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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
History of Changes
  Purpose

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 Intervention Phase
Type 2 Diabetes
 Drug: AZD6370
Drug: Placebo
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Pharmacodynamic variables [ Time Frame: Blood samples taken repeatedly during 24 hours on study day sessions ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 24
Study Start Date: February 2008
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
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

  Eligibility

Ages Eligible for Study:   30 Years to 65 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided by AstraZeneca

Additional 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
Study First Received: June 2, 2008
Last Updated: January 10, 2012
Health Authority: Sweden: Medical Products Agency

Keywords provided by AstraZeneca:
Type 2 diabetes

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

ClinicalTrials.gov processed this record on June 18, 2013