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
1 other identifier
interventional
24
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 type-2-diabetes
Started Feb 2008
Shorter than P25 for phase_1 type-2-diabetes
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 2, 2008
CompletedFirst Posted
Study publicly available on registry
June 4, 2008
CompletedJanuary 11, 2012
January 1, 2012
4 months
June 2, 2008
January 10, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pharmacodynamic variables
Blood samples taken repeatedly during 24 hours on study day sessions
Secondary Outcomes (2)
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
Study Arms (4)
Part A, arm 1
EXPERIMENTAL1\) 8 pats: AZD6370 increasing oral single doses a+b+c+placebo together with food
Part A, arm 2
EXPERIMENTAL1\) 8 pats: AZD6370 increasing oral single doses a+b+c+placebo without food
Part B, arm1, 2, and 3
EXPERIMENTAL1. AZD6370 dose x mg o.d. 2. dose x/2 mg b.i.d. 3. dose x/4 mg q.i.d.
Part B, arm 4
EXPERIMENTAL4\) Placebo
Interventions
Eligibility Criteria
You may qualify if:
- Treated with diet or metformin. Stable glycemic control indicated by no changed treatment within 3 months
- Diabetes Mellitus diagnosis \<5 years
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (3)
Research Site
Linköping, Sweden
Research Site
Luleå, Sweden
Research Site
Uppsala, Sweden
Related Publications (1)
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.
PMID: 23010558DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Klas Malmberg, MD, PhD, Prof.
AstraZeneca R&D Mölndal, SE-431 83 Mölndal, Sweden
- PRINCIPAL INVESTIGATOR
Wolfgang Kühn, MD
Quintiles AB, Phase I Services, Strandbodgatan 1, SE-753 23 Uppsala, Sweden
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 2, 2008
First Posted
June 4, 2008
Study Start
February 1, 2008
Primary Completion
June 1, 2008
Study Completion
June 1, 2008
Last Updated
January 11, 2012
Record last verified: 2012-01