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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00886366
• Date of registration: 17/04/2009
• Prospective Registration: No
• Primary sponsor: AstraZeneca
• Public title: Single Ascending Dose Study With Healthy Male Volunteers and Type II Diabetic Patients
• Scientific 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
• Date of first enrolment: April 2009
• Target sample size: 26
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT00886366
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

Sweden

Contacts

• Name: Klas Malmberg, MD, PhD
• Affiliation: AstraZeneca R&D Mölndal

• Name: Marianne Hartford
• Affiliation: CPU Sahlgrenska University Hospital

Key inclusion & exclusion 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.



Age minimum: 20 Years
Age maximum: 40 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Type 2 Diabetes

Intervention(s)

Drug: Placebo

Drug: AZD6714

Primary Outcome(s)

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(s)

Pharmacokinetic variables [Time Frame: Blood samples taken repeatedly during 24 hours on study day sessions.]

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

Secondary ID(s)

D1920C00001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors