A Study to Evaluate P-Glucose, Safety and Tolerability After Oral Single Dosing of AZD6370 in Type 2 Diabetic Patients

Type 2 Diabetes Clinical Trial

Official title:

A Dose-Ranging Study to Evaluate Fasting and Postprandial P-Glucose, Safety and Tolerability After Oral Single, B.I.D and Q.I.D Dosing of AZD6370 in Patients With Diabetes Mellitus: a Randomized, Single-Blind, Placebo-Controlled, Phase I Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00690287
• Other study ID #: D0280C00014
• Status: Completed
• Phase: Phase 1
• First received: June 2, 2008
• Last updated: January 10, 2012
• Start date: February 2008
• Est. completion date: June 2008

Study information

• Verified date: January 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the effect of AZD6370 on blood sugar and to study safety and tolerability in patients with type 2 diabetes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 65 Years

Eligibility

Inclusion Criteria:

• Treated with diet or metformin. Stable glycemic control indicated by no changed treatment within 3 months

• Diabetes Mellitus diagnosis <5 years

Exclusion Criteria:

• Clinically significant illness or clinically relevant trauma, as judged by the investigator, within two weeks before the first administration of the investigational product

• Clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• AZD6370
Oral single doses a+b+c, o.d., suspension
• AZD6370
Oral single dose, o.d., b.i.d. and q.i.d., suspension
• Placebo
Placebo

Locations

Country	Name	City	State
Sweden	Research Site	Linköping
Sweden	Research Site	Luleå
Sweden	Research Site	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacodynamic variables		Blood samples taken repeatedly during 24 hours on study day sessions	Yes
Secondary	Safety variables		Blood samples taken repeatedly during 24 hours on study day sessions	Yes
Secondary	Pharmacokinetic variables		Blood samples taken repeatedly during 24 hours on study day sessions	No