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Completed

NCT Number: NCT00690287

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

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site, Linköping, Sweden

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AZD6370

Drug

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

Placebo

Drug

Placebo

Primary outcomes

  1. Pharmacodynamic variables

    Time frame: Blood samples taken repeatedly during 24 hours on study day sessions

Secondary outcomes

  1. Safety variables

    Time frame: Blood samples taken repeatedly during 24 hours on study day sessions

  2. Pharmacokinetic variables

    Time frame: Blood samples taken repeatedly during 24 hours on study day sessions

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Jun 4, 2008
Registry last updated
Jan 11, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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