To Evaluate Safety and Tolerability After Multiple Oral Doses of AZD1656 in Type 2 Diabetes Patients on Top of Insulin

• Sponsor: AstraZeneca (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00768105
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arms: 2
• Duration (Months): 5.9
• Patients Per Site Per Month: 4

Study Details

Study Description

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 on top of insulin.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes	Drug: AZD1656; Drug: Placebo	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: A Randomized, Single-Blind, Placebo-Controlled, Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Multiple Ascending Oral Doses of AZD1656 in Subjects With T2DM Treated With Insulin
• Study Start Date: Sep 1, 2008
• Actual Primary Completion Date: Mar 1, 2009
• Actual Study Completion Date: Mar 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: AZD1656; Dose titration of oral suspension to a tolerable dose in 2-3 dose steps. Investigational product given twice daily for eight days.
Placebo Comparator: 2	Drug: Placebo; Dosing to match AZD1656

Outcome Measures

Primary Outcome Measures

1. Safety variables (AE, BP, pulse, weight, plasma glucose, laboratory variables and ECG) [Blood samples taken repeatedly during 24 hours on study day sessions]

Secondary Outcome Measures

1. Pharmacokinetic variables [Blood samples taken repeatedly during 24 hours on study day sessions]

2. Pharmacodynamic variables [Blood samples taken repeatedly during 24 hours on study day sessions]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Female with non child-bearing potential

• Diagnosed Diabetes Mellitus patients treated with insulin alone or insulin in combination with other anti-diabetic drugs. Stable blood sugar control indicated by no changed treatment within 3 months prior to study start.

• HbA1c below or equal to 11 % 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 of ischemic heart disease, stroke, transitorisk ischemic attack or symptomatic peripheral vascular disease

• Clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Chula Vista	California	United States

Sponsors and Collaborators

• AstraZeneca

Investigators

• Study Director: Klas Malmberg, MD, PhD, AstraZeneca R&D Mölndal
• Principal Investigator: Marcus Hompesch, MD, Profil Institut for Clinical Research Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00768105
• Other Study ID Numbers: D1020C00014
• First Posted: Oct 7, 2008
• Last Update Posted: Dec 3, 2010
• Last Verified: Dec 1, 2010

• Keywords provided by , ,: Type 2 diabetes
• Additional relevant MeSH terms: Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Dec 3, 2010