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

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ClinicalTrials.gov Identifier: NCT00690287
Recruitment Status : Completed
First Posted : June 4, 2008
Last Update Posted : January 11, 2012
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Drug: AZD6370 Drug: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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
Study Start Date : February 2008
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Pharmacodynamic variables [ Time Frame: Blood samples taken repeatedly during 24 hours on study day sessions ]

Secondary Outcome Measures :
  1. Safety variables [ Time Frame: Blood samples taken repeatedly during 24 hours on study day sessions ]
  2. Pharmacokinetic variables [ Time Frame: Blood samples taken repeatedly during 24 hours on study day sessions ]


Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00690287


Locations
Sweden
Research Site
Linköping, Sweden
Research Site
Luleå, Sweden
Research Site
Uppsala, Sweden
Sponsors and Collaborators
AstraZeneca
Investigators
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00690287     History of Changes
Other Study ID Numbers: D0280C00014
First Posted: June 4, 2008    Key Record Dates
Last Update Posted: January 11, 2012
Last Verified: January 2012

Keywords provided by AstraZeneca:
Type 2 diabetes

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases