Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00690287
First received: June 2, 2008
Last updated: January 10, 2012
Last verified: January 2012

June 2, 2008
January 10, 2012
February 2008
June 2008   (final data collection date for primary outcome measure)
Pharmacodynamic variables [ Time Frame: Blood samples taken repeatedly during 24 hours on study day sessions ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00690287 on ClinicalTrials.gov Archive Site
  • Safety variables [ Time Frame: Blood samples taken repeatedly during 24 hours on study day sessions ] [ Designated as safety issue: Yes ]
  • Pharmacokinetic variables [ Time Frame: Blood samples taken repeatedly during 24 hours on study day sessions ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Type 2 Diabetes
  • Drug: AZD6370
    Oral single doses a+b+c, o.d., suspension
  • Drug: AZD6370
    Oral single dose, o.d., b.i.d. and q.i.d., suspension
  • Drug: Placebo
    Placebo
  • Experimental: Part A, arm 1
    1) 8 pats: AZD6370 increasing oral single doses a+b+c+placebo together with food
    Intervention: Drug: AZD6370
  • Experimental: Part A, arm 2
    1) 8 pats: AZD6370 increasing oral single doses a+b+c+placebo without food
    Intervention: Drug: AZD6370
  • 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.
    Intervention: Drug: AZD6370
  • Experimental: Part B, arm 4
    4) Placebo
    Intervention: Drug: Placebo
Ericsson H, Sjöberg 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
June 2008
June 2008   (final data collection date for primary outcome measure)

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
Both
30 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT00690287
D0280C00014
No
AstraZeneca
AstraZeneca
Not Provided
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
AstraZeneca
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP