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To Evaluate the Response to Glucagon During Hypoglycemia

Primary Purpose

Type 2 Diabetes

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

AZD1656

Glucagon

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring Type II Diabetes, Counter-regulatory response, Hypoglycemia

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Research Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

P-Glucose levels

Secondary Outcome Measures

Safety and tolerability (AE, BP, pulse, plasma glucose, laboratory variables, weight and ECG)

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

Pharmacodynamics (P-Glucose, S-Insulin and S-C-peptide)

Full Information

NCT ID

NCT00817271

First Posted

January 5, 2009

Last Updated

May 6, 2009

Sponsor

AstraZeneca

1. Study Identification

Unique Protocol Identification Number

NCT00817271

Brief Title

To Evaluate the Response to Glucagon During Hypoglycemia

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2009

Overall Recruitment Status

Completed

Study Start Date

February 2009 (undefined)

Primary Completion Date

April 2009 (Actual)

Study Completion Date

April 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

AstraZeneca

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes

Keywords

Type II Diabetes, Counter-regulatory response, Hypoglycemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

8 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

AZD1656

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Glucagon

Intervention Description

1 mg injected 3 hr post AZD1656 morning dose on day 5 alt. day 8

Primary Outcome Measure Information:

Title

P-Glucose levels

Time Frame

Repeated sampling during the 24 hour period on day 5 and 8

Secondary Outcome Measure Information:

Title

Safety and tolerability (AE, BP, pulse, plasma glucose, laboratory variables, weight and ECG)

Time Frame

Frequent measurements during the study period

Title

Time Frame

Repeated sampling during the 24 hour period on day 5 and 8

Title

Pharmacodynamics (P-Glucose, S-Insulin and S-C-peptide)

Time Frame

Repeated sampling during the 24 hour period on day 5 and 8

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Klas Malmberg, MD, PhD, Prof.

Organizational Affiliation

AstraZeneca R&D Mölndal

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Marcus Hompesch, MD

Organizational Affiliation

Profil Institut for Clinical Research Inc.

Official's Role

Principal Investigator

Facility Information:

Facility Name

Research Site

City

Chula Vista

State/Province

California

Country

United States

12. IPD Sharing Statement

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To Evaluate the Response to Glucagon During Hypoglycemia

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