Expired Study
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Chula Vista, California


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 on top of insulin.


Criteria:

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.


Study is Available At:


Original ID:

D1020C00014


NCT ID:

NCT00768105


Secondary ID:


Study Acronym:


Brief Title:

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


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


Overall Status:

Completed


Study Phase:

Phase 1


Genders:

Both


Minimum Age:

30 Years


Maximum Age:

75 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

AstraZeneca


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

24


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Klas Malmberg, MD, PhD
Study Director
AstraZeneca R&D Mölndal

Study Dates

Start Date:September 2008
Completion Date:March 2009
Completion Type:Actual
Primary Completion Date:March 2009
Primary Completion Type:Actual
Verification Date:December 2010
Last Changed Date:December 2, 2010
First Received Date:October 6, 2008

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Pharmacodynamic variables
Time Frame:Blood samples taken repeatedly during 24 hours on study day sessions
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Pharmacokinetic variables
Time Frame:Blood samples taken repeatedly during 24 hours on study day sessions
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Safety variables (AE, BP, pulse, weight, plasma glucose, laboratory variables and ECG)
Time Frame:Blood samples taken repeatedly during 24 hours on study day sessions
Safety Issues:True

Study Interventions

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

Study Arms

Study Arm Type:Experimental
Arm Name:1
Study Arm Type:Placebo Comparator
Arm Name:2

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:AstraZeneca

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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