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

An Open-Label, Stepwise Basal Insulin Dose Titration Study Using Continuous Subcutaneous Insulin Infusion (CSII) in Oral Antidiabetic Drug-Treated Type 2 Diabetes Mellitus Subjects Followed by a 10-Week Out-Patient Maintenance Phase

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00115973

Enrollment

Registered

2005-06-27

Start date

2005-06-30

Completion date

2006-01-31

Last updated

2016-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delivery Systems, Diabetes, Diabetes Mellitus, Type 2

Keywords

Pump, Diabetes

Brief 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.

Interventions

DEVICEpump

DRUGinsulin aspart

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

30 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame
HbA1c	after 3 months

Secondary

Measure	Time frame
Fasting plasma glucose	—
Plasma glucose profiles	—
Frequency of hypoglycemic events	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026