To Evaluate the Response to Glucagon During Hypoglycemia

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00817271
• Other study ID #: D1020C00018
• Status: Completed
• Phase: Phase 1
• First received: January 5, 2009
• Last updated: May 6, 2009
• Start date: February 2009
• Est. completion date: April 2009

Study information

• Verified date: May 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypoglycemia
• Type 2 Diabetes

Intervention

Drug:
• AZD1656
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
• Glucagon
1 mg injected 3 hr post AZD1656 morning dose on day 5 alt. day 8

Locations

Country	Name	City	State
United States	Research Site	Chula Vista	California

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	P-Glucose levels		Repeated sampling during the 24 hour period on day 5 and 8	No
Secondary	Safety and tolerability (AE, BP, pulse, plasma glucose, laboratory variables, weight and ECG)		Frequent measurements during the study period	No
Secondary	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		Repeated sampling during the 24 hour period on day 5 and 8	No
Secondary	Pharmacodynamics (P-Glucose, S-Insulin and S-C-peptide)		Repeated sampling during the 24 hour period on day 5 and 8	No