Type 2 Diabetes Melitus
Conditions
Keywords
Drug Therapy
Brief summary
The purpose of this study is to determine the safety and efficacy of long-term combination therapy with alogliptin (Nesina) and thiazolidinediones in patients with type 2 diabetes mellitus who failed to respond adequately to treatment with thiazolidinediones in addition to diet therapy and exercise therapy.
Detailed description
This is a special drug use surveillance on long-term use of alogliptin with a 1-year (12-month) observational period, designed to investigate the safety and efficacy of long-term combination therapy with alogliptin and thiazolidinediones in patients with type 2 diabetes mellitus in a routine clinical setting. Participants will be patients with type 2 diabetes mellitus who failed to respond adequately to treatment with thiazolidinediones in addition to diet therapy and exercise therapy. The planned sample size is 1,000 subjects. The usual adult dosage for oral use is 1 alogliptin tablet (25 mg) once daily.
Interventions
DRUGAlogliptin
Alogliptin tablets
Sponsors
Takeda
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients who did not adequately respond to the following treatment • Treatment with thiazolidinediones in addition to diet therapy and exercise therapy
Exclusion criteria
* Patients contraindicated for Nesina 1. Patients with severe ketosis, diabetic coma or precoma, or type 1 diabetes mellitus (these patients require prompt adjustment of hyperglycemia by fluid infusion and insulin, and hence use of Nesina is not appropriate.) 2. Patients with severe infection, pre- or post-operative patients, or patients with serious traumatic injury (blood glucose control by insulin injection is desirable for these patients, and hence use of Nesina is not appropriate.) 3. Patients with a history of hypersensitivity to any ingredient of Nesina
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Reporting One or More Adverse Drug Reactions | Baseline up to 12 months | Adverse drug reactions are defined as adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. The safety analysis was planned to be assessed in alogliptin + thiazolidinedione and alogliptin + other arm separately. |
| Number of Participants Reporting One or More Serious Adverse Drug Reactions | Baseline up to 12 months | Serious adverse drug reactions are defined as serious adverse events (SAEs) which are in the investigator's opinion of causal relationship to the study treatment. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The safety analysis was planned to be assessed in alogliptin + thiazolidinedione and alogliptin + other arm separately. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Glycosylated Hemoglobin (HbA1c) | Baseline, Months 1, 3, 6, 12, and final assessment (up to 12 months) | 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 1 month, 3 months, 6 months, 12 months or final visit (last visit for a participant in the study, up to Month 12) relative to baseline. The efficacy analysis was planned to be assessed in the total alogliptin arm irrespective of the thiazolidinedione treatment. |
| Percentage of Participants of Achieving Objective Glycemic Control | Baseline, Months 1, 3, 6, 12, and final assessment (up to 12 months) | The rate of achieving objective glycemic control in HbA1c level, was calculated at 1 month, 3 months, 6 months, 12 months or final visit (last visit for a participant in the study, up to Month 12). Glycemic control was measured as \<8.0 percent, \<7.0 percent, and \<6.0 percent of glycosylated hemoglobin. The efficacy analysis was planned to be assessed in the total alogliptin arm irrespective of the thiazolidinedione treatment. |
| Change From Baseline in Fasting Blood Glucose | Baseline, Months 1, 3, 6, 12, and final assessment (up to 12 months) | The change between the fasting blood glucose value collected at 1 month, 3 months, 6 months, 12 months or final visit (last visit for a participant in the study, up to Month 12) relative to baseline. The efficacy analysis was planned to be assessed in the total alogliptin arm irrespective of the thiazolidinedione treatment. |
| Change From Baseline in Fasting Insulin | Baseline, Months 1, 3, 6, 12, and final assessment (up to 12 months) | The change between the fasting insulin value collected at 1 month, 3 months, 6 months, 12 months or final visit (last visit for a participant in the study, up to Month 12) relative to baseline. The efficacy analysis was planned to be assessed in the total alogliptin arm irrespective of the thiazolidinedione treatment. |
Participant flow
Recruitment details
Participants took part in the study at 252 investigative site in Japan from 25 March 2011 to 30 June 2014.
Pre-assignment details
Participants with a historical diagnosis of type 2 diabetes mellitus who failed to respond adequately to treatment receiving thiazolidinediones were enrolled in 1 of 2 treatment groups as follows: alogliptin + thiazolidinediones; alogliptin + other.
Participants by arm
| Arm | Count |
|---|---|
| Alogliptin + Thiazolidinedione Alogliptin 25 milligram (mg), tablets, orally, once daily for up to 12 months in participants who received a thiazolidinedione within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin. | 1,248 |
| Alogliptin + Other Alogliptin 25 mg, tablets, orally, once daily for up to 12 months in participants who did not receive a thiazolidinedione within 3 months from the start of administration of alogliptin or during the treatment period of alogliptin. | 120 |
| Total | 1,368 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 3 | 3 |
Baseline characteristics
| Characteristic | Alogliptin + Thiazolidinedione | Alogliptin + Other | Total |
|---|---|---|---|
| Age, Customized 20-29 years | 5 participants | 0 participants | 5 participants |
| Age, Customized 30-39 years | 29 participants | 4 participants | 33 participants |
| Age, Customized 40-49 years | 120 participants | 12 participants | 132 participants |
| Age, Customized 50-59 years | 214 participants | 22 participants | 236 participants |
| Age, Customized 60-69 years | 412 participants | 35 participants | 447 participants |
| Age, Customized 70-79 years | 337 participants | 39 participants | 376 participants |
| Age, Customized Greater than equal to (>=) 80 years | 130 participants | 8 participants | 138 participants |
| Age, Customized Less than (<) 20 years | 1 participants | 0 participants | 1 participants |
| Body Mass Index <18.5 kilogram/square meter (kg/m^2) | 16 participants | 0 participants | 16 participants |
| Body Mass Index >=18.5 to <25 kg/m^2 | 318 participants | 26 participants | 344 participants |
| Body Mass Index >=25 to <30 kg/m^2 | 353 participants | 31 participants | 384 participants |
| Body Mass Index >=30 kg/m^2 | 134 participants | 16 participants | 150 participants |
| Body Mass Index Unknown | 427 participants | 47 participants | 474 participants |
| Breakdown of Complications of Allergic Disease Asthma bronchial | 27 participants | 3 participants | 30 participants |
| Breakdown of Complications of Allergic Disease Dermatitis allergic | 2 participants | 0 participants | 2 participants |
| Breakdown of Complications of Allergic Disease Pollinosis | 12 participants | 0 participants | 12 participants |
| Breakdown of Complications of Allergic Disease Rhinitis allergic | 25 participants | 4 participants | 29 participants |
| Breakdown of Complications of Heart Disease Angina pectoris | 71 participants | 4 participants | 75 participants |
| Breakdown of Complications of Heart Disease Cardiac failure | 16 participants | 2 participants | 18 participants |
| Breakdown of Complications of Heart Disease Myocardial infarction | 27 participants | 3 participants | 30 participants |
| Breakdown of Complications of Heart Disease Other | 42 participants | 3 participants | 45 participants |
| Breakdown of Complications of Liver Damage Chronic hepatitis | 17 participants | 2 participants | 19 participants |
| Breakdown of Complications of Liver Damage Hepatic cirrhosis | 5 participants | 0 participants | 5 participants |
| Breakdown of Complications of Liver Damage Hepatic steatosis | 158 participants | 14 participants | 172 participants |
| Breakdown of Complications of Liver Damage Hepatitis alcoholic | 18 participants | 1 participants | 19 participants |
| Breakdown of Complications of Liver Damage Other | 8 participants | 2 participants | 10 participants |
| Breakdown of Complications of Renal Damage Glomerulonephritis | 3 participants | 0 participants | 3 participants |
| Breakdown of Complications of Renal Damage Nephrotic syndrome | 1 participants | 0 participants | 1 participants |
| Breakdown of Complications of Renal Damage Other | 126 participants | 5 participants | 131 participants |
| Breakdown of Complications of Renal Damage Renal failure chronic | 8 participants | 0 participants | 8 participants |
| Breakdown of complications of stroke-related disease Cerebral infarction | 80 participants | 7 participants | 87 participants |
| Breakdown of complications of stroke-related disease Transient ischemic attack | 1 participants | 0 participants | 1 participants |
| Breakdown of diabetic complications Diabetic nephropathy | 128 participants | 5 participants | 133 participants |
| Breakdown of diabetic complications Diabetic neuropathy | 71 participants | 6 participants | 77 participants |
| Breakdown of diabetic complications Diabetic retinopathy | 65 participants | 9 participants | 74 participants |
| Complications of Allergic Disease Had Allergic Disease Complication | 58 participants | 7 participants | 65 participants |
| Complications of Allergic Disease Had No Allergic Disease Complication | 1190 participants | 113 participants | 1303 participants |
| Complications of Dyslipidemia Had Dyslipidemia Complications | 766 participants | 63 participants | 829 participants |
| Complications of Dyslipidemia Had No Dyslipidemia Complications | 482 participants | 57 participants | 539 participants |
| Complications of Heart Disease Had Heart Disease Complications | 142 participants | 9 participants | 151 participants |
| Complications of Heart Disease Had No Heart Disease Complications | 1106 participants | 111 participants | 1217 participants |
| Complications of Heart Failure Had Heart Failure Complications | 16 participants | 2 participants | 18 participants |
| Complications of Heart Failure Had No Heart Failure Complications | 1232 participants | 118 participants | 1350 participants |
| Complications of Hypertension Had Hypertension Complications | 760 participants | 69 participants | 829 participants |
| Complications of Hypertension Had No Hypertension Complications | 488 participants | 51 participants | 539 participants |
| Complications of Hyperuricemia Had Hyperuricemia Complications | 106 participants | 10 participants | 116 participants |
| Complications of Hyperuricemia Had No Hyperuricemia Complications | 1142 participants | 110 participants | 1252 participants |
| Complications of Liver Damage Had Liver Damage Complications | 200 participants | 18 participants | 218 participants |
| Complications of Liver Damage Had No Liver Damage Complications | 1048 participants | 102 participants | 1150 participants |
| Complications of Malignant Tumor Had Malignant Tumor Complications | 13 participants | 5 participants | 18 participants |
| Complications of Malignant Tumor Had No Malignant Tumor Complications | 1235 participants | 115 participants | 1350 participants |
| Complications of Malignant Tumor (narrow definition) Had Malignant Tumor Complications | 11 participants | 2 participants | 13 participants |
| Complications of Malignant Tumor (narrow definition) Had No Malignant Tumor Complications | 1237 participants | 118 participants | 1355 participants |
| Complications of Renal Damage Had No Renal Damage Complications | 1110 participants | 115 participants | 1225 participants |
| Complications of Renal Damage Had Renal Damage Complications | 138 participants | 5 participants | 143 participants |
| Complications of Stroke-related Disease Had No Stroke-related Disease Complication | 1167 participants | 113 participants | 1280 participants |
| Complications of Stroke-related Disease Had Stroke-related Disease Complication | 81 participants | 7 participants | 88 participants |
| Degree of Hepatic Dysfunction Grade 1 | 89 participants | 10 participants | 99 participants |
| Degree of Hepatic Dysfunction Grade 2 | 11 participants | 0 participants | 11 participants |
| Degree of Hepatic Dysfunction Grade 3 | 0 participants | 0 participants | 0 participants |
| Degree of Hepatic Dysfunction Normal | 769 participants | 74 participants | 843 participants |
| Degree of Hepatic Dysfunction Unknown | 379 participants | 36 participants | 415 participants |
| Degree of Renal Dysfunction Mild | 488 participants | 46 participants | 534 participants |
| Degree of Renal Dysfunction Moderate | 174 participants | 15 participants | 189 participants |
| Degree of Renal Dysfunction Normal | 198 participants | 26 participants | 224 participants |
| Degree of Renal Dysfunction Severe | 10 participants | 0 participants | 10 participants |
| Degree of Renal Dysfunction Unknown | 378 participants | 33 participants | 411 participants |
| Diabetic complications Had Diabetic Complications | 203 participants | 15 participants | 218 participants |
| Diabetic complications Had No Diabetic Complications | 1045 participants | 105 participants | 1150 participants |
| Glycosylated Hemoglobin A1c (HbA1c) HbA1c <6.0 percent | 30 participants | 3 participants | 33 participants |
| Glycosylated Hemoglobin A1c (HbA1c) HbA1c >=6.0 to <7.0 percent | 289 participants | 27 participants | 316 participants |
| Glycosylated Hemoglobin A1c (HbA1c) HbA1c >=7.0 to <8.0 percent | 461 participants | 44 participants | 505 participants |
| Glycosylated Hemoglobin A1c (HbA1c) HbA1c >=8.0 percent | 365 participants | 36 participants | 401 participants |
| Glycosylated Hemoglobin A1c (HbA1c) Unknown | 103 participants | 10 participants | 113 participants |
| Healthcare category Inpatient | 11 participants | 0 participants | 11 participants |
| Healthcare category Outpatient | 1209 participants | 120 participants | 1329 participants |
| Healthcare category Outpatient and Inpatient | 28 participants | 0 participants | 28 participants |
| Health-related Complications Had Complications | 1064 participants | 96 participants | 1160 participants |
| Health-related Complications Had No Complications | 184 participants | 24 participants | 208 participants |
| History of Alcohol Consumption Had Alcohol Consumption | 333 participants | 34 participants | 367 participants |
| History of Alcohol Consumption Had No Alcohol Consumption | 690 participants | 60 participants | 750 participants |
| History of Alcohol Consumption Unknown | 225 participants | 26 participants | 251 participants |
| History of Allergies Had History of Allergies | 78 participants | 7 participants | 85 participants |
| History of Allergies Had No History of Allergies | 1066 participants | 95 participants | 1161 participants |
| History of Allergies Unknown | 104 participants | 18 participants | 122 participants |
| New York Heart Association (NYHA) Heart Failure Classification NYHA Class I | 15 participants | 1 participants | 16 participants |
| New York Heart Association (NYHA) Heart Failure Classification NYHA Class II | 1 participants | 1 participants | 2 participants |
| New York Heart Association (NYHA) Heart Failure Classification NYHA Class III | 0 participants | 0 participants | 0 participants |
| New York Heart Association (NYHA) Heart Failure Classification NYHA Class IV | 0 participants | 0 participants | 0 participants |
| Other Complications Had No Other Complications | 872 participants | 86 participants | 958 participants |
| Other Complications Had Other Complications | 376 participants | 34 participants | 410 participants |
| Pregnancy Status Not pregnant | 462 participants | 41 participants | 503 participants |
| Pregnancy Status Pregnant | 0 participants | 0 participants | 0 participants |
| Presence of Medical History Had No Presence of Medical History | 960 participants | 88 participants | 1048 participants |
| Presence of Medical History Had Presence of Medical History | 162 participants | 19 participants | 181 participants |
| Presence of Medical History Unknown | 126 participants | 13 participants | 139 participants |
| Sex: Female, Male Female | 462 Participants | 41 Participants | 503 Participants |
| Sex: Female, Male Male | 786 Participants | 79 Participants | 865 Participants |
| Smoking Classification Current Smoker | 204 participants | 25 participants | 229 participants |
| Smoking Classification Ex-smoker | 233 participants | 24 participants | 257 participants |
| Smoking Classification Never Smoked | 525 participants | 45 participants | 570 participants |
| Smoking Classification Unknown | 286 participants | 26 participants | 312 participants |
| Time from Diagnosis of Type 2 Diabetes >=10 years | 288 participants | 22 participants | 310 participants |
| Time from Diagnosis of Type 2 Diabetes >=2 to <5 years | 187 participants | 17 participants | 204 participants |
| Time from Diagnosis of Type 2 Diabetes <2 years | 158 participants | 35 participants | 193 participants |
| Time from Diagnosis of Type 2 Diabetes >=5 to <10 years | 247 participants | 21 participants | 268 participants |
| Time from Diagnosis of Type 2 Diabetes Unknown | 368 participants | 25 participants | 393 participants |
| Waist Circumference <85 centimeter (cm) (Male) | 60 participants | 7 participants | 67 participants |
| Waist Circumference >=85 cm (Male) | 184 participants | 17 participants | 201 participants |
| Waist Circumference <90 cm (Female) | 92 participants | 4 participants | 96 participants |
| Waist Circumference >=90 cm (Female) | 49 participants | 4 participants | 53 participants |
| Waist Circumference Unknown (Female) | 321 participants | 33 participants | 354 participants |
| Waist Circumference Unknown (Male) | 542 participants | 55 participants | 597 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 11 / 1,248 | 2 / 120 |
| serious Total, serious adverse events | 3 / 1,248 | 0 / 120 |
Outcome results
Primary
Number of Participants Reporting One or More Adverse Drug Reactions
Adverse drug reactions are defined as adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. The safety analysis was planned to be assessed in alogliptin + thiazolidinedione and alogliptin + other arm separately.
Time frame: Baseline up to 12 months
Population: The safety analysis set was defined as all participants who were enrolled and completed the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Alogliptin + Thiazolidinedione | Number of Participants Reporting One or More Adverse Drug Reactions | Rib fracture | 1 participants |
| Alogliptin + Thiazolidinedione | Number of Participants Reporting One or More Adverse Drug Reactions | Dizziness | 3 participants |
| Alogliptin + Thiazolidinedione | Number of Participants Reporting One or More Adverse Drug Reactions | Blood insulin increased | 1 participants |
| Alogliptin + Thiazolidinedione | Number of Participants Reporting One or More Adverse Drug Reactions | Photopsia | 1 participants |
| Alogliptin + Thiazolidinedione | Number of Participants Reporting One or More Adverse Drug Reactions | Hypothyroidism | 1 participants |
| Alogliptin + Thiazolidinedione | Number of Participants Reporting One or More Adverse Drug Reactions | Hypertension | 1 participants |
| Alogliptin + Thiazolidinedione | Number of Participants Reporting One or More Adverse Drug Reactions | Blood insulin decreased | 1 participants |
| Alogliptin + Thiazolidinedione | Number of Participants Reporting One or More Adverse Drug Reactions | Abdominal distension | 1 participants |
| Alogliptin + Thiazolidinedione | Number of Participants Reporting One or More Adverse Drug Reactions | Hyperglycaemia | 1 participants |
| Alogliptin + Thiazolidinedione | Number of Participants Reporting One or More Adverse Drug Reactions | Diarrhoea | 1 participants |
| Alogliptin + Thiazolidinedione | Number of Participants Reporting One or More Adverse Drug Reactions | Hand fracture | 1 participants |
| Alogliptin + Thiazolidinedione | Number of Participants Reporting One or More Adverse Drug Reactions | Eczema | 1 participants |
| Alogliptin + Thiazolidinedione | Number of Participants Reporting One or More Adverse Drug Reactions | Hypoglycaemia | 5 participants |
| Alogliptin + Thiazolidinedione | Number of Participants Reporting One or More Adverse Drug Reactions | Pruritus | 1 participants |
| Alogliptin + Thiazolidinedione | Number of Participants Reporting One or More Adverse Drug Reactions | Pyrexia | 1 participants |
| Alogliptin + Thiazolidinedione | Number of Participants Reporting One or More Adverse Drug Reactions | Arthralgia | 1 participants |
| Alogliptin + Thiazolidinedione | Number of Participants Reporting One or More Adverse Drug Reactions | Dyslipidaemia | 1 participants |
| Alogliptin + Thiazolidinedione | Number of Participants Reporting One or More Adverse Drug Reactions | Joint swelling | 1 participants |
| Alogliptin + Thiazolidinedione | Number of Participants Reporting One or More Adverse Drug Reactions | Local swelling | 1 participants |
| Alogliptin + Other | Number of Participants Reporting One or More Adverse Drug Reactions | Joint swelling | 0 participants |
| Alogliptin + Other | Number of Participants Reporting One or More Adverse Drug Reactions | Local swelling | 0 participants |
| Alogliptin + Other | Number of Participants Reporting One or More Adverse Drug Reactions | Pyrexia | 0 participants |
| Alogliptin + Other | Number of Participants Reporting One or More Adverse Drug Reactions | Blood insulin decreased | 0 participants |
| Alogliptin + Other | Number of Participants Reporting One or More Adverse Drug Reactions | Blood insulin increased | 0 participants |
| Alogliptin + Other | Number of Participants Reporting One or More Adverse Drug Reactions | Hand fracture | 0 participants |
| Alogliptin + Other | Number of Participants Reporting One or More Adverse Drug Reactions | Rib fracture | 0 participants |
| Alogliptin + Other | Number of Participants Reporting One or More Adverse Drug Reactions | Hypothyroidism | 0 participants |
| Alogliptin + Other | Number of Participants Reporting One or More Adverse Drug Reactions | Hyperglycaemia | 0 participants |
| Alogliptin + Other | Number of Participants Reporting One or More Adverse Drug Reactions | Hypoglycaemia | 1 participants |
| Alogliptin + Other | Number of Participants Reporting One or More Adverse Drug Reactions | Dyslipidaemia | 0 participants |
| Alogliptin + Other | Number of Participants Reporting One or More Adverse Drug Reactions | Dizziness | 0 participants |
| Alogliptin + Other | Number of Participants Reporting One or More Adverse Drug Reactions | Photopsia | 0 participants |
| Alogliptin + Other | Number of Participants Reporting One or More Adverse Drug Reactions | Hypertension | 0 participants |
| Alogliptin + Other | Number of Participants Reporting One or More Adverse Drug Reactions | Abdominal distension | 0 participants |
| Alogliptin + Other | Number of Participants Reporting One or More Adverse Drug Reactions | Diarrhoea | 0 participants |
| Alogliptin + Other | Number of Participants Reporting One or More Adverse Drug Reactions | Eczema | 0 participants |
| Alogliptin + Other | Number of Participants Reporting One or More Adverse Drug Reactions | Pruritus | 0 participants |
| Alogliptin + Other | Number of Participants Reporting One or More Adverse Drug Reactions | Arthralgia | 0 participants |
Primary
Number of Participants Reporting One or More Serious Adverse Drug Reactions
Serious adverse drug reactions are defined as serious adverse events (SAEs) which are in the investigator's opinion of causal relationship to the study treatment. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The safety analysis was planned to be assessed in alogliptin + thiazolidinedione and alogliptin + other arm separately.
Time frame: Baseline up to 12 months
Population: The safety analysis set was defined as all participants who were enrolled and completed the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Alogliptin + Thiazolidinedione | Number of Participants Reporting One or More Serious Adverse Drug Reactions | Hyperglycaemia | 1 participants |
| Alogliptin + Thiazolidinedione | Number of Participants Reporting One or More Serious Adverse Drug Reactions | Hypoglycaemia | 2 participants |
| Alogliptin + Other | Number of Participants Reporting One or More Serious Adverse Drug Reactions | Hyperglycaemia | 0 participants |
| Alogliptin + Other | Number of Participants Reporting One or More Serious Adverse Drug Reactions | Hypoglycaemia | 0 participants |
Secondary
Change From Baseline in Fasting Blood Glucose
The change between the fasting blood glucose value collected at 1 month, 3 months, 6 months, 12 months or final visit (last visit for a participant in the study, up to Month 12) relative to baseline. The efficacy analysis was planned to be assessed in the total alogliptin arm irrespective of the thiazolidinedione treatment.
Time frame: Baseline, Months 1, 3, 6, 12, and final assessment (up to 12 months)
Population: The efficacy assessment population was defined as participants who completed the study and had available efficacy data at baseline and post baseline.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Alogliptin + Thiazolidinedione | Change From Baseline in Fasting Blood Glucose | Baseline (n=389) | 145.4 milligram per deciliter (mg/dL) | Standard Deviation 41.25 |
| Alogliptin + Thiazolidinedione | Change From Baseline in Fasting Blood Glucose | Change at Month 1 (n=283) | -9.8 milligram per deciliter (mg/dL) | Standard Deviation 35.39 |
| Alogliptin + Thiazolidinedione | Change From Baseline in Fasting Blood Glucose | Change at Month 3 (n=301) | -11.8 milligram per deciliter (mg/dL) | Standard Deviation 37.63 |
| Alogliptin + Thiazolidinedione | Change From Baseline in Fasting Blood Glucose | Change at Month 6 (n=297) | -13.9 milligram per deciliter (mg/dL) | Standard Deviation 41.75 |
| Alogliptin + Thiazolidinedione | Change From Baseline in Fasting Blood Glucose | Change at Month 12 (n=293) | -16.2 milligram per deciliter (mg/dL) | Standard Deviation 35.46 |
| Alogliptin + Thiazolidinedione | Change From Baseline in Fasting Blood Glucose | Change at Final assessment (n=398) | -13.5 milligram per deciliter (mg/dL) | Standard Deviation 40.25 |
Secondary
Change From Baseline in Fasting Insulin
The change between the fasting insulin value collected at 1 month, 3 months, 6 months, 12 months or final visit (last visit for a participant in the study, up to Month 12) relative to baseline. The efficacy analysis was planned to be assessed in the total alogliptin arm irrespective of the thiazolidinedione treatment.
Time frame: Baseline, Months 1, 3, 6, 12, and final assessment (up to 12 months)
Population: The efficacy assessment population was defined as participants who completed the study and had available efficacy data at baseline and post baseline.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Alogliptin + Thiazolidinedione | Change From Baseline in Fasting Insulin | Baseline (n=82) | 6.32 mg/dL | Standard Deviation 3.121 |
| Alogliptin + Thiazolidinedione | Change From Baseline in Fasting Insulin | Change at Month 1 (n=54) | 0.19 mg/dL | Standard Deviation 1.519 |
| Alogliptin + Thiazolidinedione | Change From Baseline in Fasting Insulin | Change at Month 3 (n=57) | -0.02 mg/dL | Standard Deviation 1.946 |
| Alogliptin + Thiazolidinedione | Change From Baseline in Fasting Insulin | Change at Month 6 (n=60) | 0.29 mg/dL | Standard Deviation 3.505 |
| Alogliptin + Thiazolidinedione | Change From Baseline in Fasting Insulin | Change at Month 12 (n=68) | -0.32 mg/dL | Standard Deviation 1.98 |
| Alogliptin + Thiazolidinedione | Change From Baseline in Fasting Insulin | Change at Final assessment (n=82) | -0.25 mg/dL | Standard Deviation 1.951 |
Secondary
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
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 1 month, 3 months, 6 months, 12 months or final visit (last visit for a participant in the study, up to Month 12) relative to baseline. The efficacy analysis was planned to be assessed in the total alogliptin arm irrespective of the thiazolidinedione treatment.
Time frame: Baseline, Months 1, 3, 6, 12, and final assessment (up to 12 months)
Population: The efficacy assessment population was defined as participants who completed the study and had available efficacy data at baseline and post baseline.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Alogliptin + Thiazolidinedione | Change From Baseline in Glycosylated Hemoglobin (HbA1c) | Baseline (n=1124) | 7.67 percentage of glycosylated hemoglobin | Standard Deviation 1.179 |
| Alogliptin + Thiazolidinedione | Change From Baseline in Glycosylated Hemoglobin (HbA1c) | Change at Month 1 (n=879) | -0.25 percentage of glycosylated hemoglobin | Standard Deviation 0.597 |
| Alogliptin + Thiazolidinedione | Change From Baseline in Glycosylated Hemoglobin (HbA1c) | Change at Month 3 (n=1005) | -0.47 percentage of glycosylated hemoglobin | Standard Deviation 0.988 |
| Alogliptin + Thiazolidinedione | Change From Baseline in Glycosylated Hemoglobin (HbA1c) | Change at Month 6 (n=988) | -0.53 percentage of glycosylated hemoglobin | Standard Deviation 1.098 |
| Alogliptin + Thiazolidinedione | Change From Baseline in Glycosylated Hemoglobin (HbA1c) | Change at Month 12 (n=949) | -0.64 percentage of glycosylated hemoglobin | Standard Deviation 1.133 |
| Alogliptin + Thiazolidinedione | Change From Baseline in Glycosylated Hemoglobin (HbA1c) | Change at Final assessment (n=1124) | -0.57 percentage of glycosylated hemoglobin | Standard Deviation 1.143 |
Secondary
Percentage of Participants of Achieving Objective Glycemic Control
The rate of achieving objective glycemic control in HbA1c level, was calculated at 1 month, 3 months, 6 months, 12 months or final visit (last visit for a participant in the study, up to Month 12). Glycemic control was measured as \<8.0 percent, \<7.0 percent, and \<6.0 percent of glycosylated hemoglobin. The efficacy analysis was planned to be assessed in the total alogliptin arm irrespective of the thiazolidinedione treatment.
Time frame: Baseline, Months 1, 3, 6, 12, and final assessment (up to 12 months)
Population: The efficacy assessment population was defined as participants who completed the study and had available efficacy data at baseline and post baseline.
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Alogliptin + Thiazolidinedione | Percentage of Participants of Achieving Objective Glycemic Control | <7.0 percent (Month 3) (n=1005) | 47.1 percentage of participants | — |
| Alogliptin + Thiazolidinedione | Percentage of Participants of Achieving Objective Glycemic Control | <8.0 percent (Baseline) (n=1124) | 68.0 percentage of participants | 1.179 |
| Alogliptin + Thiazolidinedione | Percentage of Participants of Achieving Objective Glycemic Control | <8.0 percent (Month 1) (n=879) | 75.8 percentage of participants | 0.597 |
| Alogliptin + Thiazolidinedione | Percentage of Participants of Achieving Objective Glycemic Control | <8.0 percent (Month 3) (n=1005) | 84.2 percentage of participants | 0.988 |
| Alogliptin + Thiazolidinedione | Percentage of Participants of Achieving Objective Glycemic Control | <8.0 percent (Month 6) (n=988) | 84.5 percentage of participants | 1.098 |
| Alogliptin + Thiazolidinedione | Percentage of Participants of Achieving Objective Glycemic Control | <8.0 percent (Month 12) (n=949) | 87.1 percentage of participants | 1.133 |
| Alogliptin + Thiazolidinedione | Percentage of Participants of Achieving Objective Glycemic Control | <8.0 percent (Final assessment) (n=1124) | 83.6 percentage of participants | 1.143 |
| Alogliptin + Thiazolidinedione | Percentage of Participants of Achieving Objective Glycemic Control | <7.0 percent (Baseline) (n=1124) | 27.6 percentage of participants | — |
| Alogliptin + Thiazolidinedione | Percentage of Participants of Achieving Objective Glycemic Control | <7.0 percent (Month 1) (n=879) | 34.3 percentage of participants | — |
| Alogliptin + Thiazolidinedione | Percentage of Participants of Achieving Objective Glycemic Control | <7.0 percent (Month 6) (n=988) | 51.2 percentage of participants | — |
| Alogliptin + Thiazolidinedione | Percentage of Participants of Achieving Objective Glycemic Control | <7.0 percent (Month 12) (n=949) | 57.5 percentage of participants | — |
| Alogliptin + Thiazolidinedione | Percentage of Participants of Achieving Objective Glycemic Control | <7.0 percent (Final assessment) (n=1124) | 54.2 percentage of participants | — |
| Alogliptin + Thiazolidinedione | Percentage of Participants of Achieving Objective Glycemic Control | <6.0 percent (Baseline) (n=1124) | 2.7 percentage of participants | — |
| Alogliptin + Thiazolidinedione | Percentage of Participants of Achieving Objective Glycemic Control | <6.0 percent (Month 1) (n=879) | 3.2 percentage of participants | — |
| Alogliptin + Thiazolidinedione | Percentage of Participants of Achieving Objective Glycemic Control | <6.0 percent (Month 3) (n=1005) | 5.6 percentage of participants | — |
| Alogliptin + Thiazolidinedione | Percentage of Participants of Achieving Objective Glycemic Control | <6.0 percent (Month 6) (n=988) | 6.8 percentage of participants | — |
| Alogliptin + Thiazolidinedione | Percentage of Participants of Achieving Objective Glycemic Control | <6.0 percent (Month 12) (n=949) | 8.2 percentage of participants | — |
| Alogliptin + Thiazolidinedione | Percentage of Participants of Achieving Objective Glycemic Control | <6.0 percent (Final assessment) (n=1124) | 8.0 percentage of participants | — |