A Clinical Pharmacology Study of Saxagliptin in Patients With Type 2 Diabetes Mellitus
NCT ID: NCT01162876
Last Updated: 2017-03-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
20 participants
INTERVENTIONAL
2010-07-31
2010-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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saxagliptin
5 mg daily for 14days
saxaglipitin
oral administration of 5 mg tablet before breakfast for 14 consecutive days
Interventions
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saxaglipitin
oral administration of 5 mg tablet before breakfast for 14 consecutive days
Eligibility Criteria
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Inclusion Criteria
1. HbA1c level ≥7.0% and \< 9.0%
2. Fasting glucose level ≥130mg/dL and \<210mg/dL
3. Patients who are capable of giving informed consent
4. Patients who are able to take contraceptive measures to avoid pregnancy of the patient or the patient's partner for the entire study period and for 4 weeks after completion of the study
Exclusion Criteria
* Patients with a medical history of diabetic coma
* Patients with heart failure
* Patients with a complication of active chronic hepatitis or hepatic cirrhosis
* Patients undergoing treatment of glomerular diseases other than diabetic nephropathy
* Patients with a history or complication of malignant tumor
20 Years
65 Years
ALL
No
Sponsors
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Kyowa Kirin Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Kyushu Clinical Pharmacology Reserch Clinic
Fukuoka, , Japan
Countries
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Other Identifiers
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JapicCTI-101190
Identifier Type: OTHER
Identifier Source: secondary_id
262-09-003
Identifier Type: -
Identifier Source: org_study_id
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