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

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

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00886366

Enrollment

Registered

2009-04-22

Start date

2009-04-30

Completion date

2009-09-30

Last updated

2010-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Keywords

Type II Diabetes

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.

Interventions

DRUGAZD6714

Oral single doses a-h suspension

DRUGPlacebo

Oral single doses suspension

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

20 Years to 40 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Safety variables (AE, BP, pulse, plasma glucose, laboratory variables and ECG)	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

Measure	Time frame
Pharmacokinetic variables	Blood samples taken repeatedly during 24 hours on study day sessions.
Pharmacodynamic variables (P-Glucose, S-Insulin and C-peptide)	Blood samples taken repeatedly during 24 hours on study day sessions.

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026