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

• Conditions: Type 2 diabetes mellitus; MedDRA version: 8.1Level: LLTClassification code 10045242Term: Type II diabetes mellitus

• Registration Number: EUCTR2006-005492-17-HU
• Lead Sponsor: Takeda Global Research & Development Centre (Europe) Ltd.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11-27
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 655

Inclusion Criteria

Subject eligibility is determined based on the following criteria:
1. Males or females, 18-80 years of age, inclusive, with a historical diagnosis of type 2 diabetes.
2. The subject has failed treatment with diet and exercise for at least 2 months prior to Screening.
3. The subject is experiencing inadequate glycemic control as defined as HbA1c concentration between 7.5-11%, inclusive.
4. The subject has received less than 7 days of any antidiabetic therapy within 3 months prior to Screening.
5. The subject is capable of understanding and complying with protocol requirements.
6. The subject or the subject’s legally acceptable representative signs a written, informed consent form prior to the initiation of any study procedures.
7. The subject has a body mass index =23 kg/m2 and <45 kg/m2.
8. The subject has a fasting C-peptide =0.8 ng/mL (0.26 nmol/L).
9. The subject who has regular use of other, nonexcluded medications must be on a stable dose for at least 4 weeks prior to Screening. However, PRN (as needed) use of prescription or over-the-counter medications is allowed at the discretion of the investigator.
10. Female subjects of child-bearing potential (ie, not surgically sterilized and/or postmenopausal) must be practicing adequate contraception (as defined in Section ?9.1.11 and the informed consent form) from Screening throughout the duration of the study.
11. The subject is neither pregnant (confirmed by laboratory testing in females of childbearing potential) nor lactating.
12. The subject must be willing and able to monitor their blood concentrations with a home glucose monitor.

Additional Inclusion Criteria Prior to Randomization
In order to be eligible for randomization, each of the following additional criteria must be satisfied with a Yes” answer:
1. The subject has a HbA1c concentration between 7.5-11%, inclusive, and a fasting plasma glucose <310 mg/dL (17.5 mmol/L) at the Week -1 visit (of note, if the subject does not qualify for randomization based on these criteria, the assessment may be repeated on a weekly basis, for a maximum of 4 additional weeks).
2. The subject has been at least 75% compliant with the single-blind placebo regimen during the run-in/stabilization period, as assessed by tablet count.
3. The subject has not used oral or systemically injected glucocorticoids or use of weight-loss drugs within 3 months prior to randomization (inhaled corticosteroids are allowed).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Any subject who meets any of the following criteria will not qualify for entry into the study:
1. The subject has a systolic blood pressure =160 mmHg and diastolic blood pressure =100 mmHg.
2. The subject has hemoglobin =12 g/dL (120 gm/L) for males and =10 g/dL (100 gm/L) for females.
3. The subject has an alanine aminotransferase (ALT) =2.5x upper limit of normal.
4. The subject has a serum creatinine >2.0 mg/dL (177 micromol/L).
5. The subject has a thyroid stimulating hormone level > the upper limit of normal range.
6. The subject has a major illness or debility that in the investigator’s opinion prohibits the subject from completing the study.
7. The subject has a urine albumin/creatinine ratio of >1000 ug/mg (>113 mg/mmol) at Screening. If elevated, the subject may be rescreened within 1 week.
8. The subject has a 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 CIN I or CIN II [cervical intraepithelial neoplasia] is allowed).
9. The subject has a history of laser treatment for proliferative diabetic retinopathy within 6 months prior to Screening.
10. The subject has a history of gastroparesis.
11. The subject has New York Heart Association Class III or IV heart failure regardless of therapy. Currently treated subjects who are stable at Class I or II are candidates for the study.
12. The subject has a history of coronary angioplasty, coronary stent placement, coronary bypass surgery, or myocardial infarction within 6 months prior to Screening.
13. The subject has a history of any hemoglobinopathy that may affect determination of HbA1c.
14. The subject has a history of infection with hepatitis B, hepatitis C, or human immunodeficiency virus.
15. The subject has a history of a psychiatric disorder that will affect the subject’s ability to participate in the study.
16. The subject has a history of angioedema in association with use of angiotensin-converting enzyme inhibitors or angiotensin-II receptor inhibitors.
17. The subject has had any alteration in angiotensin-II receptor inhibitors (dose or drug) within 2 months prior to Randomization, if applicable.
18. The subject has a 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.
19. The subject has 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.
20. The subject has previously participated in an investigational study of SYR-322.
21. The subject is unable to understand verbal or written English or any other language for which a certified translation of the approved informed consent is available.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified