Study of Alogliptin Combined With Sulfonylurea in Subjects With Type 2 Diabetes Mellitus.
- Conditions
- Diabetes Mellitus
- Interventions
- Registration Number
- NCT00286468
- Lead Sponsor
- Takeda
- Brief Summary
The purpose of this study is to evaluate the efficacy and safety of alogliptin, once daily (QD), combined with a sulfonylurea in adults with type 2 diabetes mellitus.
- 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.
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 enzyme. Dipeptidyl peptidase 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 dipeptidyl peptidase IV will improve glycemic (glucose) control in patients with type 2 diabetes.
The aim of the current study is to evaluate the effectiveness of alogliptin in combination with a sulfonylurea in subjects who are inadequately controlled on a sulfonylurea alone. Individuals who participate in this study will be required to commit to a screening visit and up to 14 additional visits at the study center. Study participation is anticipated to be about 34 weeks (or 8.5 months).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 500
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Alogliptin 12.5 mg QD Alogliptin and glyburide - Alogliptin 25 mg QD Alogliptin and glyburide - Placebo Glyburide -
- Primary Outcome Measures
Name Time Method Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26. Baseline and Week 26. 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 26 or final visit and glycosylated hemoglobin collected at baseline.
- Secondary Outcome Measures
Name Time Method Change From Baseline in Insulin (Week 4). Baseline and Week 4. The change between the value of insulin collected at week 4 and insulin collected at baseline.
Change From Baseline in Glycosylated Hemoglobin (Week 4). Baseline and Week 4. 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 4 and Glycosylated Hemoglobin collected at baseline.
Change From Baseline in Glycosylated Hemoglobin (Week 8). 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). 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). 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). 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 Fasting Plasma Glucose (Week 1). Baseline and Week 1. The change between the value of fasting plasma glucose collected at final visit or week 1 and fasting plasma glucose collected at baseline.
Change From Baseline in Fasting Plasma Glucose (Week 2). Baseline and Week 2. The change between the value of fasting plasma glucose collected at week 2 and fasting plasma glucose collected at baseline.
Change From Baseline in Fasting Plasma Glucose (Week 4). Baseline and Week 4. The change between the value of fasting plasma glucose collected at week 4 and fasting plasma glucose collected at baseline.
Change From Baseline in Fasting Plasma Glucose (Week 8). Baseline and Week 8. The change between the value of fasting plasma glucose collected at week 8 and fasting plasma glucose collected at baseline.
Change From Baseline in Fasting Plasma Glucose (Week 12). Baseline and Week 12. The change between the value of fasting plasma glucose collected at week 12 and fasting plasma glucose collected at baseline.
Change From Baseline in Fasting Plasma Glucose (Week 16). Baseline and Week 16. The change between the value of fasting plasma glucose collected at week 16 and fasting plasma glucose collected at baseline.
Change From Baseline in Fasting Plasma Glucose (Week 20). Baseline and Week 20. The change between the value of fasting plasma glucose collected at week 20 and fasting plasma glucose collected at baseline.
Change From Baseline in Fasting Plasma Glucose (Week 26). Baseline and Week 26. The change between the value of fasting plasma glucose collected at week 26 or final visit and fasting plasma glucose collected at baseline.
Number of Participants With Marked Hyperglycemia (Fasting Plasma Glucose ≥ 200 mg Per dL). 26 Weeks. The number of participants with a fasting plasma glucose value greater than or equal to 200 mg per dL during the 26 week study.
Number of Participants Requiring Rescue. 26 Weeks. The number of participants requiring rescue for failing to achieve pre-specified glycemic targets during the 26 week study.
Change From Baseline in Fasting Proinsulin (Week 4). Baseline and Week 4. The change between the value of fasting proinsulin collected at week 4 and fasting proinsulin collected at baseline.
Change From Baseline in Fasting Proinsulin (Week 8). Baseline and Week 8. The change between the value of fasting proinsulin collected at week 8 and fasting proinsulin collected at baseline.
Change From Baseline in Fasting Proinsulin (Week 12). Baseline and Week 12. The change between the value of fasting proinsulin collected at week 12 and fasting proinsulin collected at baseline.
Change From Baseline in Fasting Proinsulin (Week 16). Baseline and Week 16. The change between the value of fasting proinsulin collected at week 16 and fasting proinsulin collected at baseline.
Change From Baseline in Fasting Proinsulin (Week 20). Baseline and Week 20. The change between the value of fasting proinsulin collected at week 20 and fasting proinsulin collected at baseline.
Change From Baseline in Fasting Proinsulin (Week 26). Baseline and Week 26. The change between the value of fasting proinsulin collected at week 26 or final visit and fasting proinsulin collected at baseline.
Change From Baseline in Insulin (Week 8). Baseline and Week 8. The change between the value of insulin collected at week 8 and insulin collected at baseline.
Change From Baseline in Insulin (Week 12). Baseline and Week 12. The change between the value of insulin collected at week 12 and insulin collected at baseline.
Change From Baseline in Insulin (Week 16). Baseline and Week 16. The change between the value of insulin collected at week 16 and insulin collected at baseline.
Change From Baseline in Insulin (Week 20). Baseline and Week 20. The change between the value of insulin collected at week 20 and insulin collected at baseline.
Change From Baseline in Insulin (Week 26). Baseline and Week 26. The change between the value of insulin collected at week 26 and insulin collected at baseline.
Change From Baseline in Proinsulin/Insulin Ratio (Week 4). Baseline and Week 4. The change between the ratio value of proinsulin and insulin collected at week 4 and the ratio value of proinsulin and insulin collected at baseline.
Change From Baseline in Proinsulin/Insulin Ratio (Week 8). Baseline and Week 8. The change between the ratio value of proinsulin and insulin collected at week 8 and the ratio value of proinsulin and insulin collected at baseline.
Change From Baseline in Proinsulin/Insulin Ratio (Week 12). Baseline and Week 12. The change between the ratio value of proinsulin and insulin collected at week 12 and the ratio value of proinsulin and insulin collected at baseline.
Change From Baseline in Proinsulin/Insulin Ratio (Week 16). Baseline and Week 16. The change between the ratio value of proinsulin and insulin collected at week 16 and the ratio value of proinsulin and insulin collected at baseline.
Change From Baseline in Proinsulin/Insulin Ratio (Week 20). Baseline and Week 20. The change between the ratio value of proinsulin and insulin collected at week 20 and the ratio value of proinsulin and insulin collected at baseline.
Change From Baseline in Proinsulin/Insulin Ratio (Week 26). Baseline and Week 26. The change between the ratio value of proinsulin and insulin collected at week 26 or final visit and the ratio value of proinsulin and insulin collected at baseline.
Change From Baseline in C-peptide (Week 4). Baseline and Week 4. The change between the value of C-peptide collected at week 4 and C-peptide collected at baseline.
Change From Baseline in C-peptide (Week 8). Baseline and Week 8. The change between the value of C-peptide collected at week 8 and C-peptide collected at baseline.
Change From Baseline in C-peptide (Week 12). Baseline and Week 12. The change between the value of C-peptide collected at week 12 and C-peptide collected at baseline.
Change From Baseline in C-peptide (Week 16). Baseline and Week 16. The change between the value of C-peptide collected at week 16 and C-peptide collected at baseline.
Change From Baseline in C-peptide (Week 20). Baseline and Week 20. The change between the value of C-peptide collected at week 20 and C-peptide collected at baseline.
Change From Baseline in C-peptide (Week 26). Baseline and Week 26. The change between the value of C-peptide collected at week 26 or final visit and C-peptide collected at baseline.
Number of Participants With Glycosylated Hemoglobin ≤ 6.5%. Baseline and Week 26. The number of participants with a value for the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) less than or equal to 6.5% during the 26 week study.
Number of Participants With Glycosylated Hemoglobin ≤ 7.0%. Baseline and Week 26. The number of participants with a value for the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) less than or equal to 7.0% during the 26 week study.
Number of Participants With Glycosylated Hemoglobin ≤ 7.5%. Baseline and Week 26. The number of participants with a value for the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) less than or equal to 7.5% during the 26 week study.
Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 0.5%. Baseline and Week 26. The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 0.5% during the 26 week study.
Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 1.0%. Baseline and Week 26. The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 1.0% during the 26 week study.
Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 1.5%. Baseline and Week 26. The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 1.5% during the 26 week study.
Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 2.0%. Baseline and Week 26. The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 2.0% during the 26 week study.
Change From Baseline in Body Weight (Week 8). Baseline and Week 8. The change between Body Weight measured at week 8 and Body Weight measured at baseline.
Change From Baseline in Body Weight (Week 12). Baseline and Week 12. The change between Body Weight measured at week 12 and Body Weight measured at baseline.
Change From Baseline in Body Weight (Week 20). Baseline and Week 20. The change between Body Weight measured at week 20 and Body Weight measured at baseline.
Change From Baseline in Body Weight (Week 26). Baseline and Week 26. The change between Body Weight measured at week 26 or final visit and Body Weight measured at baseline.