A Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Alogliptin Compared to Glipizide in Elderly Subjects With Type 2 Diabetes
Efficacy and Safety of Alogliptin Compared to Glipizide in Elderly Diabetics
Sponsors
Source
Takeda
Oversight Info
Has Dmc
No
Brief 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.
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.
Overall Status
Completed
Start Date
2008-06-01
Completion Date
2010-08-01
Primary Completion Date
2010-08-01
Phase
Phase 3
Study Type
Interventional
Primary Outcome
Measure |
Time Frame |
Change From Baseline in Glycosylated Hemoglobin at Week 52. |
Baseline and Week 52. |
Secondary Outcome
Measure |
Time Frame |
Change From Baseline in Glycosylated Hemoglobin |
Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 26, Week 34 and Week 42. |
Incidence of Hypoglycemia |
On occurrence (up to 52 weeks). |
Incidence of Marked Hyperglycemia (Fasting Plasma Glucose ≥200 mg Per dL). |
On Occurrence (up to 52 weeks). |
Incidence of Hyperglycemic Rescue |
On Occurrence (up to 52 weeks). |
Change From Baseline in Fasting Plasma Glucose |
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 |
Baseline and Week 52. |
Change From Baseline in Fasting Proinsulin |
Baseline, Week 12, Week 26, Week 42 and Week 52. |
Change From Baseline in Insulin |
Baseline, Week 12, Week 26, Week 42 and Week 52. |
Change From Baseline in Proinsulin/Insulin Ratio |
Baseline, Week 12, Week 26, Week 42 and Week 52. |
Homeostasis Model Assessment of Beta Cell Function |
Baseline, Week 12, Week 26, Week 42 and Week 52. |
Change From Baseline in Body Weight |
Baseline, Week 8, Week 12, Week 26, Week 42 and Week 52. |
Change From Baseline in Serum Lipids (Total Cholesterol) |
Baseline, Week 8, Week 12, Week 26, Week 42 and Week 52. |
Change From Baseline in Serum Lipids (High-Density Lipoprotein Cholesterol) |
Baseline, Week 8, Week 12, Week 26, Week 42 and Week 52. |
Change From Baseline in Serum Lipids (Low-Density Lipoprotein Cholesterol) |
Baseline, Week 8, Week 12, Week 26, Week 42 and Week 52. |
Change From Baseline in Serum Lipids (Triglycerides) |
Baseline, Week 8, Week 12, Week 26, Week 42 and Week 52. |
Change From Baseline in High Sensitivity C-reactive Protein |
Baseline, Week 12, Week 26, Week 42 and Week 52. |
Incidence of Subjects Achieving Glycosylated Hemoglobin <=7% |
Baseline and Week 52. |
Incidence of Glycosylated Hemoglobin Decrease From Baseline. |
Baseline and Week 52. |
Enrollment
441
Condition
Intervention
Intervention Type
Drug
Intervention Name
Description
Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.
Arm Group Label
Alogliptin 25 mg QD
Other Name
SYR110322
SYR-322
Intervention Type
Drug
Intervention Name
Description
Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.
Arm Group Label
Glipizide 5 mg QD
Other Name
Glucotrol
Eligibility
Criteria
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:
- 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.
Gender
All
Minimum Age
65 Years
Maximum Age
90 Years
Healthy Volunteers
No
Overall Official
Last Name |
Role |
Affiliation |
VP Biological Sciences |
Study Director |
Takeda |
Location
Facility |
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 |
LaPorte 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 |
Nyiregyhaza Hungary |
Karnal Haryana India |
Bangalore Karnataka India |
Belgaum Karnataka India |
Mumbai Maharashrta India |
Ashkelon Israel |
Haifa Israel |
Holon Israel |
Nahariya Israel |
Rishon Le-Zion Israel |
Zefat Israel |
Saltillo Coahuila Mexico |
Pachuca Hidalgo Mexico |
Morelia Michoacan Mexico |
Monterrey Nuevo Leon Mexico |
Aguascalientes Mexico |
Durango Mexico |
Guadalajara Mexico |
Mexico DF Mexico |
Nezahualcoyotl Mexico |
Arequipa Peru |
Lima Peru |
Piura Peru |
Gdansk Poland |
Krakow Poland |
Warszawa Poland |
Baia Mare Romania |
Brasov Romania |
Bucharest Romania |
Galati Romania |
Satu Mare Romania |
Arkhangelsk Russian Federation |
Irkutsk Russian Federation |
Smolensk Russian Federation |
Cape Town South Africa |
Centurion South Africa |
Durban South Africa |
Johannesburg South Africa |
Port Elizabeth South Africa |
Pretoria South Africa |
Donetsk Ukraine |
Kharkiv Ukraine |
Location Countries
Country
Hungary
India
Israel
Mexico
Peru
Poland
Romania
Russian Federation
South Africa
Ukraine
United States
Verification Date
2013-05-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Sponsor
Keywords
Has Expanded Access
No
Condition Browse
Secondary Id
2008-000959-10
U1111-1112-7905
Number Of Arms
2
Intervention Browse
Mesh Term
Alogliptin
Glipizide
Arm Group
Arm Group Label
Alogliptin 25 mg QD
Arm Group Type
Experimental
Arm Group Label
Glipizide 5 mg QD
Arm Group Type
Active Comparator
Firstreceived Results Date
N/A
Removed Countries
Country
Taiwan
Firstreceived Results Disposition Date
N/A
Study Design Info
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Study First Submitted
June 27, 2008
Study First Submitted Qc
June 27, 2008
Study First Posted
July 2, 2008
Last Update Submitted
May 22, 2013
Last Update Submitted Qc
May 22, 2013
Last Update Posted
May 24, 2013
Results First Submitted
February 17, 2013
Results First Submitted Qc
May 22, 2013
Results First Posted
May 24, 2013
ClinicalTrials.gov processed this data on December 11, 2019
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.