Efficacy of SYR-472 in Subjects With Type 2 Diabetes Mellitus

NCT00653185 | Completed Phase 2

• 2 other identifiers: 01-06-TL-SYR-472-007U1111-1183-0302
• Study Type: interventional
• Target: 369
• Locations: 12 countries
• Sites: 87

Brief Summary

The purpose of this study is to determine the efficacy, safety and tolerability of SYR-472, once daily (QD), in subjects with Type 2 Diabetes Mellitus.

Conditions

Diabetes Mellitus

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change from baseline in glycosylated hemoglobin

  Weeks 12 or Final Visit.

Secondary Outcomes (14)

• 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.

• 1,5-Anhydroglucitol

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

• Change in Proinsulin

  Weeks 4, 8, and 12 or Final Visit.

• Change in Proinsulin/insulin ratio

  Weeks 4, 8, and 12 or Final Visit.

Study Arms (5)

SYR-472 25 mg QD

EXPERIMENTAL

(with lifestyle modification and/or metformin therapy)

Drug: SYR-472

SYR-472 50 mg QD

EXPERIMENTAL

(with lifestyle modification and/or metformin therapy)

Drug: SYR-472

SYR-472 100 mg QD

EXPERIMENTAL

(with lifestyle modification and/or metformin therapy)

Drug: SYR-472

SYR-472 200 mg QD

EXPERIMENTAL

(with lifestyle modification and/or metformin therapy)

Drug: SYR-472

Placebo QD

PLACEBO COMPARATOR

(with lifestyle modification and/or metformin therapy)

Drug: Placebo

Interventions

SYR-472 DRUG

SYR-472 25 mg, tablets, orally, once daily and lifestyle modification and/or metformin for up to 12 weeks.

SYR-472 25 mg QD

Placebo DRUG

SYR-472 placebo-matching tablets, orally, once daily and lifestyle modification and/or metformin for up to 12 weeks.

Placebo 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:

• Has a historical diagnosis of type 2 diabetes mellitus.
• Has undergone less than 7 days of any antidiabetic therapy except lifestyle modification (diet/exercise) within 8 weeks prior to Screening; or has received metformin monotherapy for at least 8 weeks prior to Screening and maintained a stable daily dose of metformin for at least 12 weeks prior to randomization.
• The subject receiving metformin monotherapy at randomization must have been at least 75% compliant with his or her regimen during the Run-in/Stabilization Period as determined by subject diary and investigator assessment.
• Has received no treatment with antidiabetic agents other than metformin within the 8 weeks prior to Screening.
• Has a glycosylated hemoglobin concentration between 7.0% and 10.0%, inclusive, at Screening and at the Week -1 Visit.
• The subject's fasting C-peptide concentration is greater than or equal to 0.8 ng/mL.
• Has a fasting plasma glucose concentration less than 275 mg/dL.
• If regularly uses other non-excluded medications, must be on a stable dose for at least the 4 weeks prior to Screening.
• Has a systolic blood pressure reading less than 160 mm Hg and a diastolic pressure reading less than 100 mm Hg.
• Has a hemoglobin value greater than or equal to 12 g/dL for men and greater than or equal to 10 g/dL for women.
• Has an alanine aminotransferase level is less than or equal to 3 times the upper limit of normal.
• Males have a serum creatinine value less than 1.5 mg/dL; females have a serum creatinine value less than 1.4 mg/dL.
• Has a urine albumin/creatinine ratio less than 1000 μg/mg.
• Has a thyroid-stimulating hormone level less than or equal to the upper limit of the normal range and is clinically euthyroid.
• Females must be not be pregnant or lactating, and must agree to use adequate contraception throughout the duration of the study.

You may not qualify if:

• Is being concurrently treated with antidiabetic therapy other than metformin and lifestyle intervention.
• 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.
• Has a history of laser treatment for proliferative diabetic retinopathy within the 6 months prior to Screening.
• Has a history of treated diabetic gastric paresis.
• Has New York Heart Association class III or IV heart failure regardless of therapy.
• Has a history of coronary angioplasty, underwent coronary stent placement or coronary bypass surgery, or suffered a myocardial infarction, or stroke within the 6 months prior to Screening.
• Has a history of any hemoglobinopathy that may affect determination of glycosylated hemoglobin.
• Has a history of infection with human immunodeficiency virus.
• Has a history of a psychiatric disorder that in the investigator's opinion will affect the subject's ability to participate in the study.
• Has ingested or received systemically injected glucocorticoids within the 3 months prior to randomization. Inhaled corticosteroids are allowed.
• Has used prescription or over-the-counter weight-loss drugs within the 3 months prior to randomization.
• Has received any investigational drug within the 30 days prior to Screening or has received an investigational antidiabetic drug within the 3 months prior to Screening.
• Has received previous treatment in an investigational study of SYR-472.
• Has a known hypersensitivity to any compound related to SYR-472.

Sponsors & Collaborators

• Takeda: lead

Study Sites (87)

Unknown Facility

Birmingham, Alabama, United States

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Mobile, Alabama, United States

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Montgomery, Alabama, United States

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Pell City, Alabama, United States

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Tallassee, Alabama, United States

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Sierra Vista, Arizona, United States

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Fountain Valley, California, United States

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Los Angeles, California, United States

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National City, California, United States

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Pismo Beach, California, United States

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Clearwater, Florida, United States

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North Miami Beach, Florida, United States

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Ocoee, Florida, United States

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Orlando, Florida, United States

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Plantation, Florida, United States

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Dawsonville, Georgia, United States

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Gainesville, Georgia, United States

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Naperville, Illinois, United States

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Elkhart, Indiana, United States

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Indianapolis, Indiana, United States

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Slidell, Louisiana, United States

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Taunton, Massachusetts, United States

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Ann Arbor, Michigan, United States

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Great Falls, Montana, United States

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Scottsbluff, Nebraska, United States

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Las Vegas, Nevada, United States

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Brooklyn, New York, United States

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Charlotte, North Carolina, United States

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Shelby, North Carolina, United States

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Sparta, North Carolina, United States

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Fargo, North Dakota, United States

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Bensalem, Ohio, United States

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Dayton, Ohio, United States

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Kettering, Ohio, United States

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Central Point, Oregon, United States

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Altoona, Pennsylvania, United States

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Providence, Rhode Island, United States

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Clemson, South Carolina, United States

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Columbia, South Carolina, United States

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Greer, South Carolina, United States

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Rapid City, South Dakota, United States

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Cleveland, Tennessee, United States

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Kingsport, Tennessee, United States

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Arlington, Texas, United States

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Fort Worth, Texas, United States

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North Richland Hills, Texas, United States

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San Antonio, Texas, United States

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Spring, Texas, United States

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Sugarland, Texas, United States

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Hampton, Virginia, United States

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Richmond, Virginia, United States

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Santiago, Chile

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Temuco, Chile

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Ostrava, Czechia

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Prague, Czechia

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Guatemala City, Guatemala

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Quetzaltenango, Guatemala

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Eger, Hungary

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Szentes, Hungary

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Riga, Latvia

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Sigulda, Latvia

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Valmiera, Latvia

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Kaunas, Lithuania

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Kėdainiai, Lithuania

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Klaipėda, Lithuania

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Vilnius, Lithuania

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Ponce, Puerto Rico

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Alba Iulia, Romania

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Baia Mare, Romania

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Bihor, Romania

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Brasov, Romania

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Bucharest, Romania

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Constanța, Romania

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Ploieşti, Romania

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Satu Mare, Romania

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Târgovişte, Romania

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Kemerovo, Russia

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Moscow, Russia

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Saint Petersburg, Russia

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Ufa, Russia

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Volgograd, Russia

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Yaroslavl, Russia

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Banská Bystrica, Slovakia

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Bratislava, Slovakia

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Prešov, Slovakia

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Kharkiv, Ukraine

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Vinnytsia, Ukraine

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MeSH Terms

Conditions

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

Interventions

trelagliptin

Condition Hierarchy (Ancestors)

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

Study Officials

• Medical Director

  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: April 1, 2008
• First Posted: April 4, 2008
• Study Start: May 1, 2007
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: June 22, 2016

Record last verified: 2016-06

Locations

RU (6); US (51); HU (2); LA (3); RO (9); LI (4); CL (2); CZ (2); SL (3); GU (2); PR (1); UA (2)