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

NCT ID: NCT00690287

Last Updated: 2012-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2008-06-30

Brief Summary

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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

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Conditions

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Type 2 Diabetes

Keywords

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Type 2 diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Part A, arm 1

1\) 8 pats: AZD6370 increasing oral single doses a+b+c+placebo together with food

Group Type EXPERIMENTAL

AZD6370

Intervention Type DRUG

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

Part A, arm 2

1\) 8 pats: AZD6370 increasing oral single doses a+b+c+placebo without food

Group Type EXPERIMENTAL

AZD6370

Intervention Type DRUG

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

Part B, arm1, 2, and 3

1. AZD6370 dose x mg o.d.
2. dose x/2 mg b.i.d.
3. dose x/4 mg q.i.d.

Group Type EXPERIMENTAL

AZD6370

Intervention Type DRUG

Oral single dose, o.d., b.i.d. and q.i.d., suspension

Part B, arm 4

4\) Placebo

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Placebo

Interventions

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AZD6370

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

Intervention Type DRUG

AZD6370

Oral single dose, o.d., b.i.d. and q.i.d., suspension

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Klas Malmberg, MD, PhD, Prof.

Role: STUDY_DIRECTOR

AstraZeneca R&D Mölndal, SE-431 83 Mölndal, Sweden

Wolfgang Kühn, MD

Role: PRINCIPAL_INVESTIGATOR

Quintiles AB, Phase I Services, Strandbodgatan 1, SE-753 23 Uppsala, Sweden

Locations

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Research Site

Linköping, , Sweden

Site Status

Research Site

Luleå, , Sweden

Site Status

Research Site

Uppsala, , Sweden

Site Status

Countries

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Sweden

References

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Ericsson H, Sjoberg F, Heijer M, Dorani H, Johansson P, Wollbratt M, Norjavaara E. The glucokinase activator AZD6370 decreases fasting and postprandial glucose in type 2 diabetes mellitus patients with effects influenced by dosing regimen and food. Diabetes Res Clin Pract. 2012 Dec;98(3):436-44. doi: 10.1016/j.diabres.2012.09.025. Epub 2012 Sep 23.

Reference Type DERIVED
PMID: 23010558 (View on PubMed)

Other Identifiers

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D0280C00014

Identifier Type: -

Identifier Source: org_study_id