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Completed

NCT Number: NCT01318135

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

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).

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:

  • Had completed the core phase 2/3 sulfonylurea add-on study or the core phase 2/3 metformin add-on study.
  • Was capable of understanding and complying with protocol requirements.
  • 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:

  • 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).
  • 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).
  • 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:

  • With history or symptoms of lactic acidosis.

Treatment and study plan

Alogliptin and glimepiride

Drug

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

Alogliptin and Metformin

Drug

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

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. 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.

  21. 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.

  22. 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.

  23. 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.

  24. 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.

  25. 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.

  26. 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.

  27. 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.

  28. 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.

  29. 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.

  30. 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.

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Mar 18, 2011
Registry last updated
Aug 16, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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