To Evaluate Safety and Tolerability After Multiple Oral Doses of AZD1656 in Type 2 Diabetes Patients on Top of Metformin
This study has been completed.
Sponsor:
AstraZeneca
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00774553
First received: October 16, 2008
Last updated: January 14, 2010
Last verified: January 2010
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Purpose
The purpose of this study is to assess safety and tolerablility of AZD1656 after multiple repeated oral doses in patients with type 2 diabetes on top of metformin.
| Condition | Intervention | Phase |
|---|---|---|
|
Type 2 Diabetes |
Drug: AZD1656 Drug: Placebo |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Randomized, Single-Blind, Placebo-Controlled, Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Multiple Ascending Oral Doses of AZD1656 in Subjects With T2DM Treated With Metformin |
Resource links provided by NLM:
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- Safety variables (AE, BP, pulse, plasma glucose, laboratory variables, weight and ECG) [ Time Frame: Blood samples taken repeatedly during 24 hours on study day sessions ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Pharmacokinetic variables [ Time Frame: Blood samples taken repeatedly during 24 hours on study day sessions ] [ Designated as safety issue: No ]
- Pharmacodynamic variables [ Time Frame: Blood samples taken repeatedly during 24 hours on study day sessions ] [ Designated as safety issue: No ]
| Enrollment: | 70 |
| Study Start Date: | October 2008 |
| Study Completion Date: | January 2010 |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
AZD1656
|
Drug: AZD1656
Dose titration of oral suspension to a tolerable dose given twice daily for 10 days.
|
|
Placebo Comparator: 2
Placebo
|
Drug: Placebo
Dose titration of oral suspension to a tolerable dose given twice daily for 10 days.
|
Eligibility| Ages Eligible for Study: | 30 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Male or female (with non child-bearing potential)
- Diagnosed diabetes Mellitus patients treated with metformin alone or one other anti-diabetic drugs. Stable blood sugar control indicated by no changed treatment within 3 months prior to study start.t
- HbA1c <11 % at screening (HbA1c value according to international DCCT standard)
Exclusion Criteria:
- Clinically significant illness or clinically relevant trauma, as judged by the investigator, within two weeks before the first administration of the IP
- History of ischemic heart disease, stroke, transitorisk ischemic attack or symptomatic peripheral vascular disease
- Clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00774553
Locations
| United States, Texas | |
| Research Site | |
| San Antonio, Texas, United States | |
| India | |
| Research site | |
| Ahmedabad, India | |
Sponsors and Collaborators
AstraZeneca
Investigators
| Study Director: | Klas Malmberg, MD, PhD, Prof., | AstraZeneca R&D Mölndal |
| Principal Investigator: | Dr Emanuel DeNoia, MD | Healthcare Discoveries LLC Icon Development Solutions |
| Principal Investigator: | Sanjay Sharma, MD | Veeda Clinical Research Pvt. Ltd |
More Information
No publications provided
| Responsible Party: | Klas Malmberg, MD, PhD, Prof. Medical Science Director, Emerging Products, AstraZeneca Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00774553 History of Changes |
| Other Study ID Numbers: | D1020C00015 |
| Study First Received: | October 16, 2008 |
| Last Updated: | January 14, 2010 |
| Health Authority: | United States: Food and Drug Administration India: Ministry of Health |
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 |
Metformin Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 21, 2013