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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00115973
• Other study ID #: PDS253-1665
• Status: Completed
• Phase: Phase 1
• First received: June 26, 2005
• Last updated: October 17, 2016
• Start date: June 2005
• Est. completion date: January 2006

Study information

• Verified date: October 2016
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: January 2006
• Est. primary completion date: January 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Delivery Systems
• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Device:
• pump

Drug:
• insulin aspart

Locations

Country	Name	City	State
United States	Novo Nordisk Investigational Site	Chula Vista	California
United States	Novo Nordisk Investigational Site	Fargo	North Dakota
United States	Novo Nordisk Investigational Site	Miami	Florida
United States	Novo Nordisk Investigational Site	San Antonio	Texas
United States	Novo Nordisk Investigational Site	Willingboro	New Jersey
United States	Novo Nordisk Investigational Site	Witchita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c		after 3 months	No
Secondary	Fasting plasma glucose			No
Secondary	Plasma glucose profiles			No
Secondary	Frequency of hypoglycemic events			Yes

External Links

•   Clinical Trials at Novo Nordisk