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

NCT00995787 | Completed Phase 1

• 1 other identifier: D1020C00026
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Type II Diabetes Mellitus

Keywords

Type II diabetes mellitus; metformin; sulfonylurea

Outcome Measures

Primary Outcomes (1)

• Safety variables (AE, BP, pulse, plasma glucose, laboratory variables, weight and ECG

  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.

Secondary Outcomes (2)

• 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)

  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.

• Pharmacodynamic variables: 24 h plasma glucose, Insulin

  Samples for 24-hour plasma glucose and insulin will be collected on study days -1, 6 and 9.

Study Arms (2)

AZD1656

EXPERIMENTAL

Drug: AZD1656

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

AZD1656 DRUG

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

AZD1656

Placebo DRUG

Dose titration of oral suspension of placebo during 3 days given twice daily. Subjects will thereafter be for another 6 days

Placebo

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

San Diego, California, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

AZD1656

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Klas Malmberg, MD, PhD

  AstraZeneca R&D Mölndal, SE-431 83 Mölndal, Sweden

  STUDY DIRECTOR

• Marcus Dr. Marcus Hompesch, Dr

  Profil Institute for Clinical Research Inc.855 3rd Avenue, Suite 4400Chula VistaCA 91911, USA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 14, 2009
• First Posted: October 15, 2009
• Study Start: October 1, 2009
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: February 26, 2010

Record last verified: 2010-02

Locations

US (1)