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
No
Study drug
AZD6370, Placebo
Sex
All
Actual Enrollment
24
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
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| 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 |
Contacts
Investigators
Principal Investigator
Klas Malmberg
AstraZeneca R&D Mölndal, SE-431 83 Mölndal, Sweden
