Efficacy and Safety Study of SYR-619 in Treating Subjects With Type 2 Diabetes Mellitus

NCT00763347 | Terminated Phase 2

• 2 other identifiers: 01-06-TL-SYR-619-003U1111-1124-2377
• Study Type: interventional
• Target: 82
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to determine the efficacy and safety of SYR-619, once daily (QD), in subjects with type 2 diabetes mellitus who have not achieved glycemic control with diet and exercise, or by taking metformin.

Conditions

Diabetes Mellitus

Keywords

Glucose Metabolism Disorder; Dysmetabolic Syndrome; Type II Diabetes; Diabetes Mellitus, Lipoatrophic; Dyslipidemia; Drug Therapy

Outcome Measures

Primary Outcomes (1)

• Change from baseline in glycosylated hemoglobin.

  Week 12 or Final Visit..

Secondary Outcomes (27)

• Change from baseline in glycosylated hemoglobin.

  Weeks 4, 8 and 12 or Final Visit.

• Change from baseline in fasting plasma glucose.

  Weeks: 1, 2, 4, 8 and 12 or Final Visit.

• Change from baseline in 1,5 anhydroglucitol.

  Weeks 2, 4, 8 and 12 or Final Visit.

• Change from baseline in proinsulin.

  Weeks 4, 8 and 12 or Final Visit.

• Change from baseline in insulin.

  Weeks 4, 8 and 12 or Final Visit.

Study Arms (6)

SYR-619 12.5 mg QD

EXPERIMENTAL

Drug: SYR-619

SYR-619 50 mg QD

EXPERIMENTAL

Drug: SYR-619

SYR-619 100 mg QD

EXPERIMENTAL

Drug: SYR-619

SYR-619 200 mg QD

EXPERIMENTAL

Drug: SYR-619

Placebo QD

PLACEBO COMPARATOR

Drug: Placebo

Alogliptin 25 mg QD

ACTIVE COMPARATOR

Drug: Alogliptin

Interventions

SYR-619 DRUG

SYR-619 12.5 mg, tablets, orally, once daily for up to 12 weeks.

SYR-619 12.5 mg QD

Placebo DRUG

SYR-619 placebo-matching tablets, orally, once daily for up to 12 weeks.

Placebo QD

Alogliptin DRUG

Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.

Also known as: SYR-322

Alogliptin 25 mg QD

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, with a historical diagnosis of type 2 diabetes mellitus.
• Treatment for diabetes with either lifestyle modification or metformin or sulfonylurea alone for at least the 2 months prior to Screening; and a stable dose of either metformin or sulfonylurea for at least 12 weeks prior to randomization for subjects receiving metformin or sulfonylurea at Screening.
• Those subjects receiving metformin or sulfonylurea monotherapy at randomization must have been at least 75% compliant with their metformin or sulfonylurea regimen during the run in/stabilization period, as assessed by subject diary and investigator assessment.
• No treatment with antidiabetic agents other than metformin alone or sulfonylurea alone within the 3 months prior to Screening.
• Glycosylated hemoglobin concentration between 7.0% and 10.0%, inclusive, and a fasting plasma glucose \<275 mg/dL (\<15.27 mmol/L) at the Week -1 visit.
• Body mass index ≥23 and ≤45 kg/m2.
• Fasting C-peptide concentration ≥0.8 ng/mL (≥0.26 nmol/L). (If this screening criterion is not met, the subject still qualifies if C-peptide ≥1.5 ng/mL \[≥0.50 nmol/L\] after a challenge test).
• 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 \<160 mm Hg and diastolic pressure \<100 mm Hg.
• Hemoglobin ≥12 g/dL (≥120 gm/L) for males and ≥10 g/dL (≥100 gm/L) for females.
• Alanine aminotransferase ≤3 x upper limit of normal.
• Serum creatinine \<1.5 mg/dL (\<133 micromol/L) for males and \<1.4 mg/dL (\<124 micromol/L) for females.
• Urine albumin/creatinine ratio of \<1000 μg/mg (113 mg/mol) at Screening. If elevated, the subject may be rescreened within 1 week.
• Thyroid-stimulating hormone level ≤ the upper limit of the normal range and the subject has normal thyroid function (clinically euthyroid)
• A female subject of childbearing potential who is sexually active must agree to use adequate contraception, and must be neither pregnant nor lactating from Screening and throughout the duration of the study.

You may not qualify if:

• Concurrently treated with combined metformin and sulfonylurea antidiabetic therapy.
• 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 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 subjects 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 in the investigator's opinion will affect the subject's ability to participate in the study.
• History of alcohol abuse or substance abuse within the 2 years prior to Screening.
• The subject is required to take or intends to continue taking any disallowed medication, any prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication, including:
• Treatment with antidiabetic agents other than study drug or metformin or sulfonylurea 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 antidiabetic drugs, 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.
• 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.

Sponsors & Collaborators

• Takeda: lead

MeSH Terms

Conditions

Diabetes Mellitus; Glucose Metabolism Disorders; Diabetes Mellitus, Type 2; Diabetes Mellitus, Lipoatrophic; Dyslipidemias

Interventions

alogliptin

Condition Hierarchy (Ancestors)

Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Lipid Metabolism Disorders

Study Officials

• VP Biological Sciences

  Takeda

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2008
• First Posted: September 30, 2008
• Study Start: November 1, 2006
• Primary Completion: February 1, 2007
• Study Completion: February 1, 2007
• Last Updated: May 21, 2012

Record last verified: 2012-05