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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]

2005-004668-22

Secondary ID [2]

SYR-322-MET-008

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Diabetes Mellitus

Condition category

Condition code

Metabolic and Endocrine

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]

Treatment: Drugs

Comparator / control treatment

Control group

Outcomes

Primary outcome [1]

Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26.

Assessment method [1]

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 week 26 or final visit and glycosylated hemoglobin collected at baseline.

Timepoint [1]

Baseline and Week 26.

Secondary outcome [1]

Change From Baseline in Glycosylated Hemoglobin (Week 4).

Assessment method [1]

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 week 4 and Glycosylated Hemoglobin collected at baseline.

Timepoint [1]

Baseline and Week 4.

Secondary outcome [2]

Change From Baseline in Glycosylated Hemoglobin (Week 8).

Assessment method [2]

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 week 8 and Glycosylated Hemoglobin collected at baseline.

Timepoint [2]

Baseline and Week 8.

Secondary outcome [3]

Change From Baseline in Glycosylated Hemoglobin (Week 12).

Assessment method [3]

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 week 12 and Glycosylated Hemoglobin collected at baseline.

Timepoint [3]

Baseline and Week 12.

Secondary outcome [4]

Change From Baseline in Glycosylated Hemoglobin (Week 16).

Assessment method [4]

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 week 16 and Glycosylated Hemoglobin collected at baseline.

Timepoint [4]

Baseline and Week 16.

Secondary outcome [5]

Change From Baseline in Glycosylated Hemoglobin (Week 20).

Assessment method [5]

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 week 20 and Glycosylated Hemoglobin collected at baseline.

Timepoint [5]

Baseline and Week 20.

Secondary outcome [6]

Change From Baseline in Fasting Plasma Glucose (Week 1).

Assessment method [6]

The change between the value of fasting plasma glucose collected at final visit or week 1 and fasting plasma glucose collected at baseline.

Timepoint [6]

Baseline and Week 1.

Secondary outcome [7]

Change From Baseline in Fasting Plasma Glucose (Week 2).

Assessment method [7]

The change between the value of fasting plasma glucose collected at week 2 and fasting plasma glucose collected at baseline.

Timepoint [7]

Baseline and Week 2.

Secondary outcome [8]

Change From Baseline in Fasting Plasma Glucose (Week 4).

Assessment method [8]

The change between the value of fasting plasma glucose collected at week 4 and fasting plasma glucose collected at baseline.

Timepoint [8]

Baseline and Week 4.

Secondary outcome [9]

Change From Baseline in Fasting Plasma Glucose (Week 8).

Assessment method [9]

The change between the value of fasting plasma glucose collected at week 8 and fasting plasma glucose collected at baseline.

Timepoint [9]

Baseline and Week 8.

Secondary outcome [10]

Change From Baseline in Fasting Plasma Glucose (Week 12).

Assessment method [10]

The change between the value of fasting plasma glucose collected at week 12 and fasting plasma glucose collected at baseline.

Timepoint [10]

Baseline and Week 12.

Secondary outcome [11]

Change From Baseline in Fasting Plasma Glucose (Week 16).

Assessment method [11]

The change between the value of fasting plasma glucose collected at week 16 and fasting plasma glucose collected at baseline.

Timepoint [11]

Baseline and Week 16.

Secondary outcome [12]

Change From Baseline in Fasting Plasma Glucose (Week 20).

Assessment method [12]

The change between the value of fasting plasma glucose collected at week 20 and fasting plasma glucose collected at baseline.

Timepoint [12]

Baseline and Week 20.

Secondary outcome [13]

Change From Baseline in Fasting Plasma Glucose (Week 26).

Assessment method [13]

The change between the value of fasting plasma glucose collected at week 26 or final visit and fasting plasma glucose collected at baseline.

Timepoint [13]

Baseline and Week 26.

Secondary outcome [14]

Number of Participants With Marked Hyperglycemia (Fasting Plasma Glucose = 200 mg Per dL).

Assessment method [14]

The number of participants with a fasting plasma glucose value greater than or equal to 200 mg per dL during the 26 week study.

Timepoint [14]

26 Weeks.

Secondary outcome [15]

Number of Participants Requiring Rescue.

Assessment method [15]

The number of participants requiring rescue for failing to achieve pre-specified glycemic targets during the 26 week study.

Timepoint [15]

26 Weeks.

Secondary outcome [16]

Change From Baseline in Fasting Proinsulin (Week 4).

Assessment method [16]

The change between the value of fasting proinsulin collected at week 4 and fasting proinsulin collected at baseline.

Timepoint [16]

Baseline and Week 4.

Secondary outcome [17]

Change From Baseline in Fasting Proinsulin (Week 8).

Assessment method [17]

The change between the value of fasting proinsulin collected at week 8 and fasting proinsulin collected at baseline.

Timepoint [17]

Baseline and Week 8.

Secondary outcome [18]

Change From Baseline in Fasting Proinsulin (Week 12).

Assessment method [18]

The change between the value of fasting proinsulin collected at week 12 and fasting proinsulin collected at baseline.

Timepoint [18]

Baseline and Week 12.

Secondary outcome [19]

Change From Baseline in Fasting Proinsulin (Week 16).

Assessment method [19]

The change between the value of fasting proinsulin collected at week 16 and fasting proinsulin collected at baseline.

Timepoint [19]

Baseline and Week 16.

Secondary outcome [20]

Change From Baseline in Fasting Proinsulin (Week 20).

Assessment method [20]

The change between the value of fasting proinsulin collected at week 20 and fasting proinsulin collected at baseline.

Timepoint [20]

Baseline and Week 20.

Secondary outcome [21]

Change From Baseline in Fasting Proinsulin (Week 26).

Assessment method [21]

The change between the value of fasting proinsulin collected at week 26 or final visit and fasting proinsulin collected at baseline.

Timepoint [21]

Baseline and Week 26.

Secondary outcome [22]

Change From Baseline in Insulin (Week 4).

Assessment method [22]

The change between the value of insulin collected at week 4 and insulin collected at baseline.

Timepoint [22]

Baseline and Week 4.

Secondary outcome [23]

Change From Baseline in Insulin (Week 8).

Assessment method [23]

The change between the value of insulin collected at week 8 and insulin collected at baseline.

Timepoint [23]

Baseline and Week 8.

Secondary outcome [24]

Change From Baseline in Insulin (Week 12).

Assessment method [24]

The change between the value of insulin collected at week 12 and insulin collected at baseline.

Timepoint [24]

Baseline and Week 12.

Secondary outcome [25]

Change From Baseline in Insulin (Week 16).

Assessment method [25]

The change between the value of insulin collected at week 16 and insulin collected at baseline.

Timepoint [25]

Baseline and Week 16.

Secondary outcome [26]

Change From Baseline in Insulin (Week 20).

Assessment method [26]

The change between the value of insulin collected at week 20 and insulin collected at baseline.

Timepoint [26]

Baseline and Week 20.

Secondary outcome [27]

Change From Baseline in Insulin (Week 26).

Assessment method [27]

The change between the value of insulin collected at week 26 and insulin collected at baseline.

Timepoint [27]

Baseline and Week 26.

Secondary outcome [28]

Change From Baseline in Proinsulin/Insulin Ratio (Week 4).

Assessment method [28]

The change between the ratio value of proinsulin and insulin collected at week 4 and the ratio value of proinsulin and insulin collected at baseline.

Timepoint [28]

Baseline and Week 4.

Secondary outcome [29]

Change From Baseline in Proinsulin/Insulin Ratio (Week 8).

Assessment method [29]

The change between the ratio value of proinsulin and insulin collected at week 8 and the ratio value of proinsulin and insulin collected at baseline.

Timepoint [29]

Baseline and Week 8.

Secondary outcome [30]

Change From Baseline in Proinsulin/Insulin Ratio (Week 12).

Assessment method [30]

The change between the ratio value of proinsulin and insulin collected at week 12 and the ratio value of proinsulin and insulin collected at baseline.

Timepoint [30]

Baseline and Week 12.

Secondary outcome [31]

Change From Baseline in Proinsulin/Insulin Ratio (Week 16).

Assessment method [31]

The change between the ratio value of proinsulin and insulin collected at week 16 and the ratio value of proinsulin and insulin collected at baseline.

Timepoint [31]

Baseline and Week 16.

Secondary outcome [32]

Change From Baseline in Proinsulin/Insulin Ratio (Week 20).

Assessment method [32]

The change between the ratio value of proinsulin and insulin collected at week 20 and the ratio value of proinsulin and insulin collected at baseline.

Timepoint [32]

Baseline and Week 20.

Secondary outcome [33]

Change From Baseline in Proinsulin/Insulin Ratio (Week 26).

Assessment method [33]

The change between the ratio value of proinsulin and insulin collected at week 26 or final visit and the ratio value of proinsulin and insulin collected at baseline.

Timepoint [33]

Baseline and Week 26.

Secondary outcome [34]

Change From Baseline in C-peptide (Week 4).

Assessment method [34]

The change between the value of C-peptide collected at week 4 and C-peptide collected at baseline.

Timepoint [34]

Baseline and Week 4.

Secondary outcome [35]

Change From Baseline in C-peptide (Week 8).

Assessment method [35]

The change between the value of C-peptide collected at week 8 and C-peptide collected at baseline.

Timepoint [35]

Baseline and Week 8.

Secondary outcome [36]

Change From Baseline in C-peptide (Week 12).

Assessment method [36]

The change between the value of C-peptide collected at week 12 and C-peptide collected at baseline.

Timepoint [36]

Baseline and Week 12.

Secondary outcome [37]

Change From Baseline in C-peptide (Week 16).

Assessment method [37]

The change between the value of C-peptide collected at week 16 and C-peptide collected at baseline.

Timepoint [37]

Baseline and Week 16.

Secondary outcome [38]

Change From Baseline in C-peptide (Week 20).

Assessment method [38]

The change between the value of C-peptide collected at week 20 and C-peptide collected at baseline.

Timepoint [38]

Baseline and Week 20.

Secondary outcome [39]

Change From Baseline in C-peptide (Week 26).

Assessment method [39]

The change between the value of C-peptide collected at week 26 or final visit and C-peptide collected at baseline.

Timepoint [39]

Baseline and Week 26.

Secondary outcome [40]

Number of Participants With Glycosylated Hemoglobin = 6.5%.

Assessment method [40]

The number of participants with a value for the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) less than or equal to 6.5% during the 26 week study.

Timepoint [40]

Baseline and Week 26.

Secondary outcome [41]

Number of Participants With Glycosylated Hemoglobin = 7.0%.

Assessment method [41]

The number of participants with a value for the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) less than or equal to 7.0% during the 26 week study.

Timepoint [41]

Baseline and Week 26.

Secondary outcome [42]

Number of Participants With Glycosylated Hemoglobin = 7.5%.

Assessment method [42]

The number of participants with a value for the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) less than or equal to 7.5% during the 26 week study.

Timepoint [42]

Baseline and Week 26.

Secondary outcome [43]

Number of Participants With Glycosylated Hemoglobin Decrease From Baseline = 0.5%.

Assessment method [43]

The number 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% during the 26 week study.

Timepoint [43]

Baseline and Week 26.

Secondary outcome [44]

Number of Participants With Glycosylated Hemoglobin Decrease From Baseline = 1.0%.

Assessment method [44]

Timepoint [44]

Baseline and Week 26.

Secondary outcome [45]

Number of Participants With Glycosylated Hemoglobin Decrease From Baseline = 1.5%.

Assessment method [45]

Timepoint [45]

Baseline and Week 26.

Secondary outcome [46]

Number of Participants With Glycosylated Hemoglobin Decrease From Baseline = 2.0%.

Assessment method [46]

Timepoint [46]

Baseline and Week 26.

Secondary outcome [47]

Change From Baseline in Body Weight (Week 8).

Assessment method [47]

The change between Body Weight measured at week 8 and Body Weight measured at baseline.

Timepoint [47]

Baseline and Week 8.

Secondary outcome [48]

Change From Baseline in Body Weight (Week 12).

Assessment method [48]

The change between Body Weight measured at week 12 and Body Weight measured at baseline.

Timepoint [48]

Baseline and Week 12.

Secondary outcome [49]

Change From Baseline in Body Weight (Week 20).

Assessment method [49]

The change between Body Weight measured at week 20 and Body Weight measured at baseline.

Timepoint [49]

Baseline and Week 20.

Secondary outcome [50]

Change From Baseline in Body Weight (Week 26).

Assessment method [50]

The change between Body Weight measured at week 26 or final visit and Body Weight measured at baseline.

Timepoint [50]

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?

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]

- Multiple Cities

Recruitment postcode(s) [1]

- Multiple Cities

Recruitment outside Australia

Country [1]

United States of America

State/province [1]

Arizona

Country [2]

United States of America

State/province [2]

California

Country [3]

United States of America

State/province [3]

Colorado

Country [4]

United States of America

State/province [4]

District of Columbia

Country [5]

United States of America

State/province [5]

Florida

Country [6]

United States of America

State/province [6]

Hawaii

Country [7]

United States of America

State/province [7]

Indiana

Country [8]

United States of America

State/province [8]

Missouri

Country [9]

United States of America

State/province [9]

Nebraska

Country [10]

United States of America

State/province [10]

New Jersey

Country [11]

United States of America

State/province [11]

North Carolina

Country [12]

United States of America

State/province [12]

Ohio

Country [13]

United States of America

State/province [13]

Oregon

Country [14]

United States of America

State/province [14]

Pennsylvania

Country [15]

United States of America

State/province [15]

South Carolina

Country [16]

United States of America

State/province [16]

Texas

Country [17]

United States of America

State/province [17]

Vermont

Country [18]

Argentina

State/province [18]

Multiple Cities

Country [19]

Brazil

State/province [19]

Multiple Cities

Country [20]

Chile

State/province [20]

Multiple Cities

Country [21]

Czech Republic

State/province [21]

Multiple Cities

Country [22]

Germany

State/province [22]

Multiple Cities

Country [23]

Guatemala

State/province [23]

Multiple Cities

Country [24]

Hungary

State/province [24]

Multiple Cities

Country [25]

India

State/province [25]

Multiple Cities

Country [26]

Mexico

State/province [26]

Multiple Cities

Country [27]

Netherlands

State/province [27]

Multiple Cities

Country [28]

New Zealand

State/province [28]

Multiple Cities

Country [29]

Peru

State/province [29]

Multiple Cities

Country [30]

Poland

State/province [30]

Multiple Cities

Country [31]

South Africa

State/province [31]

Multiple Cities

Country [32]

United Kingdom

State/province [32]

Multiple Cities

Funding & Sponsors

Primary sponsor type

Commercial sector/industry

Name

Takeda

Country

Ethics approval

Ethics application status

Summary

Brief summary

The purpose of this study is to evaluate the efficacy and safety of alogliptin, once daily (QD), combined with metformin in adults with type 2 diabetes mellitus.

Trial website

https://clinicaltrials.gov/study/NCT00286442

Trial related presentations / publications

Nauck MA, Ellis GC, Fleck PR, Wilson CA, Mekki Q; Alogliptin Study 008 Group. Efficacy and safety of adding the dipeptidyl peptidase-4 inhibitor alogliptin to metformin therapy in patients with type 2 diabetes inadequately controlled with metformin monotherapy: a multicentre, randomised, double-blind, placebo-controlled study. Int J Clin Pract. 2009 Jan;63(1):46-55. doi: 10.1111/j.1742-1241.2008.01933.x.
Pratley RE, McCall T, Fleck PR, Wilson CA, Mekki Q. Alogliptin use in elderly people: a pooled analysis from phase 2 and 3 studies. J Am Geriatr Soc. 2009 Nov;57(11):2011-9. doi: 10.1111/j.1532-5415.2009.02484.x. Epub 2009 Sep 30.

Public notes

Contacts

Principal investigator

Name

VP Biological Sciences

Address

Takeda

Country

Phone

Contact person for public queries

Name

Address

Country

Phone

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

Type	Citations or Other Details
Journal	Nauck MA, Ellis GC, Fleck PR, Wilson CA, Mekki Q; ... [More Details]
Journal	Pratley RE, McCall T, Fleck PR, Wilson CA, Mekki Q... [More Details]

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

Trial Review

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