A study to evaluate P-Glucose, safety and tolerability after oral single dosing of AZD6370 in type 2 diabetic patients

Study identifier:D0280C00014

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

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

Medical condition

Type 2 Diabetes

Phase

Phase 1

Healthy volunteers

Study drug

AZD6370, Placebo

Sex

All

Actual Enrollment

Study type

Interventional

Age

30 Years - 65 Years

Date

Study Start Date: 01 Feb 2008

Primary Completion Date: 01 Jun 2008

Study Completion Date: 01 Jun 2008

Study design

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

Verification:

Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals

Collaborators

Inclusion and exclusion criteria

Location

Research Site

Uppsala, Sweden

Location

Research Site

Linköping, Sweden

Location

Research Site

Luleå, Sweden

Arms	Assigned Interventions
Experimental: Part A, arm 1 1) 8 pats: AZD6370 increasing oral single doses a+b+c+placebo together with food	Drug: AZD6370 Oral single doses a+b+c, o.d., suspension
Experimental: Part A, arm 2 1) 8 pats: AZD6370 increasing oral single doses a+b+c+placebo without food	Drug: AZD6370 Oral single doses a+b+c, o.d., suspension
Experimental: 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.	Drug: AZD6370 Oral single dose, o.d., b.i.d. and q.i.d., suspension
Experimental: Part B, arm 4 4) Placebo	Drug: Placebo Placebo

"There is no result for the study"

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=1635&filename=CSR-D0280C00014.pdf
Download
CSR-D0280C00014.pdf
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information

800-236-9933

information.center@astrazeneca.com

Investigators

Principal Investigator

Klas Malmberg

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

A study to evaluate P-Glucose, safety and tolerability after oral single dosing of AZD6370 in type 2 diabetic patients

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Research Site

Research Site

Research Site

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=1635&filename=CSR-D0280C00014.pdf

CSR-D0280C00014.pdf

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator