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Efficacy and Safety of Alogliptin Plus Metformin in Patients With Type 2 Diabetes

Information source: Takeda
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diabetes Mellitus, Type 2

Intervention: Alogliptin (Drug); Metformin (Drug); Alogliptin Placebo (Drug); Metformin Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Takeda

Official(s) and/or principal investigator(s):
Vice President, Clinical Science, Study Director, Affiliation: Takeda

Summary

The purpose of this study is to evaluate the safety and effectiveness of alogliptin combined with metformin, once daily (QD) or twice daily (BID), in participants with Type 2 Diabetes.

Clinical Details

Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of Alogliptin Plus Metformin, Alogliptin Alone, or Metformin Alone in Subjects With Type 2 Diabetes

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26

Secondary outcome:

Change From Baseline in HbA1c Over Time

Change From Baseline in Fasting Plasma Glucose Over Time

Detailed description: There are approximately 19 million people in the United States who have been diagnosed with diabetes mellitus, of which 90% to 95% are type 2. The prevalence of type 2 diabetes varies among racial and ethnic populations and has been shown to correlate with age, obesity, family history, history of gestational diabetes and physical inactivity. Over the next decade, a marked increase in the number of adults with diabetes mellitus is expected. Metformin is the usual choice of first-line therapy for type 2 diabetes. Metformin targets insulin resistance in type 2 diabetes by inhibiting hepatic glucose production and stimulating glucose uptake in skeletal muscle and adipose tissue, which results in a long-term glucose-lowering effect. Alogliptin is an inhibitor of the dipeptidyl peptidase IV enzyme. Dipeptidyl peptidase-4 enzyme 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. Both peptides exert important effects on islet beta cells to stimulate glucose-dependent insulin secretion as well as regulating beta cell proliferation and cytoprotection. Glucagon-like peptide-1, but not glucose-dependent insulinotropic peptide, inhibits gastric emptying, glucagon secretion, and food intake. Glucose-dependent insulinotropic peptide has been shown to enhance insulin secretion by

direct interaction with a glucose-dependent insulinotropic peptide - specific receptor on

islet beta cells. The glucose-lowering actions of glucagon-like peptide-1, but not glucose-dependent insulinotropic peptide, are preserved in patients with type 2 diabetes mellitus. It is expected that inhibition of dipeptidyl peptidase IV will improve glycemic (glucose) control in patients with type 2 diabetes. Based on the potential, complimentary mechanisms of action of alogliptin and metformin, this study will compare the safety and efficacy of alogliptin and metformin (SYR-322MET) on improving glycemic control in patients with type 2 diabetes mellitus who are inadequately controlled by diet adjustment and exercise alone. Participants taking part in this study will receive dietary and exercise coaching, and will monitor their own blood glucose concentrations with a home glucose monitor. Participants will also be required to maintain a hypoglycemic diary throughout the course of the study. Participation in this study is expected to last up to 34 weeks.

Eligibility

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Has historical diagnosis of Type 2 Diabetes Mellitus.

- Has been treated with diet and exercise for at least 2 months prior to Screening, and

has a Glycosylated Hemoglobin concentration between 7. 5% and 10. 0%, inclusive at Screening.

- Has received less than 7 days of any antidiabetic medication within 2 months prior to

Screening.

- Body mass index greater than or equal to 23 kg/m^2 and less than or equal to 45

kg/m^2 (except for Asian or Asian-descendant subjects for whom the range is between 20 and 35 kg/ m^2, inclusive).

- Fasting C-peptide concentration greater than or equal to 0. 8 ng/mL.

- Regularly using other, non-excluded, medications must be on a stable dose for at

least the 4 weeks prior to Screening.

- Females of childbearing potential and males who are sexually active agree to

routinely use adequate contraception from Screening throughout the duration of the study.

- Able and willing to monitor their own blood glucose concentrations with a home

glucose monitor and complete patient diaries. Exclusion Criteria:

- Hemoglobin less than 12 g/dL for males and less than 10 g/dL for females at Screening

Visit.

- Has a history of any hemoglobinopathy that may affect determination of Glycosylated

Hemoglobin.

- Has a history of laser treatment for proliferative diabetic retinopathy within the 6

months prior to Screening.

- Has a history of treatment for diabetic gastric paresis, gastric banding, or gastric

bypass surgery.

- Has a history of diabetic ketoacidosis or hyperosmolar non-ketotic coma.

- Has systolic blood pressure greater than or equal to 150 mmHg and /or diastolic

pressure greater than or equal to 90 mmHg at Screening visit.

- Has New York Heart Association Class III to IV heart failure.

- Has a history of coronary angioplasty, coronary stent placement, coronary bypass

surgery, or myocardial infarction within the 90 days prior to Screening.

- Has Alanine aminotransferase greater than 3 times the upper limit of normal at

Screening.

- Has a history of alcohol or substance abuse with the 2 years prior to Screening.

- Serum creatinine greater than or equal to 1. 5 mg/dL for males and greater than or

equal to 1. 4 mg/dL for females.

- Has 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 infection with human immunodeficiency virus, hepatitis B virus or

hepatitis C virus.

- Has any major illness or debility that in the investigator's opinion prohibits the

subject from completing the study.

- Has received any investigational drug within the 90 days prior to Screening.

- Has a history of hypersensitivity or allergy to alogliptin, other DPP-4 inhibitors,

metformin or related compounds.

- Has used oral or systematically injected glucocorticoids or weight loss drugs prior

to 2 months to screening.

Locations and Contacts

Hradec Kralove, Czech Republic

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Praha 10, Czech Republic

Zlin, Czech Republic

Znojmo, Czech Republic

Budaors, Hungary

Debrecen, Hungary

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Additional Information

Starting date: November 2009
Last updated: February 17, 2013

Page last updated: August 23, 2015

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