A Phase 2 Study of OPC-262 in Patients With Type 2 Diabetes

Diabetes, Type 2 Clinical Trial

Official title:

A Phase 2 Study of OPC-262 in Patients With Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00857558
• Other study ID #: 262-08-001
• Secondary ID: JapicCTI-090697
• Status: Completed
• Phase: Phase 2
• First received: March 4, 2009
• Last updated: March 7, 2017
• Start date: January 2009
• Est. completion date: May 2010

Study information

• Verified date: March 2017
• Source: Kyowa Hakko Kirin Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A multicenter, randomized, double-blind, placebo-controlled, group-comparison study to investigate the safety and efficacy of OPC-262 in patients with type 2 diabetes

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: May 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

Inclusion Criteria:

• Type 2 diabetes patients with HbA1c above 7.0% and below 10%

• Patients who are capable of giving informed consent

• Patients who are able to take contraceptive measures to avoid pregnancy of the patient or the patient's partner

Exclusion Criteria:

• Patients with type1 diabetes mellitus, patients with diabetes mellitus or impaired glucose tolerance (IGT) due to other specified mechanism or diseases, and patients with gestational diabetes mellitus

• Patients with a medical history of diabetes coma

• Patients with poorly-controlled hypertension

• Patients with heart failure

• Patients with a complication of active hepatitis or hepatic cirrhosis

• Patients undergoing treatment of glomeruler diseases other than diabetic nephropathy

• Patients with a history or complication of malignant tumor

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetes, Type 2

Intervention

Drug:
• saxagliptin
orally administration at 1 mg once a day for 12 weeks
• saxagliptin
orally administration at 2.5 mg once a day for 12 weeks
• saxagliptin
orally administration at 5 mg once a day for 12 weeks
• placebo
orally administration once a day for 12 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kyowa Hakko Kirin Co., Ltd

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes in HbA1C from baseline		2w, 4w, 8w, 12w, 16w
Secondary	values and changes in HbA1c form baseline		2w, 4w, 8w, 12w, 16w
Secondary	values and changes in fasting blood glucose (FSB) from baseline		2w, 4w, 8w, 12w, 16w
Secondary	adverse event		at any time