Investigate the Effect of AZD1656 on the Pharmacokinetics of Sitagliptin in Patients With Type 2 Diabetes Mellitus
A Randomised, Open, Phase I Study in Patients With Type 2 Diabetes Mellitus Treated With Metformin to Evaluate the Effect of AZD1656 on the Pharmacokinetics of Sitagliptin and Vice Versa
1 other identifier
interventional
12
1 country
1
Brief Summary
The purpose of this study is to evaluate the effects of AZD1656 on Sitagliptin pharmacokinetics and vice versa in patients with Type 2 Diabetes Mellitus.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 type-2-diabetes-mellitus
Started Mar 2010
Shorter than P25 for phase_1 type-2-diabetes-mellitus
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2010
CompletedFirst Submitted
Initial submission to the registry
March 29, 2010
CompletedFirst Posted
Study publicly available on registry
March 30, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2010
CompletedJuly 1, 2010
June 1, 2010
2 months
March 29, 2010
June 30, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To evaluate the effect of AZD1656 on the steady-state PK of sitagliptin and vice versa by assessment of AUC0-24 and Cmax
Serial PK sampling will be done on Days 5, 10 and 15
Secondary Outcomes (3)
To evaluate the effect of AZD1656 on the steady-state PK of sitagliptin and vice versa by assessment of tmax, t1/2 and CL/F
Serial PK sampling will be done on Days 5, 10 and 15
To evaluate the PK of the AZD1656 and its metabolite when AZD1656 is administered with and without sitagliptin by assessment of AUC0-24, Cmax, tmax and t1/2
Serial PK sampling will be done on Days 5, 10 and 15
To evaluate the safety of AZD1656 with and without sitagliptin by assessment of adverse events (AEs), physical examination, electrocardiogram (ECG), pulse, blood pressure (BP), weight and FPG.
Paper ECG (days 1,2,3,6,7,8,11,16), BP/pulse preentry, every residential day. Weight, physical examination preentry and follow-up. FPG on preentry, day 1,6 and 11.
Study Arms (2)
1
EXPERIMENTALAZD1656, day 1-5, AZD1656 + Sitagliptin day 6-10, Sitagliptin day 11-15.
2
EXPERIMENTALSitagliptin day 1-5, AZD1656 + Sitagliptin day 6-10, AZD1656 day 11-15.
Interventions
Eligibility Criteria
You may qualify if:
- Patients with confirmed type 2 diabetes mellitus for at least 2 months and treated with metformin.
- Body mass index between ≥19 and ≤42 kg/m2.
You may not qualify if:
- Intake of another investigational drug within the last 30 days prior to enrolment.
- Clinically significant illness or clinically relevant trauma.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (1)
Research Site
Neuss, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Stanko Skrtic
AstraZeneca Molndal Sweden
- PRINCIPAL INVESTIGATOR
Christoph Kapitza
Profil Institut für Stoffwechselforschung GmbH
- STUDY DIRECTOR
Mirjana Kujacic
AstraZeneca Molndal Sweden
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 29, 2010
First Posted
March 30, 2010
Study Start
March 1, 2010
Primary Completion
May 1, 2010
Study Completion
May 1, 2010
Last Updated
July 1, 2010
Record last verified: 2010-06