QD | Change From Baseline in Endothelial Function Through Pulse Wave Tonometry | Week 16: pre-meal (n=23;n=23;n=20) | -4.7 mmHg | Standard Error 2.52 |
| Alogliptin 25 mg QD | Change From Baseline in Endothelial Function Through Pulse Wave Tonometry | Week 16: 2 hours postmeal (n=24;n=24;n=20) | 0.1 mmHg | Standard Error 3.18 |
| Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Change From Baseline in Endothelial Function Through Pulse Wave Tonometry | Week 16: pre-meal (n=23;n=23;n=20) | -4.2 mmHg | Standard Error 2.68 |
| Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Change From Baseline in Endothelial Function Through Pulse Wave Tonometry | Week 16: 2 hours postmeal (n=24;n=24;n=20) | -1.3 mmHg | Standard Error 3.47 |
Secondary
Change From Baseline in e-Selectin
The change in e-Selectin collected at each week indicated relative to baseline.
Time frame: Baseline, Week 4 and Week 16.
Population: The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo QD | Change From Baseline in e-Selectin | Week 4: 5 minutes prior to meal (n=24;n=21; n=19) | 1.041 ng/mL | Standard Error 1.3484 |
| Placebo QD | Change From Baseline in e-Selectin | Week 16: 5 minutes prior to meal (n=24; n=25;n=21) | 1.488 ng/mL | Standard Error 2.0944 |
| Alogliptin 25 mg QD | Change From Baseline in e-Selectin | Week 4: 5 minutes prior to meal (n=24;n=21; n=19) | 0.116 ng/mL | Standard Error 1.4394 |
| Alogliptin 25 mg QD | Change From Baseline in e-Selectin | Week 16: 5 minutes prior to meal (n=24; n=25;n=21) | -1.671 ng/mL | Standard Error 2.048 |
| Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Change From Baseline in e-Selectin | Week 4: 5 minutes prior to meal (n=24;n=21; n=19) | -6.437 ng/mL | Standard Error 1.5137 |
| Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Change From Baseline in e-Selectin | Week 16: 5 minutes prior to meal (n=24; n=25;n=21) | -4.056 ng/mL | Standard Error 2.2336 |
Secondary
Change From Baseline in Fasting Plasma Glucose
The change in fasting plasma glucose collected at each week indicated relative to baseline.
Time frame: Baseline, Week 4, Week 8 and Week 16.
Population: The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo QD | Change From Baseline in Fasting Plasma Glucose | Week 4 (n=24; n=20; n=19) | -4.141 mg/dL | Standard Error 3.0027 |
| Placebo QD | Change From Baseline in Fasting Plasma Glucose | Week 16 (n=24; n=25; n=21) | 11.869 mg/dL | Standard Error 6.4897 |
| Placebo QD | Change From Baseline in Fasting Plasma Glucose | Week 8 (n=24; n=25; n=21) | 4.864 mg/dL | Standard Error 5.3254 |
| Alogliptin 25 mg QD | Change From Baseline in Fasting Plasma Glucose | Week 4 (n=24; n=20; n=19) | -20.669 mg/dL | Standard Error 3.3024 |
| Alogliptin 25 mg QD | Change From Baseline in Fasting Plasma Glucose | Week 16 (n=24; n=25; n=21) | -17.052 mg/dL | Standard Error 6.3918 |
| Alogliptin 25 mg QD | Change From Baseline in Fasting Plasma Glucose | Week 8 (n=24; n=25; n=21) | -16.293 mg/dL | Standard Error 5.2451 |
| Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Change From Baseline in Fasting Plasma Glucose | Week 16 (n=24; n=25; n=21) | -38.481 mg/dL | Standard Error 6.9709 |
| Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Change From Baseline in Fasting Plasma Glucose | Week 8 (n=24; n=25; n=21) | -38.242 mg/dL | Standard Error 5.7203 |
| Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Change From Baseline in Fasting Plasma Glucose | Week 4 (n=24; n=20; n=19) | -38.826 mg/dL | Standard Error 3.389 |
Secondary
Change From Baseline in Glycosylated Hemoglobin
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 each week indicated relative to baseline.
Time frame: Baseline, Week 8 and Week 16.
Population: The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo QD | Change From Baseline in Glycosylated Hemoglobin | Week 8: fasting (n=23; n=24; n=20) | -0.12 percentage of glycosylated hemoglobin | Standard Error 0.084 |
| Placebo QD | Change From Baseline in Glycosylated Hemoglobin | Week 16: 5 minutes prior to meal (n=24;n=25; n=21) | 0.38 percentage of glycosylated hemoglobin | Standard Error 0.131 |
| Alogliptin 25 mg QD | Change From Baseline in Glycosylated Hemoglobin | Week 8: fasting (n=23; n=24; n=20) | -0.55 percentage of glycosylated hemoglobin | Standard Error 0.083 |
| Alogliptin 25 mg QD | Change From Baseline in Glycosylated Hemoglobin | Week 16: 5 minutes prior to meal (n=24;n=25; n=21) | -0.39 percentage of glycosylated hemoglobin | Standard Error 0.129 |
| Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Change From Baseline in Glycosylated Hemoglobin | Week 8: fasting (n=23; n=24; n=20) | -1.01 percentage of glycosylated hemoglobin | Standard Error 0.09 |
| Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Change From Baseline in Glycosylated Hemoglobin | Week 16: 5 minutes prior to meal (n=24;n=25; n=21) | -0.95 percentage of glycosylated hemoglobin | Standard Error 0.14 |
Secondary
Change From Baseline in High-sensitive C-reactive Protein (Hs-CRP)
The change in hs-CRP collected at each week indicated relative to baseline.
Time frame: Baseline, Week 4 and Week 16.
Population: The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo QD | Change From Baseline in High-sensitive C-reactive Protein (Hs-CRP) | Week 4: 5 minutes prior to meal (n=24; n=21; n=19) | -1.514 mg/L | Standard Error 1.0846 |
| Placebo QD | Change From Baseline in High-sensitive C-reactive Protein (Hs-CRP) | Week 16: 5 minutes prior to meal (n=24; n=25;n=21) | 4.338 mg/L | Standard Error 2.607 |
| Alogliptin 25 mg QD | Change From Baseline in High-sensitive C-reactive Protein (Hs-CRP) | Week 4: 5 minutes prior to meal (n=24; n=21; n=19) | 0.631 mg/L | Standard Error 1.1693 |
| Alogliptin 25 mg QD | Change From Baseline in High-sensitive C-reactive Protein (Hs-CRP) | Week 16: 5 minutes prior to meal (n=24; n=25;n=21) | -0.402 mg/L | Standard Error 2.5683 |
| Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Change From Baseline in High-sensitive C-reactive Protein (Hs-CRP) | Week 4: 5 minutes prior to meal (n=24; n=21; n=19) | 0.155 mg/L | Standard Error 1.2269 |
| Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Change From Baseline in High-sensitive C-reactive Protein (Hs-CRP) | Week 16: 5 minutes prior to meal (n=24; n=25;n=21) | -0.402 mg/L | Standard Error 2.8 |
Secondary
Change From Baseline in Postprandial C-Peptide
The change in postprandial C-peptide collected at each week indicated relative to baseline.
Time frame: Baseline, Week 4 and Week 16.
Population: The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo QD | Change From Baseline in Postprandial C-Peptide | Week 4: 1 hour postprandial (n=24; n=21; n=19) | -0.106 ng/mL | Standard Error 0.2597 |
| Placebo QD | Change From Baseline in Postprandial C-Peptide | Week 4: 2 hours postprandial (n=24; n=21; n=19) | 0.311 ng/mL | Standard Error 0.3789 |
| Placebo QD | Change From Baseline in Postprandial C-Peptide | Week 4: 3 hours postprandial (n=24; n=21; n=19) | 0.376 ng/mL | Standard Error 0.4386 |
| Placebo QD | Change From Baseline in Postprandial C-Peptide | Week 4: 4 hours postprandial (n=24; n=21; n=19) | 0.256 ng/mL | Standard Error 0.3674 |
| Placebo QD | Change From Baseline in Postprandial C-Peptide | Week 4: 8 hours postprandial (n=23; n=20; n=19) | -0.063 ng/mL | Standard Error 0.153 |
| Placebo QD | Change From Baseline in Postprandial C-Peptide | Week 16: 1 hour postprandial (n=24; n=25; n=21) | -0.176 ng/mL | Standard Error 0.3474 |
| Placebo QD | Change From Baseline in Postprandial C-Peptide | Week 16: 2 hours postprandial (n=24; n=25; n=21) | -0.011 ng/mL | Standard Error 0.4337 |
| Placebo QD | Change From Baseline in Postprandial C-Peptide | Week 16: 3 hours postprandial (n=24; n=25; n=21) | 0.492 ng/mL | Standard Error 0.457 |
| Placebo QD | Change From Baseline in Postprandial C-Peptide | Week 16: 4 hours postprandial (n=24; n=25; n=21) | 0.496 ng/mL | Standard Error 0.4042 |
| Placebo QD | Change From Baseline in Postprandial C-Peptide | Week 16: 8 hours postprandial (n=24; n=24; n=21) | 0.151 ng/mL | Standard Error 0.2042 |
| Alogliptin 25 mg QD | Change From Baseline in Postprandial C-Peptide | Week 16: 4 hours postprandial (n=24; n=25; n=21) | -0.068 ng/mL | Standard Error 0.3961 |
| Alogliptin 25 mg QD | Change From Baseline in Postprandial C-Peptide | Week 4: 1 hour postprandial (n=24; n=21; n=19) | -0.300 ng/mL | Standard Error 0.2775 |
| Alogliptin 25 mg QD | Change From Baseline in Postprandial C-Peptide | Week 16: 1 hour postprandial (n=24; n=25; n=21) | -1.021 ng/mL | Standard Error 0.3405 |
| Alogliptin 25 mg QD | Change From Baseline in Postprandial C-Peptide | Week 4: 8 hours postprandial (n=23; n=20; n=19) | 0.421 ng/mL | Standard Error 0.1643 |
| Alogliptin 25 mg QD | Change From Baseline in Postprandial C-Peptide | Week 4: 2 hours postprandial (n=24; n=21; n=19) | -0.011 ng/mL | Standard Error 0.4052 |
| Alogliptin 25 mg QD | Change From Baseline in Postprandial C-Peptide | Week 16: 8 hours postprandial (n=24; n=24; n=21) | 0.588 ng/mL | Standard Error 0.2047 |
| Alogliptin 25 mg QD | Change From Baseline in Postprandial C-Peptide | Week 16: 3 hours postprandial (n=24; n=25; n=21) | -0.712 ng/mL | Standard Error 0.4478 |
| Alogliptin 25 mg QD | Change From Baseline in Postprandial C-Peptide | Week 4: 3 hours postprandial (n=24; n=21; n=19) | 0.116 ng/mL | Standard Error 0.4684 |
| Alogliptin 25 mg QD | Change From Baseline in Postprandial C-Peptide | Week 16: 2 hours postprandial (n=24; n=25; n=21) | -1.006 ng/mL | Standard Error 0.4259 |
| Alogliptin 25 mg QD | Change From Baseline in Postprandial C-Peptide | Week 4: 4 hours postprandial (n=24; n=21; n=19) | 0.393 ng/mL | Standard Error 0.3926 |
| Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Change From Baseline in Postprandial C-Peptide | Week 16: 3 hours postprandial (n=24; n=25; n=21) | -1.269 ng/mL | Standard Error 0.4882 |
| Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Change From Baseline in Postprandial C-Peptide | Week 4: 4 hours postprandial (n=24; n=21; n=19) | -1.173 ng/mL | Standard Error 0.414 |
| Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Change From Baseline in Postprandial C-Peptide | Week 4: 8 hours postprandial (n=23; n=20; n=19) | -0.911 ng/mL | Standard Error 0.1699 |
| Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Change From Baseline in Postprandial C-Peptide | Week 16: 1 hour postprandial (n=24; n=25; n=21) | -0.646 ng/mL | Standard Error 0.3712 |
| Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Change From Baseline in Postprandial C-Peptide | Week 16: 4 hours postprandial (n=24; n=25; n=21) | -1.515 ng/mL | Standard Error 0.4323 |
| Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Change From Baseline in Postprandial C-Peptide | Week 16: 2 hours postprandial (n=24; n=25; n=21) | -1.055 ng/mL | Standard Error 0.4638 |
| Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Change From Baseline in Postprandial C-Peptide | Week 4: 1 hour postprandial (n=24; n=21; n=19) | -1.199 ng/mL | Standard Error 0.2921 |
| Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Change From Baseline in Postprandial C-Peptide | Week 16: 8 hours postprandial (n=24; n=24; n=21) | -0.761 ng/mL | Standard Error 0.2194 |
| Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Change From Baseline in Postprandial C-Peptide | Week 4: 2 hours postprandial (n=24; n=21; n=19) | -1.379 ng/mL | Standard Error 0.4262 |
| Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Change From Baseline in Postprandial C-Peptide | Week 4: 3 hours postprandial (n=24; n=21; n=19) | -1.230 ng/mL | Standard Error 0.4933 |
Secondary
Change From Baseline in Postprandial Incremental Area Under the Curve Changes for Lipid Parameters.
The change in postprandial incremental area under the plasma concentration-time curve for very-low-density lipoprotein (VLDL) cholesterol, VLDL triglycerides, VLDL2 cholesterol, VLDL2 triglycerides, chylomicron cholesterol, chylomicron triglycerides, intermediate-density lipoprotein (IDL) cholesterol, and IDL triglycerides from 0 to 8 hours postdose at week 4 and week 16 relative to baseline.
Time frame: Baseline, Week 4 and Week 16.
Population: The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo QD | Change From Baseline in Postprandial Incremental Area Under the Curve Changes for Lipid Parameters. | IDL cholesterol Week 4 (n=22; n=18; n=17) | 1.473 mg.h/dL | Standard Error 1.5215 |
| Placebo QD | Change From Baseline in Postprandial Incremental Area Under the Curve Changes for Lipid Parameters. | Chylomicron cholesterol Week 4 (n=23; n=21; n=19) | -0.091 mg.h/dL | Standard Error 1.1845 |
| Placebo QD | Change From Baseline in Postprandial Incremental Area Under the Curve Changes for Lipid Parameters. | VLDL 2 cholesterol Week 4 (n=23; n=20; n=19) | -2.396 mg.h/dL | Standard Error 0.8474 |
| Placebo QD | Change From Baseline in Postprandial Incremental Area Under the Curve Changes for Lipid Parameters. | VLDL triglycerides Week 16 (n=23; n=25; n=21) | 25.194 mg.h/dL | Standard Error 29.4896 |
| Placebo QD | Change From Baseline in Postprandial Incremental Area Under the Curve Changes for Lipid Parameters. | Chylomicron triglycerides Week 16(n=23;n=25; n=21) | -18.577 mg.h/dL | Standard Error 15.2943 |
| Placebo QD | Change From Baseline in Postprandial Incremental Area Under the Curve Changes for Lipid Parameters. | VLDL 2 cholesterol Week 16 (n=23; n=25; n=21) | -2.190 mg.h/dL | Standard Error 0.7833 |
| Placebo QD | Change From Baseline in Postprandial Incremental Area Under the Curve Changes for Lipid Parameters. | IDL cholesterol Week 16 (n=22; n=23; n=19) | 0.171 mg.h/dL | Standard Error 0.6006 |
| Placebo QD | Change From Baseline in Postprandial Incremental Area Under the Curve Changes for Lipid Parameters. | Chylomicron triglycerides Week 4 (n=23; n=21; n=1 | 0.617 mg.h/dL | Standard Error 26.1603 |
| Placebo QD | Change From Baseline in Postprandial Incremental Area Under the Curve Changes for Lipid Parameters. | IDL triglycerides Week 16 (n=22; n=23; n=19) | -0.313 mg.h/dL | Standard Error 2.9265 |
| Placebo QD | Change From Baseline in Postprandial Incremental Area Under the Curve Changes for Lipid Parameters. | VLDL cholesterol Week 4 (n=23; n=21; n=19) | -6.914 mg.h/dL | Standard Error 4.311 |
| Placebo QD | Change From Baseline in Postprandial Incremental Area Under the Curve Changes for Lipid Parameters. | IDL triglycerides Week 4 (n=22; n=18; n=17) | 14.667 mg.h/dL | Standard Error 12.9991 |
| Placebo QD | Change From Baseline in Postprandial Incremental Area Under the Curve Changes for Lipid Parameters. | VLDL cholesterol Week 16 (n=23; n=25; n=21) | -4.561 mg.h/dL | Standard Error 3.479 |
| Placebo QD | Change From Baseline in Postprandial Incremental Area Under the Curve Changes for Lipid Parameters. | VLDL triglycerides Week 4 (n=23; n=21; n=19) | -9.488 mg.h/dL | Standard Error 35.4108 |
| Placebo QD | Change From Baseline in Postprandial Incremental Area Under the Curve Changes for Lipid Parameters. | Chylomicron cholesterol Week 16 (n=23; n=25; n=21) | -1.431 mg.h/dL | Standard Error 0.6001 |
| Placebo QD | Change From Baseline in Postprandial Incremental Area Under the Curve Changes for Lipid Parameters. | VLDL 2 triglycerides Week 4 (n=23; n=20; n=19) | -5.221 mg.h/dL | Standard Error 7.8102 |
| Placebo QD | Change From Baseline in Postprandial Incremental Area Under the Curve Changes for Lipid Parameters. | VLDL 2 triglycerides Week 16 (n=23; n=25; n=21) | -24.280 mg.h/dL | Standard Error 3.4497 |
| Alogliptin 25 mg QD | Change From Baseline in Postprandial Incremental Area Under the Curve Changes for Lipid Parameters. | VLDL cholesterol Week 16 (n=23; n=25; n=21) | -16.365 mg.h/dL | Standard Error 3.3125 |
| Alogliptin 25 mg QD | Change From Baseline in Postprandial Incremental Area Under the Curve Changes for Lipid Parameters. | VLDL triglycerides Week 4 (n=23; n=21; n=19) | -119.009 mg.h/dL | Standard Error 37.0255 |
| Alogliptin 25 mg QD | Change From Baseline in Postprandial Incremental Area Under the Curve Changes for Lipid Parameters. | VLDL triglycerides Week 16 (n=23; n=25; n=21) | -130.459 mg.h/dL | Standard Error 28.2397 |
| Alogliptin 25 mg QD | Change From Baseline in Postprandial Incremental Area Under the Curve Changes for Lipid Parameters. | VLDL cholesterol Week 4 (n=23; n=21; n=19) | -14.760 mg.h/dL | Standard Error 4.4843 |
| Alogliptin 25 mg QD | Change From Baseline in Postprandial Incremental Area Under the Curve Changes for Lipid Parameters. | VLDL 2 triglycerides Week 4 (n=23; n=20; n=19) | -17.960 mg.h/dL | Standard Error 8.371 |
| Alogliptin 25 mg QD | Change From Baseline in Postprandial Incremental Area Under the Curve Changes for Lipid Parameters. | VLDL 2 triglycerides Week 16 (n=23; n=25; n=21) | -18.986 mg.h/dL | Standard Error 3.3104 |
| Alogliptin 25 mg QD | Change From Baseline in Postprandial Incremental Area Under the Curve Changes for Lipid Parameters. | VLDL 2 cholesterol Week 4 (n=23; n=20; n=19) | -0.709 mg.h/dL | Standard Error 0.9059 |
| Alogliptin 25 mg QD | Change From Baseline in Postprandial Incremental Area Under the Curve Changes for Lipid Parameters. | VLDL 2 cholesterol Week 16 (n=23; n=25; n=21) | -1.445 mg.h/dL | Standard Error 0.7506 |
| Alogliptin 25 mg QD | Change From Baseline in Postprandial Incremental Area Under the Curve Changes for Lipid Parameters. | Chylomicron triglycerides Week 4 (n=23; n=21; n=1 | -115.093 mg.h/dL | Standard Error 27.428 |
| Alogliptin 25 mg QD | Change From Baseline in Postprandial Incremental Area Under the Curve Changes for Lipid Parameters. | Chylomicron triglycerides Week 16(n=23;n=25; n=21) | -136.626 mg.h/dL | Standard Error 14.6683 |
| Alogliptin 25 mg QD | Change From Baseline in Postprandial Incremental Area Under the Curve Changes for Lipid Parameters. | Chylomicron cholesterol Week 4 (n=23; n=21; n=19) | -4.474 mg.h/dL | Standard Error 1.2425 |
| Alogliptin 25 mg QD | Change From Baseline in Postprandial Incremental Area Under the Curve Changes for Lipid Parameters. | Chylomicron cholesterol Week 16 (n=23; n=25; n=21) | -5.566 mg.h/dL | Standard Error 0.5769 |
| Alogliptin 25 mg QD | Change From Baseline in Postprandial Incremental Area Under the Curve Changes for Lipid Parameters. | IDL triglycerides Week 4 (n=22; n=18; n=17) | -6.771 mg.h/dL | Standard Error 14.3964 |
| Alogliptin 25 mg QD | Change From Baseline in Postprandial Incremental Area Under the Curve Changes for Lipid Parameters. | IDL triglycerides Week 16 (n=22; n=23; n=19) | -4.045 mg.h/dL | Standard Error 2.8759 |
| Alogliptin 25 mg QD | Change From Baseline in Postprandial Incremental Area Under the Curve Changes for Lipid Parameters. | IDL cholesterol Week 4 (n=22; n=18; n=17) | -0.808 mg.h/dL | Standard Error 1.6835 |
| Alogliptin 25 mg QD | Change From Baseline in Postprandial Incremental Area Under the Curve Changes for Lipid Parameters. | IDL cholesterol Week 16 (n=22; n=23; n=19) | 0.249 mg.h/dL | Standard Error 0.5893 |
| Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Change From Baseline in Postprandial Incremental Area Under the Curve Changes for Lipid Parameters. | Chylomicron cholesterol Week 4 (n=23; n=21; n=19) | -3.628 mg.h/dL | Standard Error 1.3039 |
| Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Change From Baseline in Postprandial Incremental Area Under the Curve Changes for Lipid Parameters. | VLDL cholesterol Week 16 (n=23; n=25; n=21) | -8.747 mg.h/dL | Standard Error 3.5984 |
| Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Change From Baseline in Postprandial Incremental Area Under the Curve Changes for Lipid Parameters. | IDL cholesterol Week 16 (n=22; n=23; n=19) | 0.609 mg.h/dL | Standard Error 0.6499 |
| Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Change From Baseline in Postprandial Incremental Area Under the Curve Changes for Lipid Parameters. | Chylomicron cholesterol Week 16 (n=23; n=25; n=21) | -4.289 mg.h/dL | Standard Error 0.6265 |
| Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Change From Baseline in Postprandial Incremental Area Under the Curve Changes for Lipid Parameters. | VLDL cholesterol Week 4 (n=23; n=21; n=19) | -10.760 mg.h/dL | Standard Error 4.7065 |
| Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Change From Baseline in Postprandial Incremental Area Under the Curve Changes for Lipid Parameters. | IDL cholesterol Week 4 (n=22; n=18; n=17) | 0.195 mg.h/dL | Standard Error 1.7328 |
| Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Change From Baseline in Postprandial Incremental Area Under the Curve Changes for Lipid Parameters. | IDL triglycerides Week 4 (n=22; n=18; n=17) | -4.410 mg.h/dL | Standard Error 14.9182 |
| Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Change From Baseline in Postprandial Incremental Area Under the Curve Changes for Lipid Parameters. | VLDL triglycerides Week 16 (n=23; n=25; n=21) | -85.709 mg.h/dL | Standard Error 30.7867 |
| Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Change From Baseline in Postprandial Incremental Area Under the Curve Changes for Lipid Parameters. | VLDL 2 cholesterol Week 16 (n=23; n=25; n=21) | -1.232 mg.h/dL | Standard Error 0.8217 |
| Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Change From Baseline in Postprandial Incremental Area Under the Curve Changes for Lipid Parameters. | VLDL 2 triglycerides Week 4 (n=23; n=20; n=19) | -8.687 mg.h/dL | Standard Error 8.6678 |
| Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Change From Baseline in Postprandial Incremental Area Under the Curve Changes for Lipid Parameters. | Chylomicron triglycerides Week 4 (n=23; n=21; n=1 | -108.036 mg.h/dL | Standard Error 28.6857 |
| Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Change From Baseline in Postprandial Incremental Area Under the Curve Changes for Lipid Parameters. | VLDL 2 cholesterol Week 4 (n=23; n=20; n=19) | -1.073 mg.h/dL | Standard Error 0.9345 |
| Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Change From Baseline in Postprandial Incremental Area Under the Curve Changes for Lipid Parameters. | IDL triglycerides Week 16 (n=22; n=23; n=19) | -4.533 mg.h/dL | Standard Error 3.1885 |
| Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Change From Baseline in Postprandial Incremental Area Under the Curve Changes for Lipid Parameters. | Chylomicron triglycerides Week 16(n=23;n=25; n=21) | -129.991 mg.h/dL | Standard Error 15.9053 |
| Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Change From Baseline in Postprandial Incremental Area Under the Curve Changes for Lipid Parameters. | VLDL 2 triglycerides Week 16 (n=23; n=25; n=21) | -23.061 mg.h/dL | Standard Error 3.6369 |
| Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Change From Baseline in Postprandial Incremental Area Under the Curve Changes for Lipid Parameters. | VLDL triglycerides Week 4 (n=23; n=21; n=19) | -98.758 mg.h/dL | Standard Error 38.9818 |
Secondary
Change From Baseline in Postprandial Incremental Area Under the Curve for Lipoprotein Parameters.
Postprandial incremental area under the curve changes for very-low-density lipoprotein (VLDL) Apo B-48, VLDL Apo B 100, VLDL2 Apo B-48, VLDL2 Apo B 100, chylomicron Apo B-48, chylomicron Apo B 100, and intermediate density lipoprotein (IDL) Apo B-48, IDL Apo B 100, and triglyceride-rich remnant (TRR) lipoproteins from 0 to 8 hours postdose at week 4 and week 16 relative to baseline.
Time frame: Baseline, Week 4 and Week 16.
Population: The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo QD | Change From Baseline in Postprandial Incremental Area Under the Curve for Lipoprotein Parameters. | TRR lipoproteins Week 16 (n=24; n=25; n=21) | 2.818 mg.h/dL | Standard Error 3.125 |
| Placebo QD | Change From Baseline in Postprandial Incremental Area Under the Curve for Lipoprotein Parameters. | IDL apo B 100 Week 4 (n=18; n=10; n=13) | 0.952 mg.h/dL | Standard Error 3.3778 |
| Placebo QD | Change From Baseline in Postprandial Incremental Area Under the Curve for Lipoprotein Parameters. | IDL apo B 100 Week 16 (n=18; n=14; n=14) | 4.181 mg.h/dL | Standard Error 3.4923 |
| Placebo QD | Change From Baseline in Postprandial Incremental Area Under the Curve for Lipoprotein Parameters. | TRR lipoproteins Week 4 (n=24; n=21; n=19) | 16.147 mg.h/dL | Standard Error 5.6739 |
| Placebo QD | Change From Baseline in Postprandial Incremental Area Under the Curve for Lipoprotein Parameters. | IDL apo B-48 Week 16 (n=18; n=14; n=14) | 0.151 mg.h/dL | Standard Error 0.1368 |
| Placebo QD | Change From Baseline in Postprandial Incremental Area Under the Curve for Lipoprotein Parameters. | VLDL apo B-48 Week 4 (n=19; n=12; n=15) | -0.020 mg.h/dL | Standard Error 0.2902 |
| Placebo QD | Change From Baseline in Postprandial Incremental Area Under the Curve for Lipoprotein Parameters. | VLDL apo B-48 Week 16 (n=19; n=16; n=16) | -0.055 mg.h/dL | Standard Error 0.1956 |
| Placebo QD | Change From Baseline in Postprandial Incremental Area Under the Curve for Lipoprotein Parameters. | VLDL apo B 100 Week 4 (n=19; n=12; n=15) | 0.568 mg.h/dL | Standard Error 2.2981 |
| Placebo QD | Change From Baseline in Postprandial Incremental Area Under the Curve for Lipoprotein Parameters. | VLDL apo B 100 Week 16 (n=19; n=16; n=16) | -0.453 mg.h/dL | Standard Error 1.8388 |
| Placebo QD | Change From Baseline in Postprandial Incremental Area Under the Curve for Lipoprotein Parameters. | VLDL2 apo B-48 Week 4 (n=19; n=12; n=15) | -0.075 mg.h/dL | Standard Error 0.0776 |
| Placebo QD | Change From Baseline in Postprandial Incremental Area Under the Curve for Lipoprotein Parameters. | VLDL2 apo B-48 Week 16 (n=19; n=16; n=16) | -0.079 mg.h/dL | Standard Error 0.0674 |
| Placebo QD | Change From Baseline in Postprandial Incremental Area Under the Curve for Lipoprotein Parameters. | VLDL2 apo B 100 Week 4 (n=19; n=12; n=15) | 0.464 mg.h/dL | Standard Error 1.1846 |
| Placebo QD | Change From Baseline in Postprandial Incremental Area Under the Curve for Lipoprotein Parameters. | VLDL2 apo B 100 Week 16 (n=19; n=16; n=16) | -1.155 mg.h/dL | Standard Error 0.7985 |
| Placebo QD | Change From Baseline in Postprandial Incremental Area Under the Curve for Lipoprotein Parameters. | Chylomicron apo B-48 Week 4 (n=19; n=12; n=14) | -0.051 mg.h/dL | Standard Error 0.0236 |
| Placebo QD | Change From Baseline in Postprandial Incremental Area Under the Curve for Lipoprotein Parameters. | Chylomicron apo B-48 Week 16 (n=19; n=16; n=16) | -0.051 mg.h/dL | Standard Error 0.018 |
| Placebo QD | Change From Baseline in Postprandial Incremental Area Under the Curve for Lipoprotein Parameters. | Chylomicron apo B 100 Week 4(n=19; n=12; n=14) | -0.123 mg.h/dL | Standard Error 0.0825 |
| Placebo QD | Change From Baseline in Postprandial Incremental Area Under the Curve for Lipoprotein Parameters. | Chylomicron apo B 100 Week 16 (n=19; n=16; n=16) | -0.120 mg.h/dL | Standard Error 0.0544 |
| Placebo QD | Change From Baseline in Postprandial Incremental Area Under the Curve for Lipoprotein Parameters. | IDL apo B-48 Week 4 (n=18; n=10; n=13) | 0.002 mg.h/dL | Standard Error 0.1254 |
| Alogliptin 25 mg QD | Change From Baseline in Postprandial Incremental Area Under the Curve for Lipoprotein Parameters. | IDL apo B-48 Week 4 (n=18; n=10; n=13) | -0.247 mg.h/dL | Standard Error 0.1707 |
| Alogliptin 25 mg QD | Change From Baseline in Postprandial Incremental Area Under the Curve for Lipoprotein Parameters. | IDL apo B-48 Week 16 (n=18; n=14; n=14) | -0.188 mg.h/dL | Standard Error 0.158 |
| Alogliptin 25 mg QD | Change From Baseline in Postprandial Incremental Area Under the Curve for Lipoprotein Parameters. | VLDL2 apo B-48 Week 4 (n=19; n=12; n=15) | -0.101 mg.h/dL | Standard Error 0.0969 |
| Alogliptin 25 mg QD | Change From Baseline in Postprandial Incremental Area Under the Curve for Lipoprotein Parameters. | VLDL2 apo B 100 Week 16 (n=19; n=16; n=16) | -2.049 mg.h/dL | Standard Error 0.8732 |
| Alogliptin 25 mg QD | Change From Baseline in Postprandial Incremental Area Under the Curve for Lipoprotein Parameters. | IDL apo B 100 Week 4 (n=18; n=10; n=13) | -2.029 mg.h/dL | Standard Error 4.5494 |
| Alogliptin 25 mg QD | Change From Baseline in Postprandial Incremental Area Under the Curve for Lipoprotein Parameters. | Chylomicron apo B-48 Week 16 (n=19; n=16; n=16) | -0.113 mg.h/dL | Standard Error 0.0197 |
| Alogliptin 25 mg QD | Change From Baseline in Postprandial Incremental Area Under the Curve for Lipoprotein Parameters. | Chylomicron apo B 100 Week 4(n=19; n=12; n=14) | -0.417 mg.h/dL | Standard Error 0.1041 |
| Alogliptin 25 mg QD | Change From Baseline in Postprandial Incremental Area Under the Curve for Lipoprotein Parameters. | IDL apo B 100 Week 16 (n=18; n=14; n=14) | -2.876 mg.h/dL | Standard Error 3.9944 |
| Alogliptin 25 mg QD | Change From Baseline in Postprandial Incremental Area Under the Curve for Lipoprotein Parameters. | VLDL2 apo B-48 Week 16 (n=19; n=16; n=16) | -0.175 mg.h/dL | Standard Error 0.0732 |
| Alogliptin 25 mg QD | Change From Baseline in Postprandial Incremental Area Under the Curve for Lipoprotein Parameters. | Chylomicron apo B 100 Week 16 (n=19; n=16; n=16) | -0.419 mg.h/dL | Standard Error 0.0594 |
| Alogliptin 25 mg QD | Change From Baseline in Postprandial Incremental Area Under the Curve for Lipoprotein Parameters. | TRR lipoproteins Week 4 (n=24; n=21; n=19) | -1.071 mg.h/dL | Standard Error 6.093 |
| Alogliptin 25 mg QD | Change From Baseline in Postprandial Incremental Area Under the Curve for Lipoprotein Parameters. | VLDL apo B 100 Week 16 (n=19; n=16; n=16) | -6.967 mg.h/dL | Standard Error 2.0109 |
| Alogliptin 25 mg QD | Change From Baseline in Postprandial Incremental Area Under the Curve for Lipoprotein Parameters. | Chylomicron apo B-48 Week 4 (n=19; n=12; n=14) | -0.097 mg.h/dL | Standard Error 0.0302 |
| Alogliptin 25 mg QD | Change From Baseline in Postprandial Incremental Area Under the Curve for Lipoprotein Parameters. | TRR lipoproteins Week 16 (n=24; n=25; n=21) | -12.719 mg.h/dL | Standard Error 3.0884 |
| Alogliptin 25 mg QD | Change From Baseline in Postprandial Incremental Area Under the Curve for Lipoprotein Parameters. | VLDL apo B 100 Week 4 (n=19; n=12; n=15) | -2.670 mg.h/dL | Standard Error 2.8906 |
| Alogliptin 25 mg QD | Change From Baseline in Postprandial Incremental Area Under the Curve for Lipoprotein Parameters. | VLDL2 apo B 100 Week 4 (n=19; n=12; n=15) | 0.507 mg.h/dL | Standard Error 1.4982 |
| Alogliptin 25 mg QD | Change From Baseline in Postprandial Incremental Area Under the Curve for Lipoprotein Parameters. | VLDL apo B-48 Week 4 (n=19; n=12; n=15) | -0.491 mg.h/dL | Standard Error 0.3572 |
| Alogliptin 25 mg QD | Change From Baseline in Postprandial Incremental Area Under the Curve for Lipoprotein Parameters. | VLDL apo B-48 Week 16 (n=19; n=16; n=16) | -0.654 mg.h/dL | Standard Error 0.2077 |
| Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Change From Baseline in Postprandial Incremental Area Under the Curve for Lipoprotein Parameters. | VLDL apo B-48 Week 4 (n=19; n=12; n=15) | -0.312 mg.h/dL | Standard Error 0.318 |
| Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Change From Baseline in Postprandial Incremental Area Under the Curve for Lipoprotein Parameters. | VLDL apo B-48 Week 16 (n=19; n=16; n=16) | -0.266 mg.h/dL | Standard Error 0.2044 |
| Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Change From Baseline in Postprandial Incremental Area Under the Curve for Lipoprotein Parameters. | VLDL apo B 100 Week 4 (n=19; n=12; n=15) | -2.977 mg.h/dL | Standard Error 2.5811 |
| Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Change From Baseline in Postprandial Incremental Area Under the Curve for Lipoprotein Parameters. | Chylomicron apo B-48 Week 16 (n=19; n=16; n=16) | -0.084 mg.h/dL | Standard Error 0.0191 |
| Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Change From Baseline in Postprandial Incremental Area Under the Curve for Lipoprotein Parameters. | VLDL apo B 100 Week 16 (n=19; n=16; n=16) | -3.265 mg.h/dL | Standard Error 2.0025 |
| Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Change From Baseline in Postprandial Incremental Area Under the Curve for Lipoprotein Parameters. | IDL apo B-48 Week 4 (n=18; n=10; n=13) | -0.223 mg.h/dL | Standard Error 0.1476 |
| Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Change From Baseline in Postprandial Incremental Area Under the Curve for Lipoprotein Parameters. | VLDL2 apo B-48 Week 4 (n=19; n=12; n=15) | -0.022 mg.h/dL | Standard Error 0.087 |
| Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Change From Baseline in Postprandial Incremental Area Under the Curve for Lipoprotein Parameters. | VLDL2 apo B-48 Week 16 (n=19; n=16; n=16) | 0.002 mg.h/dL | Standard Error 0.0737 |
| Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Change From Baseline in Postprandial Incremental Area Under the Curve for Lipoprotein Parameters. | Chylomicron apo B 100 Week 4(n=19; n=12; n=14) | -0.389 mg.h/dL | Standard Error 0.096 |
| Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Change From Baseline in Postprandial Incremental Area Under the Curve for Lipoprotein Parameters. | VLDL2 apo B 100 Week 4 (n=19; n=12; n=15) | -0.781 mg.h/dL | Standard Error 1.33287 |
| Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Change From Baseline in Postprandial Incremental Area Under the Curve for Lipoprotein Parameters. | IDL apo B-48 Week 16 (n=18; n=14; n=14) | 0.021 mg.h/dL | Standard Error 0.1561 |
| Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Change From Baseline in Postprandial Incremental Area Under the Curve for Lipoprotein Parameters. | IDL apo B 100 Week 4 (n=18; n=10; n=13) | -2.769 mg.h/dL | Standard Error 3.8565 |
| Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Change From Baseline in Postprandial Incremental Area Under the Curve for Lipoprotein Parameters. | VLDL2 apo B 100 Week 16 (n=19; n=16; n=16) | -1.793 mg.h/dL | Standard Error 0.8707 |
| Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Change From Baseline in Postprandial Incremental Area Under the Curve for Lipoprotein Parameters. | IDL apo B 100 Week 16 (n=18; n=14; n=14) | 0.073 mg.h/dL | Standard Error 3.8906 |
| Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Change From Baseline in Postprandial Incremental Area Under the Curve for Lipoprotein Parameters. | TRR lipoproteins Week 4 (n=24; n=21; n=19) | -5.673 mg.h/dL | Standard Error 6.4428 |
| Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Change From Baseline in Postprandial Incremental Area Under the Curve for Lipoprotein Parameters. | TRR lipoproteins Week 16 (n=24; n=25; n=21) | -7.853 mg.h/dL | Standard Error 3.3658 |
| Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Change From Baseline in Postprandial Incremental Area Under the Curve for Lipoprotein Parameters. | Chylomicron apo B-48 Week 4 (n=19; n=12; n=14) | -0.071 mg.h/dL | Standard Error 0.0272 |
| Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Change From Baseline in Postprandial Incremental Area Under the Curve for Lipoprotein Parameters. | Chylomicron apo B 100 Week 16 (n=19; n=16; n=16) | -0.409 mg.h/dL | Standard Error 0.059 |
Secondary
Change From Baseline in Postprandial Incremental Area Under the Curve for Total Triglycerides at Week 4.
The change in postprandial incremental area under the plasma concentration-time curve from 0 to 8 hours (AUC(0-8h)) postdose at week 4 relative to baseline.
Time frame: Baseline and Week 4.
Population: The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo QD | Change From Baseline in Postprandial Incremental Area Under the Curve for Total Triglycerides at Week 4. | -16.291 mg.h/dL | Standard Error 61.1286 |
| Alogliptin 25 mg QD | Change From Baseline in Postprandial Incremental Area Under the Curve for Total Triglycerides at Week 4. | -288.490 mg.h/dL | Standard Error 65.453 |
| Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Change From Baseline in Postprandial Incremental Area Under the Curve for Total Triglycerides at Week 4. | -279.116 mg.h/dL | Standard Error 68.4947 |
Secondary
Change From Baseline in Postprandial Proinsulin
The change in postprandial proinsulin collected at each week indicated relative to baseline.
Time frame: Baseline, Week 4 and Week 16.
Population: The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo QD | Change From Baseline in Postprandial Proinsulin | Week 4: 3 hours postprandial (n=24; n=21; n=19) | -6.735 pmol/L | Standard Error 5.9547 |
| Placebo QD | Change From Baseline in Postprandial Proinsulin | Week 4: 1 hour postprandial (n=24; n=21; n=19) | -4.555 pmol/L | Standard Error 3.9248 |
| Placebo QD | Change From Baseline in Postprandial Proinsulin | Week 4: 2 hours postprandial (n=24; n=21; n=19) | -0.208 pmol/L | Standard Error 5.5216 |
| Placebo QD | Change From Baseline in Postprandial Proinsulin | Week 4: 4 hours postprandial (n=24; n=21; n=19) | -6.496 pmol/L | Standard Error 5.9756 |
| Placebo QD | Change From Baseline in Postprandial Proinsulin | Week 4: 8 hours postprandial (n=23; n=21; n=19) | -5.082 pmol/L | Standard Error 4.3735 |
| Placebo QD | Change From Baseline in Postprandial Proinsulin | Week 16: 1 hour postprandial (n=24; n=25; n=21) | 2.081 pmol/L | Standard Error 5.3253 |
| Placebo QD | Change From Baseline in Postprandial Proinsulin | Week 16: 2 hours postprandial (n=24; n=25; n=21) | 3.336 pmol/L | Standard Error 6.3373 |
| Placebo QD | Change From Baseline in Postprandial Proinsulin | Week 16: 3 hours postprandial (n=24; n=25; n=21) | 5.863 pmol/L | Standard Error 6.2769 |
| Placebo QD | Change From Baseline in Postprandial Proinsulin | Week 16: 4 hours postprandial (n=24; n=25; n=21) | 8.671 pmol/L | Standard Error 5.7153 |
| Placebo QD | Change From Baseline in Postprandial Proinsulin | Week 16: 8 hours postprandial (n=24; n=25; n=21) | 6.935 pmol/L | Standard Error 5.2859 |
| Alogliptin 25 mg QD | Change From Baseline in Postprandial Proinsulin | Week 16: 4 hours postprandial (n=24; n=25; n=21) | -21.862 pmol/L | Standard Error 5.6549 |
| Alogliptin 25 mg QD | Change From Baseline in Postprandial Proinsulin | Week 4: 3 hours postprandial (n=24; n=21; n=19) | -12.987 pmol/L | Standard Error 6.4485 |
| Alogliptin 25 mg QD | Change From Baseline in Postprandial Proinsulin | Week 16: 1 hour postprandial (n=24; n=25; n=21) | -22.812 pmol/L | Standard Error 5.2274 |
| Alogliptin 25 mg QD | Change From Baseline in Postprandial Proinsulin | Week 4: 1 hour postprandial (n=24; n=21; n=19) | -13.024 pmol/L | Standard Error 4.2068 |
| Alogliptin 25 mg QD | Change From Baseline in Postprandial Proinsulin | Week 4: 8 hours postprandial (n=23; n=21; n=19) | -5.561 pmol/L | Standard Error 4.6395 |
| Alogliptin 25 mg QD | Change From Baseline in Postprandial Proinsulin | Week 16: 3 hours postprandial (n=24; n=25; n=21) | -27.768 pmol/L | Standard Error 6.2041 |
| Alogliptin 25 mg QD | Change From Baseline in Postprandial Proinsulin | Week 4: 2 hours postprandial (n=24; n=21; n=19) | -12.568 pmol/L | Standard Error 5.9505 |
| Alogliptin 25 mg QD | Change From Baseline in Postprandial Proinsulin | Week 16: 8 hours postprandial (n=24; n=25; n=21) | -6.898 pmol/L | Standard Error 5.2307 |
| Alogliptin 25 mg QD | Change From Baseline in Postprandial Proinsulin | Week 16: 2 hours postprandial (n=24; n=25; n=21) | -29.930 pmol/L | Standard Error 6.2396 |
| Alogliptin 25 mg QD | Change From Baseline in Postprandial Proinsulin | Week 4: 4 hours postprandial (n=24; n=21; n=19) | -6.848 pmol/L | Standard Error 6.4875 |
| Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Change From Baseline in Postprandial Proinsulin | Week 16: 3 hours postprandial (n=24; n=25; n=21) | -50.058 pmol/L | Standard Error 6.7783 |
| Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Change From Baseline in Postprandial Proinsulin | Week 4: 4 hours postprandial (n=24; n=21; n=19) | -52.649 pmol/L | Standard Error 6.8526 |
| Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Change From Baseline in Postprandial Proinsulin | Week 4: 8 hours postprandial (n=23; n=21; n=19) | -35.159 pmol/L | Standard Error 4.9287 |
| Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Change From Baseline in Postprandial Proinsulin | Week 16: 1 hour postprandial (n=24; n=25; n=21) | -30.658 pmol/L | Standard Error 5.7287 |
| Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Change From Baseline in Postprandial Proinsulin | Week 16: 4 hours postprandial (n=24; n=25; n=21) | -48.757 pmol/L | Standard Error 6.1834 |
| Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Change From Baseline in Postprandial Proinsulin | Week 16: 2 hours postprandial (n=24; n=25; n=21) | -45.487 pmol/L | Standard Error 6.8516 |
| Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Change From Baseline in Postprandial Proinsulin | Week 16: 8 hours postprandial (n=24; n=25; n=21) | -28.776 pmol/L | Standard Error 5.7372 |
| Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Change From Baseline in Postprandial Proinsulin | Week 4: 1 hour postprandial (n=24; n=21; n=19) | -41.192 pmol/L | Standard Error 4.4562 |
| Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Change From Baseline in Postprandial Proinsulin | Week 4: 2 hours postprandial (n=24; n=21; n=19) | -56.478 pmol/L | Standard Error 6.3185 |
| Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Change From Baseline in Postprandial Proinsulin | Week 4: 3 hours postprandial (n=24; n=21; n=19) | -59.573 pmol/L | Standard Error 6.8034 |
Secondary
Postprandial Changes Over Time From Baseline for Glucagon
Postprandial changes over time at each week indicated relative to baseline.
Time frame: Baseline, Week 4 and Week 16.
Population: The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo QD | Postprandial Changes Over Time From Baseline for Glucagon | Week 4: 1 hour postprandial (n=24; n=21; n=19) | 7.222 pg/mL | Standard Error 3.7636 |
| Placebo QD | Postprandial Changes Over Time From Baseline for Glucagon | Week 4: 2 hours postprandial (n=24; n=21; n=19) | 1.730 pg/mL | Standard Error 3.3262 |
| Placebo QD | Postprandial Changes Over Time From Baseline for Glucagon | Week 4: 3 hours postprandial (n=24; n=21; n=19) | 6.637 pg/mL | Standard Error 3.7141 |
| Placebo QD | Postprandial Changes Over Time From Baseline for Glucagon | Week 4: 4 hours postprandial (n=24; n=20; n=18) | 2.021 pg/mL | Standard Error 4.1496 |
| Placebo QD | Postprandial Changes Over Time From Baseline for Glucagon | Week 4: 8 hours postprandial (n=22; n=20; n=19) | 1.081 pg/mL | Standard Error 3.5 |
| Placebo QD | Postprandial Changes Over Time From Baseline for Glucagon | Week 16: 1 hour postprandial (n=24; n=25; n=21) | 3.318 pg/mL | Standard Error 3.1819 |
| Placebo QD | Postprandial Changes Over Time From Baseline for Glucagon | Week 16: 2 hours postprandial (n=24; n=25; n=21) | -1.047 pg/mL | Standard Error 3.4159 |
| Placebo QD | Postprandial Changes Over Time From Baseline for Glucagon | Week 16: 3 hours postprandial (n=24; n=25; n=21) | 4.842 pg/mL | Standard Error 3.467 |
| Placebo QD | Postprandial Changes Over Time From Baseline for Glucagon | Week 16: 4 hours postprandial (n=24; n=24; n=21) | 2.801 pg/mL | Standard Error 3.183 |
| Placebo QD | Postprandial Changes Over Time From Baseline for Glucagon | Week 16: 8 hours postprandial (n=24; n=25; n=21) | 3.917 pg/mL | Standard Error 2.5383 |
| Alogliptin 25 mg QD | Postprandial Changes Over Time From Baseline for Glucagon | Week 16: 4 hours postprandial (n=24; n=24; n=21) | -8.577 pg/mL | Standard Error 3.1873 |
| Alogliptin 25 mg QD | Postprandial Changes Over Time From Baseline for Glucagon | Week 4: 1 hour postprandial (n=24; n=21; n=19) | -14.639 pg/mL | Standard Error 4.0619 |
| Alogliptin 25 mg QD | Postprandial Changes Over Time From Baseline for Glucagon | Week 16: 1 hour postprandial (n=24; n=25; n=21) | -16.955 pg/mL | Standard Error 3.1477 |
| Alogliptin 25 mg QD | Postprandial Changes Over Time From Baseline for Glucagon | Week 4: 8 hours postprandial (n=22; n=20; n=19) | -3.789 pg/mL | Standard Error 3.6665 |
| Alogliptin 25 mg QD | Postprandial Changes Over Time From Baseline for Glucagon | Week 4: 2 hours postprandial (n=24; n=21; n=19) | -17.015 pg/mL | Standard Error 3.5627 |
| Alogliptin 25 mg QD | Postprandial Changes Over Time From Baseline for Glucagon | Week 16: 8 hours postprandial (n=24; n=25; n=21) | -5.818 pg/mL | Standard Error 2.4876 |
| Alogliptin 25 mg QD | Postprandial Changes Over Time From Baseline for Glucagon | Week 16: 3 hours postprandial (n=24; n=25; n=21) | -13.602 pg/mL | Standard Error 3.4048 |
| Alogliptin 25 mg QD | Postprandial Changes Over Time From Baseline for Glucagon | Week 4: 3 hours postprandial (n=24; n=21; n=19) | -13.200 pg/mL | Standard Error 3.9753 |
| Alogliptin 25 mg QD | Postprandial Changes Over Time From Baseline for Glucagon | Week 16: 2 hours postprandial (n=24; n=25; n=21) | -20.949 pg/mL | Standard Error 3.3556 |
| Alogliptin 25 mg QD | Postprandial Changes Over Time From Baseline for Glucagon | Week 4: 4 hours postprandial (n=24; n=20; n=18) | -4.679 pg/mL | Standard Error 4.5627 |
| Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Postprandial Changes Over Time From Baseline for Glucagon | Week 16: 3 hours postprandial (n=24; n=25; n=21) | 10.84 pg/mL | Standard Error 3.726 |
| Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Postprandial Changes Over Time From Baseline for Glucagon | Week 4: 4 hours postprandial (n=24; n=20; n=18) | -8.860 pg/mL | Standard Error 4.791 |
| Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Postprandial Changes Over Time From Baseline for Glucagon | Week 4: 8 hours postprandial (n=22; n=20; n=19) | -5.150 pg/mL | Standard Error 3.7592 |
| Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Postprandial Changes Over Time From Baseline for Glucagon | Week 16: 1 hour postprandial (n=24; n=25; n=21) | -17.462 pg/mL | Standard Error 3.4144 |
| Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Postprandial Changes Over Time From Baseline for Glucagon | Week 16: 4 hours postprandial (n=24; n=24; n=21) | -10.326 pg/mL | Standard Error 3.4011 |
| Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Postprandial Changes Over Time From Baseline for Glucagon | Week 16: 2 hours postprandial (n=24; n=25; n=21) | -20.662 pg/mL | Standard Error 3.6653 |
| Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Postprandial Changes Over Time From Baseline for Glucagon | Week 4: 1 hour postprandial (n=24; n=21; n=19) | -17.704 pg/mL | Standard Error 4.2418 |
| Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Postprandial Changes Over Time From Baseline for Glucagon | Week 16: 8 hours postprandial (n=24; n=25; n=21) | -9.332 pg/mL | Standard Error 2.7108 |
| Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Postprandial Changes Over Time From Baseline for Glucagon | Week 4: 2 hours postprandial (n=24; n=21; n=19) | -22.081 pg/mL | Standard Error 3.7541 |
| Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Postprandial Changes Over Time From Baseline for Glucagon | Week 4: 3 hours postprandial (n=24; n=21; n=19) | -15.987 pg/mL | Standard Error 4.2015 |
Secondary
Postprandial Changes Over Time From Baseline for Glucagon-like Peptide-1 (GLP-1)
Postprandial changes over time at each week indicated relative to baseline.
Time frame: Baseline, Week 4 and Week 16.
Population: The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo QD | Postprandial Changes Over Time From Baseline for Glucagon-like Peptide-1 (GLP-1) | Week 4: 1 hour postprandial (n=20; n=17; n=15) | 0.52 pmol/L | Standard Error 1.167 |
| Placebo QD | Postprandial Changes Over Time From Baseline for Glucagon-like Peptide-1 (GLP-1) | Week 4: 2 hours postprandial (n=21; n=17; n=16) | 0.92 pmol/L | Standard Error 1.524 |
| Placebo QD | Postprandial Changes Over Time From Baseline for Glucagon-like Peptide-1 (GLP-1) | Week 4: 3 hours postprandial (n=21; n=17; n=16) | 1.20 pmol/L | Standard Error 1.619 |
| Placebo QD | Postprandial Changes Over Time From Baseline for Glucagon-like Peptide-1 (GLP-1) | Week 4: 4 hours postprandial (n=21; n=17; n=16) | 1.76 pmol/L | Standard Error 1.823 |
| Placebo QD | Postprandial Changes Over Time From Baseline for Glucagon-like Peptide-1 (GLP-1) | Week 4: 8 hours postprandial (n=19; n=16; n=16) | -1.01 pmol/L | Standard Error 0.955 |
| Placebo QD | Postprandial Changes Over Time From Baseline for Glucagon-like Peptide-1 (GLP-1) | Week 16: 1 hour postprandial (n=21 ; n=20; n=16) | -0.28 pmol/L | Standard Error 1.304 |
| Placebo QD | Postprandial Changes Over Time From Baseline for Glucagon-like Peptide-1 (GLP-1) | Week 16: 2 hours postprandial (n=21; n=21; n=17) | -3.59 pmol/L | Standard Error 1.451 |
| Placebo QD | Postprandial Changes Over Time From Baseline for Glucagon-like Peptide-1 (GLP-1) | Week 16: 3 hours postprandial (n=21; n=21; n=17) | -1.08 pmol/L | Standard Error 1.206 |
| Placebo QD | Postprandial Changes Over Time From Baseline for Glucagon-like Peptide-1 (GLP-1) | Week 16: 4 hours postprandial (n=21; n=21; n=17) | -0.64 pmol/L | Standard Error 1.263 |
| Placebo QD | Postprandial Changes Over Time From Baseline for Glucagon-like Peptide-1 (GLP-1) | Week 16: 8 hours postprandial (n=21; n=21; n=17) | -1.36 pmol/L | Standard Error 0.82 |
| Alogliptin 25 mg QD | Postprandial Changes Over Time From Baseline for Glucagon-like Peptide-1 (GLP-1) | Week 16: 4 hours postprandial (n=21; n=21; n=17) | -1.88 pmol/L | Standard Error 1.271 |
| Alogliptin 25 mg QD | Postprandial Changes Over Time From Baseline for Glucagon-like Peptide-1 (GLP-1) | Week 4: 1 hour postprandial (n=20; n=17; n=15) | -5.48 pmol/L | Standard Error 1.249 |
| Alogliptin 25 mg QD | Postprandial Changes Over Time From Baseline for Glucagon-like Peptide-1 (GLP-1) | Week 16: 1 hour postprandial (n=21 ; n=20; n=16) | -4.10 pmol/L | Standard Error 1.326 |
| Alogliptin 25 mg QD | Postprandial Changes Over Time From Baseline for Glucagon-like Peptide-1 (GLP-1) | Week 4: 8 hours postprandial (n=19; n=16; n=16) | -0.38 pmol/L | Standard Error 1.039 |
| Alogliptin 25 mg QD | Postprandial Changes Over Time From Baseline for Glucagon-like Peptide-1 (GLP-1) | Week 4: 2 hours postprandial (n=21; n=17; n=16) | -2.93 pmol/L | Standard Error 1.702 |
| Alogliptin 25 mg QD | Postprandial Changes Over Time From Baseline for Glucagon-like Peptide-1 (GLP-1) | Week 16: 8 hours postprandial (n=21; n=21; n=17) | 0.03 pmol/L | Standard Error 0.819 |
| Alogliptin 25 mg QD | Postprandial Changes Over Time From Baseline for Glucagon-like Peptide-1 (GLP-1) | Week 16: 3 hours postprandial (n=21; n=21; n=17) | -2.25 pmol/L | Standard Error 1.202 |
| Alogliptin 25 mg QD | Postprandial Changes Over Time From Baseline for Glucagon-like Peptide-1 (GLP-1) | Week 4: 3 hours postprandial (n=21; n=17; n=16) | -2.08 pmol/L | Standard Error 1.789 |
| Alogliptin 25 mg QD | Postprandial Changes Over Time From Baseline for Glucagon-like Peptide-1 (GLP-1) | Week 16: 2 hours postprandial (n=21; n=21; n=17) | -3.75 pmol/L | Standard Error 1.457 |
| Alogliptin 25 mg QD | Postprandial Changes Over Time From Baseline for Glucagon-like Peptide-1 (GLP-1) | Week 4: 4 hours postprandial (n=21; n=17; n=16) | 2.86 pmol/L | Standard Error 2.027 |
| Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Postprandial Changes Over Time From Baseline for Glucagon-like Peptide-1 (GLP-1) | Week 16: 3 hours postprandial (n=21; n=21; n=17) | -3.17 pmol/L | Standard Error 1.326 |
| Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Postprandial Changes Over Time From Baseline for Glucagon-like Peptide-1 (GLP-1) | Week 4: 4 hours postprandial (n=21; n=17; n=16) | -0.84 pmol/L | Standard Error 2.077 |
| Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Postprandial Changes Over Time From Baseline for Glucagon-like Peptide-1 (GLP-1) | Week 4: 8 hours postprandial (n=19; n=16; n=16) | -0.72 pmol/L | Standard Error 1.04 |
| Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Postprandial Changes Over Time From Baseline for Glucagon-like Peptide-1 (GLP-1) | Week 16: 1 hour postprandial (n=21 ; n=20; n=16) | -3.63 pmol/L | Standard Error 1.462 |
| Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Postprandial Changes Over Time From Baseline for Glucagon-like Peptide-1 (GLP-1) | Week 16: 4 hours postprandial (n=21; n=21; n=17) | -1.83 pmol/L | Standard Error 1.393 |
| Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Postprandial Changes Over Time From Baseline for Glucagon-like Peptide-1 (GLP-1) | Week 16: 2 hours postprandial (n=21; n=21; n=17) | -3.75 pmol/L | Standard Error 1.599 |
| Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Postprandial Changes Over Time From Baseline for Glucagon-like Peptide-1 (GLP-1) | Week 4: 1 hour postprandial (n=20; n=17; n=15) | -4.88 pmol/L | Standard Error 1.33 |
| Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Postprandial Changes Over Time From Baseline for Glucagon-like Peptide-1 (GLP-1) | Week 16: 8 hours postprandial (n=21; n=21; n=17) | -1.48 pmol/L | Standard Error 0.91 |
| Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Postprandial Changes Over Time From Baseline for Glucagon-like Peptide-1 (GLP-1) | Week 4: 2 hours postprandial (n=21; n=17; n=16) | -6.41 pmol/L | Standard Error 1.732 |
| Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Postprandial Changes Over Time From Baseline for Glucagon-like Peptide-1 (GLP-1) | Week 4: 3 hours postprandial (n=21; n=17; n=16) | -3.61 pmol/L | Standard Error 1.848 |
Secondary
Postprandial Changes Over Time From Baseline for Glucose
Postprandial changes over time at each week indicated relative to baseline.
Time frame: Baseline, Week 4 and Week 16.
Population: The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo QD | Postprandial Changes Over Time From Baseline for Glucose | Week 16: 2 hours postprandial (n=23; n=25; n=21) | 17.324 mg/dL | Standard Error 8.6572 |
| Placebo QD | Postprandial Changes Over Time From Baseline for Glucose | Week 4: 4 hours postprandial (n=24; n=21; n=19) | 2.930 mg/dL | Standard Error 5.3775 |
| Placebo QD | Postprandial Changes Over Time From Baseline for Glucose | Week 16: 4 hours postprandial (n=24; n=25; n=21) | 10.849 mg/dL | Standard Error 7.3084 |
| Placebo QD | Postprandial Changes Over Time From Baseline for Glucose | Week 16: 1 hour postprandial (n=24; n=25; n=21) | 11.867 mg/dL | Standard Error 8.1356 |
| Placebo QD | Postprandial Changes Over Time From Baseline for Glucose | Week 4: 8 hours postprandial (n=22; n=21; n=19) | 0.046 mg/dL | Standard Error 4.112 |
| Placebo QD | Postprandial Changes Over Time From Baseline for Glucose | Week 4: 2 hours postprandial (n=23; n=21; n=19) | -4.049 mg/dL | Standard Error 5.9932 |
| Placebo QD | Postprandial Changes Over Time From Baseline for Glucose | Week 16: 8 hours postprandial (n=24; n=25; n=21) | 3.266 mg/dL | Standard Error 5.0112 |
| Placebo QD | Postprandial Changes Over Time From Baseline for Glucose | Week 16: 3 hours postprandial (n=24; n=25; n=20) | 18.379 mg/dL | Standard Error 7.8017 |
| Placebo QD | Postprandial Changes Over Time From Baseline for Glucose | Week 4: 3 hours postprandial (n=24; n=21; n=18) | 3.200 mg/dL | Standard Error 6.3047 |
| Placebo QD | Postprandial Changes Over Time From Baseline for Glucose | Week 4: 1 hour postprandial (n=24; n=21; n=19) | -5.957 mg/dL | Standard Error 5.397 |
| Alogliptin 25 mg QD | Postprandial Changes Over Time From Baseline for Glucose | Week 4: 8 hours postprandial (n=22; n=21; n=19) | -6.077 mg/dL | Standard Error 4.2043 |
| Alogliptin 25 mg QD | Postprandial Changes Over Time From Baseline for Glucose | Week 16: 8 hours postprandial (n=24; n=25; n=21) | -5.737 mg/dL | Standard Error 4.9335 |
| Alogliptin 25 mg QD | Postprandial Changes Over Time From Baseline for Glucose | Week 4: 2 hours postprandial (n=23; n=21; n=19) | -24.721 mg/dL | Standard Error 6.2299 |
| Alogliptin 25 mg QD | Postprandial Changes Over Time From Baseline for Glucose | Week 4: 3 hours postprandial (n=24; n=21; n=18) | -19.367 mg/dL | Standard Error 6.7356 |
| Alogliptin 25 mg QD | Postprandial Changes Over Time From Baseline for Glucose | Week 4: 4 hours postprandial (n=24; n=21; n=19) | -13.907 mg/dL | Standard Error 5.6699 |
| Alogliptin 25 mg QD | Postprandial Changes Over Time From Baseline for Glucose | Week 4: 1 hour postprandial (n=24; n=21; n=19) | -35.065 mg/dL | Standard Error 5.7617 |
| Alogliptin 25 mg QD | Postprandial Changes Over Time From Baseline for Glucose | Week 16: 1 hour postprandial (n=24; n=25; n=21) | -36.189 mg/dL | Standard Error 7.9793 |
| Alogliptin 25 mg QD | Postprandial Changes Over Time From Baseline for Glucose | Week 16: 2 hours postprandial (n=23; n=25; n=21) | -29.745 mg/dL | Standard Error 8.283 |
| Alogliptin 25 mg QD | Postprandial Changes Over Time From Baseline for Glucose | Week 16: 3 hours postprandial (n=24; n=25; n=20) | -16.996 mg/dL | Standard Error 7.6465 |
| Alogliptin 25 mg QD | Postprandial Changes Over Time From Baseline for Glucose | Week 16: 4 hours postprandial (n=24; n=25; n=21) | -12.517 mg/dL | Standard Error 7.1054 |
| Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Postprandial Changes Over Time From Baseline for Glucose | Week 4: 3 hours postprandial (n=24; n=21; n=18) | -54.345 mg/dL | Standard Error 7.2106 |
| Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Postprandial Changes Over Time From Baseline for Glucose | Week 16: 8 hours postprandial (n=24; n=25; n=21) | -19.381 mg/dL | Standard Error 5.335 |
| Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Postprandial Changes Over Time From Baseline for Glucose | Week 16: 2 hours postprandial (n=23; n=25; n=21) | -61.899 mg/dL | Standard Error 9.0248 |
| Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Postprandial Changes Over Time From Baseline for Glucose | Week 4: 2 hours postprandial (n=23; n=21; n=19) | -67.718 mg/dL | Standard Error 6.5647 |
| Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Postprandial Changes Over Time From Baseline for Glucose | Week 16: 4 hours postprandial (n=24; n=25; n=21) | -41.943 mg/dL | Standard Error 7.7396 |
| Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Postprandial Changes Over Time From Baseline for Glucose | Week 16: 3 hours postprandial (n=24; n=25; n=20) | -51.891 mg/dL | Standard Error 8.4838 |
| Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Postprandial Changes Over Time From Baseline for Glucose | Week 4: 8 hours postprandial (n=22; n=21; n=19) | -27.856 mg/dL | Standard Error 4.3961 |
| Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Postprandial Changes Over Time From Baseline for Glucose | Week 4: 4 hours postprandial (n=24; n=21; n=19) | -48.643 mg/dL | Standard Error 6.0151 |
| Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Postprandial Changes Over Time From Baseline for Glucose | Week 4: 1 hour postprandial (n=24; n=21; n=19) | -65.905 mg/dL | Standard Error 6.0315 |
| Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Postprandial Changes Over Time From Baseline for Glucose | Week 16: 1 hour postprandial (n=24; n=25; n=21) | -58.168 mg/dL | Standard Error 8.6585 |
Secondary
Postprandial Changes Over Time From Baseline for Insulin
Postprandial changes over time at each week indicated relative to baseline.
Time frame: Baseline, Week 4 and Week 16.
Population: The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo QD | Postprandial Changes Over Time From Baseline for Insulin | Week 16: 1 hour postprandial (n=24; n=25; n=21) | -8.896 uIU/mL | Standard Error 4.8993 |
| Placebo QD | Postprandial Changes Over Time From Baseline for Insulin | Week 4: 4 hours postprandial (n=24; n=21; n=19) | 2.999 uIU/mL | Standard Error 3.5652 |
| Placebo QD | Postprandial Changes Over Time From Baseline for Insulin | Week 16: 3 hours postprandial (n=24; n=25; n=21) | 4.447 uIU/mL | Standard Error 4.8889 |
| Placebo QD | Postprandial Changes Over Time From Baseline for Insulin | Week 4: 1 hour postprandial (n=24; n=21; n=18) | -5.047 uIU/mL | Standard Error 3.5562 |
| Placebo QD | Postprandial Changes Over Time From Baseline for Insulin | Week 4: 8 hours postprandial (n=23; n=21; n=19) | -1.174 uIU/mL | Standard Error 1.027 |
| Placebo QD | Postprandial Changes Over Time From Baseline for Insulin | Week 4: 2 hours postprandial (n=24; n=21; n=19) | 1.405 uIU/mL | Standard Error 6.3051 |
| Placebo QD | Postprandial Changes Over Time From Baseline for Insulin | Week 16: 8 hours postprandial (n=24; n=25; n=21) | 0.495 uIU/mL | Standard Error 1.2847 |
| Placebo QD | Postprandial Changes Over Time From Baseline for Insulin | Week 16: 2 hours postprandial (n=24; n=25; n=21) | -9.258 uIU/mL | Standard Error 6.5119 |
| Placebo QD | Postprandial Changes Over Time From Baseline for Insulin | Week 4: 3 hours postprandial (n=24; n=21; n=19) | 0.637 uIU/mL | Standard Error 5.2789 |
| Placebo QD | Postprandial Changes Over Time From Baseline for Insulin | Week 16: 4 hours postprandial (n=24; n=25; n=21) | 8.405 uIU/mL | Standard Error 4.509 |
| Alogliptin 25 mg QD | Postprandial Changes Over Time From Baseline for Insulin | Week 4: 8 hours postprandial (n=23; n=21; n=19) | 2.685 uIU/mL | Standard Error 1.0772 |
| Alogliptin 25 mg QD | Postprandial Changes Over Time From Baseline for Insulin | Week 4: 1 hour postprandial (n=24; n=21; n=18) | -5.867 uIU/mL | Standard Error 3.7749 |
| Alogliptin 25 mg QD | Postprandial Changes Over Time From Baseline for Insulin | Week 4: 2 hours postprandial (n=24; n=21; n=19) | 3.161 uIU/mL | Standard Error 6.7294 |
| Alogliptin 25 mg QD | Postprandial Changes Over Time From Baseline for Insulin | Week 4: 3 hours postprandial (n=24; n=21; n=19) | 0.652 uIU/mL | Standard Error 5.6125 |
| Alogliptin 25 mg QD | Postprandial Changes Over Time From Baseline for Insulin | Week 4: 4 hours postprandial (n=24; n=21; n=19) | 5.092 uIU/mL | Standard Error 3.8075 |
| Alogliptin 25 mg QD | Postprandial Changes Over Time From Baseline for Insulin | Week 16: 1 hour postprandial (n=24; n=25; n=21) | -14.368 uIU/mL | Standard Error 4.7784 |
| Alogliptin 25 mg QD | Postprandial Changes Over Time From Baseline for Insulin | Week 16: 2 hours postprandial (n=24; n=25; n=21) | -9.528 uIU/mL | Standard Error 6.4 |
| Alogliptin 25 mg QD | Postprandial Changes Over Time From Baseline for Insulin | Week 16: 3 hours postprandial (n=24; n=25; n=21) | -9.848 uIU/mL | Standard Error 4.78 |
| Alogliptin 25 mg QD | Postprandial Changes Over Time From Baseline for Insulin | Week 16: 4 hours postprandial (n=24; n=25; n=21) | -4.753 uIU/mL | Standard Error 4.4158 |
| Alogliptin 25 mg QD | Postprandial Changes Over Time From Baseline for Insulin | Week 16: 8 hours postprandial (n=24; n=25; n=21) | 3.163 uIU/mL | Standard Error 1.2637 |
| Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Postprandial Changes Over Time From Baseline for Insulin | Week 4: 2 hours postprandial (n=24; n=21; n=19) | -28.700 uIU/mL | Standard Error 7.0572 |
| Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Postprandial Changes Over Time From Baseline for Insulin | Week 16: 4 hours postprandial (n=24; n=25; n=21) | -19.329 uIU/mL | Standard Error 4.8159 |
| Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Postprandial Changes Over Time From Baseline for Insulin | Week 16: 2 hours postprandial (n=24; n=25; n=21) | -24.777 uIU/mL | Standard Error 6.9371 |
| Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Postprandial Changes Over Time From Baseline for Insulin | Week 4: 1 hour postprandial (n=24; n=21; n=18) | -18.287 uIU/mL | Standard Error 4.0906 |
| Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Postprandial Changes Over Time From Baseline for Insulin | Week 16: 8 hours postprandial (n=24; n=25; n=21) | -6.107 uIU/mL | Standard Error 1.3728 |
| Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Postprandial Changes Over Time From Baseline for Insulin | Week 4: 4 hours postprandial (n=24; n=21; n=19) | -12.891 uIU/mL | Standard Error 4.0088 |
| Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Postprandial Changes Over Time From Baseline for Insulin | Week 4: 8 hours postprandial (n=23; n=21; n=19) | -6.000 uIU/mL | Standard Error 1.1301 |
| Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Postprandial Changes Over Time From Baseline for Insulin | Week 4: 3 hours postprandial (n=24; n=21; n=19) | -18.842 uIU/mL | Standard Error 5.9301 |
| Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Postprandial Changes Over Time From Baseline for Insulin | Week 16: 3 hours postprandial (n=24; n=25; n=21) | -23.025 uIU/mL | Standard Error 5.2049 |
| Alogliptin 25 mg QD + Pioglitazone 30 mg QD | Postprandial Changes Over Time From Baseline for Insulin | Week 16: 1 hour postprandial (n=24; n=25; n=21) | -12.162 uIU/mL | Standard Error 5.2052 |