Clinical trial NCT00995787: Safety and Tolerability of AZD1656 in Type 2 Diabetes Mellitus (T2DM) Patients Treated With Metformin and Sulfonylurea
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type II Diabetes Mellitus
Keywords: Type II diabetes mellitus
metformin
sulfonylurea
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-10-15
Enrollment: 75
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Safety variables (AE, BP, pulse, plasma glucose, laboratory variables, weight and ECG
timeFrame: 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:
measure: 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)
timeFrame: 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.
measure: Pharmacodynamic variables: 24 h plasma glucose, Insulin
timeFrame: Samples for 24-hour plasma glucose and insulin will be collected on study days -1, 6 and 9.
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Research Site
state: California
Study officials:
affiliation: AstraZeneca R&D Mölndal, SE-431 83 Mölndal, Sweden
name: Klas Malmberg, MD, PhD
role: STUDY_DIRECTOR
affiliation: Profil Institute for Clinical Research Inc.855 3rd Avenue, Suite 4400Chula VistaCA 91911, USA
name: Marcus Dr. Marcus Hompesch, Dr
role: PRINCIPAL_INVESTIGATOR
References: