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

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00747175

Purpose

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

Condition	Intervention	Phase
Type 2 Diabetes	Drug: AZD1656	Phase I

MedlinePlus related topics: Diabetes

Drug Information available for: Dextrose

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Factorial Assignment, Safety/Efficacy Study
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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Safety variables (AE, BP, pulse, plasma glucose, laboratory variables and ECG) [ Time Frame: Blood samples taken repeatedly during 24 hours on study day sessions ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Pharmacokinetic variables [ Time Frame: Blood samples taken repeatedly during 24 hours on study day sessions ] [ Designated as safety issue: No ]
Pharmacodynamic variables [ Time Frame: Blood samples taken repeatedly during 24 hours on study day sessions ] [ Designated as safety issue: No ]

Estimated Enrollment:	52
Study Start Date:	September 2008
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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)	Drug: AZD1656 Dose titration to 3 (alt 4) increasing dose-steps with oral suspension, 8 days treatment
2: Experimental Oral dose of AZD1656 titrated during 3 days to a tolerable dose (15 on active and 5 on placebo)	Drug: AZD1656 Dose titration of oral suspension to a tolerable dose, 1 month treatment

Eligibility

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00747175

Contacts

Contact: Profil Institute for Clinical Research Inc.	1-619-409-1244
Contact: AstraZeneca Clinical Study Information	800-236-9933	information.center@astrazeneca.com

Locations

United States, California
Research Site	Recruiting
Chula Vista, California, United States

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:	Klas Malmberg, MD, Phd, Prof	AstraZeneca R&D Mölndal, SE-431 83 Mölndal, Sweden
Principal Investigator:	Marcus Hompesch, MD	Profil Institute for Clinical Research Inc.

More Information

Responsible Party:	AstraZeneca Pharmaceuticals ( Klas Malmberg, MD, PhD, Prof. Medical Science Director, Emerging Products )
Study ID Numbers:	D1020C00002
Study First Received:	September 3, 2008
Last Updated:	September 8, 2008
ClinicalTrials.gov Identifier:	NCT00747175
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

Type 2 diabetes

Study placed in the following topic categories:

Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on January 14, 2009