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Safety and Efficacy Study of SYR-322 on Glycemic Control in Subjects With Type 2 Diabetes.
This study has been completed.
First Received: September 17, 2008   Last Updated: December 15, 2008   History of Changes
Sponsored by: Takeda Global Research & Development Center, Inc.
Information provided by: Takeda Global Research & Development Center, Inc.
ClinicalTrials.gov Identifier: NCT00755846
  Purpose

The purpose of this study is to determine the safety and efficacy of SYR-322 compared to diet and exercise, sulfonylurea, metformin and a combination of sulfonylurea and metformin for treating subjects with type 2 diabetes.


Condition Intervention Phase
Diabetes Mellitus
Drug: SYR-322
Drug: Placebo
Phase II

MedlinePlus related topics: Diabetes Diets Exercise and Physical Fitness
Drug Information available for: Alogliptin
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Comparison Study to Determine the Efficacy and Safety of SYR110322 in Patients With Type 2 Diabetes, Who Are Either Receiving No Current Treatment or Currently Treated With Diet and Exercise, Sulfonylurea, Metformin or a Combination of Sulfonylurea and Metformin

Further study details as provided by Takeda Global Research & Development Center, Inc.:

Primary Outcome Measures:
  • Change from Baseline in Glycosylated Hemoglobin. [ Time Frame: Day: 85. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from Baseline in Glycosylated Hemoglobin. [ Time Frame: Day: 43. ] [ Designated as safety issue: No ]
  • Change from Baseline in fasting plasma glucose and fasting fructosamine. [ Time Frame: Days: 43 and 85. ] [ Designated as safety issue: No ]
  • Change from Baseline in average daily blood glucose. [ Time Frame: Days: 43 and 85. ] [ Designated as safety issue: No ]
  • Change from Screening value in Lipid profile (total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, and triglycerides). [ Time Frame: Days: 43 and 85. ] [ Designated as safety issue: No ]
  • Incidence of hyperglycemia (proportion of self-monitored blood glucose measurements ≥200 mg/dL). [ Time Frame: At all visits. ] [ Designated as safety issue: No ]

Enrollment: 257
Study Start Date: March 2005
Study Completion Date: October 2005
Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental Drug: SYR-322
SYR-322 6.25 mg, tablets, orally, once daily for up to 12 weeks
2: Experimental Drug: SYR-322
SYR-322 12.5 mg, tablets, orally, once daily for up to 12 weeks.
3: Experimental Drug: SYR-322
SYR-322 25 mg, tablets, orally, once daily for up to 12 weeks.
4: Experimental Drug: SYR-322
SYR-322 50 mg, tablets, orally, once daily for up to 12 weeks.
5: Experimental Drug: SYR-322
SYR-322 100 mg, tablets, orally, once daily for up to 12 weeks.
6: Placebo Comparator Drug: Placebo
SYR-322 placebo-matching tablets, orally, once daily for up to 12 weeks.

Detailed Description:

Of the approximately 19 million people in the United States who have been diagnosed with diabetes mellitus, 90% to 95% have type 2 diabetes mellitus. The prevalence of type 2 diabetes mellitus varies among racial and ethnic populations and has been shown to increase with age, obesity, family history, history of gestational diabetes, and physical inactivity. Over the next decade, a disproportionate increase in the elderly population will result in a marked increase in diabetic patients, placing an ever-increasing burden on families and the health care system.

In response to this problem, TGRD is developing SYR-322, a selective, orally available inhibitor of the enzyme dipeptidyl peptidase IV. Dipeptidyl peptidase IV is thought to be primarily responsible for the in vivo degradation of 2 peptide hormones released in response to nutrient ingestion, namely glucagon-like peptide-1 and glucose-dependent insulinotropic peptide.

Individuals who want to participate in this study will be required to provide written informed consent. Study participation is anticipated to be about 14 Weeks. Multiple procedures will occur at each visit which may include blood collection, urine collection, vital signs including sitting and standing blood pressure and pulse, body height and weight, physical examinations and electrocardiograms.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Has type 2 diabetes mellitus and were either receiving no current treatment or currently treated with a sulfonylurea, metformin, or a combination of a sulfonylurea and metformin but experiencing inadequate glycemic control. Subjects qualified as receiving no current treatment if 1 of the following conditions applied:

    • Subject was newly diagnosed (ie, had not received any treatment).
    • Subject was treated with diet and exercise alone for the 3 months prior to Screening
    • Subject had received <7 continuous days of any antidiabetic therapy within the 3 months prior to Screening.
    • Subject had a diagnosis of type 2 diabetes mellitus based on current American Diabetes Association criteria: fasting plasma glucose ≥126 mg/dL, oral glucose tolerance test at 2 hours after administration of the glucose load must have been ≥200 mg/dL, or symptoms of diabetes plus casual plasma glucose ≥200 mg/dL.
  • Body mass index ≥23 kg/m2 and ≤40 kg/m2.
  • Fasting C-peptide concentration ≥0.8 ng/mL.
  • Glycosylated hemoglobin concentration between 6.8% and 11.0%.
  • Fasting plasma glucose >126 mg/dL at Screening.
  • No treatment within the 3 months prior to Screening with any other agents known to have effects on glucose (other than as described above, a sulfonylurea, metformin, or a combination of a sulfonylurea and metformin in subjects on antidiabetics), including but not limited to the following:

    • Other antidiabetic agents
    • Investigational antidiabetic agents
    • Niacin
    • Regular use of systemic glucocorticoids.
    • No treatment within the 3 months prior to Screening with weight-loss drugs
    • If taking other non-excluded medications, must have been on a stable dose of medication for at least 4 weeks.
  • Diastolic blood pressure ≤110 mm Hg and a systolic pressure of ≤180 mm Hg.
  • Female subjects could neither be pregnant (confirmed by laboratory testing) nor lactating, and if of childbearing potential must have been practicing adequate contraception.
  • 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 prohibited the subject from completing the study.
  • Hemoglobin ≥12 g/dL for males and ≥10 g/dL for females.
  • Hepatic transaminase ≤2 x upper limit of normal.

Exclusion Criteria:

  • History of cancer, other than squamous cell or basal cell carcinoma of the skin, that had not been in full remission for at least 1 year prior to Screening.
  • History of proteinuria >1000 mg/day on a 12- or 24-hour urine collection OR a urine albumin/creatinine ratio >1000 μg/mg at Screening. If elevated, the subject was to be rescreened within 1 week.
  • Serum creatinine ≥2.0 mg/dL.
  • History of proliferative diabetic retinopathy OR any history of laser-treated retinopathy.
  • History of treated peripheral or autonomic neuropathy.
  • History of systolic dysfunction congestive heart failure.
  • History of myocardial infarction within 1 year prior to Screening.
  • History of ulcerative colitis or Crohn's disease.
  • History of infection with hepatitis B, hepatitis C, or human immunodeficiency virus.
  • History of a psychiatric disorder that would affect the subject's ability to participate in the study.
  • History of anaphylactic reaction(s) to any drug.
  • History of angioedema.
  • History of alcohol or substance abuse within the last 2 years.
  • History of any surgery that could potentially affect the absorption of the study drug.
  • Receipt of any investigational drug within the preceding 30 days or a history of receipt of an investigational antidiabetic drug within the preceding 90 days.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00755846

Sponsors and Collaborators
Takeda Global Research & Development Center, Inc.
Investigators
Study Director: VP Biological Sciences Takeda Global Research & Development Center, Inc.
  More Information

No publications provided

Responsible Party: Takeda Global Research & Development Center, Inc. ( Sr. VP, Clinical Science )
Study ID Numbers: SYR-322-003
Study First Received: September 17, 2008
Last Updated: December 15, 2008
ClinicalTrials.gov Identifier: NCT00755846     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Takeda Global Research & Development Center, Inc.:
Diabetes Mellitus
Drug Therapy
Diabetes Mellitus, Type II
Type 2 Diabetes Mellitus
Hyperinsulinism
Insulin Resistance

Study placed in the following topic categories:
Hyperinsulinism
Metabolic Diseases
Metformin
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Disorder
Insulin

Additional relevant MeSH terms:
Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on May 07, 2009