To Evaluate the Response to Glucagon During Hypoglycemia

NCT00817271 | Completed Phase 1

• 1 other identifier: D1020C00018
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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

Conditions

Type 2 Diabetes

Keywords

Type II Diabetes; Counter-regulatory response; Hypoglycemia

Outcome Measures

Primary Outcomes (1)

• P-Glucose levels

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

Secondary Outcomes (3)

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

  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

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

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

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

Study Arms (2)

1

EXPERIMENTAL

Drug: AZD1656; Drug: Glucagon

2

EXPERIMENTAL

Drug: AZD1656

Interventions

AZD1656 DRUG

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; 2

Glucagon DRUG

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

1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Chula Vista, California, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Hypoglycemia

Interventions

AZD1656; Glucagon

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Proglucagon; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Klas Malmberg, MD, PhD, Prof.

  AstraZeneca R&D Mölndal

  STUDY DIRECTOR

• Marcus Hompesch, MD

  Profil Institut for Clinical Research Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 5, 2009
• First Posted: January 6, 2009
• Study Start: February 1, 2009
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: May 7, 2009

Record last verified: 2009-05

Locations

US (1)