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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00690287

Enrollment

Registered

2008-06-04

Start date

2008-02-29

Completion date

2008-06-30

Last updated

2012-01-11

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 2 diabetes

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.

Interventions

DRUGAZD6370

Oral single doses a+b+c, o.d., suspension

DRUGPlacebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

30 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Pharmacodynamic variables	Blood samples taken repeatedly during 24 hours on study day sessions

Secondary

Measure	Time frame
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

Countries

Sweden

Outcome results

None listed

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