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

Type 2 Diabetes Clinical Trial

— MAD  

Official title:

A Randomized, Single-Blind, Placebo-Controlled, Single-Centre, Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Multiple Ascending Oral Doses of AZD1656 in T2DM Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00747175
• Other study ID #: D1020C00002
• Status: Completed
• Phase: Phase 1
• First received: September 3, 2008
• Last updated: December 2, 2010
• Start date: August 2008
• Est. completion date: April 2009

Study information

• Verified date: December 2010
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 75 Years

Eligibility

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)

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• AZD1656
Dose titration to 3 (alt 4) increasing dose-steps with oral suspension, 8 days treatment
• AZD1656
Dose titration of oral suspension to a tolerable dose, 1 month treatment

Locations

Country	Name	City	State
United States	Research Site	Chula Vista	California

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety variables (AE, BP, pulse, plasma glucose, laboratory variables and ECG)		Blood samples taken repeatedly during 24 hours on study day sessions	Yes
Secondary	Pharmacokinetic variables		Blood samples taken repeatedly during 24 hours on study day sessions	No
Secondary	Pharmacodynamic variables		Blood samples taken repeatedly during 24 hours on study day sessions	No