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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00395512




Registration number
NCT00395512
Ethics application status
Date submitted
1/11/2006
Date registered
3/11/2006
Date last updated
27/03/2013

Titles & IDs
Public title
Efficacy of Alogliptin With Pioglitazone (Actos®) in Subjects With Type 2 Diabetes Mellitus
Scientific title
A Multicenter, Double-Blind Study to Determine the Efficacy and Safety of SYR-322 Plus Pioglitazone HCl (Actos®), SYR-322 Alone or Pioglitazone HCl Alone in Subjects With Type 2 Diabetes
Secondary ID [1] 0 0
2006-005492-17
Secondary ID [2] 0 0
01-06-TL-322OPI-002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Alogliptin
Treatment: Drugs - Pioglitazone
Treatment: Drugs - Placebo

Experimental: Alogliptin 25 mg QD - Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.

Active Comparator: Pioglitazone 30 mg QD - Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.

Experimental: 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 26 weeks.

Active Comparator: Alogliptin 12.5 mg QD + Pioglitazone 30 mg QD - Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.


Treatment: Drugs: Alogliptin
Alogliptin tablets.

Treatment: Drugs: Pioglitazone
Pioglitazone tablets.

Treatment: Drugs: Placebo
Matching placebo tablets.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline to Week 26 in Glycosylated Hemoglobin (HbA1c)
Timepoint [1] 0 0
Baseline and Week 26
Secondary outcome [1] 0 0
Change From Baseline in HbA1c Over Time
Timepoint [1] 0 0
Baseline and Weeks 4, 8, 12, 16 and 20.
Secondary outcome [2] 0 0
Change From Baseline in Fasting Plasma Glucose Over Time
Timepoint [2] 0 0
Baseline and Weeks 1, 2, 4, 8, 12, 16, 20 and 26.
Secondary outcome [3] 0 0
Percentage of Participants With Marked Hyperglycemia
Timepoint [3] 0 0
Weeks 1, 2, 4, 8, 12, 16, 20 and 26.
Secondary outcome [4] 0 0
Percentage of Participants Meeting Rescue Criteria
Timepoint [4] 0 0
Weeks 4, 8, 12, 16, 20 and 26.
Secondary outcome [5] 0 0
Percentage of Participants With Glycosylated Hemoglobin Less Than or Equal to 6.5%
Timepoint [5] 0 0
Week 26
Secondary outcome [6] 0 0
Percentage of Participants With Glycosylated Hemoglobin Less Than or Equal to 7.0%
Timepoint [6] 0 0
Week 26
Secondary outcome [7] 0 0
Percentage of Participants With Glycosylated Hemoglobin Less Than or Equal to 7.5%
Timepoint [7] 0 0
Week 26
Secondary outcome [8] 0 0
Percentage of Participants With a Decrease in Glycosylated Hemoglobin Greater Than or Equal to 0.5%
Timepoint [8] 0 0
Baseline and Week 26
Secondary outcome [9] 0 0
Percentage of Participants With a Decrease in Glycosylated Hemoglobin Greater Than or Equal to 1.0%
Timepoint [9] 0 0
Baseline and Week 26
Secondary outcome [10] 0 0
Percentage of Participants With a Decrease in Glycosylated Hemoglobin Greater Than or Equal to 1.5%.
Timepoint [10] 0 0
Baseline and Week 26
Secondary outcome [11] 0 0
Percentage of Participants With a Decrease in Glycosylated Hemoglobin Greater Than or Equal to 2.0%
Timepoint [11] 0 0
Baseline and Week 26
Secondary outcome [12] 0 0
Change From Baseline in Fasting Proinsulin
Timepoint [12] 0 0
Baseline and Weeks 4, 8, 12, 16, 20 and 26.
Secondary outcome [13] 0 0
Change From Baseline in Insulin
Timepoint [13] 0 0
Baseline and Weeks 4, 8, 12, 16, 20 and 26.
Secondary outcome [14] 0 0
Change From Baseline in Proinsulin/Insulin Ratio
Timepoint [14] 0 0
Baseline and Weeks 4, 8, 12, 16, 20 and 26.
Secondary outcome [15] 0 0
Change From Baseline in C-peptide Levels
Timepoint [15] 0 0
Baseline and Weeks 4, 8, 12, 16, 20 and 26.
Secondary outcome [16] 0 0
Change From Baseline in Calculated Homeostatic Model Assessment Insulin Resistance
Timepoint [16] 0 0
Baseline and Weeks 12 and 26.
Secondary outcome [17] 0 0
Change From Baseline in Homeostatic Model Assessment Beta Cell Function
Timepoint [17] 0 0
Baseline and Weeks 12 and 26.
Secondary outcome [18] 0 0
Change From Baseline in Body Weight
Timepoint [18] 0 0
Baseline and Weeks 8, 12, 20 and 26.
Secondary outcome [19] 0 0
Change From Baseline in Total Cholesterol Level
Timepoint [19] 0 0
Baseline and Weeks 4, 8, 12, 16, 20 and 26.
Secondary outcome [20] 0 0
Change From Baseline in Low-Density Lipoprotein Cholesterol
Timepoint [20] 0 0
Baseline and Weeks 4, 8, 12, 16, 20 and 26.
Secondary outcome [21] 0 0
Change From Baseline in High-Density Lipoprotein Cholesterol
Timepoint [21] 0 0
Baseline and Weeks 4, 8, 12, 16, 20 and 26.
Secondary outcome [22] 0 0
Change From Baseline in Triglyceride Levels
Timepoint [22] 0 0
Baseline and Weeks 4, 8, 12, 16, 20 and 26.
Secondary outcome [23] 0 0
Change From Baseline in Free Fatty Acids
Timepoint [23] 0 0
Baseline and Weeks 12 and 26.
Secondary outcome [24] 0 0
Change From Baseline in Plasminogen Activator Inhibitor-1
Timepoint [24] 0 0
Baseline and Weeks 12 and 26.
Secondary outcome [25] 0 0
Change From Baseline in High-sensitivity C-Reactive Protein
Timepoint [25] 0 0
Baseline and Weeks 12 and 26.
Secondary outcome [26] 0 0
Change From Baseline in Adiponectin
Timepoint [26] 0 0
Baseline and Weeks 12 and 26.
Secondary outcome [27] 0 0
Change From Baseline in Apolipoprotein A1
Timepoint [27] 0 0
Baseline and Weeks 12 and 26.
Secondary outcome [28] 0 0
Change From Baseline in Apolipoprotein A2
Timepoint [28] 0 0
Baseline and Weeks 12 and 26.
Secondary outcome [29] 0 0
Change From Baseline in Apolipoprotein B
Timepoint [29] 0 0
Baseline and Weeks 12 and 26.
Secondary outcome [30] 0 0
Change From Baseline in Apolipoprotein C-III
Timepoint [30] 0 0
Baseline and Weeks 12 and 26.
Secondary outcome [31] 0 0
Change From Baseline in Nuclear Magnetic Resonance Lipid Fractionation Total Triglycerides
Timepoint [31] 0 0
Baseline and Weeks 12 and 26.
Secondary outcome [32] 0 0
Change From Baseline in Very Low Density Lipoprotein (VLDL) / Chylomicron Particles
Timepoint [32] 0 0
Baseline and Weeks 12 and 26.
Secondary outcome [33] 0 0
Change From Baseline in VLDL / Chylomicron Triglycerides
Timepoint [33] 0 0
Baseline and Weeks 12 and 26.
Secondary outcome [34] 0 0
Change From Baseline in VLDL Particles
Timepoint [34] 0 0
Baseline and Weeks 12 and 26.
Secondary outcome [35] 0 0
Change From Baseline in Mean VLDL Particle Size
Timepoint [35] 0 0
Baseline and Weeks 12 and 26.
Secondary outcome [36] 0 0
Change From Baseline in Intermediate Density Lipoprotein (IDL) Particles
Timepoint [36] 0 0
Baseline and Weeks 12 and 26.
Secondary outcome [37] 0 0
Change From Baseline in Low Density Lipoprotein (LDL) Particles
Timepoint [37] 0 0
Baseline and Weeks 12 and 26.
Secondary outcome [38] 0 0
Change From Baseline in Mean LDL Particle Size
Timepoint [38] 0 0
Baseline and Weeks 12 and 26.
Secondary outcome [39] 0 0
Change From Baseline in High Density Lipoprotein (HDL) Particles
Timepoint [39] 0 0
Baseline and Weeks 12 and 26.
Secondary outcome [40] 0 0
Change From Baseline in Mean HDL Particle Size
Timepoint [40] 0 0
Baseline and Weeks 12 and 26.

Eligibility
Key inclusion criteria
Inclusion Criteria

- Historical diagnosis of type 2 diabetes.

- Failed treatment with diet and exercise for at least 2 months prior to Screening.

- Is experiencing inadequate glycemic control as defined as glycosylated hemoglobin
concentration between 7.5-11%, inclusive.

- Has received any antidiabetic therapy for less than 7 days within 3 months prior to
Screening.

- Has a body mass index greater than or equal to 23 kg/m2 and less than or equal to45
kg/m2.

- Fasting C-peptide greater than or equal to 0.8 ng per mL.

- Regular use of other, non-excluded medications is allowed if participant is on a
stable dose for at least 4 weeks prior to Screening.

- 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.

- Must be willing and able to monitor their blood concentrations with a home glucose
monitor.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria

- Systolic blood pressure greater than or equal to 160 mmHg and diastolic blood pressure
greater than or equal to 100 mmHg.

- Hemoglobin less than or equal to 12 g per dL for males and less than or equal to 10 g
per dL for females.

- Alanine aminotransferase greater than or equal to 2.5times the upper limit of normal.

- Serum creatinine greater than 2.0 mg per dL.

- Thyroid stimulating hormone level greater than the upper limit of normal range.

- Major illness or debility that in the investigator's opinion prohibits the subject
from completing the study.

- Urine albumin to creatinine ratio of greater than 1000 ug per mg at Screening. If
elevated, the subject may be rescreened within 1 week.

- 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 6 months
prior to Screening.

- History of gastroparesis.

- Has New York Heart Association Class I to IV heart failure regardless of therapy.

- History of coronary angioplasty, coronary stent placement, coronary bypass surgery, or
myocardial infarction within 6 months prior to Screening.

- History of any hemoglobinopathy that may affect determination of glycosylated
hemoglobin.

- History of infection with hepatitis B, hepatitis C, or human immunodeficiency virus.

- History of a psychiatric disorder that will affect 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.

- Any alteration in angiotensin-II receptor inhibitors within 2 months prior to
Randomization, if applicable.

- History of alcohol (defined as regular or daily consumption of more than 4 alcoholic
drinks per day) or substance abuse (defined as illicit drug use) within 2 years prior
to Screening.

- Received any investigational drug within 30 days prior to Screening or a history of
receipt of an investigational antidiabetic drug within 3 months prior to Screening.

- Previously participated in an investigational study of SYR-322.

- Glycosylated hemoglobin concentration between 7.5-11%, inclusive, and a fasting plasma
glucose less than 310 mg per dL.

- At least 75% compliant with the single-blind placebo regimen during the
run-in/stabilization period.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2008
Sample size
Target
Accrual to date
Final
655
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
- Kingswood
Recruitment hospital [2] 0 0
- Fitzroy
Recruitment hospital [3] 0 0
- Frankston
Recruitment postcode(s) [1] 0 0
- Kingswood
Recruitment postcode(s) [2] 0 0
- Fitzroy
Recruitment postcode(s) [3] 0 0
- Frankston
Recruitment outside Australia
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United States of America
State/province [1] 0 0
Alabama
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United States of America
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Arizona
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United States of America
State/province [3] 0 0
Arkansas
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United States of America
State/province [4] 0 0
California
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Florida
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Georgia
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Illinois
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Indiana
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Louisiana
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Maryland
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Nis
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Nitra
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Lviv
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Ukraine
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Odesa

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Takeda
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to evaluate the combination of alogliptin, once daily (QD), and
pioglitazone in patients with type 2 diabetes mellitus who are inadequately controlled with
diet and exercise alone.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00395512
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
VP, Biological Sciences
Address 0 0
Takeda
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries