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Long-term Safety Study of Alogliptin Used in Combination With Sulfonylurea or Metformin in Participants With Type 2 Diabetes in Japan

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT01318135
First received: March 16, 2011
Last updated: July 7, 2012
Last verified: July 2012
  Purpose
To evaluate the efficacy and safety of alogliptin administered as an add-on to sulfonylurea (glimepiride) or metformin, once daily (QD), twice daily (BID) or three times daily (TID).

Condition Intervention Phase
Type 2 Diabetes Mellitus Drug: Alogliptin and glimepiride Drug: Alogliptin and metformin Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Long-term, Open-label Extension Study to Investigate the Long-term Safety of Alogliptin When Used in Combination With Sulfonylurea or Metformin in Subjects With Type 2 Diabetes in Japan

Resource links provided by NLM:


Further study details as provided by Takeda:

Primary Outcome Measures:
  • Number of Participants With Adverse Events. [ Time Frame: 52 Weeks. ]
    Treatment-emergent adverse events (TEAE) are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug. A TEAE may also be a pretreatment adverse event or a concurrent medical condition diagnosed prior to the date of first dose of study drug that increases in severity after the start of dosing.


Secondary Outcome Measures:
  • Change From Baseline in Glycosylated Hemoglobin (Week 8). [ Time Frame: Baseline and Week 8. ]
    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 week 8 and glycosylated hemoglobin collected at baseline.

  • Change From Baseline in Glycosylated Hemoglobin (Week 12). [ Time Frame: Baseline and Week 12. ]
    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 week 12 and glycosylated hemoglobin collected at baseline.

  • Change From Baseline in Glycosylated Hemoglobin (Week 16). [ Time Frame: Baseline and Week 16. ]
    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 week 16 and glycosylated hemoglobin collected at baseline.

  • Change From Baseline in Glycosylated Hemoglobin (Week 20). [ Time Frame: Baseline and Week 20. ]
    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 week 20 and glycosylated hemoglobin collected at baseline.

  • Change From Baseline in Glycosylated Hemoglobin (Week 24). [ Time Frame: Baseline and Week 24. ]
    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 week 24 and glycosylated hemoglobin collected at baseline.

  • Change From Baseline in Glycosylated Hemoglobin (Week 28). [ Time Frame: Baseline and Week 28. ]
    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 week 28 and glycosylated hemoglobin collected at baseline.

  • Change From Baseline in Glycosylated Hemoglobin (Week 32). [ Time Frame: Baseline and Week 32. ]
    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 week 32 and glycosylated hemoglobin collected at baseline.

  • Change From Baseline in Glycosylated Hemoglobin (Week 36). [ Time Frame: Baseline and Week 36. ]
    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 week 36 and glycosylated hemoglobin collected at baseline.

  • Change From Baseline in Glycosylated Hemoglobin (Week 40). [ Time Frame: Baseline and Week 40. ]
    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 week 40 and glycosylated hemoglobin collected at baseline.

  • Change From Baseline in Glycosylated Hemoglobin (Week 44). [ Time Frame: Baseline and Week 44. ]
    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 week 44 and glycosylated hemoglobin collected at baseline.

  • Change From Baseline in Glycosylated Hemoglobin (Week 48). [ Time Frame: Baseline and Week 48. ]
    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 week 48 and glycosylated hemoglobin collected at baseline.

  • Change From Baseline in Glycosylated Hemoglobin (Week 52). [ Time Frame: Baseline and Week 52. ]
    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 week 52 and glycosylated hemoglobin collected at baseline.

  • Change From Baseline in Glycosylated Hemoglobin (Final Visit). [ Time Frame: Baseline and Final Visit (up to 52). ]
    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 final visit and glycosylated hemoglobin collected at baseline.

  • Change From Baseline in Fasting Blood Glucose (Week 8). [ Time Frame: Baseline and Week 8. ]
    The change between the value of fasting blood glucose collected at week 8 and baseline.

  • Change From Baseline in Fasting Blood Glucose (Week 12). [ Time Frame: Baseline and Week 12. ]
    The change between the value of fasting blood glucose collected at week 12 and baseline.

  • Change From Baseline in Fasting Blood Glucose (Week 16). [ Time Frame: Baseline and Week 16. ]
    The change between the value of fasting blood glucose collected at week 6 and baseline.

  • Change From Baseline in Fasting Blood Glucose (Week 20). [ Time Frame: Baseline and Week 20. ]
    The change between the value of fasting blood glucose collected at week 20 and baseline.

  • Change From Baseline in Fasting Blood Glucose (Week 24). [ Time Frame: Baseline and Week 24. ]
    The change between the value of fasting blood glucose collected at week 24 and baseline.

  • Change From Baseline in Fasting Blood Glucose (Week 28). [ Time Frame: Baseline and Week 28. ]
    The change between the value of fasting blood glucose collected at week 28 and baseline.

  • Change From Baseline in Fasting Blood Glucose (Week 32). [ Time Frame: Baseline and Week 32. ]
    The change between the value of fasting blood glucose collected at week 32 and baseline.

  • Change From Baseline in Fasting Blood Glucose (Week 36). [ Time Frame: Baseline and Week 36. ]
    The change between the value of fasting blood glucose collected at week 36 and baseline.

  • Change From Baseline in Fasting Blood Glucose (Week 40). [ Time Frame: Baseline and Week 40. ]
    The change between the value of fasting blood glucose collected at week 40 and baseline.

  • Change From Baseline in Fasting Blood Glucose (Week 44). [ Time Frame: Baseline and Week 44. ]
    The change between the value of fasting blood glucose collected at week 44 and baseline.

  • Change From Baseline in Fasting Blood Glucose (Week 48). [ Time Frame: Baseline and Week 48. ]
    The change between the value of fasting blood glucose collected at week 48 and baseline.

  • Change From Baseline in Fasting Blood Glucose (Week 52). [ Time Frame: Baseline and Week 52. ]
    The change between the value of fasting blood glucose collected at week 52 and baseline.

  • Change From Baseline in Fasting Blood Glucose (Final Visit). [ Time Frame: Baseline and Final Visit (up to Week 52). ]
    The change between the value of fasting blood glucose collected at final visit and baseline.

  • Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 12). [ Time Frame: Baseline and Week 12. ]
    The change between the value of blood glucose measured by the meal tolerance test collected at week 12 and blood glucose measured by the meal tolerance test collected at baseline. Meal tolerance test measures blood glucose through blood samples drawn before a meal and at 2 hours after the start of the meal.

  • Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 24). [ Time Frame: Baseline and Week 24. ]
    The change between the value of blood glucose measured by the meal tolerance test collected at week 24 and blood glucose measured by the meal tolerance test collected at baseline. Meal tolerance test measures blood glucose through blood samples drawn before a meal and at 2 hours after the start of the meal.

  • Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 52). [ Time Frame: Baseline and Week 52. ]
    The change between the value of blood glucose measured by the meal tolerance test collected at week 52 and blood glucose measured by the meal tolerance test collected at baseline. Meal tolerance test measures blood glucose through blood samples drawn before a meal and at 2 hours after the start of the meal.

  • Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Final Visit). [ Time Frame: Baseline and Final Visit (up to Week 52). ]
    The change between the value of blood glucose measured by the meal tolerance test collected at final visit and blood glucose measured by the meal tolerance test collected at baseline. Meal tolerance test measures blood glucose through blood samples drawn before a meal and at 2 hours after the start of the meal.


Enrollment: 576
Study Start Date: January 2009
Study Completion Date: April 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID Drug: Alogliptin and glimepiride
Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
Other Names:
  • SYR-322
  • Amaryl
Active Comparator: Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID Drug: Alogliptin and glimepiride
Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
Other Names:
  • SYR-322
  • Amaryl
Active Comparator: Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID Drug: Alogliptin and metformin
Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
Other Names:
  • SYR-322
  • Glycoran
Active Comparator: Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID Drug: Alogliptin and metformin
Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
Other Names:
  • SYR-322
  • Glycoran

Detailed Description:

Both insulin hyposecretion and insulin-resistance are considered to be involved in the development of type 2 diabetes mellitus.

Takeda is developing SYR-322 (alogliptin) for the improvement of glycemic control in patients with type 2 diabetes mellitus. Alogliptin is an inhibitor of the dipeptidyl peptidase IV (DPP-IV) enzyme. DPP-IV is thought to be primarily responsible for the degradation of 2 peptide hormones released in response to nutrient ingestion. It is expected that inhibition of DPP-IV will improve glycemic control in patients with type 2 diabetes.

This was a phase 2/3, multicenter, open-label study, in participants who had completed the core phase 2/3 sulfonylurea add-on study (SYR-322/CCT-005; NCT01318083) or the core phase 2/3 metformin add-on study (SYR-322/CCT-006; NCT01318109) to evaluate the safety and efficacy of alogliptin administered as an add-on to a sulfonylurea (glimepiride) or metformin continuously for 40 weeks (52 weeks from the start of study treatment with alogliptin in the core phase 2/3 sulfonylurea add-on study or the core phase 2/3 metformin add-on study).

  Eligibility

Ages Eligible for Study:   20 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Common criteria that applied to participants completing both the core phase 2/3 sulfonylurea add-on study and those completing the core phase 2/3 metformin add-on study:

  1. Had completed the core phase 2/3 sulfonylurea add-on study or the core phase 2/3 metformin add-on study.
  2. Was capable of understanding and complying with protocol requirements.
  3. Signed a written informed consent form prior to the initiation of any study procedure.

Exclusion Criteria:

Common criteria that applied to participants completing both the core phase 2/3 sulfonylurea add-on study and those completing the core phase 2/3 metformin add-on study:

  1. With clinical manifestation of hepatic impairment (eg, an aspartate aminotransferase or alanine aminotransferase value of 2.5 times or more of the upper reference limit at Week 8 of the core phase 2/3 sulfonylurea add-on study or the core phase 2/3 metformin add-on study).
  2. With clinical manifestation of renal impairment (eg, a creatinine value of 1.5 times or more of the upper reference limit at Week 8 of the core phase 2/3 sulfonylurea add-on study or the core phase 2/3 metformin add-on study).
  3. With serious cardiac disease, cerebrovascular disorder, or serious pancreatic or hematological disease (eg, a subject who requires hospital admission).

Criteria that applied only to participants completing the core phase 2/3 metformin add-on study:

1. With history or symptoms of lactic acidosis.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01318135

Sponsors and Collaborators
Takeda
Investigators
Study Director: Professor, Diabetes and Endocrine Division Department of Medicine, Kawasaki Medical School
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01318135     History of Changes
Other Study ID Numbers: SYR-322/OCT-005
JapicCTI-090902 ( Registry Identifier: JapicCTI )
U1111-1119-6196 ( Registry Identifier: WHO )
Study First Received: March 16, 2011
Results First Received: June 8, 2011
Last Updated: July 7, 2012

Keywords provided by Takeda:
Diabetes Mellitus - Type 2
Diabetes Mellitus
Drug Therapy

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glimepiride
Alogliptin
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Immunosuppressive Agents
Immunologic Factors
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 26, 2017