A Clinical Pharmacology Study of Saxagliptin in Patients With Type 2 Diabetes Mellitus

Phase 3

Completed

• Conditions: Diabetes
• Interventions: Drug: saxaglipitin

• Registration Number: NCT01162876
• Lead Sponsor: Kyowa Kirin Co., Ltd.

Brief Summary

The purpose of this study is to evaluate the pharmacokinetics and pharmacodynamics of saxagliptin administered before breakfast for 14 consecutive days in patients with type 2 diabetes mellitus.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-07-12
• Study First Submitted QC: 2010-07-14
• Study First Posted: 2010-07-15
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-07
• Last Update Posted: 2017-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Patients who meet all of the following criteria will be included:

  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 type 1 diabetes mellitus; patients with diabetes mellitus due to other specified drugs, mechanisms, or diseases; and patients with gestational diabetes mellitus
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
saxagliptin	saxaglipitin	5 mg daily for 14days

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics	daily, up to 42days	Concentrations of plasma saxagliptin and BMS-510849
Pharmacodynamics	daily, up to 42 days	Plasma DPP4 actyivity Concentrations of blood glucose, C-peptide, insulin and glucagon Plasma active GLP-1 concentration

Secondary Outcome Measures

Name	Time	Method
Safety issues	daily, up to 42 days	Adverse events, skin symptom findings, blood pressure and pulse rate, body temperature, body weight, hypoglycemic symptoms, 12-lead ECG, clinical laboratory tests, and pregnancy test (in women of childbearing potential only)

Trial Locations

Locations (1)

Kyushu Clinical Pharmacology Reserch Clinic; 🇯🇵 Fukuoka, Japan