Long-term Study of Alogliptin as an Add-on to Rapid-Acting Insulin Secretagogues in Type 2 Diabetes
The purpose of this study is to evaluate the safety and efficacy of alogliptin as an add-on to a rapid-acting insulin secretagogue (medicine that stimulates insulin release) in type 2 diabetic patients with inadequate blood glucose control despite treatment with a rapid-acting insulin secretagogue as well as diet and exercise therapies.
Drug: Rapid-acting insulin secretagogue
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||A Long-Term, Open-Label Study to Investigate the Long-Term Safety of SYR-322 When Used in Combination With Rapid-Acting Insulin Secretagogues in Subjects With Type 2 Diabetes in Japan|
- Number of Participants With Treatment Emergent Adverse Events (TEAEs) [ Time Frame: 52 Weeks ] [ Designated as safety issue: Yes ]An TEAE is any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have a causal relationship with this treatment. A serious TEAE is defined as any untoward medical occurrence that resulted in death, was life threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability or incapacity, led to a congenital anomaly/birth defect or was an important medical event that may have required intervention to prevent any of items above.
- Change From Baseline in Glycosylated Hemoglobin (HbA1c) [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]The change in the value of glycosylated hemoglobin collected at Week 52 or at the final visit relative to Baseline.
- Percentage of Participants With a Clinical Response [ Time Frame: Week 52 ] [ Designated as safety issue: No ]Clinical response is defined as an HbA1c level less than 5.8% or less than 6.5% at Week 52 or at the final visit.
- Change From Baseline in Fasting Glucose [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]The change in the value of fasting glucose collected at Week 52 or the final visit relative to Baseline.
|Study Start Date:||November 2011|
|Study Completion Date:||March 2013|
|Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
Alogliptin 25 mg (or 12.5 mg for participants with moderate renal dysfunction) tablets, orally once daily and a rapid-acting insulin secretagogue as prescribed by the Investigator for up to 52 weeks.
Other Names:Drug: Rapid-acting insulin secretagogue
Either of the following commercially available rapid-acting insulin secretagogues as prescribed by the Investigator: (i) Nateglinide: Dose: 30 mg tablet or 90 mg tablet (ii) Mitiglinide calcium hydrate: Dose: 5 mg tablet or 10 mg tablet
One alogliptin 25 mg tablet was orally administered once daily before breakfast for up to 52 weeks.
The dose of alogliptin was adjusted according to the severity of the participant's renal dysfunction based on serum creatinine (SCr) levels. Participants with moderate renal dysfunction (SCr, >1.4 - ≤2.4 mg/dL for men and >1.2 - ≤ 2.0 mg/dL for women) received alogliptin 12.5 mg tablets.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01456130
|Nagoya-shi, Aichi, Japan|
|Fukuoka-shi, Fukuoka, Japan|
|Kurume-shi, Fukuoka, Japan|
|Sapporo-shi, Hokkaido, Japan|
|Kobe-shi, Hyogo, Japan|
|Kagoshima-shi, Kagoshima, Japan|
|Kumamoto-shi, Kumamoto, Japan|
|Osaki-shi, Miyagi, Japan|
|Minou-shi, Osaka, Japan|
|Osaka-shi, Osaka, Japan|
|Kamio-shi, Saitama, Japan|
|Koshigaya-shi, Saitama, Japan|
|Adachi-ku, Tokyo, Japan|
|Chuo-ku, Tokyo, Japan|
|Study Director:||Medical Director, Clinical Science||Takeda|