Safety and Tolerability of AZD1656 in Type 2 Diabetes Mellitus (T2DM) Patients Treated With Metformin and Sulfonylurea - Full Text View

Purpose

The primary aim of this study is to evaluate the safety and tolerability of AZD1656 in T2DM patients treated with metformin and sulfonylurea.

Condition	Intervention	Phase
Type II Diabetes Mellitus	Drug: AZD1656 Drug: Placebo	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	A Randomized, Single-blind, Placebo-controlled, Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD1656 Compared to Placebo in T2DM Patients Treated With Metformin and Sulfonylurea

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 2

Drug Information available for: Metformin Metformin hydrochloride

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Safety variables (AE, BP, pulse, plasma glucose, laboratory variables, weight and ECG [ Time Frame: AE will be collected from the time for randomisation until follow-up visit. Safety variables and vital signs will be measured at the pre-entry, during study days -2 to 10 and at the follow-up visit. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Pharmacokinetic variables: (Area under the plasma concentration vs. time curve (AUC), maximum plasma concentration (Cmax), time to reach maximum plasma concentration (tmax), terminal elimination half-life (t½) and apparent oral clearance (CL/F) [ Time Frame: Blood samples for analysis of plasma concentrations of AZD1656 will be collected on study days 6 and 9. The samples for analysis of glipizide will be collected on study days -1 and 6. ] [ Designated as safety issue: No ]
Pharmacodynamic variables: 24 h plasma glucose, Insulin [ Time Frame: Samples for 24-hour plasma glucose and insulin will be collected on study days -1, 6 and 9. ] [ Designated as safety issue: No ]

Enrollment:	75
Study Start Date:	October 2009
Study Completion Date:	February 2010
Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: AZD1656	Drug: AZD1656 Dose titration of oral suspension of AZD165 during 3 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 6 days
Placebo Comparator: Placebo	Drug: Placebo Dose titration of oral suspension of placebo during 3 days given twice daily. Subjects will thereafter be for another 6 days

Eligibility

Criteria

Inclusion Criteria:

Male or females of non-childbearing potential
Patients treated with a combination of Metformin and SU (glyburide, glimepiride, glibenclamide, glipizide or gliclazide) in stable doses for at least 2 months prior to enrolment visit
Patients should have FPG in the range of 6,0 to 14 mmol/L (108 to 250 mg/dL) at enrolment and on the morning of randomisation

Exclusion Criteria:

History of ischemic heart disease, symptomatic heart failure, stroke, transitory ischemic attack or symptomatic peripheral vascular disease
Impaired renal function in terms of GFR<60 ml/min
Use of insulin, glitazones, gemfibrozil, warfarin, amiodarone within 3 months prior to enrolment (screening) and use of potent CYP450 inhibitors, e.g., ketoconazole within 14 days before randomisation

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00995787

Locations

United States, California
Research Site
San Diego, California, United States

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:	Klas Malmberg, MD, PhD	AstraZeneca R&D Mölndal, SE-431 83 Mölndal, Sweden
Principal Investigator:	Marcus Dr. Marcus Hompesch, Dr	Profil Institute for Clinical Research Inc.855 3rd Avenue, Suite 4400Chula VistaCA 91911, USA

More Information

No publications provided

Responsible Party:	MSD, AstraZeneca
ClinicalTrials.gov Identifier:	NCT00995787 History of Changes
Other Study ID Numbers:	D1020C00026
Study First Received:	October 14, 2009
Last Updated:	February 25, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

Type II diabetes mellitus
metformin
sulfonylurea

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013