A Study to Evaluate Safety, Tolerability and P-Glucose After Multiple Ascending Oral Doses of AZD1656 in Type 2 Diabetes

Phase 1

Completed

• Conditions: Type 2 Diabetes
• Interventions: Drug: AZD1656

• Registration Number: NCT00747175
• Lead Sponsor: AstraZeneca

Brief Summary

The purpose of this study is to assess safety and tolerability of AZD1656 after multiple repeated oral doses in patients with type 2 diabetes

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2008-09-03
• Study First Submitted QC: 2008-09-03
• Study First Posted: 2008-09-04
• Primary Completion: 2009-04
• Study Completion: 2009-04
• Status Verified: 2010-12
• Last Update Submitted: 2010-12-02
• Last Update Posted: 2010-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

• Male or surgically sterile female of non-childbearing potential (post-menopausal, ie natural or induced menopause with last menstruation >1 year ago and LH and FSH in the post-menopausal range, and/or have undergone hysterectomy and/or bilateral oophorectomy
• Diagnosed diabetes Mellitus patients treated with diet and exercise alone or with up to two oral anti-diabetic drugs. Stable glycemic control indicated by no changed treatment within 3 months prior to enrollment
• HbA1c ≤10.5 % at screening (HbA1c value according to international DCCT standard)

Read More

Exclusion Criteria

• Clinically significant illness or clinically relevant trauma, as judged by the investigator, within two weeks before the first administration of the IP
• History ischemic heart disease, stroke, transitorisk ischemic attack or symptomatic peripheral vascular disease
• Clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results. Positive test of Hepatitis B surface antigen, antibodies to HIV virus and antibodies to Hepatitis C virus

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
1	AZD1656	3 (alt.4) gradually increasing repeated oral doses of AZD1656 given to 3 (alt.4) groups (6 on active and 2 on placebo in each group)
2	AZD1656	Oral dose of AZD1656 titrated during 3 days to a tolerable dose (15 on active and 5 on placebo)

Primary Outcome Measures

Name	Time	Method
Safety variables (AE, BP, pulse, plasma glucose, laboratory variables and ECG)	Blood samples taken repeatedly during 24 hours on study day sessions

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic variables	Blood samples taken repeatedly during 24 hours on study day sessions
Pharmacodynamic variables	Blood samples taken repeatedly during 24 hours on study day sessions

Trial Locations

Locations (1)

Research Site; 🇺🇸 Chula Vista, California, United States