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

Phase 1

Completed

• Conditions: Type 2 Diabetes
• Interventions: Drug: AZD6370; Drug: Placebo

• Registration Number: NCT00690287
• Lead Sponsor: AstraZeneca

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Study First Submitted: 2008-06-02
• Study First Submitted QC: 2008-06-03
• Study First Posted: 2008-06-04
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-10
• Last Update Posted: 2012-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Treated with diet or metformin. Stable glycemic control indicated by no changed treatment within 3 months
• Diabetes Mellitus diagnosis <5 years

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Part A, arm 1	AZD6370	1) 8 pats: AZD6370 increasing oral single doses a+b+c+placebo together with food
Part A, arm 2	AZD6370	1) 8 pats: AZD6370 increasing oral single doses a+b+c+placebo without food
Part B, arm1, 2, and 3	AZD6370	1. AZD6370 dose x mg o.d. 2. dose x/2 mg b.i.d. 3. dose x/4 mg q.i.d.
Part B, arm 4	Placebo	4) Placebo

Primary Outcome Measures

Name	Time	Method
Pharmacodynamic variables	Blood samples taken repeatedly during 24 hours on study day sessions

Secondary Outcome Measures

Name	Time	Method
Safety variables	Blood samples taken repeatedly during 24 hours on study day sessions
Pharmacokinetic variables	Blood samples taken repeatedly during 24 hours on study day sessions

Trial Locations

Locations (1)

Research Site; 🇸🇪 Uppsala, Sweden