Long-term Study of Alogliptin as an Add-on to Rapid-Acting Insulin Secretagogues in Type 2 Diabetes
NCT01456130 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 67
Last updated 2014-04-21
Summary
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.
Conditions
Interventions
- DRUG
-
Alogliptin
Alogliptin tablets
- 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
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Medical Director, Clinical Science · Takeda
Study Design
- Allocation
- NA
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 20 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2011-11-30
- Primary Completion
- 2013-03-31
- Completion
- 2013-03-31
Countries
- Japan
Study Locations
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