CompletedNCT00707993Updated May 24, 2013Results posted

Efficacy and Safety of Alogliptin Compared to Glipizide in Elderly Diabetics

A Phase 3 interventional study of Alogliptin and Glipizide in Diabetes Mellitus, sponsored by Takeda. Completed at 80 sites in 11 countries. Open to participants aged 65 Years to 90 Years. Per ClinicalTrials.gov, last updated 2013-05-24.

Sponsored by Takeda · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 441
Allocation: Randomized
Ages: 65 Years to 90 Years
Sex: All

Study summary

The purpose of this study is to evaluate the efficacy and safety of alogliptin, once daily (QD), compared to glipizide in elderly diabetic patients who have not received treatment or are on a single oral medication.

Read the detailed description

Type 2 diabetes is among the most common chronic condition in adults 65 years of age or older. A recent National Health and Nutrition Examination Survey reported that more than 20% of adults aged 65 years or older have diabetes. These individuals are often under-treated with respect to glucose-lowering medications, and their care is complicated by the extent of their clinical and functional status. Age-related changes in physiology, diabetes-associated illnesses and other illnesses (such as renal, cardiac, and hepatic insufficiency), as well as use of multiple medications make standard oral anti-hyperglycemic therapy and insulin use problematic. In addition, hypoglycemia is more common and severe in older rather than younger patients taking oral antidiabetic drugs which can precipitate serious events such as falls and hip fractures. While avoidance of hypoglycemia is paramount in elderly diabetic patients, many commonly used medications are associated with a substantial risk for hypoglycemia. New classes of drug which avoid such complications in the elderly population are of increasing interest as this population continues to expand.

Takeda is developing SYR-322 (alogliptin) for the improvement of glycemic control in patients with type 2 diabetes mellitus. Alogliptin is an inhibitor of the dipeptidyl peptidase IV enzyme. Dipeptidyl peptidase IV is thought to be primarily responsible for the degradation of 2 peptide hormones released in response to nutrient ingestion. It is expected that inhibition of dipeptidyl peptidase IV will improve glycemic (glucose) control in patients with type 2 diabetes.

This study will compare the effectiveness and safety of alogliptin with that of glipizide (a commonly used diabetes medication) in adults who are 65 to 90 years of age with Type 2 diabetes. Individuals who participate in this study will either have failed diet and exercise therapy alone during the 2 months before Screening, or will have been receiving a single oral antidiabetic medication without obtaining good blood glucose (sugar) control.

Each participant will be required to commit to screening visits. Study participation is anticipated to be up to 59 weeks.

Conditions studied

Diabetes Mellitus

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Keywords

Glucose Metabolism Disorder
Dysmetabolic Syndrome
Type II Diabetes
Diabetes Mellitus
Lipoatrophic
Dyslipidemia
Drug Therapy

In context

Diabetes Mellitus

11,089 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 441 is above the median of 80 across 8,491 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Takeda is the lead sponsor of 1,025 studies on the registry; 92 are open to participants now.

Of its 177 completed or terminated interventional studies of FDA-regulated products, 153 (86%) have results posted.

Browse Takeda studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 65 Years to 90 Years
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Has a diagnosis of type 2 diabetes mellitus with either:
- Failed diet and exercise therapy alone as demonstrated by inadequate glycemic control while receiving no antidiabetic treatment within the two months prior to Screening, or
- Failed treatment with oral monotherapy alone (may include treatment with two or more antidiabetic agents if for less than 7 days) as demonstrated by inadequate glycemic control within the two months prior to Screening.
Body mass index greater than or equal to 23 kg/m2 and less than or equal to 45 kg/m2.
If regularly using other, non-excluded medications, must be on a stable dose for at least the 4 weeks prior to Screening.
Females of childbearing potential who are sexually active must agree to use a medically accepted means of contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.
Able and willing to monitor their own blood glucose concentrations with a home glucose monitor.
No major illness or debility that in the investigator's opinion prohibits the participant from completing the study.

Exclusion criteria

Exclusion Criteria:

Systolic blood pressure greater than or equal to 160 mm Hg and/or diastolic pressure greater than or equal to 100 mm Hg.
Hemoglobin less than or equal to 12 g/dL for males or less than or equal to 10 g/dL for females.
Alanine aminotransferase greater than or equal to 3 times the upper limit of normal.
Calculated creatinine clearance less than or equal to 50 mL/min.
Thyroid-stimulating hormone level outside of the normal range.
History of cancer, other than squamous cell or basal cell carcinoma of the skin, that has not been in full remission for at least 5 years prior to Screening.
History of laser treatment for proliferative diabetic retinopathy within the 6 months prior to Screening.
History of treated diabetic gastroparesis, gastric banding, or gastric bypass surgery.
New York Heart Association Class III or IV heart failure regardless of therapy.
History of coronary angioplasty, coronary stent placement, coronary bypass surgery, or myocardial infarction within the 6 months prior to Screening.
History of any hemoglobinopathy that may affect determination of glycosylated hemoglobin.
History of infection with Human Immunodeficiency Virus.
History of a psychiatric disorder that will affect the participant's ability to participate in the study.
History of angioedema in association with use of angiotensin-converting enzyme inhibitors or angiotensin-II receptor inhibitors.
History of alcohol or substance abuse within the 2 years prior to Screening.
History of treatment with any weight-loss drugs or oral or systemically injected glucocorticoids within the 3 months prior to Screening.
Receipt of any investigational drug within the 30 days prior to Screening.
Prior treatment in an investigational study of alogliptin.
Clinically significant medical abnormality or disease or clinically significant abnormal findings at Screening (other than type 2 diabetes) that, in the opinion of the investigator, should exclude the participant from the study.
Has donated more than 400 mL of blood within the 90 days preceding their participation in the study.
Has hypersensitivity or has had an anaphylactic reaction(s) to any DPP-4 inhibitor drug.

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 441 participants (actual)

Study arms

Experimental
Alogliptin 25 mg QD
Drug: Alogliptin
Active comparator
Glipizide 5 mg QD
Drug: Glipizide

Interventions

DrugAlogliptin
Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.
Also known as: SYR110322, SYR-322
DrugGlipizide
Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.
Also known as: Glucotrol

What researchers measure

Primary outcomes

Change From Baseline in Glycosylated Hemoglobin at Week 52.
The change in the percentage of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 52 or final visit and glycosylated hemoglobin collected at baseline.
Time frame: Baseline and Week 52.

Secondary outcomes

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 including final visit relative to baseline.
Time frame: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 26, Week 34 and Week 42.
Incidence of Hypoglycemia
Percentage of participants with at least one hypoglycemic episode during 52 week study.
Time frame: On occurrence (up to 52 weeks).
Incidence of Marked Hyperglycemia (Fasting Plasma Glucose ≥200 mg Per dL).
The number of participants with a fasting plasma glucose value ≥ to 200 mg per dL during the 52 week study.
Time frame: On Occurrence (up to 52 weeks).
Incidence of Hyperglycemic Rescue
The number of participants requiring rescue for failing to achieve pre-specified glycemic targets during the 52 week study.
Time frame: On Occurrence (up to 52 weeks).
Change From Baseline in Fasting Plasma Glucose
The change in the value of fasting plasma glucose collected at each week indicated including final visit relative to baseline.
Time frame: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 26, Week 34, Week 42 and Week 52.
Change From Baseline in 2-hour Postprandial Glucose
The change in postprandial (after eating a meal) glucose levels at week 52 relative to baseline. Standard 2-hour postprandial glucose (PPG) tests performed following an overnight fast and evaluated right before and after a 120-minute (2-hour) timeframe relative to ingestion of a standard oral glucose drink.
Time frame: Baseline and Week 52.
Change From Baseline in Fasting Proinsulin
The change between the value of fasting proinsulin collected at each week indicated including final visit relative to baseline.
Time frame: Baseline, Week 12, Week 26, Week 42 and Week 52.
Change From Baseline in Insulin
The change between the value of insulin collected at each week indicated including final visit relative to baseline.
Time frame: Baseline, Week 12, Week 26, Week 42 and Week 52.
Change From Baseline in Proinsulin/Insulin Ratio
The change between the ratio value of proinsulin and insulin collected at each week indicated including final visit relative to baseline.
Time frame: Baseline, Week 12, Week 26, Week 42 and Week 52.
Homeostasis Model Assessment of Beta Cell Function
The change between homeostasis model assessment of beta cell function collected at each week indicated including final visit relative to baseline. Homeostasis model assessment of beta cell function measures beta cell function, calculated by a constant (20) times insulin, divided by fasting plasma glucose minus a constant (3.5).
Time frame: Baseline, Week 12, Week 26, Week 42 and Week 52.
Change From Baseline in Body Weight
The change in body weight measured at each week indicated including final visit from baseline.
Time frame: Baseline, Week 8, Week 12, Week 26, Week 42 and Week 52.
Change From Baseline in Serum Lipids (Total Cholesterol)
The change in total cholesterol measured at each week indicated including final visit from baseline.
Time frame: Baseline, Week 8, Week 12, Week 26, Week 42 and Week 52.
Change From Baseline in Serum Lipids (High-Density Lipoprotein Cholesterol)
The change in high-density lipoprotein cholesterol measured at each week indicated including final visit from baseline.
Time frame: Baseline, Week 8, Week 12, Week 26, Week 42 and Week 52.
Change From Baseline in Serum Lipids (Low-Density Lipoprotein Cholesterol)
The change in low-density lipoprotein cholesterol measured at each week indicated including final visit from baseline.
Time frame: Baseline, Week 8, Week 12, Week 26, Week 42 and Week 52.
Change From Baseline in Serum Lipids (Triglycerides)
The change in triglycerides measured at each week indicated including final visit from baseline.
Time frame: Baseline, Week 8, Week 12, Week 26, Week 42 and Week 52.
Change From Baseline in High Sensitivity C-reactive Protein
The change between the high sensitivity C-reactive protein value collected at each week indicated including final visit from baseline.
Time frame: Baseline, Week 12, Week 26, Week 42 and Week 52.
Incidence of Subjects Achieving Glycosylated Hemoglobin <=7%
The percentage of participants with a value for the percentage of glycosylated hemoglobin (HbA1c; the percentage of hemoglobin that is bound to glucose) less than or equal to 6.5 and 7.0% during the 52 week study.
Time frame: Baseline and Week 52.
Incidence of Glycosylated Hemoglobin Decrease From Baseline.
The percentage of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 0.5, 1.0, 1.5 and 2.0% during the 52 week study.
Time frame: Baseline and Week 52.

Results

Posted May 24, 2013

Participant flow

Participants enrolled at 110 investigative sites in Hungary, India, Israel, Mexico, Peru, Poland, Romania, Russia, South Africa, the Ukraine and the United States from 25 June 2008 to 30 August 2010.

Participant flow — Overall Study
Milestone	Alogliptin 25 mg QD	Glipizide 5 mg QD
Started	222	219
Completed	133	125
Not completed	89	94
Withdrew: Adverse event	16	20
Withdrew: Protocol violation	4	7
Withdrew: Lost to follow-up	0	4
Withdrew: Withdrawal by subject	12	16
Withdrew: Hyperglycemic rescue	55	47
Withdrew: Other	2	0

Outcome measures

PrimaryChange From Baseline in Glycosylated Hemoglobin at Week 52.

The change in the percentage of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 52 or final visit and glycosylated hemoglobin collected at baseline.

Time frame:: Baseline and Week 52.
Reported as:: Least squares mean · percentage of Glycosylated Hemoglobin

Change From Baseline in Glycosylated Hemoglobin at Week 52.
percentage of Glycosylated Hemoglobin	Alogliptin 25 mg QD	Glipizide 5 mg QD
Change From Baseline in Glycosylated Hemoglobin at Week 52.	-0.14 ± 0.063	-0.09 ± 0.067

Statistical analysis

Alogliptin 25 mg QD vs Glipizide 5 mg QD · ANCOVA · Mean difference (final values): -0.05Treatment, randomization schedule, and geographic region as class effects; baseline value for the endpoint as a continuous covariate.

SecondaryChange 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 including final visit relative to baseline.

Time frame:: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 26, Week 34 and Week 42.
Reported as:: Least squares mean · percentage of Glycosylated Hemoglobin

Change From Baseline in Glycosylated Hemoglobin
percentage of Glycosylated Hemoglobin	Alogliptin 25 mg QD	Glipizide 5 mg QD
Week 4 (n=175; n=148)	-0.14 ± 0.047	-0.11 ± 0.051
Week 8 (n=180; n=161)	-0.27 ± 0.051	-0.23 ± 0.054
Week 12 (n=180; n=162)	-0.34 ± 0.053	-0.25 ± 0.055
Week 16 (n=180; n=162)	-0.31 ± 0.050	-0.32 ± 0.052
Week 20 (n=180; n=162)	-0.31 ± 0.051	-0.27 ± 0.054
Week 26 (n=180; n=162)	-0.28 ± 0.052	-0.25 ± 0.055
Week 34 (n=180; n=162)	-0.21 ± 0.056	-0.21 ± 0.059
Week 42 (n=180; n=162)	-0.17 ± 0.062	-0.17 ± 0.065

SecondaryIncidence of Hypoglycemia

Percentage of participants with at least one hypoglycemic episode during 52 week study.

Time frame:: On occurrence (up to 52 weeks).
Reported as:: Number · percentage of participants

Incidence of Hypoglycemia
percentage of participants	Alogliptin 25 mg QD	Glipizide 5 mg QD
Incidence of Hypoglycemia	5.4	26.0

SecondaryIncidence of Marked Hyperglycemia (Fasting Plasma Glucose ≥200 mg Per dL).

The number of participants with a fasting plasma glucose value ≥ to 200 mg per dL during the 52 week study.

Time frame:: On Occurrence (up to 52 weeks).
Reported as:: Number · participants

Incidence of Marked Hyperglycemia (Fasting Plasma Glucose ≥200 mg Per dL).
participants	Alogliptin 25 mg QD	Glipizide 5 mg QD
Baseline to <Week 4	30	17
Week 4 to <Week 8	11	5
Week 8 to <Week 12	12	8
Week 12 to <Week 16	11	8
Week 16 to <Week 20	5	4
Week 20 to <Week 26	2	3
Week 26 to <Week 34	3	8
Week 34 to <Week 42	2	4
Week 42 to Week 52	9	6
Overall	50	37

SecondaryIncidence of Hyperglycemic Rescue

The number of participants requiring rescue for failing to achieve pre-specified glycemic targets during the 52 week study.

Time frame:: On Occurrence (up to 52 weeks).
Reported as:: Number · participants

Incidence of Hyperglycemic Rescue
participants	Alogliptin 25 mg QD	Glipizide 5 mg QD
Week 2 to <Week 4	1	0
Week 4 to <Week 8	2	1
Week 8 to <Week 12	1	0
Week 12 to <Week 16	14	14
Week 16 to <Week 20	6	9
Week 20 to <Week 26	5	8
Week 26 to <Week 34	10	2
Week 34 to <Week 42	6	7
Week 42 to Week 52	10	6
Overall	50	37

SecondaryChange From Baseline in Fasting Plasma Glucose

The change in the value of fasting plasma glucose collected at each week indicated including final visit relative to baseline.

Time frame:: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 26, Week 34, Week 42 and Week 52.
Reported as:: Least squares mean · mg/dL

Change From Baseline in Fasting Plasma Glucose
mg/dL	Alogliptin 25 mg QD	Glipizide 5 mg QD
Week 2 (n=196; n=199)	-3.8 ± 1.93	-5.0 ± 1.91
Week 4 (n=217; n=213)	-7.7 ± 1.93	-7.6 ± 1.95
Week 8 (n=217; n=214)	-8.9 ± 1.76	-8.7 ± 1.77
Week 12 (n=217; n=214)	-10.2 ± 1.84	-9.9 ± 1.86
Week 16 (n=217; n=214)	-7.9 ± 1.85	-11.4 ± 1.86
Week 20 (n=217; n=214)	-9.8 ± 1.78	-8.7 ± 1.79
Week 26 (n=217; n=214)	-7.9 ± 1.97	-6.2 ± 1.99
Week 34 (n=217; n=214)	-5.4 ± 1.98	-5.7 ± 1.99
Week 42 (n=217; n=214)	-3.6 ± 2.13	-7.4 ± 2.14
Week 52 (n=217; n=214)	-2.4 ± 2.24	-4.2 ± 2.26

SecondaryChange From Baseline in 2-hour Postprandial Glucose

The change in postprandial (after eating a meal) glucose levels at week 52 relative to baseline. Standard 2-hour postprandial glucose (PPG) tests performed following an overnight fast and evaluated right before and after a 120-minute (2-hour) timeframe relative to ingestion of a standard oral glucose drink.

Time frame:: Baseline and Week 52.
Reported as:: Least squares mean · mg/dL

Change From Baseline in 2-hour Postprandial Glucose
mg/dL	Alogliptin 25 mg QD	Glipizide 5 mg QD
Week 52 PPG level (n=109; n=93)	-5.80 ± 5.530	6.30 ± 5.989
Week 52 PPG excursion (n=109; n=93)	1.82 ± 4.434	7.17 ± 4.804

SecondaryChange From Baseline in Fasting Proinsulin

The change between the value of fasting proinsulin collected at each week indicated including final visit relative to baseline.

Time frame:: Baseline, Week 12, Week 26, Week 42 and Week 52.
Reported as:: Least squares mean · pmol/L

Change From Baseline in Fasting Proinsulin
pmol/L	Alogliptin 25 mg QD	Glipizide 5 mg QD
Week 12 (n=207; n=186)	-6.0 ± 0.99	1.0 ± 1.05
Week 26 (n=211; n=194)	-4.6 ± 1.49	3.0 ± 1.56
Week 42 (n=211; n=194)	-4.6 ± 1.48	3.1 ± 1.54
Week 52 (n=211; n=194)	-4.9 ± 1.42	3.0 ± 1.48

SecondaryChange From Baseline in Insulin

The change between the value of insulin collected at each week indicated including final visit relative to baseline.

Time frame:: Baseline, Week 12, Week 26, Week 42 and Week 52.
Reported as:: Least squares mean · mcIU/mL

Change From Baseline in Insulin
mcIU/mL	Alogliptin 25 mg QD	Glipizide 5 mg QD
Week 12 (n=207; n=188)	-2.36 ± 0.673	0.84 ± 0.707
Week 26 (n=210; n=194)	-0.41 ± 1.548	3.03 ± 1.611
Week 42 (n=210; n=194)	-0.58 ± 1.254	1.53 ± 1.305
Week 52 (n=210; n=194)	-1.72 ± 1.731	3.15 ± 1.801

SecondaryChange From Baseline in Proinsulin/Insulin Ratio

The change between the ratio value of proinsulin and insulin collected at each week indicated including final visit relative to baseline.

Time frame:: Baseline, Week 12, Week 26, Week 42 and Week 52.
Reported as:: Least squares mean · ratio

Change From Baseline in Proinsulin/Insulin Ratio
ratio	Alogliptin 25 mg QD	Glipizide 5 mg QD
Week 12 (n=206; n=185)	-0.288 ± 0.1035	0.053 ± 0.1092
Week 26 (n=210; n=193)	-0.253 ± 0.4333	0.562 ± 0.4520
Week 42 (n=210; n=193)	-0.289 ± 0.1500	0.183 ± 0.1565
Week 52 (n=210; n=193)	-0.155 ± 0.0899	-0.057 ± 0.0938

SecondaryHomeostasis Model Assessment of Beta Cell Function

The change between homeostasis model assessment of beta cell function collected at each week indicated including final visit relative to baseline. Homeostasis model assessment of beta cell function measures beta cell function, calculated by a constant (20) times insulin, divided by fasting plasma glucose minus a constant (3.5).

Time frame:: Baseline, Week 12, Week 26, Week 42 and Week 52.
Reported as:: Least squares mean · percent score of beta cell function

Homeostasis Model Assessment of Beta Cell Function
percent score of beta cell function	Alogliptin 25 mg QD	Glipizide 5 mg QD
Week 12 (n=203; n=184)	-6.104 ± 8.3062	30.081 ± 8.7264
Week 26 (n=207; n=193)	-0.136 ± 9.7088	31.669 ± 10.0562
Week 42 (n=207; n=193)	-5.571 ± 7.1395	16.004 ± 7.3950
Week 52 (n=207; n=193)	-9.755 ± 13.8868	35.281 ± 14.3836

SecondaryChange From Baseline in Body Weight

The change in body weight measured at each week indicated including final visit from baseline.

Time frame:: Baseline, Week 8, Week 12, Week 26, Week 42 and Week 52.
Reported as:: Least squares mean · kg

Change From Baseline in Body Weight
kg	Alogliptin 25 mg QD	Glipizide 5 mg QD
Week 8 (n=213; n=200)	-0.42 ± 0.118	0.55 ± 0.122
Week 12 (n=215; n=203)	-0.52 ± 0.142	0.42 ± 0.146
Week 26 (n=215; n=204)	-0.68 ± 0.188	0.66 ± 0.193
Week 42 (n=215; n=204)	-0.72 ± 0.211	0.57 ± 0.216
Week 52 (n=215; n=204)	-0.62 ± 0.227	0.60 ± 0.233

SecondaryChange From Baseline in Serum Lipids (Total Cholesterol)

The change in total cholesterol measured at each week indicated including final visit from baseline.

Time frame:: Baseline, Week 8, Week 12, Week 26, Week 42 and Week 52.
Reported as:: Least squares mean · mg/dL

Change From Baseline in Serum Lipids (Total Cholesterol)
mg/dL	Alogliptin 25 mg QD	Glipizide 5 mg QD
Week 8 (n=208; n=195)	-5.6 ± 2.01	-1.6 ± 2.08
Week 12 (n=213; n=201)	-4.2 ± 2.06	-0.7 ± 2.12
Week 26 (n=213; n=201)	1.6 ± 2.03	0.1 ± 2.09
Week 42 (n=213; n=201)	0.2 ± 2.07	0.1 ± 2.13
Week 52 (n=213; n=201)	-0.8 ± 2.28	-0.5 ± 2.35

SecondaryChange From Baseline in Serum Lipids (High-Density Lipoprotein Cholesterol)

The change in high-density lipoprotein cholesterol measured at each week indicated including final visit from baseline.

Time frame:: Baseline, Week 8, Week 12, Week 26, Week 42 and Week 52.
Reported as:: Least squares mean · mg/dL

Change From Baseline in Serum Lipids (High-Density Lipoprotein Cholesterol)
mg/dL	Alogliptin 25 mg QD	Glipizide 5 mg QD
Week 8 (n=206; n=193)	-0.1 ± 0.59	1.2 ± 0.61
Week 12 (n=212; n=201)	0.4 ± 0.47	0.5 ± 0.48
Week 26 (n=212; n=201)	1.7 ± 0.50	0.2 ± 0.52
Week 42 (n=212; n=201)	1.4 ± 0.59	0.1 ± 0.61
Week 52 (n=212; n=201)	0.8 ± 0.50	0.3 ± 0.51

SecondaryChange From Baseline in Serum Lipids (Low-Density Lipoprotein Cholesterol)

The change in low-density lipoprotein cholesterol measured at each week indicated including final visit from baseline.

Time frame:: Baseline, Week 8, Week 12, Week 26, Week 42 and Week 52.
Reported as:: Least squares mean · mg/dL

Change From Baseline in Serum Lipids (Low-Density Lipoprotein Cholesterol)
mg/dL	Alogliptin 25 mg QD	Glipizide 5 mg QD
Week 8 (n=200; n=185)	-3.2 ± 1.70	-2.8 ± 1.76
Week 12 (n=208; n=195)	-2.0 ± 1.75	-2.4 ± 1.81
Week 26 (n=208; n=196)	3.1 ± 1.67	-1.1 ± 1.72
Week 42 (n=208; n=197)	1.2 ± 1.79	-0.8 ± 1.84
Week 52 (n=209; n=197)	0.9 ± 1.83	-1.4 ± 1.88

SecondaryChange From Baseline in Serum Lipids (Triglycerides)

The change in triglycerides measured at each week indicated including final visit from baseline.

Time frame:: Baseline, Week 8, Week 12, Week 26, Week 42 and Week 52.
Reported as:: Least squares mean · mg/dL

Change From Baseline in Serum Lipids (Triglycerides)
mg/dL	Alogliptin 25 mg QD	Glipizide 5 mg QD
Week 8 (n=208; n=195)	-12.8 ± 5.04	2.7 ± 5.20
Week 12 (n=213; n=201)	-15.5 ± 5.72	7.5 ± 5.89
Week 26 (n=213; n=201)	-16.3 ± 4.74	3.9 ± 4.88
Week 42 (n=213; n=201)	-12.6 ± 5.01	5.5 ± 5.16
Week 52 (n=213; n=201)	-13.2 ± 5.27	1.9 ± 5.42

SecondaryChange From Baseline in High Sensitivity C-reactive Protein

The change between the high sensitivity C-reactive protein value collected at each week indicated including final visit from baseline.

Time frame:: Baseline, Week 12, Week 26, Week 42 and Week 52.
Reported as:: Least squares mean · mg/L

Change From Baseline in High Sensitivity C-reactive Protein
mg/L	Alogliptin 25 mg QD	Glipizide 5 mg QD
Week 12 (n=209; n=192)	0.45 ± 0.699	0.10 ± 0.730
Week 26 (n=212; n=198)	-0.02 ± 0.682	0.47 ± 0.706
Week 42 (n=212; n=198)	0.33 ± 0.736	0.53 ± 0.762
Week 52 (n=212; n=198)	0.01 ± 0.656	0.21 ± 0.679

SecondaryIncidence of Subjects Achieving Glycosylated Hemoglobin <=7%

The percentage of participants with a value for the percentage of glycosylated hemoglobin (HbA1c; the percentage of hemoglobin that is bound to glucose) less than or equal to 6.5 and 7.0% during the 52 week study.

Time frame:: Baseline and Week 52.
Reported as:: Number · percentage of participants

Incidence of Subjects Achieving Glycosylated Hemoglobin <=7%
percentage of participants	Alogliptin 25 mg QD	Glipizide 5 mg QD
HbA1c ≤6.5%	22.3	18.2
HbA1c ≤7.0%	48.8	45.3

SecondaryIncidence of Glycosylated Hemoglobin Decrease From Baseline.

The percentage of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 0.5, 1.0, 1.5 and 2.0% during the 52 week study.

Time frame:: Baseline and Week 52.
Reported as:: Number · percentage of participants

Incidence of Glycosylated Hemoglobin Decrease From Baseline.
percentage of participants	Alogliptin 25 mg QD	Glipizide 5 mg QD
Decrease from Baseline in HbA1c ≥0.5%	32.1	29.0
Decrease from Baseline in HbA1c ≥1.0%	12.6	10.3
Decrease from Baseline in HbA1c ≥1.5%	5.1	2.3
Decrease from Baseline in HbA1c ≥2.0%	2.8	1.4

Adverse events

Collected over Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind study drug.. Non-serious events are listed at a 3% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Alogliptin 25 mg QD	—	16/222 (7.2%)	103/222 (46.4%)
Glipizide 5 mg QD	—	13/219 (5.9%)	105/219 (47.9%)

Most frequent serious events

Showing 10 of 31

Most frequent serious events
Event	Alogliptin 25 mg QD	Glipizide 5 mg QD
CholelithiasisHepatobiliary disorders	0/222	2/219
FallInjury, poisoning and procedural complications	2/222	0/219
Cardiac failure congestiveCardiac disorders	1/222	1/219
Cerebrovascular accidentNervous system disorders	0/222	1/219
Cholecystitis acuteHepatobiliary disorders	1/222	1/219
DizzinessNervous system disorders	0/222	1/219
Graft thrombosisInjury, poisoning and procedural complications	0/222	1/219
Ischaemic cardiomyopathyCardiac disorders	0/222	1/219
Myocardial infarctionCardiac disorders	0/222	1/219
Pyelonephritis acuteInfections and infestations	0/222	1/219

Most frequent other events

Showing 10 of 19

Most frequent other events
Event	Alogliptin 25 mg QD	Glipizide 5 mg QD
Urinary tract infectionInfections and infestations	26/222	23/219
DizzinessNervous system disorders	13/222	18/219
HeadacheNervous system disorders	16/222	15/219
DiarrhoeaGastrointestinal disorders	9/222	14/219
NasopharyngitisInfections and infestations	13/222	10/219
ArthralgiaMusculoskeletal and connective tissue disorders	10/222	12/219
HypertensionVascular disorders	12/222	10/219
Upper respiratory tract infectionInfections and infestations	12/222	5/219
Back painMusculoskeletal and connective tissue disorders	9/222	11/219
DyslipidaemiaMetabolism and nutrition disorders	5/222	10/219

Baseline characteristics

Age Continuous
Age Continuous(years)	Alogliptin 25 mg QD	Glipizide 5 mg QD	Total
Mean	70.1 ± 4.42	69.8 ± 4.07	69.9 ± 4.24

Age, Customized
Age, Customized(participants)	Alogliptin 25 mg QD	Glipizide 5 mg QD	Total
<75 years	186	193	379
≥75 years	36	26	62

Sex: Female, Male
Sex: Female, Male(Participants)	Alogliptin 25 mg QD	Glipizide 5 mg QD	Total
Female	120	123	243
Male	102	96	198

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Alogliptin 25 mg QD	Glipizide 5 mg QD	Total
Hispanic or Latino	79	70	149
Not Hispanic or Latino	143	149	292
Unknown or Not Reported	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Alogliptin 25 mg QD	Glipizide 5 mg QD	Total
American Indian or Alaska Native	12	13	25
Asian	19	26	45
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	16	20	36
White	169	154	323
More than one race	6	6	12
Unknown or Not Reported	0	0	0

Weight
Weight(kg)	Alogliptin 25 mg QD	Glipizide 5 mg QD	Total
Mean	78.60 ± 14.842	78.81 ± 15.239	78.70 ± 15.024

Body Mass Index (BMI)
Body Mass Index (BMI)(kg/m2)	Alogliptin 25 mg QD	Glipizide 5 mg QD	Total
Mean	29.58 ± 4.348	30.02 ± 4.459	29.79 ± 4.404

Diabetes duration
Diabetes duration(years)	Alogliptin 25 mg QD	Glipizide 5 mg QD	Total
Mean	6.25 ± 6.285	5.94 ± 6.276	6.10 ± 6.275

2 further baseline measures are reported on the registry.

Study locations

80 sites

Alexander City, Alabama, United States
Foothill Ranch, California, United States
Huntington Park, California, United States
Long Beach, California, United States
Los Angeles, California, United States
Redlands, California, United States
Prospect, Connecticut, United States
Bradenton, Florida, United States
Fort Myers, Florida, United States
Miami, Florida, United States
Ormond Beach, Florida, United States
Winter Park, Florida, United States
Roswell, Georgia, United States
Aurora, Illinois, United States
La Porte, Indiana, United States
South Bend, Indiana, United States
Salisbury, Maryland, United States
Clarkston, Michigan, United States
Omaha, Nebraska, United States
Hamilton, New Jersey, United States
Albuquerque, New Mexico, United States
Beachwood, Ohio, United States
Westlake, Ohio, United States
Zanesville, Ohio, United States
Bensalem, Pennsylvania, United States
Aiken, South Carolina, United States
Greenville, South Carolina, United States
Greer, South Carolina, United States
Taylors, South Carolina, United States
Corpus Christi, Texas, United States
Dallas, Texas, United States
Pasadena, Texas, United States
San Antonio, Texas, United States
Tomball, Texas, United States
Ogden, Utah, United States
Salt Lake City, Utah, United States
Budapest, Hungary
Miskoic, Hungary
Nyíregyháza, Hungary
Karnāl, Haryana, India
Bangalore, Karnataka, India
Belagavi, Karnataka, India
Mumbai, Maharashrta, India
Ashkelon, Israel
Haifa, Israel
Holon, Israel
Nahariya, Israel
Rishon LeZiyyon, Israel
Safed, Israel
Aguascalientes, Aguascalientes, Mexico
Saltillo, Coahuila, Mexico
Durango, Durango, Mexico
Pachuca, Hidalgo, Mexico
Morelia, Michoacán, Mexico
Monterrey, Nuevo León, Mexico
Guadalajara, Mexico
Mexico City, Mexico
Nezahualcóyotl, Mexico
Arequipa, Peru
Lima, Peru
Piura, Peru
Gdansk, Poland
Krakow, Poland
Warsaw, Poland
Baia Mare, Romania
Brasov, Romania
Bucharest, Romania
Galati, Romania
Satu Mare, Romania
Arkhangelsk, Russia
Irkutsk, Russia
Smolensk, Russia
Cape Town, South Africa
Centurion, South Africa
Durban, South Africa
Johannesburg, South Africa
Port Elizabeth, South Africa
Pretoria, South Africa
Donetsk, Ukraine
Kharkiv, Ukraine

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on May 24, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00707993
Lead sponsor: Takeda
Responsible party: Sponsor
First posted: Jul 2, 2008
Start date: Jun 2008
Primary completion: Aug 2010
Completion: Aug 2010
Results posted: May 24, 2013
Last update: May 24, 2013

Study contacts

VP Biological Sciences

study director · Takeda

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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