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

Novo Nordisk

Status and phase

Completed

Phase 1

Conditions

Diabetes

Diabetes Mellitus, Type 2

Delivery Systems

Treatments

Drug: insulin aspart

Device: pump

Study type

Interventional

Funder types

Industry

Identifiers

NCT00115973

PDS253-1665

Details and patient eligibility

About

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.

Enrollment

71 patients

Sex

All

Ages

30 to 70 years old

Volunteers

No Healthy Volunteers

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