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Single Ascending Dose Study With Healthy Male Volunteers and Type II Diabetic Patients

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ClinicalTrials.gov Identifier: NCT00886366
Recruitment Status : Terminated (Part A reached a predefined stopping criteria. Relevant doses for part B could not be established based on A and subsequently study was stopped.)
First Posted : April 22, 2009
Last Update Posted : December 7, 2010
Sponsor:
Information provided by:
AstraZeneca

Brief Summary:
The purpose of this study is to assess safety and tolerability of AZD6714 after single ascending oral doses in healthy male subjects and type 2 diabetic patients.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Drug: AZD6714 Drug: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Randomised, Single-Blind, Placebo-Controlled, Single-Centre, Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food Interaction After Single Ascending Oral Doses of AZD6714 in Healthy Male Volunteers and Male Type II Diabetic Patients
Study Start Date : April 2009
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
AZD6714 in 8 increasing oral single doses a-h given to 8 groups (3 on active and 1 on placebo in each group)
Drug: AZD6714
Oral single doses a-h suspension
Drug: Placebo
Oral single doses suspension
Experimental: 2
2 oral single doses d and g suspensions of AZD6714 given to 2 groups (3+1) together with food
Drug: Placebo
Oral single doses suspension
Drug: AZD6714
Oral single doses d and g suspension
Experimental: 3
Two increasing oral doses of AZD6714 and one placebo given to 2 groups with 3 type 2 diabetic patients.
Drug: Placebo
Oral single doses suspension
Drug: AZD6714
Oral single doses a-d suspension



Primary Outcome Measures :
  1. Safety variables (AE, BP, pulse, plasma glucose, laboratory variables and ECG) [ Time Frame: AEs will be collected during the whole study period (1-3 months). The other variables will be measured repeatedly during 24 hours on the study day sessions ]

Secondary Outcome Measures :
  1. Pharmacokinetic variables [ Time Frame: Blood samples taken repeatedly during 24 hours on study day sessions. ]
  2. Pharmacodynamic variables (P-Glucose, S-Insulin and C-peptide) [ Time Frame: Blood samples taken repeatedly during 24 hours on study day sessions. ]


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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Part A,Healthy male subjects, aged between ≥20 and ≤40 years.
  • Part B,Male T2DM patients, aged between ≥20 and ≤65 years. Treatment with metformin as single therapy for T2DM for at least 30 days prior to enrollment

Exclusion Criteria:

  • Part A,Clin sign illness or clin relevant trauma, as judged by the investigator, within 2 weeks before the first administration of the IP.
  • Part A Clin sign abnormalities in clinical chemistry, haematology, or urinalysis results as judged by the investigator
  • Part B, History of ischemic heart disease, symptomatic heart failure, stroke, transitory ischemic attack or symptomatic peripheral vascular disease.
  • Any clinically significant abnormality identified on physical examination, laboratory tests or ECG, which in the judgment of the investigator would compromise the patient's safety or successful participation.

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): NCT00886366


Locations
Sweden
Research Site
Goteborg, Sweden
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Klas Malmberg, MD, PhD AstraZeneca R&D Mölndal
Principal Investigator: Marianne Hartford CPU Sahlgrenska University Hospital

Responsible Party: Klas Malmberg, MD, PhD, Prof. Medical Science Director, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00886366     History of Changes
Other Study ID Numbers: D1920C00001
First Posted: April 22, 2009    Key Record Dates
Last Update Posted: December 7, 2010
Last Verified: December 2010

Keywords provided by AstraZeneca:
Type II Diabetes