- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00817271
To Evaluate the Response to Glucagon During Hypoglycemia
May 6, 2009 updated by: AstraZeneca
A Randomised, Open, Two-Way Cross-Over, Phase I Study to Evaluate the Response to Glucagon Versus the Spontaneous Counter-Regulatory Response in T2DM Patients Treated With AZD1656 and Metformin During Hypoglycemia
The purpose of this study is to evaluate the response to Glucagon versus the spontaneous hormonal response to low blood sugar levels in T2DM Patients treated with AZD1656 and Metformin
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
8
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Chula Vista, California, United States
- Research Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- type II diabetes patients, female with non child-bearing potential
- T2DM diagnosis confirmed by C-peptide >0.3nmol/L and no glutamic acid decarboxylate (GAD) antibodies at enrolment (screening)
- Treatment with metformin alone with a total daily dose not less than 1 000 mg. Stable glycaemic control indicated by unchanged treatment within 3 months prior to enrolment
Exclusion Criteria:
- History of ischemic heart disease, symptomatic heart failure, stroke, transitory ischemic attack or symptomatic peripheral vascular disease
- Signs of diabetic proliferative retinopathy or diabetic maculopathy, at screening or on an ophthalmological examination within 3 months from start of study
- Participating in another clinical study during the last 30 days prior to enrolment
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
|
Dose titration of oral suspension during 2 days to a tolerable dose given twice daily.
Subjects will thereafter be treated with this dose for another 6 days.
On day 5 and 8 the dose will be given as a single dose
1 mg injected 3 hr post AZD1656 morning dose on day 5 alt.
day 8
|
Experimental: 2
|
Dose titration of oral suspension during 2 days to a tolerable dose given twice daily.
Subjects will thereafter be treated with this dose for another 6 days.
On day 5 and 8 the dose will be given as a single dose
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
P-Glucose levels
Time Frame: Repeated sampling during the 24 hour period on day 5 and 8
|
Repeated sampling during the 24 hour period on day 5 and 8
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety and tolerability (AE, BP, pulse, plasma glucose, laboratory variables, weight and ECG)
Time Frame: Frequent measurements during the study period
|
Frequent measurements during the study period
|
Pharmacokinetic variables (Area under the plasma conc-time curve from time 0 to 24 hours post dose (AUC0-24), maximum plasma conc(Cmax), time to reach maximum plasma conc(tmax), terminal elimination half-life and apparent oral clearance
Time Frame: Repeated sampling during the 24 hour period on day 5 and 8
|
Repeated sampling during the 24 hour period on day 5 and 8
|
Pharmacodynamics (P-Glucose, S-Insulin and S-C-peptide)
Time Frame: Repeated sampling during the 24 hour period on day 5 and 8
|
Repeated sampling during the 24 hour period on day 5 and 8
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Klas Malmberg, MD, PhD, Prof., AstraZeneca R&D Mölndal
- Principal Investigator: Marcus Hompesch, MD, Profil Institut for Clinical Research Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2009
Primary Completion (Actual)
April 1, 2009
Study Completion (Actual)
April 1, 2009
Study Registration Dates
First Submitted
January 5, 2009
First Submitted That Met QC Criteria
January 5, 2009
First Posted (Estimate)
January 6, 2009
Study Record Updates
Last Update Posted (Estimate)
May 7, 2009
Last Update Submitted That Met QC Criteria
May 6, 2009
Last Verified
May 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- D1020C00018
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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