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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Indiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Louisiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Maryland
Country [11] 0 0
United States of America
State/province [11] 0 0
Massachusetts
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United States of America
State/province [12] 0 0
Michigan
Country [13] 0 0
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Mississippi
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Missouri
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Montana
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Nevada
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New Jersey
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New York
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North Carolina
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North Dakota
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Ohio
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Oregon
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Pennsylvania
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South Carolina
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Tennessee
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Texas
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Utah
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Virginia
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West Virginia
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United States of America
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Wisconsin
Country [31] 0 0
Argentina
State/province [31] 0 0
Buenos Aires
Country [32] 0 0
Argentina
State/province [32] 0 0
Córdoba
Country [33] 0 0
Brazil
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CE
Country [34] 0 0
Brazil
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GO
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Brazil
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PA
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Brazil
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PR
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Brazil
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RP
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Brazil
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SP
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Bulgaria
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Pleven
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Chile
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Santiago
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Croatia
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Slavonski Brod
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Estonia
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Pärnu
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Budapest
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Eger
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Gyula
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Mako
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Nyiregyhaza
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Pecs
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India
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Andhra Pradesh
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India
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Karnataka
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India
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Maharashtra
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India
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Tamil Nadu
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Israel
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Hadera
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Israel
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Haifa
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Israel
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Holon
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Jaffa Tel Aviv
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Jerusalem
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Israel
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Nahariya
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Latvia
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Riga
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Lithuania
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Kaunas
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Lithuania
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Kedainiai
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Mexico
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Aguascalientes
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Mexico
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Mexico City
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Mexico
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Monterrey
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New Zealand
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Christchurch
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New Zealand
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Hamilton
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Poland
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Bialystok
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Bytom
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Gdansk
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Gniewkowo
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Kamieniec Zabkowicki
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Poland
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Krakow
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Leczyca
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Romania
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Brasov
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Romania
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Bucharest
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Romania
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Galati
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Russian Federation
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Ekaterinburg
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Russian Federation
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Kazan
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Russian Federation
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Moscow
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Serbia
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Belgrade
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Serbia
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Kragujevac
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Serbia
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Nis
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Slovakia
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Nitra
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Slovakia
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Banska Bysterica
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Slovakia
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Lucenec
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Slovakia
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Riverside
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Slovakia
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Sahy
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South Africa
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Eastern Cape
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South Africa
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Gauteng
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South Africa
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Kwa-Zulu Natal
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South Africa
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Pretoria
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South Africa
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Western Province
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Ukraine
State/province [94] 0 0
Dnipropetrovsk
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Ukraine
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Kharkiv
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Ukraine
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Lviv
Country [97] 0 0
Ukraine
State/province [97] 0 0
Odesa

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

TypeCitations or Other Details
Journal Rosenstock J, Inzucchi SE, Seufert J, Fleck PR, Wi... [More Details]

Results are available at https://clinicaltrials.gov/study/NCT00395512