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

Phase 1

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 2; Delivery Systems

• Registration Number: NCT00115973
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-06
• Study First Submitted: 2005-06-26
• Study First Submitted QC: 2005-06-26
• Study First Posted: 2005-06-27
• Primary Completion: 2006-01
• Study Completion: 2006-01
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-17
• Last Update Posted: 2016-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
HbA1c	after 3 months

Secondary Outcome Measures

Name	Time	Method
Fasting plasma glucose
Plasma glucose profiles
Frequency of hypoglycemic events

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇺🇸 San Antonio, Texas, United States