Overview

A Study of the Treatment of Type 2 Diabetes With an Insulin Infusion Pump

Status:
Completed
Trial end date:
2006-01-01
Target enrollment:
0
Participant gender:
All
Summary
This trial is conducted in the United States of America (USA). This is an in-patient trial investigating stepwise dose increase in a period of up to 3-weeks followed by a 10-week out-patient maintenance period. A telephone contact visit is scheduled as a follow-up for the final clinic visit. A subject's participation in this trial would be expected to be up to 16 weeks.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Novo Nordisk A/S
Treatments:
Insulin
Insulin Aspart
Insulin, Globin Zinc
Criteria
Inclusion Criteria:

- Type 2 diabetes diagnosis at least 2 years ago

- Body Mass Index (BMI): 26-40 kg/m^2 (both inclusive)

- HbA1c: 7.5-10% (both inclusive)

- FPG values at least 140 mg/dl (7.8 mmol/l)

Exclusion Criteria:

- Use of drugs, which may interfere with the interpretation of trial results or are
known to cause clinically relevant interference with insulin action or glucose
utilization (steroids or non-specific beta-blockers)

- Current addiction to alcohol or substances of abuse or positive results on urine
screen for drug and alcohol use

- Known or suspected allergy to trial products or related products