Expired Study
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San Antonio, Texas


Purpose:

The purpose of this study is to assess the 1 month safety and tolerability after multiple oral doses of AZD1656 in patients with Type 2 Diabetes Mellitus Treated with Metformin


Criteria:

Inclusion Criteria: - Male or women of non-childbearing potential (postmenopausal, and/or have undergone hysterectomy and/or bilateral oophorectomy or salpingectomy/ tubal ligation) - Ongoing treatment with metformin on a stable dose of ≥ 1500 mg/day for at least 8 weeks prior to randomisation - HbA1c ≤ 10% at enrolment (HbA1c value according to international Diabetes Control and Complications Trial [DCCT] standard) Exclusion Criteria: - History of ischemic heart disease, symptomatic heart failure, stroke, transitory ischemic attack or symptomatic peripheral vascular disease - Clinically significant abnormalities in ECG, clinical chemistry, haematology, or urine analysis results. Positive test for Hepatitis B surface antigen or antibodies to human immunodeficiency virus (HIV) or antibodies to Hepatitis C virus


Study is Available At:


Original ID:

D1020C00019


NCT ID:

NCT00817778


Secondary ID:


Study Acronym:


Brief Title:

Study to Assess the Safety and Tolerability After Multiple Oral Doses of AZD1656 in Patients With Type 2 Diabetes Mellitus Treated With Metformin


Official Title:

A Randomised, Single-Blind, Placebo-Controlled, Phase IIA Study to Assess the Safety and Tolerability After Multiple Oral Doses of AZD1656 in Patients With Type 2 Diabetes Mellitus Treated With Metformin


Overall Status:

Completed


Study Phase:

Phase 2


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:

20


Enrollment Type:

Anticipated


Overall Contact Information

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

Study Dates

Start Date:January 2009
Completion Date:July 2009
Completion Type:Actual
Verification Date:July 2009
Last Changed Date:July 27, 2009
First Received Date:January 5, 2009

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Pharmacodynamic variables (P-Glucose, S-Insulin and S-C-peptide)
Time Frame:24 hour monitoring during specific days during the study period
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Pharmacokinetic variables (Area under the plasma conc vs. time curve (AUC), maximum plasma conc (Cmax), Plasma conc immediately before the next dose (Ctrough), time to reach maximum plasma conc, terminal elimination half-life and apparent oral clearance
Time Frame:One blood sample for analysis of plasma concentrations of AZD1656 taken on several days during the t
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Safety variables (AE, BP, pulse, plasma glucose, laboratory variables, weight and ECG)
Time Frame:Frequent measurements during the study period
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:AZD1656
Description:Dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
Arm Name:1
Intervention Type:Drug
Name:Placebo
Description:Dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
Arm Name:2

Study Arms

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

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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