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
  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:


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 April 17, 2014