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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00286442




Registration number
NCT00286442
Ethics application status
Date submitted
1/02/2006
Date registered
3/02/2006
Date last updated
3/02/2012

Titles & IDs
Public title
Efficacy and Safety of Alogliptin Combined With Metformin in Participants With Type 2 Diabetes Mellitus
Scientific title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of SYR110322 (SYR-322) When Used in Combination With Metformin in Subjects With Type 2 Diabetes
Secondary ID [1] 0 0
2005-004668-22
Secondary ID [2] 0 0
SYR-322-MET-008
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 and metformin
Treatment: Drugs - Alogliptin and metformin
Treatment: Drugs - Metformin

Experimental: Alogliptin 12.5 mg QD -

Experimental: Alogliptin 25 mg QD -

Placebo comparator: Metformin -


Treatment: Drugs: Alogliptin and metformin
Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.

Treatment: Drugs: Alogliptin and metformin
Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.

Treatment: Drugs: Metformin
Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26.
Timepoint [1] 0 0
Baseline and Week 26.
Secondary outcome [1] 0 0
Change From Baseline in Glycosylated Hemoglobin (Week 4).
Timepoint [1] 0 0
Baseline and Week 4.
Secondary outcome [2] 0 0
Change From Baseline in Glycosylated Hemoglobin (Week 8).
Timepoint [2] 0 0
Baseline and Week 8.
Secondary outcome [3] 0 0
Change From Baseline in Glycosylated Hemoglobin (Week 12).
Timepoint [3] 0 0
Baseline and Week 12.
Secondary outcome [4] 0 0
Change From Baseline in Glycosylated Hemoglobin (Week 16).
Timepoint [4] 0 0
Baseline and Week 16.
Secondary outcome [5] 0 0
Change From Baseline in Glycosylated Hemoglobin (Week 20).
Timepoint [5] 0 0
Baseline and Week 20.
Secondary outcome [6] 0 0
Change From Baseline in Fasting Plasma Glucose (Week 1).
Timepoint [6] 0 0
Baseline and Week 1.
Secondary outcome [7] 0 0
Change From Baseline in Fasting Plasma Glucose (Week 2).
Timepoint [7] 0 0
Baseline and Week 2.
Secondary outcome [8] 0 0
Change From Baseline in Fasting Plasma Glucose (Week 4).
Timepoint [8] 0 0
Baseline and Week 4.
Secondary outcome [9] 0 0
Change From Baseline in Fasting Plasma Glucose (Week 8).
Timepoint [9] 0 0
Baseline and Week 8.
Secondary outcome [10] 0 0
Change From Baseline in Fasting Plasma Glucose (Week 12).
Timepoint [10] 0 0
Baseline and Week 12.
Secondary outcome [11] 0 0
Change From Baseline in Fasting Plasma Glucose (Week 16).
Timepoint [11] 0 0
Baseline and Week 16.
Secondary outcome [12] 0 0
Change From Baseline in Fasting Plasma Glucose (Week 20).
Timepoint [12] 0 0
Baseline and Week 20.
Secondary outcome [13] 0 0
Change From Baseline in Fasting Plasma Glucose (Week 26).
Timepoint [13] 0 0
Baseline and Week 26.
Secondary outcome [14] 0 0
Number of Participants With Marked Hyperglycemia (Fasting Plasma Glucose = 200 mg Per dL).
Timepoint [14] 0 0
26 Weeks.
Secondary outcome [15] 0 0
Number of Participants Requiring Rescue.
Timepoint [15] 0 0
26 Weeks.
Secondary outcome [16] 0 0
Change From Baseline in Fasting Proinsulin (Week 4).
Timepoint [16] 0 0
Baseline and Week 4.
Secondary outcome [17] 0 0
Change From Baseline in Fasting Proinsulin (Week 8).
Timepoint [17] 0 0
Baseline and Week 8.
Secondary outcome [18] 0 0
Change From Baseline in Fasting Proinsulin (Week 12).
Timepoint [18] 0 0
Baseline and Week 12.
Secondary outcome [19] 0 0
Change From Baseline in Fasting Proinsulin (Week 16).
Timepoint [19] 0 0
Baseline and Week 16.
Secondary outcome [20] 0 0
Change From Baseline in Fasting Proinsulin (Week 20).
Timepoint [20] 0 0
Baseline and Week 20.
Secondary outcome [21] 0 0
Change From Baseline in Fasting Proinsulin (Week 26).
Timepoint [21] 0 0
Baseline and Week 26.
Secondary outcome [22] 0 0
Change From Baseline in Insulin (Week 4).
Timepoint [22] 0 0
Baseline and Week 4.
Secondary outcome [23] 0 0
Change From Baseline in Insulin (Week 8).
Timepoint [23] 0 0
Baseline and Week 8.
Secondary outcome [24] 0 0
Change From Baseline in Insulin (Week 12).
Timepoint [24] 0 0
Baseline and Week 12.
Secondary outcome [25] 0 0
Change From Baseline in Insulin (Week 16).
Timepoint [25] 0 0
Baseline and Week 16.
Secondary outcome [26] 0 0
Change From Baseline in Insulin (Week 20).
Timepoint [26] 0 0
Baseline and Week 20.
Secondary outcome [27] 0 0
Change From Baseline in Insulin (Week 26).
Timepoint [27] 0 0
Baseline and Week 26.
Secondary outcome [28] 0 0
Change From Baseline in Proinsulin/Insulin Ratio (Week 4).
Timepoint [28] 0 0
Baseline and Week 4.
Secondary outcome [29] 0 0
Change From Baseline in Proinsulin/Insulin Ratio (Week 8).
Timepoint [29] 0 0
Baseline and Week 8.
Secondary outcome [30] 0 0
Change From Baseline in Proinsulin/Insulin Ratio (Week 12).
Timepoint [30] 0 0
Baseline and Week 12.
Secondary outcome [31] 0 0
Change From Baseline in Proinsulin/Insulin Ratio (Week 16).
Timepoint [31] 0 0
Baseline and Week 16.
Secondary outcome [32] 0 0
Change From Baseline in Proinsulin/Insulin Ratio (Week 20).
Timepoint [32] 0 0
Baseline and Week 20.
Secondary outcome [33] 0 0
Change From Baseline in Proinsulin/Insulin Ratio (Week 26).
Timepoint [33] 0 0
Baseline and Week 26.
Secondary outcome [34] 0 0
Change From Baseline in C-peptide (Week 4).
Timepoint [34] 0 0
Baseline and Week 4.
Secondary outcome [35] 0 0
Change From Baseline in C-peptide (Week 8).
Timepoint [35] 0 0
Baseline and Week 8.
Secondary outcome [36] 0 0
Change From Baseline in C-peptide (Week 12).
Timepoint [36] 0 0
Baseline and Week 12.
Secondary outcome [37] 0 0
Change From Baseline in C-peptide (Week 16).
Timepoint [37] 0 0
Baseline and Week 16.
Secondary outcome [38] 0 0
Change From Baseline in C-peptide (Week 20).
Timepoint [38] 0 0
Baseline and Week 20.
Secondary outcome [39] 0 0
Change From Baseline in C-peptide (Week 26).
Timepoint [39] 0 0
Baseline and Week 26.
Secondary outcome [40] 0 0
Number of Participants With Glycosylated Hemoglobin = 6.5%.
Timepoint [40] 0 0
Baseline and Week 26.
Secondary outcome [41] 0 0
Number of Participants With Glycosylated Hemoglobin = 7.0%.
Timepoint [41] 0 0
Baseline and Week 26.
Secondary outcome [42] 0 0
Number of Participants With Glycosylated Hemoglobin = 7.5%.
Timepoint [42] 0 0
Baseline and Week 26.
Secondary outcome [43] 0 0
Number of Participants With Glycosylated Hemoglobin Decrease From Baseline = 0.5%.
Timepoint [43] 0 0
Baseline and Week 26.
Secondary outcome [44] 0 0
Number of Participants With Glycosylated Hemoglobin Decrease From Baseline = 1.0%.
Timepoint [44] 0 0
Baseline and Week 26.
Secondary outcome [45] 0 0
Number of Participants With Glycosylated Hemoglobin Decrease From Baseline = 1.5%.
Timepoint [45] 0 0
Baseline and Week 26.
Secondary outcome [46] 0 0
Number of Participants With Glycosylated Hemoglobin Decrease From Baseline = 2.0%.
Timepoint [46] 0 0
Baseline and Week 26.
Secondary outcome [47] 0 0
Change From Baseline in Body Weight (Week 8).
Timepoint [47] 0 0
Baseline and Week 8.
Secondary outcome [48] 0 0
Change From Baseline in Body Weight (Week 12).
Timepoint [48] 0 0
Baseline and Week 12.
Secondary outcome [49] 0 0
Change From Baseline in Body Weight (Week 20).
Timepoint [49] 0 0
Baseline and Week 20.
Secondary outcome [50] 0 0
Change From Baseline in Body Weight (Week 26).
Timepoint [50] 0 0
Baseline and Week 26.

Eligibility
Key inclusion criteria
Inclusion Criteria

* Diagnosis of type 2 diabetes mellitus currently treated with metformin alone but, experiencing inadequate glycemic control. The participant should have received the metformin monotherapy for at least the 3 months prior to Screening; and must have a stable dose of greater than or equal to 1500 mg metformin for at least 8 weeks prior to randomization. Participants with a maximum tolerated dose that is documented to be less than 1500 mg of metformin may also be enrolled if this dose has been stable for 8 weeks prior to randomization.
* No treatment with antidiabetic agents other than metformin within the 3 months prior to Screening. (Exception: if a participant has received other antidiabetic therapy for less than 7 days within the 3 months prior to Screening.)
* Body mass index greater than or equal to 23 kg/m2 and less than or equal to 45 kg/m2
* Fasting C-peptide concentration greater than or equal to 0.8 ng per mL. (If this screening criterion is not met, the participant still qualifies if C-peptide is greater than or equal to 1.5 ng per mL after a challenge test.
* Glycosylated hemoglobin concentration between 7.0% and 10.0%, inclusive
* If regular use of other, non-excluded medications, must be on a stable dose for at least the 4 weeks prior to Screening. However, as needed use of prescription or over-the-counter medications is allowed at the discretion of the investigator.
* Systolic blood pressure less than or equal to 180 mm Hg and diastolic pressure less than or equal to 110 mm Hg
* Hemoglobin greater than or equal to 12 g per dL for males and greater than or equal to 10 g per dL for females
* Alanine aminotransferase less than or equal to 3 time the upper limit of normal
* Serum creatinine less than1.5 mg per dL for males and less than 1.4 mg per dL for females
* Thyroid-stimulating hormone level less than or equal to the upper limit of the normal range and the participant is clinically euthyroid.
* Neither pregnant nor lactating.
* Female participants of childbearing potential must be practicing adequate contraception. Adequate contraception must be practiced for the duration of participation in 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
* Able and willing to provide written informed consent
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria
* Urine albumin to creatinine ratio of greater than 1000 µg per mg at Screening. If elevated, the participant 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. (A history of treated cervical intraepithelial neoplasia I or cervical intraepithelial neoplasia II is allowed.)
* History of laser treatment for proliferative diabetic retinopathy within the 6 months prior to Screening
* History of treated diabetic gastric paresis
* New York Heart Association Class III or IV heart failure regardless of therapy. Currently treated participants who are stable at Class I or II are candidates for the study.
* 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 hepatitis B, hepatitis C, or 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
* Receipt of any investigational drug within the 30 days prior to Screening or a history of receipt of an investigational antidiabetic drug within the 3 months prior to Screening
* Prior treatment in an investigational study of alogliptin
* Excluded Medications:

* Treatment with antidiabetic agents other than study drug or metformin is not allowed within the 3 months prior to Screening and through the completion of the end-of treatment/early termination procedures.
* Treatment with weight-loss drugs, any investigational antidiabetics, or oral or systemically injected glucocorticoids is not allowed from 3 months prior to randomization through the completion of the end-of-treatment/early termination procedures. Inhaled corticosteroids are allowed.
* Participants must be instructed not to take any medications, including over-the-counter products, without first consulting with the investigator.

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
1/03/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2007
Sample size
Target
Accrual to date
Final
527
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Multiple Cities
Recruitment postcode(s) [1] 0 0
- Multiple Cities
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
District of Columbia
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
Hawaii
Country [7] 0 0
United States of America
State/province [7] 0 0
Indiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Missouri
Country [9] 0 0
United States of America
State/province [9] 0 0
Nebraska
Country [10] 0 0
United States of America
State/province [10] 0 0
New Jersey
Country [11] 0 0
United States of America
State/province [11] 0 0
North Carolina
Country [12] 0 0
United States of America
State/province [12] 0 0
Ohio
Country [13] 0 0
United States of America
State/province [13] 0 0
Oregon
Country [14] 0 0
United States of America
State/province [14] 0 0
Pennsylvania
Country [15] 0 0
United States of America
State/province [15] 0 0
South Carolina
Country [16] 0 0
United States of America
State/province [16] 0 0
Texas
Country [17] 0 0
United States of America
State/province [17] 0 0
Vermont
Country [18] 0 0
Argentina
State/province [18] 0 0
Multiple Cities
Country [19] 0 0
Brazil
State/province [19] 0 0
Multiple Cities
Country [20] 0 0
Chile
State/province [20] 0 0
Multiple Cities
Country [21] 0 0
Czech Republic
State/province [21] 0 0
Multiple Cities
Country [22] 0 0
Germany
State/province [22] 0 0
Multiple Cities
Country [23] 0 0
Guatemala
State/province [23] 0 0
Multiple Cities
Country [24] 0 0
Hungary
State/province [24] 0 0
Multiple Cities
Country [25] 0 0
India
State/province [25] 0 0
Multiple Cities
Country [26] 0 0
Mexico
State/province [26] 0 0
Multiple Cities
Country [27] 0 0
Netherlands
State/province [27] 0 0
Multiple Cities
Country [28] 0 0
New Zealand
State/province [28] 0 0
Multiple Cities
Country [29] 0 0
Peru
State/province [29] 0 0
Multiple Cities
Country [30] 0 0
Poland
State/province [30] 0 0
Multiple Cities
Country [31] 0 0
South Africa
State/province [31] 0 0
Multiple Cities
Country [32] 0 0
United Kingdom
State/province [32] 0 0
Multiple Cities

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


Results are available at https://clinicaltrials.gov/study/NCT00286442