Safety and Efficacy Study of Alogliptin on Glycemic Control in Subjects With Type 2 Diabetes.

NCT00755846 | Completed Phase 2 Results

• 2 other identifiers: SYR-322-003U1111-1113-8352
• Study Type: interventional
• Target: 265
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to determine the safety and efficacy of alogliptin, once daily (QD), compared to diet and exercise, sulfonylurea, metformin and a combination of sulfonylurea and metformin for treating subjects with type 2 diabetes.

Conditions

Diabetes Mellitus

Keywords

Diabetes Mellitus; Drug Therapy; Diabetes Mellitus, Type II; Type 2 Diabetes Mellitus; Hyperinsulinism; Insulin Resistance

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Day 85.

  The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at day 85 or final visit and glycosylated hemoglobin collected at baseline.

  Baseline and Day 85.

Secondary Outcomes (14)

• Change From Baseline in Glycosylated Hemoglobin at Day 43.

  Baseline and Day 43.

• Change From Baseline in Fasting Plasma Glucose (Day 43).

  Baseline and Day 43

• Change From Baseline in Fasting Plasma Glucose (Day 85).

  Baseline and Day 85.

• Change From Baseline in Fasting Fructosamine (Day 43).

  Baseline and Day 43.

• Change From Baseline in Fasting Fructosamine (Day 85).

  Baseline and Day 85.

Study Arms (6)

Alogliptin 6.25 mg QD

EXPERIMENTAL

Drug: Alogliptin

Alogliptin 12.5 mg QD

EXPERIMENTAL

Drug: Alogliptin

Alogliptin 25 mg QD

EXPERIMENTAL

Drug: Alogliptin

Alogliptin 50 mg QD

EXPERIMENTAL

Drug: Alogliptin

Alogliptin 100 mg QD

EXPERIMENTAL

Drug: Alogliptin

Placebo QD

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Alogliptin DRUG

Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks

Also known as: SYR-322, SYR110322

Alogliptin 6.25 mg QD

Placebo DRUG

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

Placebo QD

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Takeda: lead

Related Publications (1)

• Pratley RE, McCall T, Fleck PR, Wilson CA, Mekki Q. Alogliptin use in elderly people: a pooled analysis from phase 2 and 3 studies. J Am Geriatr Soc. 2009 Nov;57(11):2011-9. doi: 10.1111/j.1532-5415.2009.02484.x. Epub 2009 Sep 30.

  PMID: 19793357 RESULT

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2; Hyperinsulinism; Insulin Resistance

Interventions

alogliptin

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Sr. VP, Clinical Science
• Organization: Takeda Global Research and Development Center, Inc.

clinicaltrialregistry@tpna.com

800-778-2860

Study Officials

• VP Biological Sciences

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

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 17, 2008
• First Posted: September 19, 2008
• Study Start: March 1, 2005
• Primary Completion: October 1, 2005
• Study Completion: October 1, 2005
• Last Updated: February 3, 2012
• Results First Posted: August 29, 2011

Record last verified: 2012-02