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Investigate the Effect of AZD1656 on the Pharmacokinetics of Sitagliptin in Patients With Type 2 Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT01095991
Recruitment Status : Completed
First Posted : March 30, 2010
Last Update Posted : July 1, 2010
Sponsor:
Information provided by:
AstraZeneca

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: AZD1656 Drug: Sitagliptin Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : March 2010
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1
AZD1656, day 1-5, AZD1656 + Sitagliptin day 6-10, Sitagliptin day 11-15.
Drug: AZD1656
Oral tablet bd,

Drug: Sitagliptin
Oral tablet od
Other Name: Januvia

Experimental: 2
Sitagliptin day 1-5, AZD1656 + Sitagliptin day 6-10, AZD1656 day 11-15.
Drug: AZD1656
Oral tablet bd,

Drug: Sitagliptin
Oral tablet od
Other Name: Januvia




Primary Outcome Measures :
  1. To evaluate the effect of AZD1656 on the steady-state PK of sitagliptin and vice versa by assessment of AUC0-24 and Cmax [ Time Frame: Serial PK sampling will be done on Days 5, 10 and 15 ]

Secondary Outcome Measures :
  1. 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 [ Time Frame: Serial PK sampling will be done on Days 5, 10 and 15 ]
  2. 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 [ Time Frame: Serial PK sampling will be done on Days 5, 10 and 15 ]
  3. 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. [ Time Frame: 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. ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Intake of another investigational drug within the last 30 days prior to enrolment.
  • Clinically significant illness or clinically relevant trauma.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01095991


Locations
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Germany
Research Site
Neuss, Germany
Sponsors and Collaborators
AstraZeneca
Investigators
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Study Director: Stanko Skrtic AstraZeneca Molndal Sweden
Principal Investigator: Christoph Kapitza Profil Institut für Stoffwechselforschung GmbH
Study Director: Mirjana Kujacic AstraZeneca Molndal Sweden

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Responsible Party: MSD, AstraZeneca
ClinicalTrials.gov Identifier: NCT01095991     History of Changes
Other Study ID Numbers: D1020C00032
First Posted: March 30, 2010    Key Record Dates
Last Update Posted: July 1, 2010
Last Verified: June 2010

Keywords provided by AstraZeneca:
Type 2 Diabetes Mellitus, Sitagliptin

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sitagliptin Phosphate
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action