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

Phase 1

Terminated

• Conditions: Type 2 Diabetes
• Interventions: Drug: AZD6714; Drug: Placebo

• Registration Number: NCT00886366
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-04-17
• Study First Submitted QC: 2009-04-21
• Study First Posted: 2009-04-22
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Status Verified: 2010-12
• Last Update Submitted: 2010-12-06
• Last Update Posted: 2010-12-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 26

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Research Site; 🇸🇪 Goteborg, Sweden