NCT00115973|CompletedPhase 1

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

Novo Nordisk A/S ClinicalTrials.gov

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1 other identifier

PDS253-1665

Study Type

interventional

Target

Locations

1 country

Sites

Timeline

RegisteredJun 2005

StartedJun 2005

CompletionJan 2006

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P75+ for phase_1 diabetes

Timeline

Completed

Started Jun 2005

Typical duration for phase_1 diabetes

Geographic Reach

1 country

6 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

7 months study duration

Study Start

First participant enrolled

June 1, 2005

Completed

25 days until next milestone

First Submitted

Initial submission to the registry

June 26, 2005

Completed

1 day until next milestone

First Posted

Study publicly available on registry

June 27, 2005

Completed

6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2006

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2006

Completed

Last Updated

October 18, 2016

Status Verified

October 1, 2016

Enrollment Period

7 months

First QC Date

June 26, 2005

Last Update Submit

October 17, 2016

Conditions

Diabetes Diabetes Mellitus, Type 2 Delivery Systems

Keywords

PumpDiabetes

Outcome Measures

Primary Outcomes (1)

HbA1c
after 3 months

Secondary Outcomes (3)

Fasting plasma glucose
Plasma glucose profiles
Frequency of hypoglycemic events

Interventions

pumpDEVICE

insulin aspartDRUG

Eligibility Criteria

Age30 Years - 70 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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)

You may not qualify if:

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

Contact the study team to confirm eligibility.