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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00995787
First received: October 14, 2009
Last updated: February 25, 2010
Last verified: February 2010
  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:


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

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 April 17, 2014