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

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT00747175

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

6.5

Patients Per Site Per Month

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

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

52 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

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

Study Start Date :

Aug 1, 2008

Actual Primary Completion Date :

Apr 1, 2009

Actual Study Completion Date :

Apr 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 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
Experimental: 2 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

Arm

Intervention/Treatment

Experimental: 1

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

Experimental: 2

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

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00747175

Other Study ID Numbers:

D1020C00002

First Posted:

Sep 4, 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